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New MHD Standards List

S.No IS Number IS Title Category Reaffirmation Year Document Action
1 IS/ISO 17511 : 2020/ISO 17511:2020
In Vitro Diagnostic Medical Devices - Requirements for Establishing Metrological Traceability of Values Assigned to Calibrators, Trueness Control Materials and Human Samples Methods of tests 0 Buy
2 IS 13450 : Part 2 : Sec 41 : 2020/IEC 60601-2-41:2009
Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis Product Specification 0 Buy
3 IS/IEC 61217 : 2011/IEC 61217:2011
Radiotherapy Equipment - Coordinates, Movements and Scales Dimensions 0 Buy
4 IS/ISO 9583 : 1993
lmplants for Surgery — Non-Destructive Testing - Liquid Penetrant Inspection of Metallic Surgical Implants Methods of tests 0 Buy
5 IS/ISO 9584 : 2021
Implants for Surgery - Non-Destructive Testing - Radiographic Examination of Cast Metallic Surgical Implants Methods of tests 0 Buy
6 IS/ISO/TR 14283 : 2018
Implants for Surgery - Essential Principles of Safety and Performance Saftey Standard 0 Buy
7 IS/ISO 19227 : 2018
Implants for Surgery - Cleanliness of Orthopedic Implants - General Requirements Code of Practice 0 Buy
8 IS/ISO 27427 : 2013
Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components 0 Download
9 IS/ISO 7176 : Part 26 : 2007/ISO 7176-26 : 2007
Wheelchairs: Part 26 vocabulary Terminology 0 Buy
10 IS/ISO 23409 : 2015/ISO 23409 : 2011
Male condoms - Requirements and test methods for condoms made from synthetic materials Methods of tests 2020, Jan Buy
11 IS/ISO/TR 20514 : 2005/ISO/TR 20514:2005
Health informatics - Electronic health record - Definition, scope and context Others 2020, Oct Buy
12 IS/ISO 13606 : Part 1 : 2008/ISO 13606-1:2008
Health informatics - Electronic health record communication: Part 1 reference model Others 2020, Nov Buy
13 IS/ISO 5834 : Part 2 : 2011/ISO 5834 : Part 2 : 2011
Implants for surgery - Ultra - HighMolecular - Weight polyethylene: Part 2 moulded forms Product Specification 2021, Jan Buy
14 IS/ISO 6474 : Part 1 : 2010/ISO 6474 : Part 1 : 2010
Implants for surgery - Ceramic materials: Part 1 ceramic materials based on high purity alumina Product Specification 2021, Jan Buy
15 IS 13450 : Part 2 : Sec 54 : 2016/IEC 60601-2-54:2009
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 54 X-ray equipment for radiography and radioscopy Product Specification 0 Buy
16 IS 13450 : Part 2 : Sec 63 : 2016/IEC 60601-2-63:2012
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 63 dental extra - Oral X-ray equipment Product Specification 0 Buy
17 IS 13450 : Part 2 : Sec 65 : 2016/IEC 60601-2-65:2012
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 65 dental intra - Oral X-ray equipmen Product Specification 0 Buy
18 IS/ISO 10993 : Part 5 : 2009/ISO/TS 10993-20:2006
Biological evaluation of medical devices: Part 5 tests for in vitro cytotoxicity Methods of tests 0 Buy
19 IS/ISO 5834 : Part 1 : 2005/ISO 5834 : Part 1 : 2005
Implants for surgery - Ultra - HighMolecular - Weight polyethylene: Part 1 powder form Product Specification 2021, Jan Buy
20 IS/IEC 61010 : Part 1 : 2010
Safety requirements for electrical equipment for measurement, control, and laboratory use: Part 1 general requirements Saftey Standard 0 Download
21 IS/ISO 15676 : 2005/ISO 15676:2005
Cardiovascular Implants and Artificial Organs - Requirements for Single- Use Tubing Packs for Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO) Product Specification 0 Buy
22 IS/IEC 61010 : Part 2-081 : 2009/IEC 61010 : Part 2-081 : 2009
Safety requirements for electrical equipment for measurement, control and laboratory use: Part 2 - 081 particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes Saftey Standard 0 Buy
23 IS/IEC 62220 : Part 1 : Sec 2 : 2007/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 Methods of tests 2017, May Buy
