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Database: 365,228(8 Aug 2026)
  1. HOME
  2. Standards for Medical Device Technology Development

Medical Device Technology Development

Medical Device Technology Development, Total:455 items.

The international standard classification for "Medical Device Technology Development" includes: Medical equipment in general , Medical equipment , Surgical instruments and materials , Sterilization and disinfection in general .

The Chinese standard classification for "Medical Device Technology Development" includes: General and microsurgical devices , Medical apparatus and devices in general , Public medical equipment .

Inner Mongolia Provincial Standard of the People's Republic of China

Group Standards of the People's Republic of China

  • T/GDMDMA 0013-2022 Classification and Definition of Technology Readiness Levels for Medical Devices
  • T/SZZX 018-2024 Specifications for thread screw and nut for medical devices
  • T/ZMDS 20002-2017 Guidance on the use of AGILE practices in the development of medical device
  • T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing
  • T/SAMD 0002-2024 Specifications for thread screw and nut for medical devices
  • T/ZMDS 40002-2021 Guidelines for design and development for in vitro diagnostic medical devices for point-of-care testing（POCT）

Shandong Provincial Standard of the People's Republic of China

  • DB3710/T 237-2024 Medical Device Unique Identification Application Technical Specification
  • DB37/T 4841-2025 Technical Specifications for Reusable Supply of Medical Soft Devices

Professional Standard - Medicine

  • YY 1276-2016 Requirements for the development, validation and routine control of dry heat sterilization process for medical devices
  • YY/T 1474-2016 Medical devices－Application of risk management to medical devices
  • YY/T 0193-1994 Specification for anodic oxidation film for aluminum parts of medical devices
  • YY/T 0995-2015 Medical devices for human assisted reproductive technology―Terminology and definitions
  • YY/T 1987-2025 Medical devices using brain-computer interface technology
  • YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
  • YY 91055-1999 Paint coating for medical devices. Classification and speciation
  • YY/T 0316-2008 Medical devices - Application of risk management to medical devices
  • YY/T 1276-2016 Requirements for the development,validation and routine control of dry heat sterilization process for medical devices
  • YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
  • YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
  • YY/T 0316-2016 Medical devices-Application of risk management to medical devices

Guangdong Provincial Standard of the People's Republic of China

  • DB4403/T 541-2024 Technical Specifications for the Monitoring and Reporting of Adverse Events of Medical Devices in Healthcare Institutions

Qinghai Provincial Standard of the People's Republic of China

  • DB63/T 2466-2025 Provincial-level On-site Sampling Technical Specifications for Medical Devices

Jiangsu Provincial Standard of the People's Republic of China

  • DB32/T 5123-2025 General Technical Specification for Usability Testing of Medical Devices

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

  • GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process 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

Professional Standard - Post and Telecommunication

  • YD/T 6284-2024 Technical requirements for intelligent medical device cybersecurity capabilities

Association of German Mechanical Engineers

National Standardisation Body (ASRO)

  • STAS 12916-1991 Human use medical instruments. Retractors. General technical requirements for quality
  • STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology
  • STAS 12670-1988 Medical instruments SURGICAL SCISSORS General technical requirements for quality

German Institute for Standardization

Association for Electrical, Electronic & Information Technologies (VDE)

European Committee for Standardization (CEN)

  • EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
  • EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development@ validation and routine control of a sterilization process for medical devices
  • EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
  • 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 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • EN ISO 25424:2019/A1:2022 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
  • EN ISO 25424:2019/prA1:2021 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021)
  • CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices

Gosstandart of Russia

  • GOST R 15.013-2016 System of products development and launching into manufacture. Medical devices
  • GOST R 59767-2021 Medical devices. Risk management. Risk assessment in the desing and development of medical devices
  • GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
  • GOST R 57504-2017 Medical devices. Syringe pumps. Technical requirements for governmental purchases
  • GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
  • GOST R 50444-2020 Medical instruments, apparatus and equipment. General technical requirements
  • GOST R 71579-2024 Medical electrical equipment. Phototherapy devices. Technical condition control methods
  • GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
  • GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure

Australian/New Zealand Standard (AU-AS/NZS)

Association for the Advancement of Medical Instrumentation

  • AAMI/ISO 20857:2010(R2015) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • 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 ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
  • AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs
  • AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
  • AAMI/ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
  • AAMI/ISO 14971:2007(R2016) Medical Devices - Application of Risk Management to Medical Devices
  • AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • AAMI/IEC 62366:2007(R2013) 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

