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Reagents Medical Devices

Reagents Medical Devices, Total:500 items.

In the international standard classification, Reagents Medical Devices involves: Laboratory medicine, Medical sciences and health care facilities in general, Analytical chemistry, Sterilization and disinfection, Medical equipment, Pharmaceutics, Vocabularies, Applications of information technology, Information sciences. Publishing, Rubber and plastics products, Software development and system documentation, Quality, Graphical symbols, Dentistry, Birth control. Mechanical contraceptives.


RU-GOST R, Reagents Medical Devices

  • GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
  • GOST R 51088-2013 In vitro diagnostic medical devices. Reagents, kits, the test-systems, control materials, culture media. Requirements to devices and to supporting documentation
  • GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
  • GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
  • GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
  • GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
  • GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
  • GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
  • GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
  • GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
  • GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
  • GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
  • GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
  • GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
  • GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
  • GOST R 55544-2013 Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software
  • GOST R 56429-2015 Medical devices. Clinical evaluation
  • GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
  • GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
  • GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
  • GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
  • GOST R ISO 17664-2012 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • GOST R 57449-2017 Medical devices. Guidance on the application of ISO 14971

Korean Agency for Technology and Standards (KATS), Reagents Medical Devices

  • KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
  • KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
  • KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
  • KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
  • KS P 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
  • KS P IEC 62366-1:2018 Medical devices — Part 1:Application of usability engineering to medical devices
  • KS P IEC 62366-1:2021 Medical devices — Part 1: Application of usability engineering to medical devices
  • KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
  • KS P ISO 15223-2007(2012) Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
  • KS P ISO TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
  • KS P IEC TR 62366-2:2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

KR-KS, Reagents Medical Devices

  • KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
  • KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
  • KS P ISO 17664-2-2022 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
  • KS P 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
  • KS P IEC 62366-1-2018 Medical devices — Part 1:Application of usability engineering to medical devices
  • KS P IEC 62366-1-2021 Medical devices — Part 1: Application of usability engineering to medical devices
  • KS P ISO TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems
  • KS P IEC TR 62366-2-2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

ES-UNE, Reagents Medical Devices

  • UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
  • UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN ISO 17664-1:2022 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 (ISO 17664-1:2021)

Association Francaise de Normalisation, Reagents Medical Devices

  • NF EN ISO 23640:2015 Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro
  • NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • NF S99-211:2013 Medical devices - Application of risk management to medical devices
  • NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF EN ISO 14971/A11:2021 Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
  • NF EN ISO 14971:2019 Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
  • NF S98-116-2*NF 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
  • NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
  • NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
  • NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
  • NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
  • NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
  • NF S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.
  • NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique
  • NF S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
  • NF S98-107-1*NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices
  • NF S98-116-1*NF EN 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
  • NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
  • NF S90-031:1985 Medico-surgical equipment. Intra-uterine devices.
  • NF S91-170:1996 Dentistry. Medical devices for denstistry. Instruments.
  • NF S90-463:1982 Medical and surgical equipment. Surgical instruments. Scissors. Dimensions and tests.

German Institute for Standardization, Reagents Medical Devices

国家药品监督管理局, Reagents Medical Devices

  • YY/T 1579-2018 In vitro diagnostic medical devices and in vitro diagnostic reagent stability evaluation

European Committee for Standardization (CEN), Reagents Medical Devices

  • EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
  • EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
  • EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
  • EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
  • EN 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 (ISO 17664-1:2021)
  • EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
  • prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements

AENOR, Reagents Medical Devices

  • UNE-EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
  • UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN 1639:2010 Dentistry - Medical devices for dentistry - Instruments

Group Standards of the People's Republic of China, Reagents Medical Devices

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Reagents Medical Devices

  • GB/T 27949-2011 Hygienic requirements for medical items disinfection
  • GB 27949-2011 General Requirements for Disinfectants for Medical Devices
  • GB/T 42062-2022 Medical devices—Application of risk management to medical devices
  • GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
  • GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices

国家市场监督管理总局、中国国家标准化管理委员会, Reagents Medical Devices

  • GB 27949-2020 General requirements of disinfectant of medical instruments

RO-ASRO, Reagents Medical Devices

  • STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS
  • STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

British Standards Institution (BSI), Reagents Medical Devices

  • BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
  • BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
  • BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
  • BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
  • BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
  • BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
  • BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
  • BS EN 556-2:2015 Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
  • 23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices
  • 23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
  • BIP 2071-2005 Medical devices: ISO 13485 and ISO 9001
  • 19/30378069 DC BS ISO 17664-2. 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
  • BS PD ISO/TR 19727:2017 Medical devices. Pump tube spallation test. General procedure
  • BS EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices

CEN - European Committee for Standardization, Reagents Medical Devices

  • EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
  • EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • EN 1441:1997 Medical Devices - Risk Analysis
  • EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"

ZA-SANS, Reagents Medical Devices

  • SANS 14971:2008 Medical devices - Application of risk management to medical devices
  • SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments
  • SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

