39 The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded in 2025 2025-Oct-22 367 KB

BIS Standards Medical Equipment and Hospital Planning Department Category 1: Surgical Instruments (MHD 01) S. No. IS No Title 1 IS 10383:1982 Specification for scissors, nail, curved on flat 2 IS 10384:1982 Scissors, Bandage, Smith's Pattern 3 IS 10414:2024 Autopsy Instruments - Bowel Scissors ( ) 4 IS 10445:1982 Specification for scissors, bandage and clothing, angled to side 5 IS 10599:1993 Surgical Instruments - Needle Holders, Hegar's Pattern - Sizes, Shape and Dimensions 6 IS 10615:1983 Needle Holder, Bozemann's Pattern 7 IS 10637:1992 Surgical instruments - Forceps, spinter, Arthur's pattern Shape and dimensions 8 IS 10638:1983 Forceps, Sponge Holding, Foerster's Pattern, Smooth or Serrated Jaws 9 IS 10984:1984 Scissors, Dissecting, Curved on Flat, Pott's Pattern 10 IS 11497:2014 Catheter, Foley’s Rubber, for Prolonged Urinary Drainage — Specification 11 IS 11502:1992 Surgical instruments - Forceps tissue, adson - Browns patternshape and dimensions ( ) 12 IS 11545:1992 Surgical instruments - Haemostatic, forceps, Adson's pattern - Shape and dimensions 13 IS 11558:1992 Surgical instruments - Vessel, forceps, Debakey's pattern - Sizes, shape and dimensions 14 IS 11595:1992 Surgical instruments - Peritoneum, forceps, McKulicz's pattern - Shape and dimensions 15 IS 11640 (Part 1):1986 Retractor, General Surgery - Part 1 : Schonborn's Pattern 16 IS 11640 (Part 2):1987 Retractor, General Surgery - Part 2 : Kocher's Pattern 17 IS 11640 (Part 3):1987 Retractor - Part 3 Israel's Pattern 18 IS 11640 (Part 4):1987 Retractor - Part 4 Abdominal, Fritsch's Pattern 19 IS 11640 (Part 5):1987 Retractor - Part 5 Korte's Pattern 20 IS 11640 (Part 6):1987 Retractor, General Surgery - Part 6 Volkmann's Pattern 21 IS 11640 (Part 7):1987 Retractor - Part 7 Abdominal and Liver, Mikulicz's Pattern 22 IS 12103:1987 Specification for skin graft expander 23 IS 12815:2024 Autopsy Instruments - Knife ( ) 24 IS 12822:1989 Surgical Instruments - Forceps Intestinal Mayo-Robson's Pattern 25 IS 12841 (Part 1):1989 Surgical Instruments - Needle Holders - Part 1 : Mathieu's Pattern 26 IS 12841 (Part 2):1989 Surgical Instruments - Needle Holders - Part 2 : With Carbide Inserts, Stratte's Pattern 27 IS 12841 (Part 3):1989 Surgical Instruments - Needle Holders - Part 3 : Heaney's Pattern 28 IS 12841 (Part 4):1989 Surgical Instruments - Needle Holders - Part 4 : With Carbide Inserts, Debakey's Pattern 29 IS 13127:1991 Surgical instruments - Suture - Clip applying forceps, wachenfeld type shape, dimensions and mass 30 IS 13198:1991 Surgical instruments - Trocar holding forceps, vogel type - Shape, dimensions and mass 31 IS/ISO 13402:1995 Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure 32 IS 15732 (Part 1):2018 / ISO 8600-1 : 2015 Endoscopes - Medical Endoscopes and Endotherapy Devices Part 1 General Requirements ( ) 33 IS 15732 (Part 2):2019 / ISO 8600-2 : 2015 Endoscopes - Medical endoscopes and endotherapy devices: Part 2 particular requirements for rigid bronchoscopes 34 IS 15732 (Part 3):2025 / ISO 8600-3:2019 Endoscopes - Medical endoscopes and endotherapy devices Part 3 Determination of field of view and direction of view of endoscopes with optics ( ) 35 IS 15732 (Part 3):2006 / ISO 8600-3 : 1997 Optics and photonics - Medical endoscopes and endotherapy devices: Part 3 determination of field of view and direction of view of endoscopes with optics 36 IS 15732 (Part 4):2021/ ISO 8600-4:2014 Endoscopes - Medical endoscopes and endotherapy devices Part 4: Determination of maximum width of insertion portion ( ) 37 IS 15732 (Part 5):2025 / ISO 8600-5:2020 Medical endoscopes and endotherapy devices Part 5: Determination of optical resolution of rigid endoscopes with optics 38 IS 15732 (Part 6):2025 / ISO 8600-6:2020 Medical endoscopes and endotherapy devices Part 6 Vocabulary 39 IS 15732 (Part 7):2019 / ISO 8600-7 : 2012 Endoscopes - Medical endoscopes and endotherapy devices - Part 7: Basic requirements for medical endoscopes of water-resistant type First revsion First Revision First revision First Revision First Revision First Revision

40 IS 15732 (Part 8):2025 / ISO 8600-8:2021 Medical endoscopes and endotherapy devices Part 8 Particular requirements for capsule endoscopes 41 IS 3318:1965 General requirements for surgical scalpels and knives 42 IS 3319:1995 Blades, surgical, detachable (Bard Parker Type) and handles - Specification ( ) 43 IS 3320:1973 Specification for surgical scalpels ( ) 44 IS 3642 (Part 1):1990 / ISO 7151 Surgical instruments - Specification: Part 1 Non - Cutting, articulated instruments ( ) 45 IS 3643:1992 Surgical instruments - Dissecting forceps (Serrated And Toothed) - Shapes and dimensions ( ) 46 IS 3644:1992 Surgical instruments - Artery forceps Halsted's Mosquito pattern - Shape and dimensions 47 IS 3645:1992 Surgical instruments - Artery forceps Spencer Wells pattern - Size, shape and dimensions 48 IS 3759:2024 Skin grafting blade ( ) 49 IS B3759:1987 Specification for blades, skin grafting 50 IS 3767:1966 Specification for hook, skin, gillies pattern 51 IS 3787:1966 Specification for gag, mouth, cleft palate 52 IS 4085:2024 Autopsy Instruments — Amputation Knife ( ) 53 IS 4085:1967 Specification for knives, amputating 54 IS 4094:1967 Forceps, Sterilizer, Cheatle's Pattern 55 IS 4244:1967 Specification for retractors, skin, double ended 56 IS 4245:1967 Specification for needle holder (Gillies) combined with scissors, for plastic surgery 57 IS 4275:2025 Plastic Surgery Instruments - Kilner Scissors ( ) 58 IS 4275:1967 Specification for Scissors, Kilner's for Plastic Surgery 59 IS 4281:2025 Plastic Surgery Instruments - McIndoe Scissors ( ) 60 IS 4281:1967 Specification for Scissors, McIndoe's, for Plastic Surgery 61 IS 4282:1992 Surgical instruments - Dissecting forceps, plastic surgery - Shapes and dimensions ( ) 62 IS 4490:1968 Forceps, Dilating, Trousseau's 63 IS 4513:1968 Specification for scissors, surgical dressing and stitch 64 IS 4587:1968 Specification for raspatories, cleft palate, for plastic surgery 65 IS 5738:1970 Specification for cystoscope 66 IS 5750:1970 Specification for Sigmoidoscope 67 IS 6434:1971 Bow, Hare Lip Traction (Denis Browne's pattern) 68 IS 6435:1971 Specification for strippers, tendon 69 IS 6437:1970 Specification for stripper, fascia 70 IS 6989:2024 Autopsy Instruments — Chisel ( ) 71 IS 6990:2024 Autopsy Instruments — Brain Knife ( ) 72 IS 6996:2024 Autopsy Instruments - Cartilage Knife ( ) 73 IS/ISO 7153-1:2016 Surgical instruments - Materials: Part 1 Metals 74 IS 7388:1992 Surgical instruments - Forceps, tissue, Allis pattern - Shape, size and dimensions 75 IS 7501:1974 Specification for speculum, rectal, kellys pattern 76 IS 7502:1974 Clamp, Intestine, Kocher's Pattern 77 IS 7507:1974 Specification for forceps, stone, bladder 78 IS 7521:1974 Dissector, Kocher's Pattern 79 IS 7522:1975 Retractor, Abdominal, Morris' Pattern 80 IS 7531:1990 Surgical instruments - Corrosion resistance of stainless steel surgical instruments - Methods of tests ( ) 81 IS 7561:1992 Surgical instruments - Forceps, Gallstone, Desjardin's pattern - Shape and dimensions 82 IS 7566:1992 Surgical instruments - Forceps, spring clip compressing, Michel's pattern - Shape and dimensions Fourth Revision First Revision Second Revision First Revision Second Revision First Revision First Revision First Revision First Revision First Revision First Revision First revision First Revision

83 IS 7579:1992 Surgical instruments - Forceps,intestine holding, Denis Browne's pattern - Shape and dimensions 84 IS 7628:1975 Clamp, Stomach, Moynihan's Pattern 85 IS 7665:1975 Clamp, Intestine, Crushing, Lever Action, Payr's Pattern 86 IS/ISO 7741:1986 / ISO 7741 : 1986 Instruments for surgery - Scissors and shears - General requirements and test methods 87 IS 7858:1991 Surgical microscope - Specification ( ) 88 IS 7870:1992 Surgical instruments - Needle, holder, Mayo-Hegar's and Crile-Wood's Patterns - Shape and dimensions 89 IS 7892:1975 Specification for Retractor, double and single, blunt hooks 90 IS 7893:1992 Surgical instruments - Forceps, towel, Backhaus's pattern - Shape. size and dimensions 91 IS 7912:1975 Scoop, Stanley Boyd's Pattern 92 IS 7980:1976 Specification for handle of skin grafting blade 93 IS 7994:1976 Needle Holder, Barron's Pattern 94 IS 8031:1976 Dissector, Watson Cheyne's Pattern 95 IS 8040:1992 Surgical instruments - Artery, forceps,Kocher's pattern - Shape and dimensions 96 IS 8253:1976 Lever, Bone, Bristow's Pattern 97 IS 8340:1977 Needle, Aneurism, Syme's Pattern 98 IS 8341:1977 Retractor, Goitre, Joll's Pattern 99 IS 8372:1977 Retractor, Alae, Kilner's Pattern 100 IS 8377:1977 Bougie, Lister's and Clutton's Patterns 101 IS 8424:1977 Specification for Gag, Mouth, Lane’s Pattern 102 IS 8583:1991 Surgical instruments - Gall duct dilators, Bake's pattern 103 IS 8584:1992 Surgical instruments - Peritonium, forceps, Babcock's pattern - Shapes, sizes and dimensions 104 IS 8585:1977 Specification for bougie, oesophageal 105 IS 8586:1977 Suction Tube, Poole's Pattern 106 IS 8853:1978 Specification for retractor, cheek 107 IS 8854:1978 Retractor, Czerny's Pattern 108 IS 8855:1978 Retractor, Langenbeck's Pattern 109 IS 8889:1992 Surgical Instruments - Forceps, Stone, Kidney, Randall's Pattern - Shapes and Dimensions 110 IS 8965:1978 Retractor, Deaver's Pattern 111 IS 9144:1979 Specifications for Director and Guide, Cairn’s Pattern 112 IS 9145:1979 Dilator, Rectal, Hegar's Pattern 113 IS 9146:1979 Scissors, Dissecting, Straight and Curved on Flat, Mayo's Pattern 114 IS 9149:1979 Specification for probe with eye 115 IS 9150:1979 Specification for cylinder, dermabraison plastic surgery 116 IS 9165 (Part 1):1992 Surgical instruments - Needles, suture: Part 1 specification ( ) 117 IS 9165 (Part 2):1992 Surgical instruments - Needles, suture: Part 2 eyed needles - Sizes, shapes and dimensions 118 IS 9183:1979 Suction Tube, Magill's Pattern 119 IS 9184:1979 Specification for forceps, disimpaction, maxillary, for plastic surgery 120 IS 9649:1980 Specification for introducer, catheter, urethral 121 IS 9650:1980 Hook, Joseph's Pattern 122 IS 9651:1980 Clamp, Intestine Holding, Schoemaker's Pattern 123 IS 9689:1980 Specification for microtome knives First Revision First Revision Category 2: Orthopaedic Instruments, Implants And Accessories (MHD 02) S. No. IS No Title

1 IS 10121 (Part 1):1982 Specification for metal bone screws – Mechanical requirements and methods of test Part 1 Screws with asymmetrical thread, variable fitting (Spherical), Stainless Steel 2 IS 10121 (Part 2):1982 Specification for metal bone screws - Mechanical requirements and methods of test Part 2 Screws with asymmetrical thread, constant fitting (Spherical), stainless steel 3 IS 10128:2023 Knowles Pin ( ) 4 IS 10155:2024 Lower Femoral Blade Plate - Specification ( ) 5 IS 10235 (Part 1):1982 Glossary of terms Part 1 General medical terms for surgical implants 6 IS 10235 (Part 2):1982 Glossary of terms in Orthopaedics Part 2 Mechanics and materials for implants 7 IS 10235 (Part 3):1982 Glossary of terms in Orthopaedics Part 3 Orthopaedic surgery 8 IS 10326:1982 Spreader, Plaster Cast, Henning's Pattern 9 IS 10327:1982 Bender, Plaster, Bohler's Pattern 10 IS 10338:1982 Specification for saw, plaster, hand 11 IS 10349:1982 Rasp for Hip Prothesis, Thompson's and Moore's Patterns 12 IS 10727:2023 Nail, Square, Ulna - Specification ( ) 13 IS 10728:2023 Nail, Square, Radius - Specification ( ) 14 IS 10729:1983 Specification for nail set, kuntscher 15 IS 10730:1983 Osteotome, Whitchurch Howell's Pattern 16 IS 11568:1986 Forceps, Bone Holding, Semb's Pattern 17 IS 11569:2023 Specification for Cervical Collar ( ) 18 IS 11569:1986 Specification for cervical collar 19 IS 11953:1986 Specification for driver and bender for rush intramedullary pin 20 IS 12088:1987 Specification for bone plate, dynamic compression 21 IS 12172:1987 Specification for distraction cervical collar 22 IS 12304:1987 Specification for Plastic Cervical Collar 23 IS 12304:2024 Plastic Cervical Collar — Specification ( ) 24 IS H12304:1987 Plastic Cervical Collar (HINDI) 25 IS 12375 (Part 1):2015 / ISO 7206-1 : 2008 Implants for surgery - Partial and total hip joint prostheses Part 1 Classification and designation of dimensions ( ) 26 IS 12375 (Part 2):2018 / ISO 7206-2 : 2011 Implants for surgery - Partial and total hip joint prostheses Part 2 Articulating surfaces made of metallic, ceramic and plastics materials ( ) 27 IS 12375 (Part 4):2016 / ISO 7206-4 : 2010 Implants for surgery - Partial and total hip joint prostheses Part 4 Determination of endurance properties and performance of stemmed femoral components ( ) 28 IS 12375 (Part 6):2018 / ISO 7206-6 : 2013 Implants for surgery - Partial and total hip joint prostheses Part 6 Endurance properties testing and performance requirements of neck region of stemmed femoral components ( ) 29 IS 12375 (Part 10):2023 / ISO 7206-10: 2018 Implants for surgery - Partial and total hip-joint prostheses Part 10 Determination of resistance to static load of modular femoral heads 30 IS 12375 (Part 12):2024 / ISO 7206-12: 2016 Implants for Surgery - Partial and Total Hip Joint Prostheses Part 12: Deformation Test Method for Acetabular Shells 31 IS 12375 (Part 13):2024 / ISO 7206-13: 2016 Implants for Surgery - Partial and Total Hip Joint Prostheses Part 13 Determination of Resistance to Torque of Head Fixation of Stemmed Femoral Components 32 IS 12376 (Part 1):2015 / ISO 7207-1 : 2007 Implants for surgery - Components for partial and total knee joint prostheses Part 1 Classification, definitions and designation of dimensions ( ) 33 IS 12376 (Part 2):2025 / ISO 7207-2 : 2011 Implants for Surgery - Components for Partial and Total Knee-joint Prostheses Part 2 Articulating Surfaces made of Metal Ceramic and Plastics Materials 34 IS/ISO 12891-1:2015 Retrieval and analysis of surgical implants Part 1 Retrieval and handling 35 IS/ISO 13175-3:2012 Implants for surgery - Calcium phosphates Part 3 Hydroxyapatite and beta - Tricalcium phosphate bone substitutes 36 IS/ISO 13179-1:2014 Implants for Surgery - Plasma Sprayed Unalloyed Titanium Coatings on Metallic Surgical Implants Part 1 General Requirements 37 IS/ISO 13356:2015 Implants for Surgery – Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP) 38 IS 13423:1992 Good manufacturing practices for orthopaedic implants - Guide 39 IS/ISO 13779-3:2018 Implants for surgery - Hydroxyapatite Part 3 chemical analysis and characterization of crystallinity and phase purity First Revision First Revision First Revision First Revision First Revision First Revision Second Revision First Revision First Revision First Revision Second Revision

40 IS/ISO 13779-4:2018 Implants for surgery - Hydroxyapatite Part 4 determination of coating adhesion strength 41 IS/ISO 13779-6:2015 Implants for surgery - Hydroxyapatite Part 6 powders 42 IS/ISO 13781:2017 Implants for surgery - homopolymers, copolymers and blends on poly (Lactide) - In vitro degradation testing 43 IS 14227:1995 / ISO 8615 : 1991 Implants for surgery - Fixation devices for use in the ends of the femur in adults 44 IS 14228:1996 / ISO 8827 : 1988 Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements 45 IS 14229:1995 / ISO 9585 : 1990 Implants for surgery - Determination of bending strength and stiffness of bone plates 46 IS 14239 (Part 1):2018 / ISO 9714-1 : 2012 Orthopaedic drilling instruments Part 1 Drill bits, taps and countersink cutters ( ) 47 IS/ISO/TR 14283:2018 Implants for Surgery - Essential Principles of Safety and Performance 48 IS/ISO 15309:2013 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices 49 IS/ISO 16402:2008 Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics 50 IS/ISO 17327-1:2018 Non-active surgical implants - Implant coating Part 1 General requirements 51 IS 18074 (Part 1):2023 / ISO 5834-1: 2019 Implants for surgery - Ultra-high-molecular-weight polyethylene Part 1 Powder form 52 IS 18074 (Part 2):2023 / ISO 5834-2: 2019 Implants for surgery - Ultra-high-molecular-weight polyethylene Part 2 Moulded forms 53 IS 18074 (Part 3):2024 / ISO 5834-3: 2019 Implants for Surgery - Ultra-high-molecular-weight Polyethylene Part 3 Accelerated Ageing Methods 54 IS 18074 (Part 4):2024 / ISO 5834-4: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene Part 4 Oxidation Index Measurement Method 55 IS 18074 (Part 5):2024 / ISO 5834-5:2019 Implants for Surgery - Ultra-high-molecular-weight Polyethylene Part 5: Morphology Assessment Method 56 IS 18075 (Part 1):2023 / ISO 14243-1:2009 Implants for surgery - Wear of total knee-joint prostheses Part 1 Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test 57 IS 18075 (Part 2):2023 / ISO 14243-2: 2016 Implants for surgery - Wear of total knee-joint prostheses Part 2 Methods of measurement 58 IS 18075 (Part 3):2023 / ISO 14243-3:2014 Implants for surgery - Wear of total knee-joint prostheses Part 3 Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test 59 IS 18075 (Part 5):2025 / ISO 14243-5:2019 Implants for Surgery - Wear of Total Knee Prostheses Part 5 Durability Performance of the Patellofemoral Joint 60 IS 18076:2023 / ISO 14630: 2012 Non-active surgical implants - General requirements 61 IS 18078:2023 / ISO 5836: 1988 Implants for surgery - Metal bone plates - Holes corresponding to screws with asymmetrical thread and spherical under-surface 62 IS 18079:2023 / ISO 9269: 1988 Implants for surgery - Metal bone plates - Holes and slots corresponding to screws with conical under-surface 63 IS 18125 (Part 1):2023 / ISO 14879-1: 2020 Implants for surgery - Total knee-joint prostheses Part 1 Determination of endurance properties of knee tibial trays 64 IS 18261 (Part 3):2023 / ISO 5832-3: 2021 Implants for Surgery - Metallic Materials Part 3 Wrought Titanium 6-Aluminium 4-Vanadium Alloy Second Revision 65 IS 18261 (Part 5):2023 / ISO 5832-5: 2022 Implants for Surgery - Metallic Materials Part 5 Wrought Cobalt-Chromium-Tungsten Nickel ( ) 66 IS 18261 (Part 6):2023 / ISO 5832-6: 2022 Implants for Surgery - Metallic Materials Part 6 Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy First Revision 67 IS 18359:2023 / ISO 13779-2:2018 Implants for surgery - Hydroxyapatite Part 2 Thermally sprayed coatings of hydroxyapatite 68 IS 18537 (Part 2):2024 / ISO 12891-2 : 2020 Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants 69 IS 18555 (Part 12):2024 / ISO 5832-12:2019 Implants for surgery - Metallic materials Part 12 Wrought cobalt-chromium-molybdenum alloy 70 IS 18555 (Part 14):2024 / ISO 5832-14:2019 Implants for surgery - Metallic materials Part 14 Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy 71 IS 18592 (Part 2):2024 / ISO/TR 17327-2:2021 Non-active surgical implants - Implant coating Part 2 Reference standards related to coatings 72 IS 18950:2025 / ISO 17853: 2011 Wear of Implant Materials - Polymer and Metal Wear Particles - Isolation and Characterization 73 IS 18983:2025 / ISO 19213: 2017 Implants for surgery - Test methods of material for use as a cortical bone model 74 IS 18984:2025 / ISO/TS 20721: 2020 Implants for surgery - General guidelines and requirements for assessment of absorbable metallic implants 75 IS 18985:2025 / ISO 22926: 2023 Implants for surgery - Specification and verification of synthetic anatomical bone models for testing 76 IS 18986:2025 / ISO 16087: 2013 Implants for Surgery - Roentgen Stereo Photogrammetric Analysis for the Assessment of Migration of Orthopaedic Implants 77 IS 19066 (Part 1):2025 / ISO 14242-1:2014 Implants for Surgery - Wear of Total Hip-Joint Prostheses Part 1 Loading and Displacement Parameters for Wear-testing Machines and Corresponding Environmental Conditions for Test 78 IS 19066 (Part 2):2025 / ISO 14242-2:2016 Implants for Surgery - Wear of Total Hip-Joint Prostheses Part 2 Methods of Measurement 79 IS 19066 (Part 3):2025 / ISO 14242-3:2009 Implants for Surgery - Wear of Total Hip-Joint Prostheses Part 3 Loading and Displacement Parameters for Orbital Bearing Type Wear Testing Machines and Corresponding Environmental Conditions for Test First Revision First Revision

