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  1. HOME
  2. Standards for Medical device cooling holes

Medical device cooling holes

Medical device cooling holes, Total:479 items.

The international standard classification for "Medical device cooling holes" includes: Medical equipment in general , Steel wire, wire ropes and link chains , Medical equipment , Medical Sciences and health care facilities in general .

The Chinese standard classification for "Medical device cooling holes" includes: Medical apparatus and devices in general , General and microsurgical devices , Steel wire and wire rope , Public medical equipment , Medical science .

未注明发布机构

Professional Standard - Medicine

  • YY/T 0297-1997 Clinical investigation of medical devices
  • YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
  • YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
  • YY/T 0316-2016 Medical devices-Application of risk management to medical devices
  • YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
  • YY/T 0316-2008 Medical devices - Application of risk management to medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

  • GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
  • GB/T 42062-2022 Medical devices—Application of risk management to medical devices
  • GB/T 43312-2023 Steel wire ropes for medical devices

国家食品药品监督管理局

  • YY/T 1474-2016 Medical devices－Application of risk management to medical devices

国家药监局

  • YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer

Professional Standard - Agriculture

  • GB/Z 44363-2024 Pyrogenicity—Principles and methods for pyrogen testing of medical devices

Group Standards of the People's Republic of China

卫生健康委员会

Jiangsu Provincial Standard of the People's Republic of China

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

German Institute for Standardization

SCC

  • DIN 96138 E:2011 Draft Document - Medical instruments - Tympanum perforators type Lucae
  • CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
  • CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
  • AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
  • DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
  • DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
  • CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
  • ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
  • CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
  • DIN 13189 E:2008 Draft Document - Medical instruments - Laminectomy punches type Ferris-Smith-Kerrison
  • DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
  • AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
  • DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
  • CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
  • DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
  • MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
  • DIN 96056:2016 Medical instruments - Bone raspatory
  • DANSK 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
  • CSA ISO 17664-2:2023 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
  • 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
  • DIN 58857:2019 Medical instruments - Directors
  • BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
  • SN-CR 14060:2000 Medical device traceability
  • CAN/CSA-ISO 17664-2-2023 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
  • 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
  • NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
  • UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • DANSK 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
  • NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
  • NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
  • AENOR 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
  • NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
  • AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
  • UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
  • DANSK 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
  • DANSK DS/EN ISO 17664-2:2024 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 (ISO 17664-2:2021)
  • NS-EN ISO 17664-2:2023 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 (ISO 17664-2:2021)
  • NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
  • NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
  • DANSK DS/ISO/TR 21582:2021 Pyrogenicity – Principles and methods for pyrogen testing of medical devices
  • DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
  • DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
  • NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
  • DIN 58274:2016 Medical instruments - Iris forceps
  • CAN/CSA-ISO 17664-1-2023 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
  • BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
  • DIN 96057:2016 Medical instruments - Raspatory type Sedillot
  • DIN 13184:2016 Medical instruments - Bone holding forceps Farabeuf's
  • DIN 58318:2019 Medical instruments - Elevators Langenbeck's
  • NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
  • DIN 58319:2019 Medical instruments - Elevators Williger
  • NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
  • DIN EN 556-1 E:2023 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023
  • CAN/CSA-ISO 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)
  • ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices
  • UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
  • AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
  • DIN 58259:2017 Medical instruments - Needle holder type Masson
  • DIN 13460 E:2016 Draft Document - Medical instruments - Needle holder type Heaney
  • DIN 58295:2017 Medical instruments - Retractor type Volkmann
  • DANSK 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)
  • NS-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)
  • DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
  • DIN 58287:2017 Medical instruments - Retractor type Körte
  • DIN EN ISO 17664-2 E:2023 Draft Document - 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 (ISO 17664-2:2021); German and English version prEN ISO 176...
  • DIN 58288:2017 Medical instruments - Retractor type Langenbeck
  • DIN 96160 E:2011 Draft Document - Medical instruments - Wire guide
  • DIN 58286:2017 Medical instruments - Retractor type Kocher
  • UNE-EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)
  • CEI EN 62366-1:2016 Medical devices Part 1: Application of usability engineering to medical devices
  • BS 5736-5:1982 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices
  • DIN 58276:2017 Medical instruments - Forceps type Adson
  • DIN 58785:2017 Medical instruments - Ear specula type Hartmann
  • DIN 13119 E:2008 Draft Document - Medical instruments - Bowel scissors
  • DIN 13175 E:2012 Draft Document - Medical instruments - Tongue forceps type Young
  • UNE-CR 14060:2001 Medical device traceability.
  • AAMI ST108:2023 Water for the processing of medical devices
  • DIN 13117 E:2012 Draft Document - Medical instruments - Bone shears
  • DIN 58861:2017 Medical instruments - Osteotomes type Lambotte
  • DIN 58846 E:2017 Draft Document - Medical instruments - Raspatories
  • NS-EN 1441:1997 Medical devices — Risk analysis
  • AS ISO 14155:2002 Clinical investigation of medical devices
  • DIN 58857 E:2019 Draft Document - Medical instruments - Directors
  • DIN 13128 E:2016 Draft Document - Medical instruments - Intestinal forceps type Allis
  • DIN 58794 E:2008 Draft Document - Medical instruments - Ear forceps
  • DIN 58860:2017 Medical instruments - Osteotomes type Lexer
  • DIN EN ISO 14971 E:2018 Draft Document - Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018
  • 05/30140005 DC BS EN ISO 14971 ED 2. Medical devices. Application of risk management to medical devices