Japanese Industrial Standards Committee (JISC), Reagents Medical Devices

  • JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
  • JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
  • JIS T 62366-1:2022 Medical devices -- Part 1: Application of usability engineering to medical devices
  • JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

TH-TISI, Reagents Medical Devices

  • TIS 14971-2013 Medical devices.application of risk management to medical devices
  • TIS 2278-2006 Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices

Professional Standard - Medicine, Reagents Medical Devices

  • YY/T 0316-2016 Medical devices.Application of risk management to medical devices
  • YY/T 0316-2008 Medical devices.Application of risk management to medical devices
  • YY/T 0316-2003 Medical devices-Application of risk management to medical devices
  • YY/T 1911-2023 Medical device coagulation test methods
  • YY/T 0468-2015 Medical devices.Quality management.Medical device nomenclature data structure
  • YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
  • YY/T 0297-1997 Clinical investigation of medical devices
  • YY/T 1406.1-2016 Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software
  • YY/T 1406.1-2016/IEC/TR 80002-1 Medical Device Software Part 1: Guidelines for YY/T 0316 Applied to Medical Device Software
  • YY/T 0615.1-2007 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
  • YY/T 0615.2-2007 Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices

International Electrotechnical Commission (IEC), Reagents Medical Devices

  • IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
  • IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
  • IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
  • IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62366-1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices
  • ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
  • ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
  • ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems

International Organization for Standardization (ISO), Reagents Medical Devices

  • ISO 14971:2000 Medical devices - Application of risk management to medical devices
  • IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • 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
  • IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices — Amendment 1
  • ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
  • ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
  • ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
  • ISO/TR 19727:2017 Medical devices — Pump tube spallation test — General procedure
  • IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
  • IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
  • IEC/TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
  • IEC 62366-1:2015/AMD1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
  • ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
  • IEC 62366-1:2015/AMD 1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
  • ISO 14971:2019 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements

未注明发布机构, Reagents Medical Devices

  • DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
  • BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
  • DIN EN 540:1993 Clinical testing of medical devices on humans
  • DIN EN ISO 10993-18:2009 Biological assessment of medical devices
  • NF S90-463 Medical surgical equipment. Surgical medical instruments. Scissors. Dimensions and tests.

Danish Standards Foundation, Reagents Medical Devices

  • DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
  • DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • DS/CEN/CR 14060:2001 Medical device traceability
  • DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
  • DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
  • DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
  • DS/EN 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 (ISO 17664-1:2021)
  • DS/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
  • DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
  • DS/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
  • DS/EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
  • DS/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
  • DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

Standard Association of Australia （SAA）, Reagents Medical Devices

  • AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
  • AS/NZS 4815 Set:2008 Sterilising Medical instruments Set
  • ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

国家食品药品监督管理局, Reagents Medical Devices

  • YY/T 1474-2016 Application of medical device usability engineering to medical devices
  • YY/T 1607-2018 Method for setting radiation sterilization dose of medical devices

American National Standards Institute （ANSI), Reagents Medical Devices

  • ANSI/AAMI/ISO 17664-2:2022 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
  • ANSI/AAMI/ISO 17664-1:2022 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
  • ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1
  • ANSI/AAMI ST108:2023 Water for the processing of medical devices

Canadian Standards Association (CSA), Reagents Medical Devices

CENELEC - European Committee for Electrotechnical Standardization, Reagents Medical Devices

  • EN 62366:2008 Medical devices - Application of usability engineering to medical devices

国家药监局, Reagents Medical Devices

  • YY/T 0802-2020 Disposal of medical devices Information provided by medical device manufacturers
  • YY/T 1808-2021 In vitro skin irritation test for medical devices
  • YY/T 1733-2020 Guidelines for Dose Distribution Testing of Radiation Sterilization Irradiation Devices for Medical Devices

PL-PKN, Reagents Medical Devices

Lithuanian Standards Office , Reagents Medical Devices

  • LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
  • LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
  • LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • LST EN 1639-2010 Dentistry - Medical devices for dentistry - Instruments

US-FCR, Reagents Medical Devices

AT-ON, Reagents Medical Devices

  • OENORM EN 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 (ISO/FDIS 17664-1:2021)

CH-SNV, Reagents Medical Devices

  • SN EN 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 (ISO 17664-1:2021)

卫生健康委员会, Reagents Medical Devices

VN-TCVN, Reagents Medical Devices

  • TCVN 6916-2001 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied

Jiangsu Provincial Standard of the People's Republic of China, Reagents Medical Devices

  • DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions
  • DB32/T 4553-2023 Guidelines for Monitoring Adverse Events of Medical Devices in Medical Institutions

GOSTR, Reagents Medical Devices

  • GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
  • GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit

US-AAMI, Reagents Medical Devices

EU/EC - European Union/Commission Legislative Documents, Reagents Medical Devices

  • MEDDEV 2.15-2008 GUIDELINES ON MEDICAL DEVICES Committees/Working Groups contributing to the implementation of the Medical Device Directives (REV 3)

IN-BIS, Reagents Medical Devices

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