80 IS 19066 (Part 4):2025 / ISO 14242-4:2018 Implants for Surgery - Wear of Total Hip-Joint Prostheses Part 4 Testing Hip Prostheses Under Variations in Component Positioning which Results in Direct Edge Loading 81 IS 19070:2025 / ISO 14949:2001 Implants for Surgery - Two-Part Addition-Cure Silicone Elastomers 82 IS 19071:2025 / ISO 16061: 2021 Instruments for Use in Association with Non-Active Surgical Implants - General Requirements 83 IS 19072:2025 / ISO 14607: 2018 Non-Active Surgical Implants - Mammary Implants - Particular Requirements 84 IS 19180:2025 / ISO 21535 : 2007 Non-Active surgical implants - Joint replacement implants - Specific requirements for hip-joint Replacement implants 85 IS 19193:2025 / ISO 21536 : 2023 Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee-Joint Replacement Implants 86 IS 19223:2025 / ISO 13782 : 2019 Implants for Surgery - Metallic Materials - Unalloyed Tantalum for Surgical Implant Applications (First Revision) 87 IS/ISO 19227:2018 / ISO 19227 : 2018 Implants for Surgery - Cleanliness of Orthopedic Implants - General Requirements 88 IS 19233 (Part 1):2025 Implants for Surgery - Coatings on Metallic Surgical Implants Part 1 Plasma-Sprayed Coatings Derived from Titanium or Titanium 6 Aluminum-4 Vanadium Alloy Powders 89 IS/ISO 21534:2007 Non - Active surgical implants - Joint replacement implants - Particular requirements 90 IS/ISO 21535:2007 Non - Active surgical implants - Joint replacement implants - Specific requirements for hip - Joint replacement implants 91 IS/ISO 21536:2007 Non - Active surgical implants - Joint replacement implants - Specific requirements for knee - Joint replacement implants 92 IS 5089:1969 Specification for blade plate, blount type 93 IS 5347 (Part 1):1986 Requirements for orthopaedic implants Part 1 general requirements ( ) 94 IS 5347 (Part 17):2002 / ISO 13782 : 1996 Requirements for orthopedic implants Part 17 metallic materials - Unalloyed tantalum for surgical implant applications 95 IS 5395 (Part 1):1989 / ISO 5837-1 : 1985 Specification for Surgical Implants - Intramedullary nailing systems for bone surgery Part 1 Intramedullary nails with cloverleaf or v - shaped cross - section ( ) 96 IS 5396:1969 Specification for guide pin for kuntscher nail 97 IS 5397:1969 Specification for reamer, flexible for kuntscher nail (Meddulary canal) 98 IS 5574:1970 Specification for forceps, wire cutting, compound action, orthopaedic 99 IS 5580:2024 Stille Pattern Orthopaedic Chisels - Specification ( ) 100 IS 5581:2024 Bohler's Stirrup - Specification ( ) 101 IS 5583:2024 Stille Pattern Orthopaedic Osteotomes - Specification ( ) 102 IS 5585:1970 Specification for mallet, rubber-capped 103 IS 5589:1970 Specification for saw handle, bone amputation, orthopaedic 104 IS 5590:1970 Specification for saw blade, bone amputation 105 IS 5601:1970 Specification for gouges, stille pattern, orthopaedic 106 IS 5803:1970 Specification for twist drill used in orthopaedic surgery 107 IS/ISO 5832:2014
Implants for Surgery – Metallic Materials Part 4 Cobalt-Chromium-Molybdenum Casting Alloy 108 IS/ISO 5832-1:2016 Implants for surgery - Metallic materials Part 1 Wrought stainless steel 109 IS/ISO 5832-2:2018 Implants for surgery - Metallic materials Part 2 Unalloyed titanium (First Revision) 110 IS/ISO 5832-5:2005 Implants for surgery - Metallic materials Part 5 wrought cobalt - Chromium - Tungsten - Nickel alloy 111 IS/ISO 5832-7:2016 Implants for surgery - Metallic materials Part 7 Forgeable and cold-formed Cobalt-Chromium-Nickel-Molybdenum-Iron alloy 112 IS 18261 (Part 9):2024 / ISO 5832-9:2019 Implants for Surgery - Metallic materials Part 9 Wrought High Nitrogen Stainless Steel First Revision 113 IS/ISO 5832-11:2014 Implants for surgery - Metallic materials Part 11 Wrought Titanium 6-Aluminium 7-Niobium alloy 114 IS/ISO 5838-1:2013 Implants for Surgery - Metallic Skeletal Pins and Wires Part 1 General Requirements 115 IS 5847:1970 Specification for pin chuck for introducing steinman pins 116 IS 5848:1996 / ISO 5838-2 Implants for surgery - Skeletal pins and wires - Steinmann skeletal pins - Dimensions ( ) 117 IS 6187:1971 Specification for saw, wire (Gigli Pattern) 118 IS 6233:2023 Bone Cutting Stille Liston Pattern Forceps - Specification ( ) 119 IS 6252:2024 Scissors Bandage Listers Pattern - Specification ( ) 120 IS 6281:2023 Bone Awl ( ) Second Revision Second Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision

121 IS 6289:2024 Orthopaedic Epiphyseal Staple - Specification ( ) 122 IS 6319:2024 Bone Clamp - Lowman Type - Specification ( ) 123 IS 6371:2023 Lane's, Lane-Fagge's and Fergusson's Patterns Bone Holding Forceps - Specification ( ) 124 IS 18530 (Part 1):2025 Implants for Surgery - Ceramic Materials Part 1 Ceramic Materials Based on High Purity Alumina ( ) 125 IS/ISO 6474-1:2010 Implants for surgery - Ceramic materials Part 1 ceramic materials based on high purity alumina 126 IS 18530 (Part 2):2024 / ISO 6474-2:2019 Implants for surgery - Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement ( ) 127 IS 6484:2023 Fergusson's Pattern Orthopaedic Gouge Forceps - Specification ( ) 128 IS 6485:2023 Angular Orthopaedic Gouge Forceps - Specification ( ) 129 IS 6486:2024 Lane's Pattern Orthopaedic Gouge Forceps - Specification ( ) 130 IS 6501:2023 Stille Luer's Pattern Orthopaedic Gouge Forceps - Specification ( ) 131 IS 6801 (Part 1):1999 / ISO 8319-1 Orthopaedic instruments - Drive connections Part 1 Keys for use with screws with hexagon socket heads ( ) 132 IS 6801 (Part 2):1987 / ISO 8319-2:1986 Specification for drive connections for orthopaedic instruments Part 2 Screw drivers for single slot head screws, screws with cruciate slot and cross-recessed head screws ( ) 133 IS 6975:1973 Specification for reamer, trochanteric, orthopedic 134 IS 6976:1973 Specification for awl, kuntscher, diamond pointed 135 IS 6982:1973 Specification for gauge for intramedullary nails 136 IS 7055:1973 Specification for drivers, kuntscher, nail, orthopaedic 137 IS 7102:1973 Specification for screw, bone, leinbach, medullary 138 IS 7105 (Part 1):1973 Specification for extractor for kuntscher nail Part 1 Handle type 139 IS 7105 (Part 2):1986 Specification for extractor for kuntscher nail: Part 2 Striker type 140 IS 7106:1973 Specification for extractor, staple, orthopaedic 141 IS 7107:1973 Specification for punch, staple, orthopaedic 142 IS 7108:1973 Specification for hammer for kuntscher nail extractor 143 IS 7109:1973 Specification for starter, staple, orthopaedic 144 IS 7109:2025 Orthopaedic Staple Starter - Specification ( ) 145 IS 7111:1973 Specification for inserter, staple, orthopaedic 146 IS 7111:2025 Orthopaedic Staple Inserter - Specification ( ) 147 IS 7398:2024 Farabeuf Pattern Bone Holding Forceps - Specification ( ) 148 IS 7435:1974 Rongeur, Ruskin's Pattern 149 IS 7442:1974 Forceps, Bone Cutting, Straight and Angular, Liston's Pattern 150 IS 7629:1975 Specification for bender, plate, orthopaedic 151 IS 7650:1975 Specification for drill, hand, bone, universal, micro and kirschner 152 IS 7817:1975 Specification for impactor for hip prosthesis 153 IS 7818:1975 Specification for broach, moore type, for hip prosthesis 154 IS 7819:2024 Nylon-Headed Orthopaedic Mallet - Specification ( ) 155 IS 7841:1975 Specification for compression plate, muller type 156 IS 7846:1975 Specification for extractor for Hip Prosthesis 157 IS 8261 (Part 1):1976 Specification for pins and wires, skeletal, traction Part 1 Kirschner wires 158 IS 8261 (Part 2):1976 Specification for pins and wires, skeletal, traction Part 2 Guide wires 159 IS 8261 (Part 3):1976 Specification for pins and wires, skeletal, traction Part 3 Pins and wires, fixation and threaded 160 IS 8332:2024 Gigli Saw Handle - Specification ( ) 161 IS 8608:1977 Specification for countersinks, pilot type, for orthopaedic use 162 IS 8641:2015 / ISO 5833 : 2002 Implants for surgery - Acrylic resin cements ( ) 163 IS 8755:1977 Method for testing biological compatibility of metals for surgical implants First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision Second Revision First Revision First Revision First Revision First Revision First Revision First Revision Third Revision

164 IS 8922:1978 Specification for depth gauge for orthopaedic use 165 IS 8926:2023 Bone Skid, Murphy Lane's Pattern - Specification ( ) 166 IS 9265:2023 Clamp, Compression, Muller's Pattern - Specification ( ) 167 IS/ISO 9583:1993 lmplants for Surgery - Non-Destructive Testing - Liquid Penetrant Inspection of Metallic Surgical Implants 168 IS/ISO 9584:2021 Implants for Surgery - Non-Destructive Testing - Radiographic Examination of Cast Metallic Surgical Implants 169 IS 9829 (Part 1):1996 / ISO 5835 :1991 Implants for surgery - Metal bone screws Part 1 with hexagonal drive connection, spherical under surface of head, asymmetrical thread - Dimensions ( ) 170 IS 9829 (Part 2):1996 / ISO 9268 : 1988 Implants for surgery - Metal bone screws Part 2 with conical under - Surface of head - Dimensions ( ) 1 IS 10156:1982 Specification for cannula, intra - Uterine, hysterosalpingography 2 IS 10545:1992 Gynaecological and obstetric instruments - Clamp, curved on flat, Heaney's pattern - Shape and dimensions 3 IS/ISO 11249:2018 Copper-Bearing Intrauterine Contraceptive Devices —Guidance on the Design, Execution, Analysis and Interpretation of Clinical Studies 4 IS 12256:1988 Specification for curette, uterine, biopsy, angled 5 IS 12270:1988 Cannula, Spackmann's Pattern 6 IS 12271:2025 Laproscopic Trocar And Cannula - Specification ( ) 7 IS 12271:1988 Specification for laproscopic trocar and cannula 8 IS 13009:2021 Fallopian rings - Requirements and test methods 9 IS/ISO 16037:2002 Rubber condoms for clinical trials - Measurement of physical properties 10 IS 17692:2021 Male condoms Guidance on the use of IS ISO 4074 and IS ISO 23409 in the quality management of condoms 11 IS 17810:2022 Additional Lubricants for Male Natural Rubber Latex Condoms — Effect on Condom Strength 12 IS 17811:2022 Guidance on Sample Handling for Determination of Bursting Volume and Pressure and Testing for Freedom from Holes for Male Condom 13 IS 17962:2022 Female condoms - Requirements and test methods ( ) 14 IS 18561:2024 No-Scalpel Vasectomy Instruments — Specification 15 IS 18562:2024 PPIUCD Insertion Forceps Specification 16 IS 18587:2024 Female condoms Use of ISO 25841 and the quality management of female condoms 17 IS/ISO 23409:2015 Male condoms - Requirements and test methods for condoms made from synthetic materials 18 IS/ISO 29941:2010 Condoms - Determination of nitrosamines migrating from natural rubber latex condoms 19 IS/ISO 29942:2011 Prophylactic dams - Requirements and test methods 20 IS/ISO 29943-1:2017 Condoms Guidance on clinical studies Part 1: Male condoms clinical function studies based on self-reports 21 IS/ISO 29943-2:2017 Condoms Guidance on clinical studies Part 2: Female condoms clinical function studies based on self-reports 22 IS/ISO 4074:2015 Natural rubber latex male condoms - Requirements and test methods ( ) 23 IS 5829:2025 Uterine Sound - Specification ( ) 24 IS 5829:1982 Specification for sound, uterine ( ) 25 IS 5849:2025 Anterior Vaginal Wall Retractor Sims Pattern - Specification ( ) 26 IS 5849:1970 Retractor, Anterior Vaginal Wall (Sim's pattern) 27 IS 5906:2025 Vaginal Speculum Cuscos Pattern - Specification ( ) 28 IS 5906:1970 Speculum, Vaginal (Cusco's pattern) 29 IS 6111:2025 Suction Type Uterine Curette - Specification ( ) 30 IS 6111:1971 Specification for curette, uterine (Suction Type) 31 IS 6112:1971 Speculum, Vaginal, Double Ended (Sim's Pattern) 32 IS 6114:2025 Gynaecological Instruments - Forceps, Uterine Vulsellum - Shape and Dimensions ( ) 33 IS 6114:1991 Gynaecological instruments forceps, uterine vulsellum - Shape and dimensions ( ) 34 IS 6115:2025 Gynaecological Instruments- Forceps , Uterine Tenaculum - Shape and Dimensions ( ) First Revision First Revision First Revision First Revision First Revision First Revision First Revision Second revision First Revision First revision First revision First revision Second Revision First Revision Second Revision Category 3: Obstetric and Gynaecological Instruments and Appliances (MHD 03) S. No. IS No Title

35 IS 6115:1991 Gynaecological instruments - Forceps, uterine tenaculum - Shape and dimensions ( ) 36 IS 6373:2025 Mucus Sucker - Specification ( ) 37 IS 6373:1971 Specification for sucker, mucus 38 IS 6499:1971 Curette, Uterine, Double-ended, Sharp, Sim's Pattern 39 IS 6505:1971 Curette, Uterine, Double-ended, Sharp and Blunt, Sim's Pattern 40 IS 6505:2025 Sim's Pattern Double-Ended, Sharp and Blunt, Uterine Curette -Specification ( ) 41 IS 6510:1971 Specification for curette, endometrial biopsy, suction type 42 IS 6565:1972 Stethoscope (foetoscope ) for - Foetal Heart Sounds, Pinard's Pattern 43 IS 6578:1992 Obstetrics instruments - Forceps, ovum - Shape and dimensions ( ) 44 IS 6584:1972 Dilators, Uterine, Single Ended, Hegar's Pattern 45 IS 6589:1992 Gynaecological Instruments - Forceps, uterine, dressing, Bozemann's pattern - Shape and dimensions 46 IS 6957:1973 Specification for curette, blunt, uterine 47 IS 6957:2025 Curette, Blunt Uterine - Specification ( ) 48 IS 6959:1973 Specification for scissors, embryotomy, curved on flat 49 IS 6960:1973 Specification for catheters, metal, female 50 IS 6999:1973 Specification for Cannula, Artificial Insemination 51 IS 7080 (Part 1):1992 MTP suction apparatus - Specification: Part 1 Manually operated ( ) 52 IS 7080 (Part 2):1992 MTP suction apparatus - Specification: Part 2 Electrical - Cum - Manually operated ( ) 53 IS 7080 (Part 3):2024 MTP Suction Apparatus Specification Part 3 Electrically Operated ( ) 54 IS 7100:1973 Hook, Decapitation, Jardine's Pattern 55 IS 7103:1973 Specification for scissors, episiotomy 56 IS 7115:1973 Specification for apparatus, tubal patency 57 IS 7116:1973 Specification for forceps, midwifery, short 58 IS 7117:1973 Specification for scissors, umbilical cord 59 IS 7432:1974 Clamp, Myomectomy, Bonney's Pattern 60 IS 7433:1992 Obstetrics Instruments - Forceps, round ligament, Bonney's pattern - Shape and dimensions 61 IS 18593:2024 Copper-Bearing Contraceptive Intrauterine Devices - Requirements and Tests (ISO 7439 : 2023, MOD) ( ) 62 IS 7475:1992 Obstetric instruments - Clamp, vaginal, angled - Shape and dimensions ( ) 63 IS 7480:1974 Perforator, Simpson's Pattern 64 IS 7484:1974 Retractor, Vaginal, Purandare's Pattern 65 IS 7725:1975 Hook, IUCD, Shirodkar's Pattern 66 IS 7735:1992 Forceps, sponge holding - Shape and dimensions ( ) 67 IS 7736:1975 Specification for screw, myoma 68 IS 7737:1975 Specification for forceps, punch, cervical biopsy 69 IS 7964:1992 Obstetric instruments - Forceps, caesarean section, haemostasis, green - Armytage pattern - Shape and dimensions ( ) 70 IS 7981 (Part 1):1976 Instruments, Tuboplasty - Part I : Occluder, Cervical, Shirodkar's Pattern 71 IS 7981 (Part 2):1976 Specification For Instruments. Tuboplasty - Part II : Cannula, Shirodkar's Pattern 72 IS 7981 (Part 3):1976 Instruments, Tuboplasty - Part III : Guide, Shirodkar's Pattern 73 IS 7981 (Part 4):1976 Instruments, Tuboplasty - Part IV : Probe, Single Ended, Shirodkar's Pattern 74 IS 7981 (Part 5):1976 Instruments, Tuboplasty - Part V : Probe, Double-Ended, Shirodkar's Pattern 75 IS/ISO 8009:2014 Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests ( ) 76 IS 8313:1977 Specification for cannula, flexible, karman type 77 IS 8459:1977 Specification for menstrual regulation syringe First Revision First revision First Revision First Revision First Revision Second Revision First Revision Third Revision Second Revision First Revision First Revision First Revision First Revision

78 IS 9756:1981 Specification for cups, vacuum extraction 1 IS 10272:1982 Specification for draffin suspension apparatus 2 IS 10272:2025 ENT Surgery Instruments - Draffin Suspension Apparatus - Specification ( ) 3 IS 10344:2024 Davis-Boyle Gag Frame and Tongue Plates Specification ( ) 4 IS 10725:2024 Myringotomy Knife - Specification ( ) 5 IS 10726:2024 Meatal Skin Incision Knife - Specification ( ) 6 IS 10786:2024 St. Clair Thomsons Rhinoscopic Mirror Specification ( ) 7 IS 10846:2024 Killian's Pattern Nasal Speculum - Specification ( ) 8 IS 11318:1985 Bronchoscope, Aspirating, Negus' Pattern 9 IS 11319:1985 Oesophagoscope, Negus' Pattern 10 IS 12901 (Part 1):2024 Laryngeal Forceps Part 1 Fine Grasping Crocodile Jaws Straight Specification ( ) 11 IS 12901 (Part 2):2024 Laryngeal Forceps Part 2 Oval Cup Specification ( ) 12 IS 13169:1991 Ent surgery instruments head mirror - Specification 13 IS 13169:2025 ENT Surgery Instruments - Head Mirror - Specification ( ) 14 IS 17407:2020 Digital Otoscope — Handheld Type 15 IS 17750 (Part 7):2021 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear and auditory brainstem Implant Systems ( ) 16 IS 3758:2018 Hooks, aural - Specification ( ) 17 IS 3760:2021 Probe, Aural, Jobson Horne’s Pattern — Specification ( ) 18 IS 3788:2024 Aural Specula Specification ( 19 IS 3799:2019 Forceps, aural and nasal, crocodile action - Specification ( ) 20 IS 3807:2024 Aural and Nasal Dressing Forceps - Specification ( ) 21 IS 4487:2024 ENT Surgery Instruments - Forceps ,Tonsil Artery (Birketts Pattern) - Specification ( ) 22 IS 4488:2018 Forceps, Tonsil Holding (Muck's and White's Patterns) Specification ( ) 23 IS 4489:2018 Forceps, Nasal Turbinate, Luc’s — Specification ( ) 24 IS 4504:2018 Forceps, peritonsillar - Specification ( ) 25 IS 4514:2018 Forceps, Tonsil Dissecting (Waugh's Pattern) - Specification ( ) 26 IS 4520:2018 Forceps, Punch, Nasal Citelli's Antrum and Hajek's Sphenoidal— Specification ( ) 27 IS 4959:2018 Raspatory, Nasal, Howarth's— Specification ( ) 28 IS 4994:2025 ENT Surgery Instruments - Redressing Forceps - Walsham's pattern - Specification ( ) 29 IS 4994:1968 Specification for Forceps, Redressing, Walsham's Right, Left and Straightening 30 IS 5338:2024 Eustachian Catheter - Specification ( ) 31 IS 5377:1969 Specification for Speculum, Nasal, Thudichum's 32 IS 5377:2025 ENT Surgery Instruments - Nasal Speculum - Thudichum's Pattern - Specification ( ) 33 IS 5412:2025 ENT Surgery Instruments - Nasal Saws - Joseph's pattern - specification ( ) 34 IS 5412:1969 Specification For Saws, Nasal, Joseph's Pattern 35 IS 5720:2024 Mollison's Pattern Self-Retaining Mastoid Retractor Specification ( ) 36 IS 5723:2024 Mallet with Fluted/Milled Handle for ENT Surgery - Specification ( ) 37 IS 5747:2024 Lempert's Pattern Endaural Retractor - Specification ( ) 38 IS 6464:2000 ENT Diagnostic Instruments - Tuning Forks (Gardiner Brown's Pattern) 39 IS 6465:1972 Specification For Trocar, Antral With Cannula (Tilley Lichtwitz' Pattern) 40 IS 6465:2025 ENT Surgery Instruments - Antral Trocar with Cannula - Tilley Lichtwitz's Pattern - Specification ( ) Category 4: Ear, Nose, Throat and Head & Neck Surgery (ENT - H&N) Instruments (MHD 04) S. No. IS No Title First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision of IS 3760 First Revision) First Revision Second Revision Second Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision

41 IS 6514:1972 Specification for Nasal Cartilage Knife (Ballenger's Pattern) 42 IS 6514:2025 ENT Surgery Instruments - Nasal Cartilage Knife - Ballenger's Pattern - Specification ( ) 43 IS 7710:1975 Specification for Snare Tonsil, Eve's Pattern 44 IS 7710:2025 ENT Surgery Instruments - Tonsil Snare - Eve's Pattern - Specification ( ) 45 IS 7712:1975 Specification for Curette, Adenoid, St. Clair Thomson's Pattern 46 IS 7712:2025 ENT Surgery Instruments - Adenoid Curette - St. Clair Thomson's Pattern - Specification ( ) 47 IS 7713:1975 Specification for Retractor, Light Model, Weislander's Pattern 48 IS 7713:2025 ENT Surgery Instruments - Retractor - Weislander's Pattern - Specification ( ) 49 IS 7756:2025 ENT Surgery Instruments - Tongue Depressor - Lack's Pattern - Specification ( ) 50 IS 7756:1975 Specification for Depressor, Tongue, Lack's Pattern 51 IS 8093:2025 ENT Surgery Instruments - Curette - Ballance's Pattern - Specification ( ) 52 IS 8093:1976 Specification for Curette, Ballance's Pattern 53 IS 8094:2024 Cawthornes Pattern Cerumen Hook Specification 54 IS 8128:2024 Farabeuf's Pattern Elevator Specification 55 IS 8129:2024 Forceps - Tonsil Artery, Curved (Scotts Pattern) - Specification 56 IS 8136:2024 Dundas Grant's Pattern Seeker Specification 57 IS 8157:2024 Heath's Pattern Granulation Forceps Specification 58 IS 8199:1976 Specification for Tracheostomy Tubes, Fuller's Pattern 59 IS 8315:1977 Specification For Forceps, Redressing, Asch's Pattern 60 IS 8315:2025 ENT Surgery Instruments - Redressing Forceps - Asch's Pattern - Specification ( ) 61 IS 8316:1977 Retractor, Hajek's Pattern 62 IS 8327:1977 Forceps, Nodule, Vocal, Chevalier Jackson's Pattern 63 IS 8343:1977 Forceps, Biopsy, Peterson's Pattern 64 IS 8734:1978 Forceps, Cutting and Removing Large Specimens, Chevalier Jackson's Pattern 65 IS 8735:1978 Tube, Suction, Yankauer's Pattern 66 IS 8743:1994 ENT surgery instruments - Forceps, direct bronchoscopy, with alligator jaws and tenaculum points, Irwin Moore's pattern 67 IS 8825:2025 ENT Surgery Instruments - Suction Irrigation Cannula - Specification ( ) 68 IS 8825:1978 Specification for cannula, suction irrigation with locking device, microlaryngeal 69 IS 8837:2025 ENT Surgery Instruments - Suction Tube with Stylet - Specification ( ) 70 IS 8837:1978 Specification for suction tubes with stylet microlaryngeal surgery 71 IS 8838:1978 Specification for forceps, cup, straight, microlaryngeal surgery 72 IS 8839:1978 Specification for forceps, cup upwards, microlaryngeal surgery 73 IS 8840:1978 Specification for scissors, microlaryngeal surgery 74 IS 9058:2024 Zoellner's Pattern Upward Cutting Knife - Specification ( ) 75 IS 9059:2024 Zoellner's Pattern Downward Cutting Knife - Specification ( ) 76 IS 9479:2024 Shea's Pattern 25, 45, and 90 Angle Fenestra Hook for Ear Surgery - Specification ( ) 77 IS 9480:2024 Shea's Pattern Left and Right Elevators For Ear Surgery - Specification ( ) 78 IS 9526:2024 Crocodile Jaw Stapedectomy Scissors - Specification ( ) 79 IS 9544:2024 Round Cup, Elongated Cup and Oval Cup Jaws Stapedectomy Forceps - Specification ( ) 80 IS 9558:1980 Specification for gauge, depth, PTFE(Teflon) piston 81 IS 9564:2024 Serrated, Smooth and Mc Gee Wire Closing Jaws Stapedectomy Forceps - Specification ( ) 82 IS 9718:2025 PTFE Piston Cutting Jig - Specification ( ) 83 IS 9718:1981 Specification for jig, cutting, PTFE piston First Revision First Revision First Revision First Revision First Revision First Revision (First Revision) (First Revision) (First Revision) (First Revision) (First Revision) First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision

Category 5: Ophthalmic Instruments and Appliances (MHD 05) S. No. IS No Title 1 IS 10009:1981 Specification For Breaker And Holder, Razor Blade, Barraquer's Pattern 2 IS 10045:1981 Specification For Punch, Lacrymal Bone, Beyer's Pattern 3 IS 10058:1985 Specification For Forceps, Fixation, Graefe's Pattern (Modified) ( ) 4 IS/ISO 10342:2010 Ophthalmic instruments - Eye refractometers 5 IS 10389:1983 Specification For Fixation Hook, Eye, Guthrie's Pattern 6 IS 10390:1983 Specification for muscle hook 7 IS 10408:1983 Specification For Spatula, Eye, Green's Pattern 8 IS 10847:1984 Specification for Speculum with Screw Adjustment, Eye, Right and Left, Arruga's Pattern 9 IS 10848:2024 Ophthalmic Instruments Bishop-Harmon Anterior Chamber Irrigator - Specification First Revision 10 IS/ISO 10938:2016 Ophthalmic Optics - Chart Displays for Visual Acuity Measurement - Printed, Projected and Electronic ( ) 11 IS/ISO 10939:2017 Ophthalmic instruments Slit-lamp microscopes First Revision 12 IS/ISO 10940:2009 Ophthalmic instruments - Fundus cameras 13 IS/ISO 10942:2006 Ophthalmic instruments - Direct ophthalmoscopes 14 IS/ISO 10943:2011 Ophthalmic instruments - Indirect ophthalmoscopes 15 IS 11244:1985 Specification for trephine, bone lacrimal with handle 16 IS/ISO 11979-1:2018 Ophthalmic implants Intraocular lenses Part 1:Vocabulary First Revision 17 IS/ISO 11979-2:1999 Ophthalmic implants - Intraocular lenses: Part 2 optical properties and test methods 18 IS/ISO 11979-3:2012 Ophthalmic Implants - Intraocular Lenses Part 3 Mechanical Properties and Test Methods ( ) 19 IS/ISO 11979-4:2008 Ophthalmic implants - Intraocular lenses: Part 4 labelling and information 20 IS/ISO 11979-6:2014 Ophthalmic implants - Intraocular lenses: Part 6 Shelf - Life and transport stability testing 21 IS/ISO 11979-5:2018 Ophthalmic implants - Intraocular lenses Part 7: Clinical investigations of intraocular lenses for the correction of aphakia ( ) 22 IS/ISO 11979-7:2024 Ophthalmic implants Intraocular lenses Part 7 Clinical investigations of intraocular lenses for the correction of aphakia ( ) 23 IS/ISO 11979-8:2018 Ophthalmic implants Intraocular lenses Part 8 Fundamental requirements ( ) 24 IS/ISO 11979-9:2006 Ophthalmic Implants - Intraocular Lenses Part 9 Multifocal Intraocular Lenses 25 IS/ISO 11979-10:2018 Ophthalmic implants Intraocular lenses Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes ( ) 26 IS/ISO 11986:2017 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release 27 IS/ISO 12865:2006 Ophthalmic instruments - Retinoscopes 28 IS 13783:1993 Optics and optical instruments - Ophthalmology - Graduated dial scale 29 IS 14895:2000 Ophthalmic instruments - Spuds, foreign body - Waltons sizes 1 and 1.5 mm wide, stainless steel - Specification 30 IS/ISO 16671:2015 Ophthalmic implants - Irrigating solutions for ophthalmic surgery 31 IS 17772 (Part 1):2022 Ophthalmic optics Semi-finished spectacle lens blanks Part 1: Specifications for single-vision and multifocal lens blanks 32 IS 17772 (Part 2):2022 Ophthalmic optics Semi-finished spectacle lens blanks Part 2: Specifications for progressive-power and degressive-power lens blanks 33 IS 18291:2023 Ophthalmic Instruments - Perimeters (ISO 12866: 1999 + AMD 1: 2008, MOD) 34 IS/ISO 18369-1:2017 Ophthalmic optics Contact lenses Part 1 Vocabulary classification system and recommendations for labeling specifications ( ) 35 IS/ISO 18369-2:2017 Ophthalmic optics - Contact lenses Part 2: Tolerances First Revision 36 IS/ISO 18369-3:2017 Ophthalmic Optics - Contact Lenses Part 3 Measurement Methods ( ) 37 IS/ISO 18369-4:2017 Ophthalmic optics - Contact lenses Part 4: Physicochemical properties of contact lens materials ( ) 38 IS 18378:2023 Ophthalmic optics - Spectacle frames Measuring system and vocabulary ( ) 39 IS 18570:2024 Ophthalmic instruments - Refractor heads 40 IS 18571:2024 Ophthalmic instruments - Synoptophores 41 IS 18572:2024 Ophthalmic instruments - Ophthalmometers First Revision First Revision First Revision First Revision Second revision First Revision First Revision First Revision First Revision First Revision First Revision

42 IS 18574:2024 Ophthalmic optics - Contact lens care products Method to assess contact lens care products with contact lenses in a lens case challenged with bacterial and fungal organisms 43 IS 18575:2024 Ophthalmic optics - Contact lenses and contact lens care products Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens solution interactions 44 IS 18576:2024 Ophthalmic optics - Spectacle frames Requirements and test methods 45 IS 18577:2024 Ophthalmic optics - Review of the test methods used to assess scratch and abrasion resistance of spectacle lenses 46 IS 18578:2024 Ophthalmic Optics - Single-Vision Ready-to-Wear Near-Vision Spectacles - Specification 47 IS 18580:2024 Ophthalmic instruments - Trial frames 48 IS 18581 (Part 2):2024 Optics and photonics - Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery 49 IS 18583 (Part 1):2024 Optics and optical instruments - Test lenses for calibration of focimeters Part 1: Reference lenses for focimeters used for measuring spectacle lenses 50 IS 18583 (Part 2):2024 Optics and optical instruments - Test lenses for calibration of focimeters Part 2: Test lenses for focimeters used for measuring contact lenses 51 IS 18584:2024 Ophthalmic optics and instruments - Optical devices for enhancing low vision 52 IS 18585:2024 Ophthalmic instruments - Optical coherence tomograph for the posterior segment of the human eye 53 IS 18586:2024 Ophthalmic optics and instruments - Instruments to measure axial distances in the eye 54 IS 18599:2024 Ophthalmic optics and instruments - Reporting aberrations of the human eye 55 IS 18613:2024 Ophthalmic instruments - Corneal topographers 56 IS 18614:2024 Ophthalmic implants - Ocular endotamponades 57 IS 18638 (Part 1):2024 Ophthalmic instruments - Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments 58 IS 18638 (Part 2):2024 Ophthalmic instruments - Fundamental requirements and test methods Part 2: Light hazard protection 59 IS 18639:2024 Ophthalmic implants - Ophthalmic viscosurgical devices 60 IS 18642:2024 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety 61 IS 18658 (Part 5):2024 Ophthalmic implants - Intraocular lenses Part 5:Biocompatibility 62 IS 18853:2024 Ophthalmic optics - Contact lenses and contact lens care products - Labelling 63 IS 18864:2024 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements 64 IS 18882:2025 Ophthalmic instruments - Indirect ophthalmoscopes 65 IS 18886:2025 Ophthalmic instruments - Direct ophthalmoscopes 66 IS 18917:2025 Ophthalmic optics - Mounted spectacle lenses 67 IS 18918:2025 Ophthalmic optics - Spectacle lenses -Vocabulary 68 IS 18919:2024 Ophthalmic optics and instruments Near reading charts 69 IS 4569 (Part 1):1985 Specification for scissors, eye: Part 1 Corneal ( ) 70 IS 4569 (Part 2):1985 Specification for scissors, eye: Part 2 Conjuctival, blunt and sharp - Point scissors ( ) 71 IS 4569 (Part 3):1985 Specification for scissors, eye: part 3 Scissors, tenotomy ( ) 72 IS 4569 (Part 4):1985 Specification For Scissors, Eye Part 4 Scissors, Enucleation ( ) 73 IS 4569 (Part 5):1985 Specification For Scissors, Eye Part 5 Scissors, Spring Action, Vanna's Pattern (Modified) ( ) 74 IS 4569 (Part 6):1985 Specification For Scissors, Eye Part 6 Scissors, Iris (Second Revision) 75 IS 4790:1989 Eye Surgery Instruments -Knife, Corneal Splitting, Lang's And Tooke's Pattern (Modified) Specification ( ) 76 IS 4978:2024 EYE SURGERY INSTRUMENTS TOOTHED FIXATION FORCEPS - SPECIFICATION 77 IS 5157:1981 Specification for forceps, eye, Iris ( ) 78 IS 5232:2024 EYE SURGERY INSTRUMENTS - FORCEPS EYE CILIA BEERS PATTERN MODIFIED - SPECIFICATION 79 IS 5367:1969 Specification For Forceps, Eye, Strabismus, For Advancement (Prince's And Worth's Patterns) 80 IS 5668:2024 EYE SURGERY INSTRUMENTS - FORCEPS EYE DISSECTING SERRATED FINE - SPECIFICATION 81 IS 5678:2023 CONJUNCTIVAL SUTURE FORCEPS MOORFIELDS PATTERN - SPECIFICATION 82 IS 5721:2024 PERIPHERAL IRIDECTOMY FORCEPS SINCLAIRS PATTERN -SPECIFICATION 83 IS 5722:1970 Specification For Hook, Eye, Iris (Tyrrell's Pattern) Second Revision Second Revision Second Revision Second Revision Second Revision Second Revision First Revision

84 IS 6420:1989 Eye Surgery Instruments - Retractor, Eye Lachrymal Sac, Muller's Pattern (Modified) - Specification ( ) 85 IS 7734:1975 Specification For Forceps, Eys, Peripheral Iridectomy, Traquair's Pattern 86 IS 7758:1975 Specification For Curette, Eye, Evacuation, Moorfield's Pattern 87 IS 7762:1975 Specification for hook, eyelid 88 IS 7767:1975 Specification For Spatula, Eye, Cyclodialysis, Sinclair's Pattern 89 IS 7786:1975 Specification For Retractor, Eyelid, Desmarre's Pattern 90 IS/ISO 7998:2005 Ophthalmic optics - Spectacle frames - Lists of equivalent terms and vocabulary 91 IS 8106:1976 Specification For Needle Holder, Eye, Kalt's Pattern 92 IS 8109:1976 Specification For Needle Holder, Eye, Castroviejo's Pattern 93 IS 8181:1976 Specification for repositor, Iris 94 IS/ISO 8596:2017 Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation ( ) 95 IS/ISO 8598-1:2014 Optics and optical instruments - Focimeters: Part 1 General purpose instruments 96 IS/ISO 8612:2009 Ophthalmic instruments - Tonometers 97 IS 8771:1985 Specification For Needle Holder, Eye, Scissors And Forceps Combined, Castroviejo's Pattern (Modified) ( ) 98 IS 8772:1985 Specification For Needle Holder, Eye, Barraquer's Pattern (Modified) ( ) 99 IS 8773:1985 Specification For Dissector, Lacrimal Sac, Lang's Pattern (Modified) ( ) 100 IS 8810:1985 Specification For Rougine For Lacrimal Sac, Rollet's Pattern (Modified) ( ) 101 IS/ISO 8980-1:2017 Ophthalmic optics Uncut finished spectacle lenses Part 1 Specifications for single-vision and Multifocal Lenses ( ) 102 IS/ISO 8980-2:2017 Ophthalmic optics Uncut finished spectacle lenses Part 2: Specifications for power-variation lenses 103 IS/ISO 8980-3:2022 Ophthalmic optics -Uncut finished spectacle lenses Part 3 Transmittance specifications and test methods ( ) 104 IS/ISO 8980-4:2006 Ophthalmic optics - Uncut finished spectacle lenses: Part 4 specifications and test methods for anti - Reflective coatings 105 IS/ISO 8980-5:2005 Ophthalmic optics - Uncut finished spectacle lenses: Part 5 minimum requirements for spectacle lens surfaces claimed to be abrasion-resistant 106 IS 9061:1989 Eye Surgery Instruments - Dilators, Punctum, Wilder's Pattern (Modified) - Specification ( ) 107 IS 9062:1987 Specification For Probes, Lacrimal, Bowman's Pattern (Modified) ( ) 108 IS 9134:1987 Specification For Trephine, Corneal, Castroviejo's Pattern (Modified) ( ) 109 IS 9329:1987 Specification For Speculum, Eye, Clark's Pattern (Modified) ( ) 110 IS 9378:1987 Specification For Speculum, Eye, Castroviejo's Pattern (Modified) ( ) 111 IS 9626:2024 Ophthalmic Instruments Castroviejo Caliper - Specification ( ) 112 IS 9688:1992 Eye surgery instruments - Hooks, strabismus - Specification ( ) 113 IS/ISO 9801:2009 Ophthalmic instruments - Trial case lenses 114 IS 9983:1981 Specification for wire vectis and lens expressor, eye 115 IS 9984:2024 Ophthalmic Instruments Air Injection Cannula - Specification ( ) 1 IS 10540:1991 Cardiovascular Surgery Instruments - Clamps, Atrial Appendage, Glover's Pattern - Shape and Dimensions 2 IS 10541:1991 Cardiovascular surgery instruments - Clamps vena cava,satinsky pattern shape, sizes and dimensions ( ) 3 IS 11566:2024 Thoracic Surgery Instruments - Valve Retractors -ƞ Specification ( ) 4 IS/ISO 11658:2012 Cardiovascular Implants and Extracorporeal Organs Blood/Tissue Contact Surface Modifications for Extracorporeal Perfusion Systems 5 IS/ISO 12417-1:2015 Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements 6 IS 13940:1994 Cardiovascular surgery instruments - Clamps, bulldog, DeBakey,ring handle - Shape and dimensions 7 IS/ISO 15674-2004:2016 Cardiovascular implants and artificial organs - Hard - Shell cardiotomy/venous reservoir systems (With/without Filter) and soft venous reservoir bags ( ) 8 IS/ISO 15675:2016 Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision Second Revision First revision First Revision First Revision First Revision Second Revision Category 6: Medical and Surgical Cardiology Equipment (MHD 06) S. No. IS No Title

9 IS/ISO 15676:2016 Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation ECMO ( ) 10 IS 17646 (Part 1):2021 Preparation and quality management of fluids for haemodialysis and related therapies : Part 1 General requirements 11 IS 17646 (Part 2):2021 Preparation and quality management of fluids for haemodialysis and related therapies Part 2 Water treatment equipment for haemodialysis applications and related therapies 12 IS 17646 (Part 3):2021 Preparation and quality management of fluids for haemodialysis and related therapies Part 3 Water for haemodialysis and related therapies 13 IS 17646 (Part 4):2021 Preparation and quality management of fluids for haemodialysis and related therapies Part 4 Concentrates for haemodialysis and related therapies 14 IS 17646 (Part 5):2021 Preparation and quality management of fluids for haemodialysis and related therapies Part 5 Quality of dialysis fluid for haemodialysis and related therapies 15 IS 17708:2021 Cardiovascular implants and artificial organs Checklists for use of extracorporeal circulation equipment 16 IS 17709:2022 Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements 17 IS 17710:2021 Cardiac rhythm management devices- Symbols to be used with cardiac rhythm management device labels and information to be supplied General requirements 18 IS 17712 (Part 2):2021 Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads 19 IS 17712 (Part 3):2021 Implants for surgery Cardiac pacemakers Part 3: Low-profile connectors IS-1 for implantable pacemakers 20 IS 17745:2021 Cardiovascular implants and extracorporeal systems Cardiac valve repair devices 21 IS 17746:2021 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements 22 IS 17750 (Part 4):2025 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4 : 2022, MOD) 23 IS 17750 (Part 5):2021 Implants for surgery Active Implantable Medical Devices Part 5: Circulatory Support Devices 24 IS 17750 (Part 6):2022 Implants for Surgery Active Implantable Medical Devices Part 6 Particular Requirements for Active Implantable Medical Devices Intended to Treat Tachyarrhythmia Including Implantable Defibrillators 25 IS 17751 (Part 2):2024 Cardiovascular Implants and Extracorporeal Systems - Vascular Device-Drug Combination Products Part 2 Local Regulatory Information ( ) 26 IS 17840 (Part 1):2022 Cardiovascular Implants Cardiac Valve Prostheses Part 1 General Requirements 27 IS 17840 (Part 2):2022 Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitute First Revision 28 IS 17840 (Part 3):2022 Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Transcatheter Techniques First Revision 29 IS 17841 (Part 2):2022 Cardiovascular Implants Endovascular Devices Part 2 Vascular Stents First Revision 30 IS 17841 (Part 4):2023 Cardiovascular Implants Endovascular Devices Part 4 Application of ISO 17327-1 for Coated Endovascular Devices 31 IS 17842:2022 Active Implantable Medical Devices Electromagnetic Compatibility EMC Test Protocols for Implantable Cardiac Pacemakers Implantable Cardioverter Defibrillators and Cardiac Resynchronization Devices 32 IS 17843:2022 Cardiovascular Implants and Extracorporeal Systems Cardiovascular Absorbable Implants 33 IS 18207:2023 Evaluation of CPB Devices Relative to their Capabilities of Reducing the Transmission of Gaseous Microemboli GME to a Patient during Cardiopulmonary Bypass 34 IS/ISO 18241:2016 Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps 35 IS/ISO 18242:2016 Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps 36 IS 18903:2025 Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 37 IS 18927:2024 Cardiovascular implants - Transcatheter cardiac occluders (ISO 22679 : 2021, MOD) 38 IS 18974:2025 Cardiovascular Implants and Artificial Organs - Cannulae for Extracorporeal Circulation (ISO 18193 : 2021, MOD) 39 IS/ISO 25539-1:2017 Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses ( ) 40 IS/ISO 25539-3:2011 Cardiovascular implants - Endovascular devices: Part 3 vena cava filters 41 IS 6395:2024 Thoracic Surgery Instruments - Auricle Clamps, Crafoords Pattern -ƞ Specification ( ) 42 IS 6436:1989 Thoracic Surgery Instruments - Rib Spreader, Finochietto's Pattern, Adult Size 43 IS 6442:2024 Thoracic Surgery Instruments -ƞ Rib Shears, Tudor Edward's Pattern - Specification ( ) 44 IS 6466:2024 Thoracic Surgery Instruments - Needle Holder - Specification 45 IS 6467:2024 Thoracic Surgery Instruments -ƞ Rib Periosteotome, Alexander's Pattern -ƞ Specification ( ) 46 IS 6468:2024 Thoracic Surgery Instruments -ƞ Empyema Trocar, Nelson's Pattern -ƞ Specification ( ) 47 IS 6777:1989 Thoracic and cardiovascular surgery instruments - Forceps, dissecting, lung - Specification ( ) First revision First Revision First Revision Second Revision Second Revision Second Revision Second Revision First Revision

48 IS 6778:2024 Thoracic Surgery Instruments -ƞ Lung Forceps, Duval's Pattern -ƞ Specification ( ) 49 IS 6780:2024 Thoracic Surgery Instruments -ƞ Artery Forceps, Robert's Pattern -ƞ Specification ( ) 50 IS/ISO 7198:2016 Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches 51 IS /ISO 7199:2016 Cardiovascular implants and artificial organs - Blood - Gas exchangers (Oxygenators) ( ) 52 IS 7345:1994 Cardiovascular surgery instruments - Anastomosis forceps and clamps - Patterns, shapes and dimensions ( ) 53 IS 7346:2024 Thoracic Surgery Instruments -ƞ Rib Raspatories -ƞ Specification ( ) 54 IS 7355:2024 Thoracic Surgery Instruments -ƞ Rib Spreader, Tuffier's Pattern -ƞ Specification ( ) 56 IS 7379:2024 Thoracic Surgery Instruments -ƞ Straight and Angular Patent Ductus Clamps -ƞ Specification ( ) 57 IS 7382:2024 Thoracic Surgery Instruments -ƞ Rib Shears, Thomas Pattern -ƞ Specification ( ) 58 IS 7399:1987 Knife, Sternum, Lebsche's Pattern 59 IS 7434:2024 Thoracic Surgery Instruments -Scapula Retractor -Specification ( ) 60 IS 7972:2024 Thoracic Surgery Instruments -Dissecting Scissors -Specification ( ) 61 IS 8317:1991 Cardiovascular surgery instruments - Clamps, vascular, angled at 45 - Shape and dimensions ( ) 62 IS 8335:1991 Cardiovascular Surgery Instruments - Clamps, Auricle, Satinsky Pattern - Sizes, Shape and Dimensions 63 IS 8345:1994 Cardiovascular surgery instruments - Clamps, bulldog, cross action type - Specification ( ) 64 IS 8549:2024 Thoracic Surgery Instruments - Angled Scissors - Specification ( ) 65 IS/ISO 8637-1:2017 Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators 66 IS/ISO 8637-2:2018 Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters 67 IS/ISO 8637-3:2018 Extracorporeal Systems for Blood Purification Part 3 Plasmafilters 68 IS 8890:1991 Thoracic surgery instruments - Clamps,bronchus - Types, shapes and dimensions (First Revision) 69 IS 9928:1981 Clamp, Aortic, DeBakey's Pattern (Spoon Shaped angled Jaw) 70 IS 9950:2024 Thoracic Surgery Instruments -ƞ Vascular Clamp -ƞ Specification ( ) 71 IS 9951:2024 Thoracic Surgery Instruments -ƞ Blunt End Scissors -ƞ Specification ( ) 72 IS 9987:2024 Thoracic Surgery Instruments -ƞMultipurpose Clamps -ƞ Specification ( ) 1 IS 10157:2023 Neurological Percussor ( ) 2 IS 10172:1982 Specification for burs and perforators for drill brace 3 IS 10172:2023 Drill Brace - Burs and Perforators ( ) 4 IS 10174:2023 Skull Traction Tongs - Crutchfield's Pattern ( ) 5 IS 10183:2024 Self- Retaining Retractor For Laminectomy ( ) 6 IS 10676:2024 Brain Spatula -ƞ Olivecrona's Pattern ( ) 7 IS 10677:2024 Intervertebral Disc Rongeur ( ) 8 IS 10765:2024 Cushing's Pattern Toothed and Bayonet Shaped Dissecting Forceps ( ) 9 IS 13141:2023 Leksell's Rongeur for Neurosurgery ( ) 10 IS 13175:2025 Neurosurgical Instruments - Needle Holder - Shape and Dimensions ( ) 11 IS 13180:2023 Neurosurgery - Scoville Trephine ( ) 12 IS 14139 (Part 1):2024 Neurosurgical Implants Part 1 Self-Closing Intracranial Aneurysm Clips ( ) 13 IS 14679:1999 Neurosurgical implants - Implantable peripheral nerve stimulators 14 IS/ISO 14708-1:2014 Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer ( ) 15 IS/ISO 14708-3:2017 Implants for surgery - Active implantable medical devices: Part 3 implantable neurostimulators ( ) 16 IS 17744:2021 Implants for surgery Minimum data sets for surgical implants 17 IS/ISO 7197:2006 Neurosurgical implants - Sterile, singleuse hydrocephalus shunts and components Second Revision Second Revision Second Revision Second Revision Second Revision Second Revision Second Revision Second Revision Second Revision Second Revision First Revision First Revision Second Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision Second Revision First Revision First Revision Category 7: Neurosurgery Instruments Implants and Accessories (MHD 07) S. No. IS No Title