Comitato Elettrotecnico Italiano

Ente Nazionale Italiano di Unificazione

  • UNI CEI EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • UNI EN ISO 17665-1:2007 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
  • UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
  • UNI EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
  • UNI EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
  • UNI EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for 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
  • EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
  • EC 1-2015 UNI EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • UNI EN ISO 11135:2020 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • UNI EN ISO 14937:2002 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
  • UNI EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • UNI CEI EN ISO 14971:2009 Medical devices - Application of risk management to 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 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

Standards Norway

  • NS-EN 15424:2007 Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
  • NS-EN ISO 25424:2011 Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
  • NS-EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
  • NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements

Spanish Association for Standardization (UNE)

  • UNE-EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
  • UNE-EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
  • 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)
  • AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
  • UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
  • AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices

Danish Standards Foundation

  • DS/EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
  • DANSK DS/EN ISO 25424:2011 Sterilization of medical devices – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices
  • DANSK DS/EN ISO 17665:2024 Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices
  • DS/ISO 15223-2:2011 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
  • DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
  • DANSK DS/ISO 15223-2:2011 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
  • 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 ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
  • 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
  • DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • 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

GCC Standardization Organization

  • GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
  • OS GSO ISO 22441:2024 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
  • 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 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

The Directorate General of Specifications and Metrology (DGSM)

  • OS GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
  • OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
  • OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

Japanese Industrial Standards Committee (JISC)

  • JIS T 0063:2020 Guide to the development and inclusion of aspects of safety in standards for 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 14971:2020 Medical devices -- Application of risk management to medical devices

Kingdom of Bahrain Testing and Metrology Directorate

  • BH GSO ISO 25424:2017 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
  • BH GSO ISO 15223-2:2017 Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation
  • 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
  • BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure

Canadian Standards Association (CSA)

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 15223-2:2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
  • KS P ISO 15223-2-2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
  • KS P ISO 15223-2-2019(2024) Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
  • KS A ISO/IEC GUIDE 63:2003 Guide to the development and inclusion of safety aspects in International Standards for 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 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 20857-2024 Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for 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 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure

Bureau of Indian Standards

  • IS/ISO 15223-2-2010 Medical devices —— Symbols to be Used with Medical Device Labels, Labelling, and Information to be Supplied Part 2 Symbol Development, Selection and Validation
  • IS 18319-2024 Sterilization of Health Care Products-Moist Heat-Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • IS/ISO 11135-2014 Sterilization of Health-Care Products —— Ethylene Oxide —— Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

Lithuanian Standards Office

  • LST EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)

Polski Komitet Normalizacyjny (PKN)

  • PN Z54094-1972 Medical and surgical instruments Forceps Technical requirements and tes?s
  • PN Z58022-1973 Medical instruments ynaecological curettes echnical requirements and tests

International Organization for Standardization (ISO)

  • ISO/IEC Guide 63:1999 Guide to the development and inclusion of safety aspects in International Standards for medical devices
  • ISO/IEC GUIDE 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
  • ISO 14937:2000/Cor 1:2003 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Technical Corrigendum 1
  • 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/DIS 11135 Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
  • ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

British Standards Institution (BSI)

  • 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 EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
  • BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
  • 08/30154605 DC BS ISO 15223-2. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 2. Symbol development, selection and validation
  • BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to 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 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
  • 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 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • PD CEN/TR 15133:2005 Nomenclature Collective terms and codes for groups of 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
  • BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
  • 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

Association Francaise de Normalisation

  • NF S98-105*NF EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • NF EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • NF S99-211:2013 Medical devices - Application of risk management to medical devices
  • NF EN ISO 20857:2013 Sterilization of healthcare products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF ISO 15223-2:2010 Medical devices - Symbols for use with labels, labeling and information requirements relating to medical devices - Part 2: development, selection and validation of symbols
  • NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • NF EN ISO 11135:2014 Sterilization of healthcare products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for 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 EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.

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

American National Standards Institute （ANSI)

  • ANSI/AAMI ST98-2022 Requirements for cleaning validation in medical device manufacturing Requirements for developing and validating cleaning processes for medical devices
  • 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 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure

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

Standard Association of Australia （SAA）

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

Swedish Institute for Standards

  • SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)

Military Standards (MIL-STD)

European Committee for Electrotechnical Standardization（CENELEC）

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

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