24 IS/ISO 10993 : Part 10 : 2010/ISO 10993-10:2010
Biological evaluation of medical devices: Part 10 tests for irritation and skin sensitization Methods of tests 0 Buy
25 IS/ISO 10993 : Part 15 : 2000/ISO 10993-15:2000
Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys Methods of tests 0 Buy
26 IS/ISO 10993 : Part 17 : 2002/ISO 10993-17 : 2002
Biological evaluation of medical devices: Part 17 establishment of allowable limits for leachable substances Methods of tests 0 Buy
27 IS/ISO 3826 : Part 2 : 2008/ISO 3826-2 : 2008
Plastics collapsible containers for human blood and blood components: Part 2 graphical symbols for use on labels and instruction leaflets Product Specification 0 Buy
28 IS/ISO 15883 : Part 1 : 2006/ISO 15883-1 : 2006
Washer - Disinfectors: Part 1 general requirements, terms and definitions and tests Product Specification 0 Buy
29 IS 13450 : Part 2 : Sec 21 : 2018/IEC 60601-2-21:2009
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 21 infant radiant warmer Product Specification 0 Buy
30 IS/ISO 14708 : Part 2 : 2012/ISO 14708-2:2019
Implants for surgery - Active implantable medical devices: Part 2 cardiac pacemakers Product Specification 2018, Jan Buy
31 IS 13450 : Part 2 : Sec 25 : 2018/IEC 60601-2-25:2011 Medical electrical equipment - Part 2 Particular requirements for the basic safe
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs Product Specification 0 Buy
32 IS 13450 : Part 2 : Sec 27 : 2018/IEC 60601-2-27:2011
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment Product Specification 0 Buy
33 IS/ISO 21549 : Part 7 : 2016/ISO 21549-7 : 2016
Health informatics - Patient healthcard data: Part 7 medication data Others 0 Buy
34 IS/ISO 16021 : 2000/ISO 16021 : 2000
Urine-Absorbing Aids — Basic Principles for Evaluation of Single-Use Adult-Incontinence- Absorbing Aids from the Perspective of Users and Caregivers Code of Practice 0 Buy
35 IS/ISO 11658 : 2012/ISO 11658 : 2012
Cardiovascular Implants and Extracorporeal Organs — Blood/Tissue Contact Surface Modifications for Extracorporeal Perfusion Systems 0 Buy
36 IS/ISO 3826 : Part 4 : 2015/ISO 3826-4 : 2015
Plastics Collapsible Containers for Human Blood and Blood Components Part 4 Aphaeresis Blood Bag Systems with Integrated Features 0 Buy
37 IS/IEC 61331 : Part 2 : 2014
Protective Devices Against Diagnostic Medical X-Radiation Part 2 Translucent Protective Plates 0 Buy
38 IS 13450 : Part 2 : Sec 26 : 2018/IEC 60601-2-26 : 2012
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 26 Electroencephalographs 0 Buy
39 IS/ISO/TS 22077 : Part 3 : 2015/ISO/TS 22077-3 : 2015
Health Informatics ― Medical Waveform Format Part 3 Long Term Electrocardiography Others 0 Buy
40 IS/ISO 11137 : Part 1 : 2006/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 0 Buy
41 IS/ISO/IEEE 11073 : Part 10419 : 2016/ISO/IEEE 11073-10419
Health informatics - Personal health device communication: Part 10419 device specialization - Insulin pump Others 0 Buy
42 IS/ISO/TS 22077 : Part 2 : 2015/ISO 22077-2 : 2015
Health informatics ? Medical waveform format: Part 2 electrocardiography Others 0 Buy
43 IS 13450 : Part 2 : Sec 62 : 2018/IEC 60601-2-62 : 2013
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 62 high intensity therapeutic ultrasound (Hitu) equipment 0 Buy
44 IS/ISO 13959 : 2014/ISO 13959 : 2014
Water for haemodialysis and related therapies 0 Buy
45 IS/ISO 17822 : Part 1 : 2014/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 Terminology 0 Buy
46 IS/ISO/IEEE 11073 : Part 10422 : 2017/ISO/IEEE 11073-10422
Health informatics - Personal health device communication: Part 10422 device specialization - Urine analyser Others 0 Buy
47 IS/ISO 11073 : Part 91064 : 2009/ISO/IEEE 11073-91064