18 IS 8174:2025 Neurosurgical Instruments- Forceps Artery Dandys Pattern-Shape and Dimensions ( ) 19 IS 8175:2025 Neurosurgical Instruments -Forceps Artery Straight and Curved on Flat Hugh Cairns Pattern - Shape and Dimensions ( ) 20 IS 8176:2023 Dissectors - Penfield's Pattern ( ) 21 IS 8334:2025 Rongeur, Cranial, Dahlgren's Pattern - Specification ( ) 22 IS 8380:2023 Double Action Rongeur - Olivecrona's Pattern ( ) 23 IS 8695:2025 Forceps, Dressing, Bayonet Shape, Gushing's Pattern - Specification ( ) 24 IS 8696:2025 Guide, Saw, De Martel's Pattern - Specification ( ) 25 IS 8799:2023 Kerrison Rongeur ( ) 26 IS 9041:2023 Neurosurgery - Periosteal Elevator ( ) 27 IS 9072:2023 Pituitary Rongeur ( ) 28 IS 9073:2023 Neuro-suction Tubes ( ) 29 IS 9074:2023 Raney Clips and Applicators ( ) 30 IS 9408:2024 Self-Retaining Retractor for Neurosurgery ( ) 31 IS 9410 (Part 1):2023 Silver Clip Sets Part 1 Clip Cutting and Forming Forceps ( ) 32 IS 9410 (Part 2):2023 Silver Clip Sets Part 2 Clip Applying Forceps ( ) 33 IS 9410 (Part 3):2023 Silver Clip Sets Part 3 Clip Racks ( ) 34 IS 9903:2023 Skull Brace ( ) 35 IS 9904:2023 Dural Hooks ( ) 36 IS 9911:2025 Brain Cannula - Specification ( ) 37 IS 9914:2023 Ice Tong Calipers - Cone's Pattern ( ) 38 IS 9933:2023 Brain Retractors ( ) 1 IS 10011:2022 Dentistry Polymer-based restorative materials ( ) 2 IS 10088:2025 Dental Retractor - Specification ( ) 3 IS 10088:1981 Specification for retractor, dental 4 IS/ISO 10139-1:2018 Dentistry - Soft Lining Materials for Removable Dentures Part 1 Materials for Short-term Use 5 IS/ISO 10139-2:2016 Dentistry - Soft Lining Materials for Removable Dentures Part 2 Materials for Long-term Use 6 IS 10309:1982 Specification for key, torquing, edgewise 7 IS 10309:2025 Edgewise Torquing Key - Specification ( ) 8 IS 10353:1982 Pliers, McKellops' Type, Dental 9 IS 10354:1982 Specification for torch, alcohol, dental 10 IS/ISO 10451:2010 Dentistry Contents of technical file for dental implant systems 11 IS 10663:2003 Dental rotary instruments - Steel and carbide burs ( ) 12 IS 10664 (Part 2):2022 Dentistry Rotary bur instruments Part 2 Finishing burs ( ) 13 IS 10798:2019 Dentistry - Information system on the location of dental equipment in the working area of the oral health care provider ( ) 14 IS 10828:1984 Pliers, Band Contouring, Dental Johnson's Pattern 15 IS 10836 (Part 1):1984 Pliers, Loop Bending, Dental, Tweed's Pattern - Part 1 : Fixed Beak, Type 1 16 IS 11044:1984 Specification for acrylic trimmers, dental 17 IS 11045:1984 Specification for metal trimmers, dental 18 IS 11317:1985 Specification for shears, laboratory, straight, dental 19 IS 11394:1985 Specification for pliers, distal end cutting, with safety hold, dental 20 IS 11929:1986 Specification for adopters, band, dental Second Revision Second Revision First Revision First Revision First Revision First revision First Revision First Revision First Revision First Revision First Revision First Revision Second revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision Second Revision First Revision First Revision First Revision Second Revision First Revision Category 8: Dentistry (MHD 08) S. No. IS No Title

21 IS/ISO 11953:2010 Dentistry - Implants - Clinical performance of Hand Torque Instruments 22 IS 12181:2018 Dental materials - Determination of colour stability ( ) 23 IS 12374:2020 Dentistry Coupling Dimensions for Handpiece Connectors ( ) 24 IS 12507:1988 General requirements for dental pliers 25 IS 12601:1989 Dental instruments - Pliers, lip-safe, flat nose - Specification 26 IS 12602:1989 Dental instruments - Nippers, cutting, carbide tip - Specificaition 27 IS 12624:2023 Dentistry Endodontic obturating materials ( ) 28 IS 12764:2019 Dentistry - Hose connectors for air driven dental handpieces ( ) 29 IS/ISO 13397-1:1995 Periodontal curettes dental scalers and excavators Part 1: General requirements 30 IS 13701:2024 Dentistry - Test Methods for Rotary Instruments ( ) 31 IS/ISO 14801:2016 Dentistry - Implants - Dynamic Loading Test for Endosseous Dental Implants 32 IS/ISO/TR 15599:2002 Digital codification of dental laboratory procedures 33 IS/ISO 16954:2015 Dentistry Test methods for dental unit waterline biofilm treatment 34 IS/ISO 17304:2013 Dentistry Polymerization shrinkage: Method for determination of polymerization shrinkage of polymer-based restorative materials 35 IS 17694:2021 Dentistry Polymer-based pit and fissure sealants 36 IS 17696:2021 Dentistry- Test Method for Determining Radio-Opacity of Materials 37 IS 17697:2021 Dentistry- Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file 38 IS 17698:2021 Dentistry- Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of a technical file 39 IS 17700:2021 Dentistry Handpieces and motors 40 IS 17701:2021 Dentistry - Polymer-Based Luting Materials Containing Adhesive Components 41 IS 17702:2021 Dentistry - Integrated dental floss and handles 42 IS 17703:2021 Dentistry - Cartridge syringes 43 IS 17704:2021 Dentistry - Fluoride varnishes 44 IS 17705:2021 Dentistry - Adhesion Notched edge shear bond strength test 45 IS 17749:2021 Dentistry Dental explorer 46 IS 17774:2022 Dentistry - Elastomeric impression and bite registration materials 47 IS 17859 (Part 1):2022 Dentistry Endodontic instruments Part 1: General requirements 48 IS 17859 (Part 2):2024 Dentistry Endodontic instruments Part 2 Enlargers 49 IS 17859 (Part 3):2023 Dentistry Endodontic instruments Part 3 Compactors 50 IS 17859 (Part 4):2024 Dentistry Endodontic Instruments Part 4 Auxiliary Instruments 51 IS 17859 (Part 5):2023 Dentistry Endodontic instruments Part 5 Shaping and cleaning instruments 52 IS 17859 (Part 6):2024 Dentistry Endodontic Instruments Part 6 Numeric Coding System 53 IS 17895:2023 Dentistry Vocabulary 54 IS/ISO 17937:2015 Dentistry Osteotome 55 IS 17960:2022 Dentistry Coiled springs for use in orthodontics 56 IS 17961:2022 Dentistry Oral care products Manual interdental brushes 57 IS 17967:2022 Dentistry Hydrocolloid impression materials ( ) 58 IS 17968:2022 Dentistry Denture adhesives ( ) 59 IS/ISO 1797:2017 Dentistry - Shanks for rotary and oscillating instruments 60 IS 18101:2023 Dentistry Wires for use in orthodontics 61 IS 18191:2023 Dentistry Vocabulary for Dental Implants Systems and Related Procedure 62 IS 18217:2023 Dentistry Vocabulary and designation system for forensic oro-dental data 63 IS 18489 (Part 1):2024 Dentistry Digital impression devices Part 1 Method for assessing accuracy First Revision First Revision Third Revision Second Revision Second Revision (First Revision) (First Revision) First Revision First Revision

64 IS 18490:2024 Dentistry - Interoperability of CAD/CAM systems 65 IS 18491:2024 Dentistry - Digitizing Devices for CAD/CAM Systems for Indirect Dental Restorations - Test Methods for Assessing Accuracy 66 IS 18492 (Part 1):2024 Dentistry - Nomenclature of oral anomalies Part 1 Code for the representation of oral anomalies 67 IS 18492 (Part 2):2024 Dentistry Nomenclature of oral anomalies Part 2 Developmental anomalies of teeth 68 IS 18493 (Part 1):2024 Dental Elevators Part 1 General Requirements 69 IS 18493 (Part 2):2024 Dental elevators Part 2 Warwick James elevators 70 IS 18493 (Part 3):2024 Dental elevators Part 3 Cryer elevators 71 IS 18493 (Part 4):2024 Dental elevators Part 4 Coupland elevators 72 IS 18493 (Part 5):2024 Dental elevators Part 5 Bein elevators 73 IS 18493 (Part 6):2024 Dental Elevators Part 6 Flohr Elevators 74 IS 18494:2024 Dentistry Corrosion resistance of dental amalgam 75 IS 18496:2024 Dentistry - Polymer-based Crown and Veneering Materials 76 IS 18497:2024 Dentistry - Operating Lights 77 IS 18498:2024 Dentistry - Oral Surgical Scalpel Handle (ISO 20570:2018, MOD) 78 IS 18502 (Part 1):2024 Dentistry Dental rubber dam technique Part 1 Hole punch 79 IS 18502 (Part 2):2024 Dentistry - Dental rubber dam instruments Part 2 Clamp forceps 80 IS 18503:2024 Dentistry Intraoral spatulas 81 IS 18610:2024 Dentistry - Torque transmitter for handpieces 82 IS 18634:2024 Dentistry - Central suction source equipment 83 IS 18670:2024 Dentistry Designation system for dental implants 84 IS 18672:2024 Dentistry Vocabulary of process chain for CADCAM systems 85 IS 18675:2024 Dentistry - Single-use cartridges for local anaesthetics 86 IS 18677:2024 Dentistry - Sterile injection needles for single use 87 IS 18679:2024 Dentistry - Minimal dental implant data set for clinical use 88 IS 18681 (Part 3):2024 Dentistry - Number coding system for rotary instruments Part 3 Specific characteristics of burs and cutters 89 IS 18681 (Part 4):2024 Dentistry - Number Coding System for Rotary Instruments Part 4 Specific Characteristics of Diamond Instruments 90 IS 18681 (Part 6):2024 Dentistry - Number coding system for rotary instruments Part 6: Specific characteristics of abrasive instruments 91 IS 18681 (Part 7):2024 Dentistry - Number coding system for rotary instruments Part 7 Specific characteristics of mandrels and special instruments 92 IS 18682 (Part 2):2024 Dentistry Periodontal curettes dental scalers and excavators Part 2: Periodontal curettes of Gr-type 93 IS 18682 (Part 3):2024 Periodontal curettes dental scalers and excavators Part 3: Dental scalers H-type 94 IS 18683 (Part 1):2024 Dentistry - Diamond rotary instruments Part 1 General requirements 95 IS 18683 (Part 2):2024 Dentistry - Rotary Diamond Instruments Part 2 Discs 96 IS 18684:2024 Dentistry Casting and baseplate waxes 97 IS 18686:2024 Dentistry Dental tweezers 98 IS 18729:2024 Dentistry - Torsion test of implant body/connecting part joints of endosseous dental implant systems 99 IS 18775:2024 Dentistry - Intraoral camera 100 IS 18776:2024 Dentistry - Tissue punches 101 IS 18777:2024 Dentistry - Vocabulary of process chain from dental CT to CAD/CAM for implant prosthetic restorations ' Backward planning in the digital process chain 102 IS 18778:2024 Dentistry - Spoons and bone curettes 103 IS 18779:2024 Dentistry - Analysis of fluoride concentration in aqueous solutions by use of fluoride ion-selective electrode 104 IS 18780:2024 Dentistry - Reprocessable cartridge syringes for intraligamentary injections 105 IS 18781 (Part 1):2024 Dentistry - Materials for Dental Instruments Part 1 Stainless Steel 106 IS 18786:2024 Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection

107 IS 18787:2024 Dentistry - Multifunction handpieces 108 IS 18788:2024 Dentistry - Excavators 109 IS 18789:2024 Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements 110 IS 18790 (Part 1):2024 Dentistry - Mobile dental units and dental patient chairs Part 1 General requirements 111 IS 18790 (Part 2):2024 Dentistry - Mobile dental units and dental patient chairs Part 2 Air, water, suction and wastewater systems 112 IS 18798:2024 Dentistry - Dentifrices - Requirements, Test Methods and Marking 113 IS 18803:2024 Dentistry - Brazing materials 114 IS 18810:2024 Dentistry - Elastomeric auxiliaries for use in orthodontics 115 IS 18811 (Part 1):2024 Dentistry - Chairside denture base relining materials Part 1 Hard type materials 116 IS 18812:2024 Dentistry - Test Methods for Tensile Bond Strength to Tooth Structure 117 IS 18813:2024 Dentistry - Ceramic Materials 118 IS 18822:2024 Dentistry - Oral Care Products - Oral Rinses 119 IS 18823:2024 Dentistry - Endodontic Absorbent Points 120 IS 18825:2024 Dentistry - Machinable Ceramic Blanks 121 IS 18826:2024 Dentistry - Artificial Teeth for Dental Prostheses 122 IS 18858:2024 Dentistry - Metallic materials for fixed and removable restorations and appliances 123 IS 18868:2024 Dentistry - Corrosion Test Methods for Dental Amalgam 124 IS 18870:2024 Dentistry - Determination of the Strength of Dental Amalgam by the Hertzian Indentation Strength (HIT) Method 126 IS 18967:2024 Dentistry - Designation System for Tooth Developmental Stages 127 IS 18976:2025 Dentistry - Powder Jet Handpieces and Powders (ISO 20608 : 2018, MOD) 128 IS 18987:2025 Dentistry - Colour Tabs for Intraoral Tooth Colour Determination 129 IS 18991:2025 Dentistry - Designation System for Supernumerary Teeth 130 IS 18992:2025 Dentistry - Classification of Tooth Restorations Preparation 131 IS 18993:2025 Dentistry - Rotational Adaptability Test Between Implant Body and Implant Abutment in Dental Implant Systems 132 IS 18995 (Part 1):2025 Dentistry - Laboratory Cutters Part 1 Steel Laboratory Cutters 133 IS 18995 (Part 2):2025 Dentistry - Laboratory Cutters Part 2 Carbide laboratory cutters 134 IS 18995 (Part 3):2025 Dentistry - Laboratory Cutters Part 3 Carbide Cutters for Milling Machines 135 IS 18995 (Part 4):2025/ ISO 7787-4:2002 Dental Rotary Instruments - Cutters Part 4 Miniature Carbide Laboratory Cutters 136 IS 18996 (Part 1):2025 Dentistry - Extraction Forceps Part 1 General Requirements 137 IS 18996 (Part 2):2025 Dentistry - Extraction Forceps Part 2 Designation (ISO 9173-2 : 2010, MOD) 138 IS 18996 (Part 3):2025 Dentistry - Extraction Forceps Part 3 Design (ISO 9173-3 : 2014, MOD) 139 IS 18999 (Part 1):2025 Dentistry - General Requirements of Hand Instruments Part 1 Non-Hinged Hand Instruments 140 IS/ISO 19023:2018 Dentistry - Orthodontic anchor screws 141 IS 19043:2025 Dentistry - Evaluation of Antibacterial Activity of Dental Restorative Materials, Luting Materials, Fissure Sealants and Orthodontic Bonding or Luting Materials (ISO 3990 : 2023, MOD) 142 IS 19044:2025 Dentistry - Polymer-Based Composite Machinable Blanks (ISO 5139 : 2023, MOD) 143 IS 19045:2025 Dentistry - Corrosion Test Methods for Metallic Materials (ISO 10271 : 2020, MOD) 144 IS 19046:2025 Dentistry - Magnetic Attachments (ISO 13017 : 2020, MOD) 145 IS 19049:2025 Dentistry - External Tooth Bleaching Products (ISO 28399 : 2021, MOD) 146 IS 19051:2025 Dentistry - Trephine Burs 147 IS 19054:2025 Dentistry - Machining Accuracy of Computer-Aided Milling Machines ' Methods of Test 148 IS/ISO 19490:2017 Dentistry Sinus membrane elevator 149 IS/ISO 2157:2016 Dentistry - Nominal diameters and designation code numbers for rotary instruments 150 IS/ISO 21672-1:2012 Dentistry Periodontal probes Part 1: General requirements (First Revision)

151 IS/ISO 21672-2:2012 Dentistry Periodontal probes Part 2: Designation 152 IS 18495:2024 Dentistry - Dental Amalgam 153 IS/ISO 27020:2019 Dentistry Brackets and tubes for use in orthodontics 154 IS 3875:1983 Specification for hot plate, wax levelling, dental 155 IS 3876:1985 Specification for knife, plaster, dental 156 IS 3877:2025 Dental Wax Knife - Specification 157 IS 3877:1967 Specification for wax knife, dental 158 IS 3878:1967 Specification for plaster shears, dental 159 IS 3887:2024 Cutting Type Dental Instruments ' General Requirements 160 IS 3889:1985 Specification for chisels, dental 161 IS 3890 (Part 1):1986 Specification for instruments, plastic filling, dental: Part 1 designation numbers 1, 3, 4, 5 and 6 162 IS 3890 (Part 2):1967 Specification for instruments, plastic filling, dental: Part ii designation numbers 12, 20, 21, 46, 47, 153 and 183 163 IS 4316:1991 Orthodontic pliers, snipe nose - Shape,dimensions and tests 164 IS 4319 (Part 2):1986 Specification for pliers, stretching and contouring, dental: Part 2 pliers, contouring ( 165 IS 4714:1985 Specification for scalers, dental, No. Sc 1/2, 3/4 and 5/6 166 IS 4715:2024 Dental Excavators 167 IS 4975:1986 Specification for elevators, dental, No. 1, 2 and 3 168 IS 5004:2024 Dental Cutting Spoons 169 IS 5005:2024 Dental Burnishers 170 IS 5017:2024 Dental Carvers 171 IS 5178:1969 Specification for gingival margin trimmers, dental, No. GMT 1/2, 3/14, 5/6 and 718 172 IS 5181:1969 Specification for press, flask, dental 173 IS 5185:2024 Dental Articulators 174 IS 5211:1969 Specification for scissors, dental No. 1, straight and curved on flat 175 IS 5212:1969 Specification for scissors,crown, dental, straight and curved on flat 176 IS 5217:1969 Specification for clamp, flask, dental 177 IS 5227:2024 Dental Flasks 178 IS 5576:1985 Specification for carriers, amalgam, dental, No. 1 and 2 179 IS 5582:1986 Specification for mandrels, dental, No. 1, 2 and 3 180 IS 5763:1970 Specification for occlusal plane guide, dental 181 IS 5794:1986 Specification - For pliers, pin - Roughening and bending, dental ( 182 IS 5795:1991 Orthodontic pliers, Crown and ligating, Howe's pattern - Shape, dimensions and tests 183 IS 6020:2022 Dentistry Intra-oral mirrors 184 IS 6038:1979 Specification for dental impression (Modellinc) compound 185 IS 6116 (Part 1):2021/ ISO 7494-1:2018 Dentistry - Stationary dental units and dental patient chairs Part 1: General requirements 186 IS 6116 (Part 2):2024/ ISO 7494-2:2022 Dentistry - Stationary dental units and dental patient chairs Part 2 Air, water, suction and wastewater systems 187 IS 6292:1986 Specification for cotton wool holder, dental 188 IS/ISO 6360-1:2004 Dentistry -- Number coding system for rotary instruments -- Part 1: General characteristics 189 IS/ISO 6360-2:2004 Dentistry - Number Coding System For Roatry Instruments Part 2 Shapes 190 IS/ISO 6360-5:2007 Dentistry Number coding system for rotary instruments Part 5: Specific characteristics of root-canal instruments 191 IS 6815:2025 Dental Matrix Retainers - Specification 192 IS 6822:1972 Cutter, Distal Arch Wire, Dental 193 IS 6829:1991 Dental instruments - Orthodontic pliers, angle wire bending - Shape, dimensions and tests ( ) (Second Revision) (First Revision) (First Revision) (First Revision) (Second Revision) (First Revision) (First Revision) (First Revision) First Revision) (First Revision) (First Revision ) (First Revision) (First Revision) (First Revision) (First Revision) (First Revision) (First Revision) (First Revision) (First Revision) First Revision) (Second Revision) (First Revision) (First Revision) (First Revision) First Revision

194 IS 6846:1972 General requirements for control unit for airturbine, dental 195 IS 6870:1986 Specification for pliers, loop bending, dental 196 IS/ISO 6873:2013 Dentistry - Gypsum products 197 IS/ISO 6876:2012 Dentistry - Root canal sealing materials 198 IS 6882 (Part 2):2018 Dentistry - Base Polymers Part 2 Orthodontic Base Polymers 199 IS 6887 (Part 2):2018 Dentistry - Base Polymers Part 2 Orthodontic Base Polymers 200 IS/ISO 6887-1:2018 Dentistry - Base Polymers Part 1 Denture Base Polymers 201 IS 7066:2025 Dental Instrument-Cabinet Trays - Specification 202 IS 7066:1973 Specification for trays, instrument - Cabinet, dental 203 IS 7333:1991 Orthodontic pliers, spring forming - Shape and dimensions 204 IS 7334:1988 Specification for pliers, clasp adjusting, dental 205 IS 7335:1974 Specification for pliers, closing loop, nance type, dental 206 IS 7338:1991 Orthodontic pliers, band removing, posterior - Shape and dimensions 207 IS 7340:1974 Specification for pliers, pin and ligature cutting, dental 208 IS 7425:1974 Specification for dental casting investment for gold alloys 209 IS 7467:1974 Specification for bands, matrix, dental, No. 1 and 2 210 IS 7474:1986 Specification for pliers, collar, dental 211 IS 7476:1974 Specification for nippers, cutting, dental 212 IS 7676:1975 Specification for chisel, osseous, dental 213 IS 7677:1986 Specification for exolevers, apical, dental 214 IS 7780:1975 Specification for pliers, ligature forming, dental 215 IS 7781:1975 Specification for pliers, angle ribbon arch with groove, dental 216 IS/ISO 7786:2001 Dental rotary instruments Laboratory abrasive instruments 217 IS 7833:1975 Specification for knives, Gingivectomy, Dental 218 IS 7853:1975 Specification for surveyor, cast, dental 219 IS 8021:2024 Dental Sticky Wax ( ) 220 IS 8284:1976 Pusher, Band, Dental, Mershon's Pattern 221 IS 8287:1986 Specification for pliers, band stretching and contouring, parrot beak, denta 222 IS 8346:2018 Dentistry - Operator's Stool 223 IS 8528:1988 Specification for pliers, anterior band forming, double beak, dental 224 IS 8529:1989 Dentalinstruments - Pliers,posterior band forming,double beak specification 225 IS 8815:2019 Dentistry - Designation system for teeth and areas of the oral cavity 227 IS 8864:1978 Specification for autopolymerizing (Acrylic) resins for dental use 228 IS 8948:1989 Dental instruments - Pliers, ligature tying - Specification 229 IS 8949:1989 Dental Instruments - Pliers, Curved, Howe's Pattern 230 IS 9003:2024 Acrylizer (Curing Unit) - Specification 231 IS 9699:1981 Specification for chisel, dental, large 232 IS 9717:1980 Specification for trays, impression, dental 233 IS 9774:1981 Specification for pliers, bracket opening, dental 234 IS/ISO 9917-1:2007 Dentistry - Water-Based Cements Part 1 Powder/Liquid Acid-Base Cements 235 IS/ISO 9917-2:2017 Dentistry - Water - Based cement: Part 2 resin - Modified cements (First Revision) (First Revision) (First Revision) ( First Revision ) (First Revision) ( First Revision ) (First Revision) (First Revision) (First Revision) (First Revision) (First Revision) First Revision l (First Revision) ( Second Revision ) (First Revision) (First Revision) (Second Revision) (First Revision) (First Revision) ( First Revision ) (First Revision) Category 9: Assistive Products including Rehabilitation Appliances, Orthotic and Prosthetic Items Sectional Committee (MHD 09) S. No. IS No Title

