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medical device pressure

medical device pressure, Total:312 items.

In the international standard classification, medical device pressure involves: Medical equipment, Valves, Applications of information technology, Laboratory medicine, Pharmaceutics, Vocabularies, Sterilization and disinfection, Rubber and plastics products, Software development and system documentation, Quality, Medical sciences and health care facilities in general, Graphical symbols, Dentistry.


International Organization for Standardization (ISO), medical device pressure

  • ISO 1135-5:2015 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus
  • 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 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators

German Institute for Standardization, medical device pressure

British Standards Institution (BSI), medical device pressure

  • BS EN 738-4:1999 Pressure regulators for use with medical gases - Low-pressure regulators intended for incorporation into medical equipment
  • 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 EN ISO 10524-4:2009 Pressure regulators for use with medical gases. Low-pressure regulators
  • BS EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Low-pressure regulators
  • 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

RU-GOST R, medical device pressure

  • 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 R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
  • 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 ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
  • 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 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing

Group Standards of the People's Republic of China, medical device pressure

CEN - European Committee for Standardization, medical device pressure

  • 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"

Association Francaise de Normalisation, medical device pressure

  • 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 S95-179/A1:2002 Pressure regulators for use with medical gases - Part 4 : low-pressure regulators intended for incorporation into medical equipment.
  • 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 S95-159-4*NF EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4 : low-pressure regulators

European Committee for Standardization (CEN), medical device pressure

  • 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

ZA-SANS, medical device pressure

  • SANS 14971:2008 Medical devices - Application of risk management to medical devices

Korean Agency for Technology and Standards (KATS), medical device pressure

  • 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 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

Japanese Industrial Standards Committee (JISC), medical device pressure

  • 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

KR-KS, medical device pressure

  • 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

TH-TISI, medical device pressure

  • TIS 14971-2013 Medical devices.application of risk management to medical devices

Professional Standard - Medicine, medical device pressure

  • 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 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

International Electrotechnical Commission (IEC), medical device pressure

  • 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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, medical device pressure

  • 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

未注明发布机构, medical device pressure

  • 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

Danish Standards Foundation, medical device pressure

  • 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

ES-UNE, medical device pressure

  • 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 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN 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 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)

Standard Association of Australia （SAA）, medical device pressure

  • AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
  • AS/NZS 4815 Set:2008 Sterilising Medical instruments Set
  • AS 3840.1:1998 Pressure regulators for use with medical gases - Pressure regulators and pressure regulators with flow-metering devices

国家食品药品监督管理局, medical device pressure

  • YY/T 1474-2016 Application of medical device usability engineering to medical devices

American National Standards Institute （ANSI), medical device pressure

  • 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), medical device pressure

CENELEC - European Committee for Electrotechnical Standardization, medical device pressure

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

国家药监局, medical device pressure

  • YY/T 0802-2020 Disposal of medical devices Information provided by medical device manufacturers

Lithuanian Standards Office , medical device pressure

  • 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

AENOR, medical device pressure

  • 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

PL-PKN, medical device pressure

US-FCR, medical device pressure

AT-ON, medical device pressure

  • 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, medical device pressure

  • 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, medical device pressure

VN-TCVN, medical device pressure

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

RO-ASRO, medical device pressure

  • STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS

Jiangsu Provincial Standard of the People's Republic of China, medical device pressure

  • DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions

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