Health informatics - Standard communication protocol: Part 91064 computer - Assisted electrocardiography Others 0 Buy
48 IS/ISO 13606 : Part 5 : 2010/ISO 13606-5 : 2010
Health informatics - Electronic health record communication: Part 5 interface specification Others 0 Buy
49 IS/ISO 14155 : 2011/ISO 14155:2011
Clinical investigation of medical devices for human subjects - Good clinical practice Others 0 Buy
50 IS/ISO/IEEE 11073 : Part 10408 : 2010/ISO/IEEE 11073-10408
Health informatics - Personal health device communication: Part 10408 device specialization - Thermometer Others 0 Buy
51 IS/ISO/IEEE 11073 : Part 10415 : 2010/ISO/IEEE 11073-10408
Health informatics - Personal health device communication: Part 10415 device specialization - Weighing scale Others 0 Buy
52 IS/ISO/IEEE 11073 : Part 10417 : 2017/ISO/IEEE 11073-10417
Health informatics - Personal health device communication: Part 10417 device specialization - Glucose meter Others 0 Buy
53 IS/ISO/IEEE 11073 : Part 10418 : 2014/ISO/IEEE 11073-10418
Health informatics - Personal health device communication: Part 10418 device specialization: international normalized ratio (INR) monitor Others 0 Buy
54 IS/ISO/IEEE 11073 : Part 10441 : 2015/ISO/IEEE 11073-10441
Health informatics - Personal health device communication: Part 10441 device specialization - Cardiovascular fitness and activity monitor Others 0 Buy
55 IS/ISO/IEEE 11073 : Part 10420 : 2012/ISO/IEEE 11073-10420
Health Informatics — Personal Health Device Communication Part 10420 Device Specialization — Body Composition Analyzer Others 0 Buy
56 IS/ISO/IEEE 11073 : Part 10421 : 2012/ISO/IEEE 11073-10421
Health informatics - Personal health device communication: Part 10421 device specialization - Peak expiratory flow monitor (Peak Flow) Others 0 Buy
57 IS/ISO/IEEE 11073 : Part 10425 : 2016/ISO/IEEE 11073-10425
Health informatics - Personal health device communication: Part 10425 device specialization - Continuous glucose monitor (CGM) Others 0 Buy
58 IS/ISO/IEEE 11073 : Part 10427 : 2018/ISO/IEEE 11073-10427
Health informatics - Personal health device communication: Part 10427 device specialization - Power status monitor of personal health devices Others 0 Buy
59 IS 13450 : Part 2 : Sec 36 : 2019/IEC 60601-2-36:2014
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 36 equipment for extra corporeally induced lithotripsy Product Specification 0 Buy
60 IS 17194 : 2019
Surgical ankle boot with broad toe (Child And Adult Size) - Specification Product Specification 0 Download
61 IS/ISO 1797 : 2017/ISO 1797:2017
Dentistry - Shanks for rotary and oscillating instruments Product Specification 0 Buy
62 IS/ISO 22674 : 2016/ISO 22674:2016
Dentistry - Metallic materials for fixed and removable restorations and appliances Product Specification 0 Buy
63 IS/ISO 11137 : Part 3 : 2017/ISO 11137-3 : 2017
Sterilization of Health Care Products ― Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control Others 0 Buy
64 IS/IEC/TR 62366 : Part 2 : 2016/IEC/TR 62366-2:2016
Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices Code of Practice 0 Buy
65 IS/ISO 11986 : 2017/ISO 11986:2018
Ophthalmic optics Contact lenses and contact lens care products Determination of preservative uptake and release Code of Practice 0 Buy
66 IS 11040 : Part 1 : 2015/ISO 11040-1 : 2015
Prefilled syringes Part 1 : Glass cylinders for dental local anaesthetic cartridges Product Specification 0 Buy
67 IS/ISO 17327 : Part 1 : 2018
Non-active surgical implants Implant coating Part 1: General requirements Methods of tests 0 Buy
68 IS/ISO 11040 : Part 4 : 2015/ISO 11040-4 : 2015
Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling Product Specification 0 Buy
69 IS/ISO 10781 : 2015/ISO HL 10781:2015
Health Informatics HL 7 Electronic Health Record-System Functional Model, Release 2 (EHR FM) Others 0 Buy