1 IS 10110:1982 Specification for table spoon terminal device for artificial limbs 2 IS 10111:1982 Specification for table fork terminal device for artificial limbs 3 IS 10537:1983 Specification for ankle bolt for sach foot 4 IS 10538:1983 Specification for kitchen knife terminal device for artificial limbs 5 IS 10539:1983 Specification for sickle terminal device for artificial limbs 6 IS 10926:1984 Specification for tweezer terminal device for artificial limbs 7 IS 10928:1984 Specification for table, tilting, manual 8 IS 10929:1984 Specification for hook voluntary opening terminal device for artificial limbs 9 IS 10976:1993 Wheelchairs - Nomenclature, terms and definitions 10 IS 11242:1985 Specification for lumbo - Sacral flexion - Extension and lateral - Flexion control brace 11 IS 11243:1985 Specification for thoraco - Lumbo - Sacral flexion - Extension and lateral - Flexion control brace 12 IS 11279:2024 Braille Slate ' Specification ( ) 13 IS 11316:1985 Specification for cosmetic hand, artificial limb 14 IS 11646 (Part 1):2003 Cane for visually handicapped - Specification: Part 1 rigid, long and white ( ) 15 IS 11646 (Part 2):1986 Specification for cane for visually handicapped: Part 2 folding type 16 IS 11647:1986 Specification for braille paper 17 IS 11708:1986 Specification for hand, mechanical 18 IS 12104:1987 Specification for abacus for visually handicapped 19 IS 12152:1987 Specification for pocket frame, braille writing 20 IS 12184:1987 Specification for stylus for braille writing 21 IS 12439:1988 Specification for signature guide for visually impaired 22 IS 12664 (Part 1):2003 Artificial limbs - Sach foot for lower extremity prostheses: Part 1 design and dimensions ( ) 23 IS 12683 (Part 1):1989 Measuring devices for visually impaired persons - Specification: Part 1 scale, general purposes 24 IS 12683 (Part 2):1989 Artificial limbs - Measuring devices for visually impaired persons: Part 2 type 25 IS 12683 (Part 3):2000 Measuring devices for visually impaired persons - Specification: Part 3 goniometer 26 IS 13017:1991 Rehabilitation equipment - Walker rollator - Specification 27 IS 13822:1993 Braille duplicating sheet specification 28 IS 13837:1993 Braille duplicating machine specification 29 IS 13970 (Part 1):2023 Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses ( 30 IS 13970 (Part 2):2023 Prosthetics and orthotics Vocabulary Part 2: Terms relating to external limb prostheses and wearers of these prostheses ( ) 31 IS 13970 (Part 3):2023 Prosthetics and orthotics Vocabulary Part 3: Terms relating to orthoses ( ) 32 IS 14429:1997 Braille shorthand machine - Specification 33 IS 14723:1999 Artificial limbs - Knee shin assembly - Specification 34 IS 14879:2000 Anterior spinal hyperextension (ASH) brace - Specification 35 IS 15376 (Part 1):2003 Ostomy collection bags: Part 1 vocabulary 36 IS 15376 (Part 2):2003 Ostomy collection bags: Part 2 requirements and test methods 37 IS/ISO 16021:2000 Urine-Absorbing Aids - Basic Principles for Evaluation of Single-Use Adult-Incontinence- Absorbing Aids from the Perspective of Users and Caregivers 39 IS 17063:2018 Specification for rehabilitation equipment - rough terrain active wheelchairs, folding, rider - I, adult and child size 40 IS 17154:2024 Battery Operated Motorized Tricycle - Specification ( ) 41 IS 17155:2019 Tricycle, Single hand propelled (Right/Left) (Junior Size) - Specification 42 IS 17155:2025 Tricycle Single Hand Propelled (Right/Left) (Junior Size) - Specification ( ) 43 IS 17157:2019 Multi utility tricycle - specification 44 IS 17194:2019 Surgical ankle boot with broad toe (Child And Adult Size) - Specification (First Revision) First Revision First Revision First Revision First Revision) First Revision First Revision First Revision First revision

45 IS 18295:2023 Assistive products for persons with vision impairments and persons with vision and hearing impairments Acoustic and tactile signals for pedestrian traffic lights 46 IS 18296:2023 Assistive products for blind and vision-impaired persons Tactile walking surface indicators 49 IS 18558 (Part 1):2025 Assistive products for walking manipulated by one arm ' Requirements and Methods of Test Part 1 Elbow crutches 50 IS 18558 (Part 4):2025 Walking aids manipulated by one arm ' Requirements and test methods Part 4 Walking sticks with three or more legs (ISO 11334-4 : 1999, MOD) 51 IS 18559 (Part 1):2024 Tips for assistive products for walking Requirements and test methods Part 1: Friction of tips 52 IS 18559 (Part 2):2024 Tips for assistive products for walking Requirements and test methods Part 2: Durability of tips for crutches 53 IS 18560:2024 Assistive products Classification and terminology 54 IS 18651 (Part 1):2024 Wheelchairs Part 1: Determination of static stability 55 IS 18651 (Part 2):2024 Wheelchairs Part 2: Determination of dynamic stability of electrically powered wheelchairs 56 IS 18651 (Part 3):2024 Wheelchairs Part 3: Determination of effectiveness of brakes 57 IS 18651 (Part 4):2024 Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range 58 IS 18651 (Part 5):2024 Wheelchairs Part 5: Determination of dimensions mass and manoeuvring space 59 IS 18651 (Part 6):2024 Wheelchairs Part 6: Determination of maximum speed of electrically powered wheelchairs 60 IS 18651 (Part 7):2024 Wheelchairs Part 7: Measurement of seating and wheel dimensions 61 IS 18651 (Part 8):2025 Wheelchairs Part 8: Requirements and test methods for static impact and fatigue strengths 62 IS 18651 (Part 9):2024 Wheelchairs Part 9: Climatic tests for electric wheelchairs 63 IS 18651 (Part 10):2024 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs 64 IS 18651 (Part 11):2024 Wheelchairs Part 11: Test dummies 65 IS 18651 (Part 13):2024 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces 66 IS 18651 (Part 15):2024 Wheelchairs Part 15: Requirements for information disclosure documentation and labelling 67 IS 18651 (Part 19):2024 Wheelchairs Part 19: Wheelchairs for use as seats in motor vehicles 68 IS 18651 (Part 21):2025 Wheelchairs Part 21 Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters and battery chargers 69 IS 18651 (Part 22):2025 Wheelchairs Part 22 Set-up procedures 70 IS 18651 (Part 25):2025 Wheelchairs Part 25 Lead-acid batteries and chargers for powered wheelchairs Requirements and test methods 71 IS 18651 (Part 28):2025 Wheelchairs Part 28 Requirements and test methods for stair-climbing devices 72 IS 18651 (Part 30):2025 Wheelchairs Part 30 Wheelchairs for changing occupant posture Test methods and requirements 73 IS 18653 (Part 1):2024 Assistive products for walking manipulated by both arms Requirements and test methods Part 1: Walking frames 74 IS 18653 (Part 2):2024 Assistive products for walking manipulated by both arms - Requirements and test methods Part 2 Rollators 75 IS 18653 (Part 3):2024 Walking aids manipulated by both arms Requirements and test methods Part 3: Walking tables 76 IS 18660:2024 Accessible design Auditory guiding signals in public facilities 77 IS 18665:2024 Prosthetics ' Structural testing of lower-limb prostheses ' Requirements and test methods 78 IS 18831:2024 Assistive products for personal hygiene that support users - Requirements and Methods of Test 79 IS 19189:2025 Accessible design Information contents figuration and display methods of tactile guide maps 80 IS 19190:2025 Accessible Design Application of Braille on Signage Equipment and Appliances 81 IS/ISO 21856:2022 Assistive products General requirements and test methods 82 IS/ISO 22523:2006 External limb prostheses and external orthoses - Requirements and test methods 83 IS/ISO 22675:2016 Prosthetics - Testing of ankle - Foot devices and foot units - Requirements and test methods 84 IS 4534:1980 Specification for adapter for terminal devices, artificial limbs (First Revision) 85 IS 4535:1968 Specification for saw - Grip terminal device for artificial limbs 86 IS 4554:1968 Specification for hammers terminal devices, ball pein and claw, for artificial limbs 87 IS 4555:1980 Specification for biprong terminal device, draughtsman, for artificial - Limbs ( ) 88 IS 4556:1968 Specification for typing finger terminal device for artificial limbs 89 IS 4567:1968 Specification for pliers terminal device, quick - Grip, for artificial limbs First Revision

90 IS 4577:1980 Specification for spade - Grip terminal device for artificial limbs ( ) 91 IS 4609:1980 Specification for pencil - Holding device for artificial limbs ( ) 92 IS 4675:1968 Specification for light split - Hook device for artificial limbs 93 IS 4677:1968 Specification for steering appliance for artificial limbs 94 IS 5015:1969 Specification for knife - Terminal device for artificial limbs 95 IS 5143:2024 Adjustable Axillary Crutches -ƞ Specification ( ) 96 IS 5144:1980 Specification for metal forearm crutches (Canadian Pattern) ( ) 97 IS 5145:1969 Specification for walking sticks 98 IS 5150:1969 Specification for rubber tips for crutches and walking sticks 99 IS 5586:1970 Specification for metal component for sectional forearm 100 IS 5594:1983 Specification for wrist unit, rotary, for hand prosthesis ( ) 101 IS 5603:1983 Specification for mechanical elbow joint ( 102 IS 5607:1970 Specification for semi - Automatic elbow joint 103 IS 5665:1982 Specification for shoulder wheel ( ) 104 IS 5745:1986 Specification for heel socket and plate for orthosis ( ) 105 IS 5796:1970 Specification for disc type weight set for physio - Therapy exercisers other than pulley arrangements 106 IS 5809:1986 Specification for ankle joint for orthosis ( ) 107 IS 5810:1986 Specification for knee joint with lock for orthosis ( ) 108 IS 5827:1982 Specification for paraffin wax bath ( ) 109 IS 5956:1986 Specification for hip joint with lock for orthosis ( ) 110 IS 5963:1971 Specification for knee joint without lock for steel orthopaedic calipers 111 IS 5964:1971 Specification for round spur for orthopaedic calipers 112 IS 6069:1971 Specification for sliding seat exerciser 113 IS 6099:1991 Rehabilitation equipement - Invalid walkers with crutches - Specification ( ) 114 IS 6205:1982 Specification for stationary cycle exerciser for adults ( ) 115 IS 6221:1971 Specification for pelvic band for steel orthopaedic calipers and braces 116 IS 6222:1971 Specification for thigh band for orthopaedic calipers and braces 117 IS 6223:1971 Specification for calf band for orthopaedic calipers and braces 118 IS 6224:1980 Specification for tuber band for orthopaedic calipers and braces 119 IS 6275:1971 Specification for lower extremity full length brace with joints with locks 120 IS 6302:1971 Specification for whirlpool bath 121 IS 6414:1972 Specification for parallel walking bars, adult and child sizes, for the handicapped 122 IS 6571:1991 Rehabilitation equipment - Wheelchairs, non - Folding, adult size, institutional model - Specification ( ) 123 IS 6624:1972 Specification for basic hand splint, palmar arch support 124 IS 6625:1972 Specification for basic hand splint component 125 IS 6626:1972 Specification for basic hand splint, forearm piece 126 IS 6781:1972 Specification for staple ankle joint 127 IS 6802:1986 Specification for prosthetic hip joint ( ) 128 IS 6809:1990 Rehabilitation equipment - Fixed height walking frame - Specification ( ) 129 IS 6810:1990 Rehabilitation equipment - Metal tripod and tetrapod sticks - Specification ( ) 130 IS 6812:2003 Knee joint, uniaxial for below knee prostheses - Specification ( ) 131 IS 6979:1973 Specification for cerebral palsy chai, tubula, institutional model 132 IS 6992:1982 Specification for cerebral palsy chair, domestic model ( ) First Revision First Revision Third Revision First Revision First Revision First Revision) First Revision First Revision First Revision First Revision First Revision First Revision Second Revision First Revision First Revision First Revision First Revision First Revision Second Revision First Revision

133 IS 6993:1973 Specification for pan knee joint 134 IS 6995:1973 Specification for cruciform below - Knee joint 135 IS/ISO 7176-26:2007 Wheelchairs: Part 26 vocabulary 136 IS 7373:2003 Hip disarticulation joint unit for lower limb prosthetic fitments - Specification ( ) 137 IS 7419:1983 Requirements for stairs for physical rehabilitation ( ) 138 IS 7454:2024 Rehabilitation Equipment - Wheelchairs, Folding, Adult Size - Specification ( ) 139 IS 7924:1976 Specification for thigh blocks, wooden 140 IS 8086:2024 Rehabilitation Equipment - Wheelchairs, Folding, Junior Size - Specification ( ) 141 IS 8088:2019 Tricycle, hand propelled - specification ( ) 142 IS 8088:2025 Tricycle Hand Propelled - Specification ( ) 143 IS 8492:1985 Specification for ankle blocks, wooden ( ) 144 IS 8511:1985 Specification for valves for suction socket for artificial limbs ( ) 145 IS/ISO 8669-2:1996 Urine Collection Bags Part 2 Requirements and Test Methods 146 IS 8798:1978 Specification for wheel, multipurpose 147 IS 9471 (Part 1):1980 Specification for modular lower limb orthotic components: Part 1 stirrups 148 IS 9471 (Part 2):1980 Specification for modular lower limb orthotic components: Part 2 stirrups, split 149 IS 9471 (Part 3):2024 Modular Lower Limb Orthotic Components -ƞ Specification Part 3 Stirrup Plates ( ) 150 IS 9471 (Part 4):2024 Modular Lower Limb Orthotic Components -ƞ Specification Part 4 Joint Unit, Ankle ( ) 151 IS 9471 (Part 5):1980 Specification for modular lower limb orthotic components: Part 5 joint unit, knee 152 IS 9471 (Part 5/Sec 2):2019 Specification for modular lower limb orthotic components: Part 5 joint unit section 2 standard knee 153 IS 9471 (Part 6):2024 Modular Lower Limb Orthotic Components -ƞ Specification Part 6 Orthotic Hip Joint (Joint Unit, Hip Drop Lock) ( ) 154 IS 9471 (Part 7):2024 Modular Lower Limb Orthotic Components -ƞ Specification Part 7 Orthotic Joint Bars, Ankle and Knee (Upper and Lower) ( ) 155 IS 9797:1981 Specification for cycle, fret - Saw 1 IS 10269:2024 Medical Laboratory Glass Apparatus - Haemocytometer - Specification ( ) 2 IS 10867:2018 Single - Use containers for human venous blood specimen collection ( ) 3 IS 11383:1985 Specification for thin walled glass capillary pipettes 4 IS 12622:1989 Medical thermometers for hypothermia, subnormal range - Specification 5 IS 14284:1995 Laboratory glassware - Disposable pasteur pipettes - Specification 6 IS 18298:2023 Clinical Laboratory Testing and in Vitro Medical Devices Requirements for in Vitro Monitoring Systems for Self-Testing of Oral Anticoagulant Therapy ( ) 7 IS 3055 (Part 1):1994 Clinical thermometers: Part 1 solid stem type - Specification ( ) 8 IS 3055 (Part 2):2004 Clinical thermometers: Part 2 enclosed scale type - Specification ( ) 9 IS 3740:2024 Medical Laboratory Glassware Glass Tubes for Pathology Work - Specification ( 10 IS 3741 (Part 1):1990 Medical instruments sedimentation tubes - Specification: Part 1 westergren tube ( ) 11 IS 3741 (Part 2):1990 Medical glass instruments - Sedimentation tubes - Specification: Part 2 wintrobe tube ( ) 12 IS 3742:1990 Medical glass instruments - Pipettes, dilution for haemocytometers specification ( ) 13 IS 4067:1967 Specification for tube, swab (West Type), for throat 14 IS 4069:2024 Medical Laboratory Glassware - Urinometer - Specification ( ) 15 IS 4087:2024 Medical Laboratory Glassware Pipette for Haemoglobinometer and Blood Pipette for Biochemical Work - Specification ( ) 16 IS 4364:2024 Medical Laboratory Glassware Serological Pipettes - Specification ( ) 17 IS 4381:1967 Specification for pathological microscope 18 IS 4444:2024 Medical Laboratory Glassware -Bacteriological Bottles -Specification ( ) Second Revision First Revision Second Revision Second Revision First Revision Second revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision Second Revision Third Revision First Revision) Second Revision Second Revision Second Revision First Revision Second Revision First Revision First Revision Category 10: Medical Laboratory Instruments (MHD 10) S. No. IS No Title

19 IS 4529:1968 Specification for glass tubes for medical thermometers 20 IS 4708:2024 Medical Laboratory Glassware - Conical Urine Glass - Specification ( ) 21 IS 4754:2024 Medical Laboratory Glassware - Staining Troughs and Jar - Specification ( ) 22 IS 5155:1969 Specification for pipettes, ostwald - Folin type 23 IS 6606:2024 Medical Laboratory Glass Apparatus Esbachs Albuminometer Specification First Revision 24 IS 6942:1973 Specification for flask, roux, bacteriological, with or without offset neck (1000 Ml Nominal Capacity) 25 IS 6943:2024 Medical Laboratory Glassware - Cover Glass used with Haemocytometer - Specification ( ) 26 IS 6944:1973 Specification for bottle, bijou, bacteriological 27 IS 7039:1973 Specification for tube, culture, screw cap 28 IS 7183:1973 Specification for flask, culture, haffkine 29 IS 8501:1977 Specification for anaerobic jar 30 IS 9430:1980 Specification for tube, haemometer 1 IS/ISO 10524-3:2019 Pressure regulators for use with medical gases- Part 3: Pressure regulators integrated with cylinder valves VIPRs ( ) 2 IS/ISO 10524-4:2008 Pressure regulators for use with medical gases: Part 4 low - Pressure regulators 3 IS/ISO 18697-4:2024 Lung Ventilators Part 4 Particular Requirements for User-œ Powered Resuscitators (ISO 10651-4 : 2023, MOD) ( ) 4 IS/ISO 10651-5:2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance: Part 5 gas - Powered emergency resuscitators 5 IS/ISO 11197:2019 Medical Supply Units ( ) 6 IS 11378:2002/ ISO 5358 Anaesthetic machines for use with humans ( ) 7 IS 12417:1988 Specification for suction apparatus, pedal operated 8 IS 13200:2023/ ISO 4135:2022 Anaesthetic and Respiratory Equipment Vocabulary ( ) 9 IS 13450 (Part 2/Sec 12):2023 Medical Electrical Equipment Part 2 Particular requirements for basic safety and essential performance Section 12 Critical care ventilators ( ) 10 IS 13450 (Part 2/Sec 13):2024/ ISO 80601-2-13:2022 Medical Electrical Equipment: Part 2 Particular Requirements for the Basic Safety and Essential Performance: Sec 13 Anaesthetic Workstation ( ) 11 IS 13450 (Part 2/Sec 55):2025/ ISO 80601-2-55:2018 Medical Electrical Equipment Part 2 Particular Requirements for The Basic Safety and Essential Performance Section 55 Respiratory Gas Monitors 12 IS 13450 (Part 2/Sec 67):2025/ ISO 80601-2-67:2020 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 67 Oxygen-Conserving Equipment 13 IS 13450 (Part 2/Sec 70):2022/ ISO 80601-2-70:2020 Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 70 : Sleep apnoea breathing therapy equipment 14 IS 13450 (Part 2/Sec 72):2025/ ISO 80601-2-72:2023 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 72 Home Healthcare Environment Ventilators for Ventilator-Dependent Patients 15 IS 13450 (Part 2/Sec 74):2025/ ISO 80601-2-74:2021 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 74 Respiratory Humidifying Equipment 16 IS 13450 (Part 2/Sec 79):2023/ ISO 80601-2-79:2018 Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 79 - Ventilatory support equipment for ventilatory impairment 17 IS 13450 (Part 2/Sec 80):2023/ ISO 80601-2-80:2018 Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 80 - Ventilatory support equipment for ventilatory insufficiency 18 IS 13450 (Part 2/Sec 84):2023/ ISO 80601-2-84:2020 Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 84 Ventilators for emergency medical services environment 19 IS 13450 (Part 2/Sec 90):2025/ ISO 80601-2-90:2021 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 90 Respiratory High-flow Therapy Equipment 20 IS/ISO 14408:2005 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information 21 IS/ISO 15001:2010 Anaesthetic and respiratory equipment - Compatibility with oxygen ( ) 22 IS/ISO 15002:2008 Flow - Metering devices for connection to terminal units of medical gas pipeline systems 23 IS/ISO 18467:2024 Anaesthetic and Respiratory Equipment -ƞ Tracheobronchial Tubes ( ) 24 IS 17426:2020 ICU Ventilators for use in COVID-19 - Specification First Revision First Revision Second Revision First Revision First Revision First Revision First Revision Second Revision First Revision First Revision First Revision First Revision Category 11: Anesthetic, Resuscitation and Allied Equipment (MHD 11) S. No. IS No Title

25 IS 17587:2021 Specification for Pedal operated resuscitator 26 IS 17625 (Part 2/Sec 69):2021/ ISO 80601-2-69 : 2020 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 69 Oxygen Concentrator Equipment 27 IS 17812 (Part 1):2022/ ISO 9170-1:2017 Terminal Units for Medical Gas Pipeline Systems : Part 1 Terminal Units for use with Compressed Medical Gases and Vacuum ( ) 28 IS 18306:2023 Pneumatic Tourniquet- Specification 29 IS 18360:2023/ ISO 18082 : 2014 Anaesthetic and Respiratory Equipment Dimensions of Non-Interchangeable Screw-Threaded NIST Low-Pressure Connectors for Medical Gases 30 IS 18361 (Part 1):2023/ ISO 10524-1 : 2018 Pressure Regulators for use with Medical Gases : Part 1 Pressure Regulators and Pressure Regulators with Flow-Metering Devices first revision 31 IS 18361 (Part 2):2023/ ISO 10524-2 : 2018 Pressure Regulators for use with Medical Gases Part 2 Manifold and line pressure regulators ( ) 32 IS 18375 (Part 1):2023/ ISO 10079-1:2022 Medical Suction Equipment Part 1 Electrically Powered Suction Equipment 33 IS 18375 (Part 2):2023/ ISO 10079-2:2022 Medical Suction Equipment Part 2 Manually Powered Suction Equipment ( ) 34 IS 18375 (Part 3):2023/ ISO 10079-3:2022 Medical Suction Equipment Part 3 Suction Equipment Powered from a Vacuum or Positive pressure Gas Source ( ) 35 IS 18375 (Part 4):2025/ ISO 10079-4: 2021 Medical Suction Equipment Part 4: General Requirements 36 IS 18377:2024/ ISO 5366:2016 Anaesthetic and Respiratory Equipment Tracheostomy Tubes and Connectors 37 IS 18460:2024/ ISO 8836:2019 Suction Catheters for Use in the Respiratory Tract 38 IS 18691:2024/ ISO 5367 : 2023 Anaesthetic and Respiratory Equipment-Breathing Sets and Connectors 39 IS 18696:2024/ ISO 5364 : 2016 Anaesthetic and Respiratory Equipment- Oropharyngeal Airways 40 IS 18766 (Part 1):2025/ ISO 18562-1: 2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process 41 IS 18766 (Part 2):2024/ ISO 18562-2:2024 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications Part 2: Tests for Emissions of Particulate Matter 42 IS 18766 (Part 3):2025/ ISO 18562-3:2024 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications Part 3: Tests for Emissions of Volatile Organic Substances 43 IS 18766 (Part 4):2025/ ISO 18562-4:2024 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications Part 4: Tests for Leachables in Condensate 44 IS 18772 (Part 2/Sec 87):2024 / ISO 80601-2-87: 2021 Medical electrical equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 87 High Frequency Ventilators 45 IS 18784:2024/ ISO 17510: 2015 Medical Devices ' Sleep Apnoea Breathing Therapy - Masks and Application Accessories 46 IS 18785:2024/ ISO 23368: 2022 Anaesthetic and Respiratory Equipment - Low-Flow Nasal Cannulae for Oxygen Therapy 47 IS 18805:2024/ ISO 5359:2014 Anaesthetic and Respiratory Equipment Low-Pressure Hose Assemblies for Use with Medical Gases 48 IS 18827:2024/ ISO 5361:2023 Anaesthetic and respiratory equipment Tracheal tubes and connectors 49 IS 18834:2024/ ISO 11712:2023 Anaesthetic and respiratory equipment Supralaryngeal airways and connectors 50 IS 19133 (Part 2):2025/ ISO 9360-2:2001 Anaesthetic and respiratory equipment Heat and moisture exchangers HMEs for humidifying respired gases in humans Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml 51 IS 19150:2025/ ISO 26825:2020 Anaesthetic and Respiratory Equipment User-Applied Labels for Syringes Containing Drugs Used During Anaesthesia - Colours Design and Performance 52 IS 19171:2025/ ISO 18190:2016 Anaesthetic and Respiratory Equipment ' General Requirements for Airways and Related Equipment 53 IS 19186 (Part 2):2025/ ISO 23328-2:2002 Breathing System Filters for Anaesthetic and Respiratory Use Part 2: Non-Filtration Aspects 54 IS 19187:2025/ ISO 19223:2019 Lung Ventilators and Related Equipment - Vocabulary and Semantics 55 IS 19227 (Part 1):2025/ ISO 23328-1:2003 Breathing System Filters for Anaesthetic and Respiratory Use Part 1: Salt Test Method to Assess Filtration Performance 56 IS 19228 (Part 1):2025 /ISO 9360-1:2000 Anaesthetic and respiratory equipment Heat and moisture exchangers HMEs for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 ml 57 IS/ISO 26782:2009 Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans 58 IS/ISO 27427:2013 Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components 59 IS 3390:1988 Specification for sphygmomanometers, mercurial ( ) 60 IS 3391:1965 Specification for stethoscopes 61 IS 3393:2024 Mouth Props and Airways (London Hospital Pattern) - Specification ( ) 62 IS 4113:2022 / ISO 7376:2020 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation 63 IS/ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors: Part 1 cones and sockets ( ) 64 IS/ISO 5356-2:2012 Anaesthetic and respiratory equipment - Conical connectors: Part 2 screw - Threaded weight - Bearing connectors 65 IS/ISO 5362:2006 Anaesthetic reservoir bags 66 IS/ISO 5364:2008 Anaesthetic and respiratory equipment - Oropharyngeal airways First Revision First Revision Second Revision Second Revision Second Revision First Revision First Revision