GSO

  • GSO ISO/TR 19727:2021 Medical devices — Pump tube spallation test — General procedure
  • BH GSO ISO/TR 19727:2022 Medical devices — Pump tube spallation test — General procedure
  • GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
  • BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
  • OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
  • BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
  • OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
  • GSO ISO 17664-2:2023 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
  • GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
  • BH GSO ISO 17664-2:2023 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
  • GSO ISO/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
  • GSO ISO 17664:2014 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • BH GSO ISO/TR 80002-2:2022 Medical device software — Part 2: Validation of software for medical device quality systems

RU-GOST R

  • 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 R ISO 20857-2016 Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for 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 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/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

British Standards Institution (BSI)

  • BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
  • BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
  • BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
  • BS EN ISO 14971:2001 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 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
  • BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
  • BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
  • BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
  • PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices
  • 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 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
  • BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
  • BS PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices

CEN - European Committee for Standardization

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

Japanese Industrial Standards Committee (JISC)

  • 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

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
  • KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
  • 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 62366-1:2021 Medical devices — Part 1: Application of usability engineering to medical devices
  • KS P IEC 62366-1:2018 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

International Organization for Standardization (ISO)

  • ISO 14971:2019 Medical devices — Application of risk management to 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/TR 21582:2021 Pyrogenicity — Principles and methods for pyrogen testing of 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

Association Francaise de Normalisation

  • NF S99-211:2013 Medical devices - Application of risk management to medical devices
  • NF EN ISO 14971:2019 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 Medical devices - Application of risk management to medical devices
  • 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
  • FD S99-513*FD ISO/TR 21582:2021 Pyrogenicity - Principles and methods for pyrogen testing of medical devices
  • 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
  • FD ISO/TR 21582:2021 Pyrogenicity - Principles and test methods for the detection of pyrogens on medical devices

KR-KS

  • 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

European Committee for Standardization (CEN)

  • 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
  • EN ISO 17664-2:2023 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 (ISO 17664-2:2021)

ZA-SANS

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

TH-TISI

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

International Electrotechnical Commission (IEC)

  • 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 TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
  • IEC 62366:2007/AMD1:2014 Medical devices - 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

ES-UNE

  • UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN ISO 14971:2020 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)

Standard Association of Australia （SAA）

Danish Standards Foundation

  • 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/ISO/TR 21582:2021 Pyrogenicity – Principles and methods for pyrogen testing of medical devices
  • 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 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed 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/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 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/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

American National Standards Institute （ANSI)

  • 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

CENELEC - European Committee for Electrotechnical Standardization

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

DIN

  • DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • DIN 96056:2023 Medical instruments - Bone raspatory
  • DIN 13173:2023 Medical instruments - Dressing forceps
  • DIN 13176:2023 Medical instruments - Organ grasping forceps
  • DIN EN ISO 17664-2:2024 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 (ISO 17664-2:2021); German version EN ISO 17664-2:2023
  • DIN 96074:2023 Medical instruments - Elevator type Freer
  • DIN 13460:2023 Medical instruments - Needle holder type Heaney
  • DIN 96057:2023 Medical instruments - Raspatory type Sedillot
  • DIN 58249:2023 Medical instruments - Retractors type Weitlaner
  • DIN 58247:2023 Medical instruments - Retractors type Roux
  • DIN 13128:2023 Medical instruments - Intestinal forceps type Allis

AENOR

  • 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

Canadian Standards Association (CSA)

Lithuanian Standards Office

  • 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

US-FCR

PL-PKN

AT-ON

  • 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

  • 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)

VN-TCVN

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

RO-ASRO

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

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