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  1. HOME
  2. Standards for Overseas Data of Medical Devices

Overseas Data of Medical Devices

Overseas Data of Medical Devices, Total:246 items.

The international standard classification for "Overseas Data of Medical Devices" includes: Implants for surgery, prosthetics and orthotics , Medical equipment in general , Medical equipment .

The Chinese standard classification for "Overseas Data of Medical Devices" includes: General and microsurgical devices , Extracorporeal circulation, artificial organ and prosthesis device , Medical apparatus and devices in general , Public medical equipment .

Professional Standard - Medicine

  • YY/T 0316-2016 Medical devices-Application of risk management to medical devices
  • YY/T 1654-2019 Tissue engineering medical device products—Alginate
  • YY/T 1752-2020 Basic data set of unique device identification database
  • YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
  • YY/T 1753-2020 Reporting guide of unique device identification database
  • YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
  • YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
  • YY/T 1474-2016 Medical devices－Application of risk management to medical devices
  • YY/T 0316-2008 Medical devices - Application of risk management to medical devices
  • YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
  • YY/T 1808-2021 In vitro skin irritation test for medical devices

Chongqing Provincial Standard of the People's Republic of China

  • DB50/T 1863-2025 Specification for Testing Sterilization Parameters of Imported Medical Devices

Guangdong Provincial Standard of the People's Republic of China

  • DB4403/T 277-2022 Medical device unique identification data interface specification

Hubei Provincial Standard of the People's Republic of China

  • DB42/T 2088.2-2023 Hubei Province Drugs, Medical Devices, and Cosmetics Supervision Data Collection Specifications Part 2: Medical Devices

Jiangsu Provincial Standard of the People's Republic of China

  • DB32/T 4856-2024 Data collection and application specifications for home medical devices
  • DB3211/T 1054-2022 Data collection and application specifications for household medical devices

Group Standards of the People's Republic of China

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

  • GB/T 42062-2022 Medical devices—Application of risk management to medical devices

American National Standards Institute （ANSI)

  • ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
  • ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to 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

Gosstandart of Russia

Kingdom of Bahrain Testing and Metrology Directorate

  • BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
  • BH GSO EN 13532:2022 General requirements for in vitro diagnostic medical devices for self-testing
  • BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
  • 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

Comitato Elettrotecnico Italiano

  • CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • CEI CEN/TR 17223:2019 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
  • CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices

Danish Standards Foundation

  • DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
  • DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • DANSK DS/EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  • DANSK DS/EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices
  • DANSK DS/CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices – Quality management systems – Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • 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
  • DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
  • DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
  • 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
  • DANSK DS/EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
  • DANSK DS/CEN/CR 13217:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
  • DS/CEN/CR 13217:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale

Association for the Advancement of Medical Instrumentation

  • AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • AAMI/ISO 14971:2007(R2016) Medical Devices - Application of Risk Management to Medical Devices
  • AAMI/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to medical devices
  • AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs
  • AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to 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
  • AAMI SW87:2012 Application of quality management system concepts to medical device data systems

Association Francaise de Normalisation

  • NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
  • NF S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.
  • NF S90-031:1985 Medico-surgical equipment. Intra-uterine devices.
  • NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  • NF S90-463 Medical surgical equipment. Surgical medical instruments. Scissors. Dimensions and tests.
  • NF S90-463:1982 Medical and surgical equipment. Surgical instruments. Scissors. Dimensions and tests.
  • NF S99-211:2013 Medical devices - Application of risk management to medical devices
  • NF S90-701:1988 MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
  • FD S99-212*FD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
  • NF S90-445:1985 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. ORTHOPAEDIC JOINT PROSTHESES. BASIC REQUIREMENTS.
  • NF EN ISO 14971:2019 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 S99-211/A11*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 S90-460:1982 Medical and surgical equipment. Surgical instruments. Haemostatic forceps. Dimensions and tests.
  • NF S90-221:1986 Medico-surgical equipment. Transfusion equipment. 500 ml glass bottles.
  • NF S90-222:1986 Medico-surgical equipment. Transfusion equipment. 250 ml glass bottles.

Ente Nazionale Italiano di Unificazione

  • UNI CEI EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • UNI EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  • UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
  • UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
  • EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2022 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • UNI 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
  • UNI EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized medical devices
  • UNI CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • UNI EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

Korean Agency for Technology and Standards (KATS)

  • 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 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 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 23640-2019(2024) In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

GCC Standardization Organization

  • GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
  • BH GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
  • OS GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
  • GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
  • GSO EN 13532:2021 General requirements for in vitro diagnostic medical devices for self-testing
  • 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

German Institute for Standardization

Standards Norway

  • NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
  • NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
  • NS-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  • SN-CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • NS-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing

Lithuanian Standards Office

  • LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)

Spanish Association for Standardization (UNE)

European Committee for Standardization (CEN)

  • EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • 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)
  • CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
  • EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • EN ISO 21549-6:2008 Health informatics - Patient healthcard data - Part 6: Administrative data (ISO 21549-6:2008)
  • EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'

International Organization for Standardization (ISO)

  • ISO/TS 20225:2001 Global medical device nomenclature for the purpose of regulatory data exchange
  • ISO 14971:2019 Medical devices — Application of risk management to medical devices
  • ISO 14971:2000 Medical devices - Application of risk management to medical devices
  • ISO/ASTM TR 52916:2022 Additive manufacturing for medical — Data — Optimized medical image data
  • ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
  • ISO 21549-6:2008 Health informatics - Patient healthcard data - Part 6: Administrative data
  • ISO 21549-5:2015 Health informatics - Patient healthcard data - Part 5: Identification data
  • ISO 21549-5:2008 Health informatics - Patient healthcard data - Part 5: Identification data

Swedish Institute for Standards

  • SS-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  • SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
  • SS-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)
  • SS-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

British Standards Institution (BSI)

  • BS PD CR 14230:2001 Global medical device nomenclature for the purpose of regulatory data exchange
  • BS EN ISO 14971:2012 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 ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
  • BS PD CEN ISO/ASTM/TR 52916:2022 Additive manufacturing for medical. Data. Optimized medical imagedata
  • BS PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • 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 14971:2019 Medical devices. Application of risk management to medical devices
  • PD 6630:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale
  • 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 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
  • BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • 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
  • 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 ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
  • BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
  • BS PD 6630:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale

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 14971:2020 Medical devices -- Application of risk management to medical devices

South African Bureau of Standard

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

Thai Industrial Standards Institute (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 62366:2007 Medical devices - Application of usability engineering to medical devices

American Society for Testing and Materials (ASTM)

  • ASTM F882-84(2002) Standard Performance and Safety Specification for Cryosurgical Medical Instruments

Canadian Standards Association (CSA)

The Directorate General of Specifications and Metrology (DGSM)

Standard Association of Australia （SAA）

  • AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

European Committee for Electrotechnical Standardization（CENELEC）

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

Military Standards (MIL-STD)

Bureau of Indian Standards

  • IS 18742-2-2024 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

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