67 IS 5622:1970 Soda-Lime Canisters for Use with Gas Anaesthetic Apparatus ( Waters' to-and-Fro) 68 IS 5680:1969 Specification for rubber tubing for medical use 69 IS 6190:1971 Specification for anaesthetic face masks 70 IS 6194:1971 Specification for intermittent positive pressure respirator, bag type, manually operated 71 IS 6207:1971 Specification for trolleys for oxygen cylinders 72 IS 7176:2024 Drawover Portable Type Anaesthetic Apparatus -ƞ Specification ( ) 73 IS 18466 (Part 1):2024 / ISO 7396-1:2016 Medical Gas Pipeline Systems Part 1: Pipeline Systems for Compressed Medical Gases and Vacuum ( ) 74 IS/ISO 7396-2:2007 Medcal gas pipelines systems: Part 2 gas scavenging disposal systems 75 IS 7625:1975 Gag, Mouth, Doyen's Pattern 76 IS 7652:1988 Specification for sphygmomanometer, aneroid type ( ) 77 IS 7885:2025 Macintosh Pattern's Spray - Specification ( ) 78 IS 7885:1985 Spray, Macintosh's Pattern 79 IS/IEC 80601-2-30:2018 Medical electrical equipment: Part 2 - 30 particular requirements for basic safety and essential performance of automated non - Invasive sphygmomanometers 80 IS/ISO 81060-1:2007 Non - Invasive sphygmomanometers: Part 1 requirements and test methods for non - Automated measurement type 81 IS/ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type 82 IS 8254 (Part 1):2024 Valve, Non-Rebreathing ' Specification Part 1 Ruben's Pattern ( ) 83 IS 8254 (Part 2):2024 Valve, Non-Rebreathing - Specification Part 2 Ambu-Hesse's Pattern ( ) 84 IS 8312:2025 Forceps of Magill's Pattern to Place Endotracheal Tube - Specification ( ) 85 IS 8312:1977 Forceps, Introducing, Endotracheal Tube, Magill's Pattern 86 IS/ISO 9170-2:2008 Terminal units for medical gas pipeline systems: Part 2 terminal units for anaesthetic gas scavenging systems 87 IS 9462:1980 Specification for humidifier, nebulizing, ventury type 1 IS 10258 (Part 1):2022/ ISO 7886-1:2017 Sterile hypodermic syringes for single use Part 1: Syringes for manual use ( ) 2 IS 10258:2002/ ISO 7886-1 Sterile hypodermic syringes for single use ( ) 3 IS 10258 (Part 2):2024/ ISO 7886-2:2020 Sterile hypodermic syringes for single use Part 2 Syringes for use with power-driven syringe pumps 4 IS 10258 (Part 3):2021/ ISO 7886-3:2020 Sterile hypodermic syringes for single use Part 3 Auto-disabled syringes for fixed-dose immunization First Revision 5 IS 10258 (Part 4):2024/ ISO 7886-4:2018 Sterile Hypodermic Syringes for Single Use Part 4 Syringes with Re-use Prevention Feature 6 IS/ISO 10555-3:2013 Intravascular catheters - Sterile and single - Use catheters: Part 3 central venous catheters ( ) 7 IS/ISO 10555-5:2013 Intravascular catheters - Sterile and single - Use catheters: Part 5 over - Needle peripheral catheters ( ) 8 IS 10654:2018/ ISO 7864 : 2016 Sterile hypodermic needles for single use - Requirements and test methods ( ) 9 IS 11040 (Part 1):2015 Prefilled syringes Part 1 : Glass cylinders for dental local anaesthetic cartridges 10 IS/ISO 11040-2:2011 Prefilled syringes Part 2 Plunger stoppers for dental local anaesthetic cartridges 11 IS/ISO 11040-3:2012 Prefilled syringes Part 3 Seals for dental local anaesthetic cartridges 12 IS/ISO 11040-4:2015 Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling 13 IS/ISO 11040-5:2012 Prefilled syringes Part 5 Plunger stoppers for injectables 14 IS 11043:1984 Specification for needle, epidural 15 IS/ISO 11135:2014 Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices 16 IS/ISO 11137-1:2006 Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices 17 IS/ISO 11137-2:2013 Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose 18 IS/ISO 11137-3:2017 Sterilization of Health Care Products -¢ Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control 19 IS/ISO 11138-1:2017 Sterilization of Health Care Products -¢ Biological Indicators Part 1 General Requirements Second Revision First Revision First Revision Second Revision First Revision First Revision First Revision Third Revision Second Revision First Revision First Revision Fourth Revision Category 12: Hospital Equipment and Surgical Disposable Products (MHD 12) S. No. IS No Title

20 IS/ISO 11138-2:2017 Sterilization of Health Care Products -¢ Biological Indicators Part 2 Biological Indicators for Ethylene Oxide Sterilization Processes 21 IS/ISO 11138-3:2017 Sterilization of Healthcare Products -¢ Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes 22 IS/ISO 11138-4:2017 Sterilization of Health Care Products -¢ Biological Indicators Part 4 Biological Indicators for Dry Heat Sterilization Processes 23 IS/ISO 11138-5:2017 Sterilization of Health Care Products -¢ Biological Indicators Part 5 Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes 24 IS/ISO 11140-3:2007 Sterilization of health care products - Chemical indicators: Part 3 class 2 indicator systems for use in the bowie and dick - Type steam penetration test 25 IS/ISO 11140-4:2007 Sterilization of health care products - Chemical indicators: Part 4 class 2 indicators as an alternative to the bowie and dick - Type test for detection of steam penetration 26 IS/ISO 11140-5:2007 Sterilization of health care products - Chemical indicators: Part 5 class 2 indicators for bowie and dick - Type air removal tests 27 IS/ISO 1135-3:2016 Transfusion equipment for medical use Part 3 Blood-taking sets for single use 28 IS/ISO 1135-4:2015 Transfusion Equipment for Medical Use Part 4 Transfusion Sets for Single use, Gravity Feed 29 IS/ISO 11418-1:2016 Containers and Accessories for Pharmaceutical Preparations Part 1 Drop-Dispensing Glass 30 IS/ISO 11418-2:2016 Containers and Accessories for Pharmaceutical Preparations Part 2 Screw-Neck Glass Bottles for Syrups 31 IS/ISO 11418-3:2016 Containers and Accessories for Pharmaceutical Preparations Part 3 Screw-Neck Glass Bottles ( Veral ) for Solid and Liquid Dosage Forms 32 IS/ISO 11418-5:2015 Containers and Accessories for Pharmaceutical Preparations Part 5 Dropper Assemblies 33 IS/ISO 11418-7:2016 Containers and Accessories for Pharmaceutical Preparations Part 7 Screw-Neck Vials Made of Glass Tubing for Liquid Dosage Forms 34 IS/ISO 11607:2019 Packaging for terminally sterilized medical devices -ƞ Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision 35 IS/ISO 11607-2:2019 Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision) 36 IS/ISO 11737-1:2018 Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products 37 IS/ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part 2 Tests of sterility performed in the definition validation and maintenance of a sterilization process 38 IS 12173:1987 Specification for cervical halter 39 IS 12227:2020/ ISO 8537 : 2016 Sterile Single-Use Syringes, With or Without Needle, for Insulin ( ) 40 IS 12430:1987 Safety code for installation, servicing maintenanceand of sterilizers 41 IS/ISO 13408-1:2008 Aseptic processing of health care products Part 1 General requirements 42 IS/ISO 13408-2:2018 Aseptic processing of health care products Part 2 Sterilizing filtration 43 IS 13422:2024/ ISO 10282:2023 Single-use Sterile Rubber Surgical Gloves ' Specification ( ) 44 IS 13422:1992 Disposable surgical rubber gloves specification 45 IS/ISO 13926-1:2018 Pen systems Part 1 Glass cylinders for pen-injectors for medical use 46 IS/ISO 13926-2:2017 Pen systems Part 2 Plunger stoppers for pen-injectors for medical use 47 IS B14316:1995 Swabs, Small, in Bag of 50 (Bi-lingual) 48 IS/ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices 49 IS 15113:2002 Clinical electrical thermometers with maximum device - Specification 50 IS 15354 (Part 1):2023/ ISO 11193-1:2020 Single-use medical examination gloves Part 1 Specification for gloves made from rubber latex or rubber solution Second Revision 51 IS/ISO 15378:2017 Primary Packaging Materials for Medicinal Products -ƞ Particular Requirements for the Application of ISO 9001 : 2015, with Reference to Good Manufacturing Practice (GMP) 52 IS 15537:2021/ ISO 9187-1:2018 Injection equipment for medical use Part 1 Ampoules for injectables ( ) 53 IS 15537 (Part 2):2023/ ISO 9187-2:2010 Injection equipment for medical use Part 2: One-point-cut OPC ampoules 54 IS/ISO 15883-1:2006 Washer - Disinfectors: Part 1 general requirements, terms and definitions and tests 55 IS/ISO 15883-2:2006 Washer - Disinfectors: Part 2 requirements and tests for washer - Disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc 56 IS/ISO 15883-3:2006 Washer - Disinfectors: Part 3 requirements and tests for washer - Disinfectors employing thermal disinfection for human waste containers 57 IS/ISO 15883-6:2011 Washer-disinfectors -Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment Second Revision First Revision First Revision

58 IS 16004:2024/ ISO 6009:2016 Hypodermic Needles for Single Use ' Colour Coding for Identification ( ) 59 IS 16097:2013 Sterile single use scalp vein (Winged Needle) infusion set 60 IS 17547:2021 Specification for Vaccine Freezer or Combined Vaccine Freezer and Water-Pack Freezer: Compression Cycle, General Requirements and Testing Methods 61 IS 17588:2021 Specification for Cold Box - General requirements and Test methods 62 IS 17589:2021 Specification for Water Packs for use as ice-packs, cool-packs and warm-packs, Requirements and Test methods 63 IS 18240 (Part 89):2023/ ISO 11139:2018 Sterilization of health care products Vocabulary of terms used in sterilization and related equipment and process standards 64 IS 18243:2023/ ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 106 65 IS 18244:2023/ ISO 21387:2020 Sterilization of medical devices Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release 66 IS 18245:2023/ ISO/TS 16775:2021 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607- 2 67 IS 18287:2023/ ISO/TS 22421 Sterilization of health care products Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities 68 IS 18288:2023/ ISO 20696:2018 Sterile urethral catheters for single use 69 IS 18292 (Part 1):2024/ ISO 10555-1:2023 Intravascular Catheters - Sterile and Single-Use Catheters Part 1 General Requirements 70 IS 18292 (Part 4):2024/ ISO 10555-4:2023 Intravascular Catheters - Sterile and Single-Use Catheters Part 4 Balloon Dilatation Catheters ( ) 71 IS 18292 (Part 6):2023/ ISO 10555-6:2015 Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted ports 72 IS 18292 (Part 7):2024/ ISO 10555-7:2023 Intravascular Catheters - Sterile and Single-Use Catheters Part 7 Peripherally Inserted Central Catheters 73 IS 18293 (Part 3):2023/ ISO 13926-3:2019 Pen systems Part 3 Seals for pen-injectors for medical use 74 IS 18294 (Part 4):2023/ ISO/TS11137-4:2020 Sterilization of health care products Radiation Part 4: Guidance on process control 75 IS 18319:2024/ ISO 17665 : 2024 Sterilization of Health Care Products - Moist Heat - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices ( ) 76 IS 18344 (Part 4):2023/ ISO 15883-4:2018 Washer-disinfectors Part 4 Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes 77 IS 18446 (Part 6):2024/ ISO 11140-6:2022 Sterilization of Health Care Products - Chemical Indicators Part 6 Type 2 Indicators and Process Challenge Devices for Use in Performance Testing of Small Steam Sterilizers 78 IS 18451:2023/ ISO 20697:2018 Sterile drainage catheters and accessory devices for single use 79 IS 18446 (Part 1):2023/ ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements 80 IS 18468 (Part 5):2024/ ISO 15883-5:2021 Washer-disinfectors Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy 81 IS 18469 (Part 7):2023/ ISO 11138-7:2019 Sterilization of health care products Biological indicators Part 7: Guidance for the selection use and interpretation of results 82 IS 18469 (Part 8):2023/ ISO 11138-8:2021 Sterilization of health care products Biological indicators Part 8: Method for validation of a reduced incubation time for a biological indicator 83 IS 18474 (Part 5):2024/ ISO 1135-5:2015 Transfusion equipment for medical use Part 5 Transfusion sets for single use with pressure infusion apparatus 84 IS 18478:2024/ ISO 20698:2018 Catheter systems for neuraxial application Sterile and single-use catheters and accessories 85 IS 18529:2024/ ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewire 86 IS 18618:2024/ ISO/TS 5111:2022 Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products 87 IS 18723:2024/ ISO 6717:2021 In vitro diagnostic medical devices ' Single-use containers for the collection of specimens from humans other than blood 88 IS 18730:2024/ ISO 14160:2020 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices 89 IS 18735:2024/ ISO 15747:2018 Plastic Containers for Intravenous Injections 90 IS 18742 (Part 1):2024/ ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices Part 1 Critical and semi-critical medical devices 91 IS 18742 (Part 2):2024/ ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices Part 2 Non-critical medical devices 92 IS 18744:2024/ ISO 20069:2019 Guidance for assessment and evaluation of changes to drug delivery systems 93 IS 18855:2024/ ISO/TS 23128:2019 Medical Devices ' Transfusion Set and Blood Bag Compatibility Test Method 94 IS 18863 (Part 3):2024/ ISO 11737-3:2023 Sterilization of Health Care Products - Microbiological Methods Part 3 Bacterial Endotoxin Testing 95 IS 18866:2024/ ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices - Requirements and Test Methods First Revision First Revision First Revision

96 IS 18871:2024/ ISO 28620:2020 Medical Devices ' Non-Electrically Driven Portable Infusion Devices 97 IS 18872:2024/ ISO 21881:2019 Sterile Packaged Ready for Filling Glass Cartridges 98 IS 18879 (Part 2):2024/ ISO 8536-2:2023 Infusion Equipment for Medical Use Part 2 Closures for Infusion Bottles 99 IS 18879 (Part 3):2024/ ISO 8536-3:2009+Amd1:2022 Infusion Equipment for Medical Use Part 3 Aluminium Caps for Infusion Bottles 100 IS 18879 (Part 5):2024/ ISO 8536-5:2004 Infusion Equipment for Medical Use Part 5 Burette Infusion Sets for Single Use, Gravity Feed 101 IS 18879 (Part 6):2024/ ISO 8536-6:2016 Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles 102 IS 18879 (Part 7):2024/ ISO 8536-7:2009 Infusion Equipment for Medical Use Part 7 Caps Made of Aluminium-Plastics Combinations for Infusion Bottles 103 IS 18879 (Part 8):2024/ ISO 8536-8:2015 Infusion equipment for medical use Part 8 Infusion sets for single use with pressure infusion apparatus 104 IS 18879 (Part 9):2024/ ISO 8536-9:2015 Infusion Equipment for Medical Use Part 9 Fluid Lines for Single Use with Pressure Infusion Equipment 105 IS 18879 (Part 10):2024/ ISO 8536-10:2015 Infusion Equipment for Medical Use Part 10 Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment 106 IS 18879 (Part 11):2024/ ISO 8536-11:2015 Infusion Equipment for Medical Use Part 11 Infusion Filters for Single Use with Pressure Infusion Equipment 107 IS 18879 (Part 12):2024/ ISO 8536-12:2021 Infusion Equipment for Medical Use Part 12 Check Valves for Single Use 108 IS 18879 (Part 13):2024/ ISO 8536-13:2016 Infusion Equipment for Medical Use Part 13 Graduated Flow Regulators for Single Use with Fluid Contact 109 IS 18879 (Part 14):2024/ ISO 8536-14:2016 Infusion Equipment for Medical Use Part 14 Clamps and Flow Regulators for Transfusion and Infusion Equipment without Fluid Contact 110 IS 18879 (Part 15):2024/ ISO 8536-15:2022+Amd1:2023 Infusion Equipment for Medical Use Part 15 Light-Protective Infusion Sets for Single Use 111 IS 18880:2024/ ISO 13004:2022 Sterilization of Health Care Products ' Radiation ' Substantiation of Selected Sterilization Dose: Method VDmaxSD 112 IS 18881 (Part 1):2025/ ISO 13408-1:2023 Aseptic Processing of Health Care Products Part 1 General Requirements 113 IS 18881 (Part 3):2024/ ISO 13408-3:2006 Aseptic Processing of Health Care Products Part 3 Lyophilization 114 IS 18881 (Part 4):2024/ ISO 13408-4:2005 Aseptic Processing of Health Care Products Part 4 Clean-in-Place Technologies 115 IS 18881 (Part 5):2024/ ISO 13408-5:2006 Aseptic Processing of Health Care Products Part 5 Sterilization in Place 116 IS 18881 (Part 6):2024/ ISO 13408-6:2021 Aseptic Processing of Health Care Products Part 6 Isolator Systems 117 IS 18881 (Part 7):2024/ ISO 13408-7:2012 Aseptic Processing of Health Care Products Part 7 Alternative Processes for Medical Devices and Combination Products 118 IS 18980:2025 Blood Donor Couch 119 IS 18981:2025 Dialysis Chair 120 IS 19099:2025 Vaccine Carriers - General Requirements and Test Methods 121 IS 19106:2025 Refrigerator or Combined Refrigerator and Water-Pack Freezer Intermittent Mains Powered ' Compression Cycle ' General Requirements and Test Methods 122 IS 1984 (Part 1):2023/ ISO 8362-1:2018 Injection containers and accessories Part 1 Injection vials made of glass tubing ( ) 123 IS 1984 (Part 2):2023/ ISO 8362-4:2011 Injection containers and accessories Part 2 Injection vials made of moulded glass ( ) 124 IS 1984 (Part 3):2023/ ISO 8362-3:2001 Injection containers and accessories Part 3: Aluminum caps for injection vials 125 IS 1984 (Part 4):2023/ ISO 8362-2:2015 Injection containers and accessories Part 4: Closures for injection vials 126 IS 17901:2025/ ISO 8362-2:2024 Injection Containers and Accessories Part 4 Closures for Injection Vials ( ) 127 IS 1984 (Part 5):2024/ ISO 8362-5:2016 Injection Containers and Accessories Part 5 Freeze Drying Closures for Injection Vials 128 IS 1984 (Part 6):2024/ ISO 8362-6:2010 Injection Containers and Accessories Part 6 Caps Made of Aluminium-Plastics Combinations for Injection Vials 129 IS 3118:1978 Specification for electric bacteriological incubators ( ) 130 IS 3119:1978 Specification for hot air sterilizers ( ) 131 IS/ISO 3826-1:2019 Plastics collapsible containers for human blood and blood components Part 1 Conventional containers ( ) 132 IS/ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components: Part 2 graphical symbols for use on labels and instruction leaflets 133 IS/ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components: Part 3 blood bag systems with integrated features 134 IS/ISO 3826-4:2015 Plastics Collapsible Containers for Human Blood and Blood Components Part 4 Aphaeresis Blood Bag Systems with Integrated Features 135 IS 3829 (Part 1):1999 Specification for steam sterilizers: Part 1 horizontal cylindrical and horizontal rectangular steam sterilizers, pressure type (For Hospital And Pharmaceutical Use) ( ) 136 IS 3829 (Part 2):1978 Specification for steam sterilizers: Part 2 horizontal cylindrical high speed steam sterilizers, pressure type ( ) 137 IS 3829 (Part 3):1985 Specification for steam sterilizers: Part 3 pressure sterilizers, vertical cylindrical type 138 IS 3830:1979 Specification for water stills for pyrogen - Free distilled water ( ) First Revision Third Revision First Revision First Revision First Revision First Revision Second Revision First Revision Second Revision

139 IS 3831:1979 Specification for sterilizer, shallow (Dressing Drum) 140 IS 3992:1982 Specification for trays, kidney ( ) 141 IS 3993:1993 Trays, instruments - Specification ( ) 142 IS 4033:1968 General requirements for hospital furniture 143 IS 4035:1967 Specification for trolleys, stretcher 144 IS 4036:1967 Specification for trolleys, patient 145 IS 4037:1967 Specification for stretchers and stretcher carriers 146 IS 4266:1967 Specification for lockers, bedside for hospital use 147 IS 4267:1967 Specification for stands, wash hand basin 148 IS 4445:1967 Specification for filter and filter chamber for blood transfusion 149 IS 4445:2025 Filter and Filter Chamber for Blood Transfusion - Specification ( ) 150 IS 4455:1967 Specification for trolleys, soiled linen 151 IS 4458:1967 Specification for screens, bedside 152 IS 4494:1968 Specification for tables, overbed 153 IS 4769:1968 Specification for trolley, dressing 154 IS 4787:1968 Specification for table, examination 155 IS 5022:1989 Sterilizer, instruments, table model ( ) 156 IS 5035:1969 Specification for sterilizers, bowl and utensil (Pedal Type) 157 IS 5291:1969 Specification for tables, operation, hydraulic, major 158 IS 5631:1970 Specification for trolley, instrument, plain and curved 159 IS 5880:1970 Specification for stand, saline - Cum - Irrigator 160 IS 6083:1971 Specification for table, obstetric, labour 161 IS 6106:1971 Specification for tables, operation, hydraulic, minor 162 IS 6328:1971 Specification for table, operation, general purposes (Non - Hydraulic) 163 IS 6593:1972 Specification for electric serological water - Baths 164 IS 6904:1973 Specification for receptacle, waste 165 IS 6905:1973 Instruments Table, Mayo's Type 166 IS 7083:1973 Specification for trolley, medicine 167 IS 7091:1973 Specification for lifter, bed, adjustable 168 IS 7099:1973 Specification for trolley, dressing drum 169 IS 7350:1974 Specification for needles, spinal 170 IS 7378:1974 Bed, Fowler's, Hospital 171 IS 7387:1974 Needle, Biopsy, Liver, Silverman's Pattern 172 IS 7596:1974 Table, Operation, Orthopaedic, Albee's Type 173 IS/ISO 80369-7:2016 Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications 174 IS 8078:1976 Specification for table, operation, paediatric 175 IS 8079:1976 Specification for table, operation, urological 176 IS 8462:1977 Specification for sterilizer, portable, vertical, pressure type 177 IS B8462:1977 Sterilizer, Portable, Vertical, Pressure Type (BI-LINGUAL) 178 IS/ISO 8536-1:2011 Infusion equipment for medical use Part 1 Infusion glass bottles 179 IS/ISO 8536-4:2019 Infusion equipment for medical use Part 4: Infusion sets for single use gravity feed 180 IS 9132:1979 Specification for table, operation, folding type 181 IS 9133:1979 Specification for trolley for general medical store First Revision Second Revision First Revision Third Revision

Category 13: Veterinary Hospital Planning and Surgical Instruments (MHD 13) S. No. IS No Title Category 14: Hospital Planning (MHD 14) S. No. IS No Title 1 IS 10568:2024 Teat Knife- Mclean's - Specification ( ) 2 IS 10937:2024 Bull Nose Ring and Key - Specification ( ) 3 IS 10938:2024 Double Edged Searcher with Handle and Sheath - Specification ( ) 4 IS 10940:1984 Specification for castrator 5 IS 10953:2024 Single Channel Uterine Catheter (Nelson Type) - Specification ( ) 6 IS 10954:2025 Catheter for Cow - Specification ( ) 7 IS 10954:1984 Specification for catheter, cow 8 IS 10955:2024 Veterinary Surgical Instruments - Gimlet for Trephine - Specification ( ) 9 IS 10963:1984 Specification for forceps, hoof testing 10 IS 10963:2025 Veterinary Surgical Instruments - Hoof Testing Forceps - Specification ( ) 11 IS 10964:1984 Specification for forceps bullet, veterinary 12 IS 12243:1988 Specification for rasp, tooth, reversible 13 IS 12245:2024 Veterinary Surgical Instruments - Teat Dilators (Hudson) - Specification ( ) 14 IS 12246:1988 Specification for Irons, pyro - Puncture with copper needles 15 IS 12302:1988 Specification for chisel, tooth, guarded (Large Animals) 16 IS 12329:2024 Veterinary Surgical Instruments - Self-Centring Bone Holding Forceps - Specification ( ) 17 IS 12344:1988 Specification for reduction forceps 18 IS 12344:2024 Veterinary Surgical Instruments - Reduction Forceps - Specification ( ) 19 IS 12670:1989 Veterinary - Pump stomach specification 20 IS 12670:2025 Veterinary Instruments - Stomach Pump - Specification 21 IS 14420:1996 Tracheal tubes for large animals used for veterinary anaesthesia - Specification 1 IS 10905 (Part 1):1984 Recommendations for basic requirements of general hospital buildings: Part 1 Administrative and hospital services department buildings 2 IS 10905 (Part 2):1984 Recommendations for basic requirements of general hospital buildings: Part 2 medical services department buildings 3 IS 10905 (Part 3):1984 Recommendations for basic requirements of general hospital buildings: Part 3 engineering services department buildings 4 IS 12377:2016 Classification and matrix for various categories of hospitals ( ) 5 IS 12433 (Part 1):1988 Basic requirements for hospital planning: Part 1 up to 30 bedded hospital 6 IS 12433 (Part 2):2001 Basic requirements for hospital planning: Part 2 up to 100 bedded hospital 7 IS/ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes ( ) 8 IS 13808 (Part 1):1993 Quality management procedures for out - Patient department (OPD) and emergency services - Guidelines: Part 1 upto 30 bedded hospitals 9 IS 13808 (Part 2):1993 Quality management procedures for diagnostic and blood transfusion services - Guidelines: Part 1 up to 30 - Bedded hospitals 10 IS 13808 (Part 3):1995 Quality management for hospital services (Upto 30 - Bedded Hospitals) - Guidelines: Part 3 wards, nursing services and operation theatre 11 IS 13808 (Part 4):1996 Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 4 hospital support services 12 IS 13808 (Part 5):1996 Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 5 hospital equipment management 13 IS/ISO 14971:2019 Medical devices - Application of risk management to medical devices ( ) 14 IS/ISO 15189:2022 Medical Laboratories Requirements for Quality and Competence ( ) 15 IS/ISO 15190:2003 Medical Laboratories - Requirements for Safety 16 IS 15195:2002 Performance guidelines for quality assurance in hospital services up to 30 - Bedded hospitals 17 IS/ISO 15195:2018 Laboratory Medicine - Requirements for the Competence of Calibration Laboratories Using Reference Measurement Procedures 18 IS/ISO 15223-1:2016 Medical Devices -Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( ) First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision (First Revision) First Revision First Revision First Revision Third Revision Second Revision

19 IS/ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection and validation 20 IS 15461:2004 Performance guidelines for quality assurance in hospital services up to 100 - Bedded hospitals 21 IS 15551:2003 Quality management systems - Guidelines for process improvements in health service organizations 22 IS 15784:2007 Healthcare facilities - Particular requirements 23 IS 15902:2011 Guidelines For Nursing Home 24 IS 15903:2010 Guidelines For Maternity Nursing Home 25 IS 15904:2011 Guidelines For Single Doctor Clinic - Including Dental Clinic 26 IS/ISO 16142-1:2016 Medical Devices - Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards 27 IS/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices: Part 2 General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards 28 IS 17722:2021 / ISO/TS 22583:2019 Guidance for supervisors and operators of point-of-care testing POCT devices 29 IS/ISO 17822-1:2014 In vitro diagnostic test systems - Qualitative nucleic acid - Based in vitro examination procedures for detection and identification of microbial pathogens: Part 1 general requirements, terms and definitions 30 IS 17898:2023 / ISO 15190:2020 Medical laboratories Requirements for safety ( ) 31 IS 17922 (Part 1):2023 / IEC 62366-1: 2015 CSV Medical Devices Part 1: Application of Usability Engineering 32 IS 17964 (Part 3):2025 / ISO 80369-3 : 2016 Small-bore connectors for liquids and gases in healthcare applications Part 3 Connectors for enteral applications 33 IS 17964 (Part 20):2023 / ISO 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods 34 IS 18105 (Part 1):2023 / ISO 15223-1:2021 Medical devices Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements 35 IS 18131:2023 / ISO 17822:2020 In vitro diagnostic test systems Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens Laboratory quality practice guide ( ) 36 IS 18132:2023 / ISO 22367 : 2020 Medical laboratories - Application of risk management 37 IS/ISO 18250-1:2018 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1 General requirements and common test methods 38 IS/ISO 18250-3:2018 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3 Enteral Applications 39 IS/ISO 18250-6:2019 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6 Neural Applications 40 IS/ISO 18250-7:2018 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 7 Connectors for intravascular infusion 41 IS/ISO 18250-8:2018 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 8 Citrate-based anticoagulant solution for apheresis applications 42 IS 18325:2023 / ISO/TS 20914:2019 Medical laboratories Practical guidance for the estimation of measurement uncertainty 43 IS 18374:2023 / ISO 23162:2021 Basic semen examination Specification and test methods 44 IS 18376:2023 / ISO/TR 20416: 2020 Medical devices Post-market surveillance for manufacturers 45 IS 18949:2025 /ISO 5741 : 2023 Healthcare Organization Management - Pandemic Response - Temporary Medical Facility 46 IS 19173 (Part 1):2025 / IEC/TR 80002-1 : 2009 Medical Device Software Part 1 Guidance on the Application of ISO 14971 to Medical Device Software 47 IS/ISO 20417:2021 Medical devices Information to be supplied by the manufacturer 48 IS/ISO/TS 20658:2023 Requirements for the collection and transport of samples for medical laboratory examinations ( ) 49 IS/ISO 20776-1:2019 Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 1 Broth Micro-Dilution Reference Method for Testing the in vitro Activity of Antimicrobial Agents Against Rapidly Growing Aerobic Bacteria Involved in Infectious Diseases 50 IS/ISO 20776-2:2021 Clinical Laboratory Testing and In Vitro Diagnostic Test Systems -ƞ Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 2 Evaluation of Performance of Antimicrobial Susceptibility Test Devices Against Reference Broth Micro-Dilution ( ) 51 IS/ISO/TS 22367:2008 Medical Laboratories - Reduction of Error through Risk Management and Continual Improvement 52 IS 23485:2019 Medical devices - Quality management system requirements and essential principles of safety and performance for medical devices 53 IS/ISO/TR 24971:2020 Medical Devices Guidance on the Application of ISO 14971 ( ) 54 IS/ISO 35001:2019 Biorisk management for laboratories and other related organisations 55 IS/ISO 62304:2015 Medical device software - Software life cycle processes First Revision First Revision First Revision First Revision First Revision

56 IS/IEC/TR 62366-2:2016 Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices 57 IS/ISO/TR 80002-2:2017 Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems 58 IS/IEC/TR 80002-3:2014 Medical device software Part 3: Process reference model of medical device software life cycle processes IEC 62304 59 IS/ISO 80369-1:2018 Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements 60 IS/IEC 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications Part 5 Connectors for limb cuff inflation applications 61 IS/IEC 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications Part 6 Connectors for neuraxial applications 1 IS/ISO/TS 10974:2018 Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device 2 IS 11393:1985 Specification for scintillation counters 3 IS 11478:2018 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems ( ) 4 IS 11753:1986 Specification for electrical impedance plethysmograph 5 IS 11789:2024 Determination of the Maximum Symmetrical Radiation Field of X-Ray Tube Assemblies and X-Ray Source Assemblies for Medical Diagnosis (IEC 60806 : 2022, MOD) ( ) 6 IS 13450 (Part 1):2024 Medical electrical equipment Part 1 General requirements for basic safety and essential performance ( ) 7 IS 13450 (Part 1/Sec 2):2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 2 Electromagnetic disturbances Requirements and tests ( ) 8 IS 13450 (Part 1/Sec 3):2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 3 Radiation protection in diagnostic X-ray equipment ( ) 9 IS 13450 (Part 1/Sec 6):2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 6 Usability ( ) 10 IS 13450 (Part 1/Sec 8):2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 8 General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ( ) 11 IS 13450 (Part 1/Sec 9):2024 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Section 9 Requirements for environmentally conscious design 12 IS 13450 (Part 1/Sec 10):2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 10 Requirements for the development of physiologic closed-loop controllers (First Revision) 13 IS 13450 (Part 1/Sec 11):2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance , Section 11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ( ) 14 IS 13450 (Part 1/Sec 12):2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 12 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment 15 IS 13450 (Part 2/Sec 1):2018 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 1 Electron accelerators in the range 1 MeV to 50 MeV ( ) 16 IS 13450 (Part 2/Sec 2):2024 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 2 High frequency surgical equipment and high frequency surgical accessories First revision 17 IS 13450 (Part 2/Sec 3):2024 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 3 Short-wave therapy equipment ( ) 18 IS 13450 (Part 2/Sec 4):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators ( ) 19 IS 13450 (Part 2/Sec 5):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 5 ultrasonic physiotherapy equipment ( ) 20 IS 13450 (Part 2/Sec 6):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 6 microwave therapy equipment 21 IS 13450 (Part 2/Sec 8):2019 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 8 Therapeutic X-ray equipment operating in the range 10 kV to 1 MV 22 IS 13450 (Part 2/Sec 10):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 10 nerve and muscle stimulators 23 IS 13450 (Part 2/Sec 11):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 11 gamma beam therapy equipment ( Category 15: Electromedical, Diagnostic Imaging and Radiotherapy Equipment (MHD 15) S. No. IS No Title First Revision First Revision Third Revision Second Revision First Revision First revision First Revision First Revison First Revision First revision First Revision First Revision First Revision)

24 IS 13450 (Part 2/Sec 16):2019 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 16 haemodialysis, haemodiafiltration and haemofiltration equipment 25 IS 13450 (Part 2/Sec 17):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 17 automatically - Controlled brachytherapy afterloading equipment ( ) 26 IS 13450 (Part 2/Sec 18):2014 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 18 endoscopic equipment 27 IS 13450 (Part 2/Sec 19):2023 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 19 Infant Incubators ( ) 28 IS 13450 (Part 2/Sec 20):2023 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 20 Infant Transport Incubators ( ) 29 IS 13450 (Part 2/Sec 21):2023 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer ( ) 30 IS 13450 (Part 2/Sec 22):2021 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 22 surgical cosmetic therapeutic and diagnostic laser equipment ( ) 31 IS 13450 (Part 2/Sec 23):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 23 transcutaneous partial pressure monitoring equipment 32 IS 13450 (Part 2/Sec 24):2019 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 24 infusion pumps and controllers ( ) 33 IS 13450 (Part 2/Sec 25):2018 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs 34 IS 13450 (Part 2/Sec 26):2021 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 26 Electroencephalographs 35 IS 13450 (Part 2/Sec 27):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment 36 IS 13450 (Part 2/Sec 29):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 29 radiotherapy simulators ( ) 37 IS 13450 (Part 2/Sec 31):2021 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 31 External Cardiac Pacemakers with Internal Power Source ( ) 38 IS 13450 (Part 2/Sec 33):2025 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 33 Magnetic resonance equipment for medical diagnosis (IEC 60601-2-33: 2022 MOD) ( ) 39 IS 13450 (Part 2/Sec 33):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 33 magnetic resonance equipment for medical diagnosis 40 IS 13450 (Part 2/Sec 34):2019 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 34 Invasive blood pressure monitoring equipment 41 IS 13450 (Part 2/Sec 35):2023 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets pads or mattresses and intended for heating in medical use 42 IS 13450 (Part 2/Sec 36):2019 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 36 equipment for extra corporeally induced lithotripsy 43 IS 13450 (Part 2/Sec 37):2019 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 37 ultrasonic medical diagnostic and monitoring equipment 44 IS 13450 (Part 2/Sec 39):2019 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 39 peritoneal dialysis equipment 45 IS 13450 (Part 2/Sec 40):2020 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 40 Electromyographs and evoked response equipment 46 IS 13450 (Part 2/Sec 41):2020 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis 47 IS 13450 (Part 2/Sec 41):2025 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis (IEC 60601-2-41: 2021 MOD) ( 48 IS 13450 (Part 2/Sec 43):2024 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 43 X-ray equipment for interventional procedures ( ) 49 IS 13450 (Part 2/Sec 44):2016 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 44 X-ray equipment for computed tomography ( ) 50 IS 13450 (Part 2/Sec 45):2024 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 45 Mammographic X-ray equipment and mammographic stereotactic devices ( ) First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision First Revision) Second revision First Revision Second revision

51 IS 13450 (Part 2/Sec 46):2025 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 46 Operating tables (IEC 60601-2-46: 2023 MOD) ( ) 52 IS 13450 (Part 2/Sec 46):2020 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 46 Operating tables 53 IS 13450 (Part 2/Sec 47):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 47 ambulatory electrocardiographic systems 54 IS 13450 (Part 2/Sec 50):2022 Medical electrical equipment Part 2 Particular requirements for the Basic Safety and essential performance Section 50 Infant Phototherapy Equipment 55 IS 13450 (Part 2/Sec 52):2020 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 52 Medical beds 56 IS 13450 (Part 2/Sec 54):2024 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 54 X-ray equipment for radiography and radioscopy ( ) 57 IS 13450 (Part 2/Sec 62):2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 62 high intensity therapeutic ultrasound (HITU) equipment 58 IS 13450 (Part 2/Sec 63):2024 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 63 Dental extra-oral X-ray equipment First revision 59 IS 13450 (Part 2/Sec 65):2024 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 65 Dental intra-oral X-ray equipment First revision 60 IS 13450 (Part 2/Sec 68):2020 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 68 X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment 61 IS 13450 (Part 2/Sec 76):2019 Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 76 low energy ionized gas haemostasis equipment 62 IS/ISO 13450-2-10):2024 Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 10 Nerve and muscle stimulators ( ) 63 IS 13709:1993 Medical electrical equipment - Dental X-ray equipment radiation safety 64 IS 14180:2019 Graphical symbols for electrical equipment in medical practice ( ) 65 IS/ISO 14708-2:2019 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers ( ) 66 IS 15584:2005 Medical X-ray films 67 IS 18443:2025 Medical electrical equipment X-ray tube assemblies for medical diagnosis Focal spot dimensions and related characteristics 68 IS 18448 (Part 1):2024 Medical electrical equipment Diagnostic X-rays Part 1 Determination of quality equivalent filtration and permanent filtration 69 IS 18448 (Part 2):2024 Medical electrical equipment Diagnostic X-rays Part 2 Guidance and rationale on quality equivalent filtration and permanent filtration 70 IS 18470:2024 Ultrasonics Physiotherapy Systems Field Specifications and Methods of Measurement in the Frequency Range 05 MHz to 5 MHz 72 IS/IEC 60335-2-27:2009 Household and Similar Electrical Appliances Safety Part 2-27 Particular Requirements for Appliances for Skin Exposure to Optical Radiation 73 IS/IEC 60580:2019 Medical electrical equipment Dose area product meters 74 IS/IEC/TR 60788:2004 Medical electrical equipment - Glossary of defined terms 75 IS/IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics 76 IS/IEC 61170:1993 Radiotherapy simulators - Guidelines for functional performance characteristics 77 IS/IEC 61217:2011 Radiotherapy Equipment - Coordinates, Movements and Scales 78 IS/IEC 61262-1:1994 Medical Electrical Equipment - Characteristics of Electro-Optical X-Ray Image Intensifiers 79 IS/IEC 61262-2:1994 Medical electrical equipment characteristics of electro - Optical X-ray image intensifiers: Part 2 determination of the conversion factor 80 IS/IEC 61262-3:1994 Medical electrical equipment - Characteristics of Electro - Optical X-ray image intensifiers: Part 3 determination of the luminance distribution and luminance non - Uniformity 81 IS/IEC 61262-4:1994 Medical Electrical Equipment - Characteristics of Electro-Optical X-Ray Image Intensifiers Part 4 Determination of the Image Distortion 82 IS/IEC 61331-1:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 1: DETERMINATION OF ATTENUATION PROPERTIES OF MATERIALS 83 IS/IEC 61331-2:2014 Protective Devices Against Diagnostic Medical X-Radiation Part 2 Translucent Protective Plates 84 IS/IEC 61331-3:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS 85 IS/IEC 61675-1:2022 Radionuclide Imaging Devices - Characteristics and Test Conditions Part 1 Positron Emission Tomographs ( ) 86 IS/IEC 61675-2:2015 Radionuclide imaging devices - Characteristics and test conditions: Part 2 gamma cameras for planar, whole body, and spect imaging First Revision First revision First revision First Revision First Revision First Revision

87 IS/IEC 61676:2002 Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology 88 IS/IEC 61685:2001 Ultrasonics - Flow measurement systems - Flow test object 89 IS/IEC 61847:1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics 90 IS/IEC/TR 61948-3:2018 Nuclear medicine instrumentation - Routine tests: Part 3 positron emission tomographs 91 IS/IEC 62083:2009 Medical electrical equipment Requirements for the safety of radiotherapy treatment planning systems 92 IS/IEC 62220-1-1:2015 Medical Electrical Equipment - Characteristics of Digital X-ray Imaging Devices Part 1-1 Determination of the Detective Quantum Efficiency -ƞ Detectors Used in Radiographic Imaging 93 IS/IEC 62220-1-3:2008 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part:1-3 Determination of the detective quantum efficiency - Detectors used in dynamic imaging 94 IS/IEC 62220-1- 2:2007 Medical electrical equipment - Characteristics of digital X-ray imaging devices: Part 1-2 determination of the detective quantum efficiency detectors used in mammography 95 IS/IEC 6235:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (First Revision) 96 IS/IEC/TS 62556:2014 Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems 97 IS/IEC 62563-1:2016 Medical Electrical Equipment - Medical Image Display System Part 1 Evaluation Method 98 IS/IEC/TS 62566:2014 Ultrasonics -Field Characterization -Specification and Measurement of Field Parameters for High Intensity Therapeutic Ultrasound (HITU) Transducers and Systems 99 IS 7620 (Part 1):1986 Specification for diagnostic medical X-ray equipment: Part 1 general and safety requirements ( ) 100 IS 7620 (Part 2):1986 Specification for diagnostic medical X-ray equipment: Part 2 performance requirements ( ) 101 IS 7620 (Part 3):1991 Medical electrical equipment - Diagnostic X-ray equipmbnts: Part 3 radiation safety requirements 102 IS/IEC 80601-2-35:2009 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets, pads or mattresses and intended for heating in medical use 103 IS/IEC 80601-2-49:2018 Medical electrical equipment Part 2- Particular requirements for basic safety and essential performance- Sec 49 Multifunction patient monitors 104 IS/ISO 80601-2-56:2017 Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 56 clinical thermometers for body temperature measurement 105 IS/IEC 80601-2-58:2016 Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 58 Lens removal devices and vitrectomy devices for ophthalmic surgery 106 IS/IEC 80601-2-59:2017 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 59 Screening thermographs for human febrile temperature screening 107 IS/ISO 80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 1 IS/ISO 10159:2011 Health informatics - Messages and communication - Web access reference manifest 2 IS/ISO/IEEE 11073-00103:2015 Health informatics - Personal health device communication: Part 00103 overview 3 IS/ISO/IEEE 11073-10101:2004 Health Informatics - Point-of-Care Medical Device Communication Part 10101 Nomenclature 4 IS/ISO/IEEE 11073-10102:2014 Health Informatics — Point-of-care Medical Device Communication, Part 10102 Nomenclature — Annotated ECG 5 IS/ISO/IEEE 11073-10103:2014 Health Informatics — Point-of-Care Medical Device Communication, Part 10103 Nomenclature — Implantable Device, Cardiac 6 IS/ISO/IEEE 11073-10201:2020 Health Informatics — Device Interoperability Part 10201 Point-of-Care Medical Device Communication — Domain Information Model 7 IS/ISO/IEEE 11073-10207:2019 Health Informatics — Personal Health Device Communication, Part 10207 Domain Information and Service Model for Service-Oriented Point-of Care Medical Device Communication 8 IS/ISO/IEEE 11073-10404:2022 Health Informatics — Device Interoperability, Part 10404 Personal Health Device Communication — Device Specialization — Pulse Oximeter 9 IS/ISO/IEEE 11073-10406:2012 Health informatics - Personal health device communication: Part 10406 device specialization - Basic electrocardiograph (Ecg) (1 - to 3 - Lead ECG) 10 IS/ISO/IEEE 11073-10407:2022 Health informatics - Device interoperability Part 10407 Personal health device communication - Device specialization - Blood pressure monitor (First Revision) 11 IS/ISO/IEEE 11073-10408:2022 Health Informatics — Device Interoperability, Part 10408 Personal Health Device Communication — Device Specialization — Thermometer First Revision First Revision (First Revision) (First Revision) (First Revision) Category 16: Health Informatics (MHD 17) S. No. IS No Title

12 IS/ISO/IEEE 11073-10415:2022 Health Informatics — Device Interoperability, Part 10415 Personal Health Device Communication — Device Specialization — Weighing Scale 13 IS/ISO/IEEE 11073-10417:2017 Health informatics - Personal health device communication: Part 10417 device specialization - Glucose meter 14 IS/ISO/IEEE 11073-10418:2014 Health informatics - Personal health device communication: Part 10418 device specialization: international normalized ratio (INR) monitor 15 IS/ISO/IEEE 11073-10419:2019 Health Informatics — Personal Health Device Communication, Part 10419 Device Specialization —Insulin Pump 16 IS/ISO/IEEE 11073-10420:2022 Health Informatics — Device Interoperability, Part 10420 Personal Health Device Communication — Device Specialization — Body Composition Analyser 17 IS/ISO/IEEE 11073-10421:2012 Health informatics - Personal health device communication: Part 10421 device specialization - Peak expiratory flow monitor (Peak Flow) 18 IS/ISO/IEEE 11073-10422:2017 Health informatics - Personal health device communication: Part 10422 device specialization - Urine analyser 19 IS/ISO/IEEE 11073-10424:2019 Health informatics - Personal health device communication: Part 10424 device specialization - Sleep apnoea breathing therapy equipment (SABTE) 20 IS/ISO/IEEE 11073-10427:2018 Health informatics - Personal health device communication: Part 10427 device specialization - Power status monitor of personal health devices 21 IS/ISO/IEEE 11073-10441:2015 Health informatics - Personal health device communication: Part 10441 device specialization - Cardiovascular fitness and activity monitor 22 IS/ISO/IEEE 11073-10442:2015 Health Informatics — Personal Health Device Communication, Part 10442 Device Specialization — Strength Fitness Equipment 23 IS/ISO/IEEE 11073-10471:2010 Health informatics - Personal health device communication: Part 10471 device specialization - Independent living activity hub 24 IS/ISO/IEEE 11073-10472:2012 Health informatics - Personal health device communication: Part 10472 device specialization - Medication monitor 25 IS/ISO/IEEE 11073-20101:2004 Health informatics - Point-of-care medical device communication: Part 20101 application profiles - Base standard 26 IS/ISO/IEEE 11073-20601:2022 Health Informatics — Device Interoperability, Part 20601 Personal Health Device Communication — Application Profile — Optimized Exchange Protocol 27 IS/ISO/IEEE 11073-20702:2018 Health Informatics — Point-of-Care Medical Device Communication Part 20702 Medical Devices Communication Profile for Web Services 28 IS/ISO/IEEE 11073-30200:2004 Health Informatics -ƞ Point-of-Care Medical Device Communication Part 30200 Transport Profile -ƞ Cable Connected 29 IS/ISO/IEEE 11073-30400:2012 Health informatics - Point-of-care medical device communication: Part 30400 interface profile - Cabled ethernet 30 IS/ISO 11073-90101:2008 Health informatics - Point-of-care medical device communication: Part 90101 analytical instruments - Point-of-care test 31 IS/ISO 11239:2023 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging ( ) 32 IS/ISO 11240:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement 33 IS/ISO 11615:2017 Health Informatics Identification of Medicinal Products Data Elements and Structures for the Unique Identification and Exchange of Regulated Medicinal Product Information 34 IS/ISO 11616:2017 Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information 35 IS/ISO/IEC 11703-20601:2018 Health Informatics -ƞ Personal Health Device Communication Part 20601 Application Profile -ƞ Optimized Exchange Protocol 36 IS/ISO 12052:2017 Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management ( ) 37 IS/ISO 12381:2019 Health Informatics Explicit time-related expressions for healthcare-specific problems 38 IS/ISO 13119:2022 Health Informatics Clinical knowledge resources Metadata First Revision 39 IS/ISO 13120:2019 Health Informatics Syntax to represent the content of healthcare classification systems Classification Markup Language ClaML 40 IS/ISO 13940:2015 Health Informatics -ƞ System of Concepts to Support Continuity of Care 41 IS/ISO/TS 13972:2022 Health Informatics Clinical information models Characteristics structures and requirements ( ) 42 IS/ISO/TS 14441:2013 Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment 43 IS/ISO 16278:2016 Health informatics Categorial structure for terminological systems of human anatomy 44 IS/ISO 17090-1:2013 Health informatics - Public key infrastructure: Part 1 overview of digital certificate services 45 IS/ISO 17090-1:2023 Health informatics Public key infrastructure Part 1 Overview of digital certificate services ( ) 46 IS/ISO 17090-2:2015 Health informatics - Public key infrastructure: Part 2 certificate profile 47 IS 17090 (Part 3):2008/ ISO 17090-3 : 2008 Health Informatics -ƞ Public Key Infrastructure Part 3 Policy Management of Certification Authority 48 IS 17090 (Part 3):2021/ ISO 17090-3:2021 Health informatics Public key infrastructure Part 3 Policy management of certification authority ( ) 49 IS/ISO 17090-4:2023/ ISO 17090-4:2020 Health informatics Public key infrastructure Part 4 Digital signatures for healthcare documents ( ) 50 IS/ISO 17090-4:2014 Health informatics - Public key infrastructure: Part 4 digital signatures for healthcare documents (First Revision) (First Revision) (First Revision) (First Revision) First Revision First Revision First Revision First Revision First Revision First Revision

51 IS/ISO 17090-5:2017 Health informatics - Public key infrastructure: Part 5 authentication using healthcare PKI credentials 52 IS/ISO 17117-1:2018 Health informatics Terminological resources Part 1 Characteristics 53 IS/ISO/TS 17117-2:2022 Health informatics Terminological resources Part 2 Implementation CapabilityTIC 54 IS 17762:2022/ ISO/TR 11636:2009 Health Informatics Dynamic on-demand virtual private Network for health information infrastructure 55 IS 17763:2022/ ISO/TR 17522:2015 Health informatics Provisions for Health Applications on mobilesmart Devices 56 IS 17764:2022/ ISO TS 19293:2018 Health informatics Requirements for a record of a dispense of a medicinal product 57 IS 17765:2022/ ISO TR 21835:2020 Health informatics Personal health data Generated on a daily basis 58 IS 17766:2022/ ISO 21091:2013 Health informatics Directory services for healthcare Providers subjects of care and other entities 59 IS 17767:2024/ ISO/TS 17251:2023 Health informatics - Business Requirements for a Syntax to Exchange Structured Dose Information for Medicinal Products ( ) 60 IS 17768:2022/ ISO/TS 22756:2020 Health Informatics Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes 61 IS 17769:2022/ ISO 17523:2016 Health informatics Requirements for Electronic prescriptions 62 IS 17770:2022/ ISO TR 20831:2017 Health informatics Medication management Concepts and definitions 63 IS 17771:2022/ ISO 17115 : 2020 Health informatics - Representation of categorial structures of terminology (CatStructure) 64 IS/ISO/TR 17791:2013 Health informatics - Guidance on standards for enabling safety in health software 65 IS 17797:2022/ ISO 22857:2013 Health informatics Guidelines on data protection to facilitate Trans border flows of personal health data 66 IS 17798:2022/ ISO TS 20428:2017 Health informatics Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records 67 IS 17851:2022/ ISO/TR 22696:2020 Health informatics Guidance on the identification and authentication of connectable Personal Healthcare Devices PHDs 68 IS 17852:2022/ ISO TS 21547:2010 Health informatics Security requirements for archiving of Electronic health records Principles 69 IS 17887:2022/ ISO 25720:2009 Health informatics Genomic Sequence Variation Markup Language GSVML 70 IS 17888:2022/ ISO 27269:2021 Health informatics International patient summary 71 IS/ISO/TS 17975:2022 Health Informatics Principles and data requirements for consent in the collection use or disclosure of personal health information ( ) 72 IS 18198 (Part 1):2023/ ISO/TS 11633-1:2019 Health informatics Information security management for remote maintenance of medical devices and medical information systems Part 1 Requirements and risk analysis 73 IS 18199:2023/ ISO 11238:2018 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances 74 IS 18216:2023/ ISO/TS 16791:2020 Health informatics Requirements for international machine-readable coding of medicinal product package identifiers 75 IS 18218 (Part 2):2023/ ISO/TR 11633-2:2021 Health informatics Information security management for remote maintenance of medical devices and medical information systems Part 2 Implementation of an information security management system ISMS 76 IS/ISO 1828:2012 Health informatics - Categorial structure for terminological systems of surgical procedures 77 IS 18301 (Part 1):2023/ ISO 13606-1:2019 Health informatics Electronic health record communication : Part 1 Reference model 78 IS 18301 (Part 2):2023/ ISO 13606-2:2019 Health informatics Electronic health record communication : Part 2 Archetype interchange specification 79 IS 18301 (Part 3):2023/ ISO 13606-3:2019 Health informatics Electronic health record communication Part 3 Reference archetypes and term lists 80 IS 18301 (Part 4):2023/ ISO 13606-4:2019 Health informatics Electronic health record communication Part 4 Security 81 IS 18301 (Part 5):2023/ ISO 13606-5:2019 Health informatics Electronic health record communication Part 5 Interface specification 82 IS 18302 (Part 1):2023/ ISO 12967-1:2020 Health informatics Service architecture HISA Part 1 Enterprise viewpoint 83 IS 18302 (Part 2):2023/ ISO 12967-2:2020 Health informatics Service architecture HISA Part 2 Information viewpoint 84 IS 18302 (Part 3):2023/ ISO 12967-3:2020 Health informatics Service architecture HISA Part 3 Computational viewpoint 85 IS 18303:2023/ ISO 27789:2021 Health informatics Audit trails for electronic health records 86 IS/ISO 18308:2011 Health informatics - Requirements for an electronic health record architecture 87 IS 18796:2024/ ISO 29585:2023 Health Informatics - Framework for Healthcare and Related Data Reporting 88 IS 18799:2024/ ISO 41064:2023 Health Informatics - Standard Communication Protocol - Computer-Assisted Electrocardiography 89 IS 18865 (Part 5):2024 ISO 21549-5:2023 Health Informatics - Patient Healthcard Data Part 5 Identification Data 90 IS 18865 (Part 7):2024/ ISO 21549-7:2024 Health informatics - Patient Healthcard Data Part 7 Medication Data 91 IS 18867 (Part 1):2024/ ISO 22077-1:2022 Health Informatics - Medical Waveform Format Part 1 Encoding Rules First Revision First Revision

92 IS 18867 (Part 2):2024/ ISO 22077-2:2023 Health Informatics - Medical Waveform Format Part 2 Electrocardiography 93 IS 18867 (Part 3):2024/ ISO 22077-3:2023 Health Informatics - Medical Waveform Format Part 3 Long-term Electrocardiography 94 IS 18869:2024/ ISO/TS 14265:2024 Health Informatics - Classification of Purposes for Processing Personal Health Information 95 IS 18875 (Part 10101):2025 Health Informatics - Device Interoperability Part 10101 Point-of-Care Medical Device Communication - Nomenclature 96 IS 18875 (Part 10425):2024/ ISO/IEEE 11073-10425:2019 Health Informatics - Personal Health Device Communication Part 10425 Device Specialization - Continuous Glucose Monitor (CGM) 97 IS 18878:2024/ ISO 10781:2023 Health Informatics - HL7 Electronic Health Record-System Functional Model, Release 2.1 (EHR FM) 98 IS/ISO 20301:2014 Health informatics - Health cards - General characteristics (First Revision) 99 IS/ISO 20302:2022 Health informatics Health cards Numbering system and registration procedure for issuer identifiers 100 IS/ISO/TR 20514:2005 Health informatics - Electronic health record - Definition, scope and context 101 IS/ISO 21090:2011 Health Informatics -ƞ Harmonized Data Types for Information Interchange 102 IS/ISO 21549-1:2013 Health Informatics -ƞ Patient Healthcard Data Part 1 General Structure 103 IS/ISO 21549-2:2014 Health Informatics -ƞ Patient Healthcard Data Part 2 Common objects 104 IS/ISO 21549-3:2014 Health Informatics - Patient Healthcard Data - Part 3: Limited Clinical Data 105 IS/ISO 21549-4:2014 Health Informatics -ƞ Patient Health Card Data Part 4 Extended Clinical Data 106 IS 21549 (Part 6):2008/ ISO 21549-6 : 2008 Health Informatics - Patient Health Card Data Part 6 Administrative Data 107 IS/ISO 21549-8:2010 Health informatics - Patient health card data: Part 8 links 108 IS/ISO 21860:2020 Health informatics Reference standards portfolio RSP Clinical imaging 109 IS/ISO/TS 22220:2011 Health informatics - Identification of subjects of health care 110 IS/ISO/TS 22272:2021 Health Informatics Methodology for analysis of business and information needs of health enterprises to support standards based architectures 111 IS/ISO 22600-1:2014 Health informatics - Privilege management and access control: Part 1 Overview and policy management 112 IS/ISO 22600-2:2014 Health informatics - Privilege management and access control: Part 2 Formal models 113 IS/ISO 22600-3:2014 Health informatics - Privilege management and access control: Part 3 Implementations 114 IS/ISO 23903:2021 Health Informatics Interoperability and integration reference architecture Model and framework 115 IS/ISO 25237:2017 Health informatics - Pseudonymization 116 IS/ISO/TS 27527:2010 Health informatics - Provider identification 117 IS/ISO 27799:2016 Health informatics - Information security management in health using ISO/IEC 27002 118 IS/ISO/TR 4421:2023 Health Informatics - Introduction to Ayurveda Informatics 119 IS/IEC/TR 80001-2-2:2012 Application of risk management for it - Networks incorporating medical devices: Part 2 - 2 guidance for the disclosure and communication of medical device security needs, risks and controls 120 IS/IEC 82304-1:2016 Health software: Part 1 General requirements for product safety 121 IS/ISO/TS 82304-2:2021 Health software Part 2 Health and wellness appsQuality and reliability 1 IS/ISO 10993-2:2006 Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements ( ) 2 IS/ISO 10993-3:2014 Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity ( ) 3 IS/ISO 10993-4:2017 Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood 4 IS/ISO 10993-5:2009 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity 5 IS/ISO 10993-6:2016 Biological evaluation of medical devices Part 6 Tests for local effects after implantation 6 IS/ISO 10993-11:2017 Biological evaluation of medical devices Part 11 Tests for systemic toxicity 7 IS/ISO 10993-12:2021 Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials 8 IS/ISO 10993-13:2010 Biological evaluation of medical devices Part 13 Identification and quantification of degradation products from polymeric medical devices 9 IS/ISO 10993-14:2001 Biological evaluation of medical devices Part 14 Identification and quantification of degradation products from ceramics 10 IS/ISO 10993-16:2017 Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables 11 IS/ISO 10993-17:2002 Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances Category 17: In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices (MHD 19) S. No. IS No Title First Revision First Revision

12 IS/ISO 10993-18:2020 Biological evaluation of medical devices Part 18 Chemical characterization of medical device materials within a risk management process 13 IS/ISO/TS 10993-20:2006 Biological evaluation of medical devices Part 20 Principles and methods for immunotoxicology testing of medical devices 14 IS/ISO/TR 10993-22:2017 Biological Evaluation of Medical Devices Part 22 Guidance on Nanomaterials 15 IS/ISO 13022:2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices 16 IS/ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice 17 IS/ISO 15197:2013 In vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring System for Self-Testing in Managing Diabetes Mellitus ( ) 18 IS/ISO 15198:2004 Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer 19 IS/ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process 20 IS/ISO 17511:2020 In Vitro Diagnostic Medical Devices - Requirements for Establishing Metrological Traceability of Values Assigned to Calibrators, Trueness Control Materials and Human Samples 21 IS 17713:2023 In-Vitro Diagnostic Devices - ELISA Plate Reader 22 IS 17714:2023 In-Vitro Diagnostic Devices - Automated ELISA Processor 23 IS 17715:2023 In-vitro Diagnostic Device - ELISA Plate Washer 24 IS 17716:2024 In-vitro Diagnostic (IVD) Devices - Blood Gas Analyzers 25 IS 17717 (Part 1):2023 In-Vitro Diagnostic Device - Automated Clinical chemistry Analyzer - Part 1 Wet Chemistry Analyzer 26 IS 17717 (Part 2):2023 In-Vitro Diagnostic (IVD) Device - Automated Clinical Chemistry Analyzer Part 2 Dry Chemistry Analyzer 27 IS 17718:2022 Performance testing of In-vitro Diagnostics IVD Reagent Kit alpha - Amylase CNP-G3 Liquid Stable Clinical Chemistry Reagents/ Kits 28 IS 17719:2023 In-Vitro Diagnostic (IVD) Medical Device - Automatic Slide Staining Instrument 29 IS 17720:2023 In-vitro Diagnostic Device - Automated Blood Culture and Microbial Detection System 30 IS 17721:2024 In-vitro Diagnostic (IVD) Devices - Electrolyte Analyzer 31 IS 17724 (Part 1):2023 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1 General Requirements (IEC 61010-1: 2010 + AMD1:2016 + COR1:2019, MOD) 32 IS 17724 (Part 2):2023 Safety Requirements for Electrical Equipment for Measurement, Control, And Laboratory Use Part 2 Particular Requirements for Laboratory Equipment used in Mixing and Stirring 33 IS 17724 (Part 3):2024 Safety Requirements for Electrical Equipment for Measurement, Control, And Laboratory Use Part 3 Particular Requirements of Automatic and Semi-Automatic Laboratory Equipment used for Analysis and Other Purposes 34 IS 17724 (Part 4):2023 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 4 Particular Requirements for In-Vitro Diagnostic (IVD) Medical Equipment (IEC 61010-2-101 : 2018, MOD) 35 IS 17784 (Part 1):2023 Electrical Equipment for Measurement, Control and Laboratory Use - EMC Requirements Part 1 General Requirements (IEC 61326-1: 2020, MOD) 36 IS 17784 (Part 2):2023 Electrical equipment for measurement, control and laboratory use - EMC requirements Part 2 Particular requirements for In-vitro diagnostic (IVD) medical equipment (IEC 61326-2-6 : 2020, MOD) 37 IS 17932 (Part 1):2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) 38 IS 17932 (Part 2):2024 Biological Evaluation of Medical Devices Part 2 Framework for identification and quantification of potential degradation products 39 IS 17932 (Part 3):2024 Biological Evaluation of Medical Devices Part 3 Identification and quantification of degradation products from metals and alloys 40 IS 17932 (Part 4):2024 Biological Evaluation of Medical Devices Part 4 Physico-chemical morphological and topographical characterization of materials 41 IS 17932 (Part 5):2024 Biological Evaluation of Medical Devices Part 5 Ethylene oxide sterilization residuals 42 IS 17932 (Part 6):2023 Biological Evaluation of Medical Devices Part 6 Tests for skin sensitization (ISO 10993-10 : 2021, MOD) 43 IS 17932 (Part 7):2024 Biological Evaluation of Medical Devices Part 7 Tests for irritation ISO 10993-23:2021 MOD 44 IS/ISO 22442-1:2015 Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management 45 IS/ISO 22442-2:2015 Medical Devices Utilizing Animal Tissues and their Derivatives Part 2 Controls on Sourcing, Collection and Handling 46 IS/ISO 22442-3:2007 Medical Devices Utilizing Animal Tissues and their Derivatives Part 3 Validation of the Elimination and/or Inactivation of Viruses and Transmissible Spongiform Encephalopathy (TSE) Agents 47 IS/ISO/TR 22442-4:2010 Medical Devices Utilizing Animal Tissues and their Derivatives Part 4 Principles for Elimination and/or Inactivation of Transmissble Spongifrom Encephalopathy (TSE) Agents and Validation Assays for those Processes 48 IS/ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents First Revision

49 IS/ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants 50 IS/ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry 1 IS/ISO/TR 13121:2011 Nanotechnologies - Nanomaterial risk evaluation 2 IS/ISO/TR 17302:2015 Nanotechnologies Framework for identifying vocabulary development for nanotechnology applications in human healthcare 3 IS 17707:2021 / ISO/TS 22082:2020 Nanotechnologies Assessment of nanomaterial toxicity using dechorionated zebrafish embryo 4 IS 17711:2021 / ISO 21973:2020 Biotechnology General requirements for transportation of cells for therapeutic use 5 IS 18152:2023 / ISO/TR 12885:2018 Nanotechnologies Health and safety practices in occupational settings 6 IS 18514:2024 / ISO 22412:2017 Particle size analysis Dynamic light scattering DLS 7 IS 18607:2024 / ISO 24421:2023 Biotechnology Minimum requirements for optical signal measurements in photometric methods for biological samples 8 IS 18609:2024 / ISO 20399:2022 Biotechnology Ancillary materials present during the production of cellular therapeutic products and gene therapy products 9 IS 18617:2024 / ISO 23033:2021 Biotechnology Analytical methods General requirements and considerations for the testing and characterization of cellular therapeutic products 10 IS 18644:2024 / ISO/TS 23565:2021 Biotechnology Bioprocessing General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use 11 IS 18856:2024 / ISO 19007:2018 Nanotechnologies In vitro MTS assay for measuring the cytotoxic effect of nanoparticles 12 IS 18857:2024 / ISO/TR 22019:2019 Nanotechnologies — Considerations for Performing Toxicokinetic Studies with Nanomaterials 13 IS 18902:2024 / ISO/TR 19057:2017 Nanotechnologies — Use and Application of Acellular In-vitro Tests and Methodologies to Assess Nanomaterial Biodurability 14 IS/ISO 20391-1:2018 / ISO 20391-1:2018 Biotechnology Cell counting Part 1: General guidance on cell counting methods 15 IS/ISO 20391-2:2019 / ISO 20391-2:2019 Biotechnology Cell counting Part 2: Experimental design and statistical analysis to quantify counting method performance 16 IS/ISO 20395:2019 / ISO 20395:2019 Biotechnology Requirements for evaluating the performance of quantification methods for nucleic acid target sequences qPCR and dPCR 17 IS/ISO 20397-1:2022 Biotechnology Massively parallel sequencing Part 1: Nucleic acid and library preparation 18 IS/ISO 20397-2:2021 Biotechnology Massively parallel sequencing Part 2: Quality evaluation of sequencing data 19 IS/ISO 20404:2023 Biotechnology Bioprocessing General requirements for the design of packaging to contain cells for therapeutic use 20 IS/ISO/TS 20660:2019 Nanotechnologies Antibacterial Silver Nanoparticles Specification of Characteristics and Measurement Methods 21 IS/ISO/TS 23367-1:2022 Nanotechnologies Performance characteristics of nanosensors for chemical and biomolecule detection Part 1: Detection performance 22 IS/ISO 29701:2010 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (Lal) test 23 IS/IEC/TS 80004-5:2011 Nanotechnologies - Vocabulary: Part 5 nano/bio interface 24 IS/IEC/TS 80004-7:2011 Nanotechnologies - Vocabulary: Part 7 diagnostics and therapeutics for healthcare 1 IS 18200 (Part 1):2024 / ISO 23907-1:2019 Sharps Injury Protection — Requirements and Test Methods, Part 1 Single-Use Sharps Containers 2 IS 18481:2024 / ISO 23908:2011 Sharps Injury Protection - Requirements and Test Methods - Sharps Protection Features for Single-use Hypodermic Needles Introducers for Catheters and Needles Used for Blood Sampling 3 IS 19314:2025 Non-chlorinated Plastic Biomedical Waste Bag 1 IS 17533:2021 Paraffin Dispenser 2 IS 17534:2021 Embalming Machine Specification 3 IS 17535:2021 Grossing Station Automated Specification 4 IS 17543:2021 Basic Requirements for Tissue Embedding station 5 IS 17584:2021 Specification for Dissection Table 6 IS 17741:2021 / ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect store and analyze biological material for forensic purposes - Requirements 7 IS 17742 (Part 1):2021 Forensic sciences Part 1: Terms and definitions 8 IS 17742 (Part 2):2021 Forensic sciences Part 2: Recognition Recording Collecting Transport and Storage of Items Category 18: Medical Biotechnology and Medical Nanotechnology (MHD 20) S. No. IS No Title Category 19: Hospital Biomedical Waste Management and Infection Control (MHD 21) S. No. IS No Title Category 20: Anatomy and Forensic Sciences Equipment (MHD 23) S. No. IS No Title

9 IS 18307:2023 Isolated Organ Bath 10 IS 18308:2023 Polygraph 11 IS 18366:2023 Physiograph 12 IS 18737:2024 Protocol for Medico-Legal Examination of Accused of Sexual Assault (Standard Operating Procedure) 13 IS 18757:2024 Protocol for Medico-Legal Examination of Survivor of Sexual Assault (Standard Operating Procedure)