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  1. HOME
  2. Standards for Class II medical device sales

Class II medical device sales

Class II medical device sales, Total:200 items.

The international standard classification for "Class II medical device sales" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "Class II medical device sales" includes: Medical apparatus and devices in general , Public medical equipment .

Shanghai Provincial Standard of the People's Republic of China

  • DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

Group Standards of the People's Republic of China

  • T/SHSPTA 007-2024 Compliance Management Norms for Advertising of Medical Devices in Retail Enterprises
  • T/SHSPTA 003-2024 Specification for medical device advertisement compliance management by retail enterprises

Professional Standard - Medicine

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

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

Canadian Standards Association (CSA)

US Federal Contractor Registration (USFCR)

German Institute for Standardization

National Standardisation Body (ASRO)

Association Francaise de Normalisation

  • NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
  • NF S99-211:2013 Medical devices - Application of risk management to medical devices
  • NF EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for the labeling of medical devices containing phthalates
  • NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF EN ISO 14971:2019 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 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.

Swedish Institute for Standards

  • SS-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • 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

Ente Nazionale Italiano di Unificazione

South African Bureau of Standard

  • SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments
  • SANS 14971:2008 Medical devices - Application of risk management to medical devices

European Union/Commission

GCC Standardization Organization

  • 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 2628:2021 Medical devices and supplies classification criteria
  • 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

British Standards Institution (BSI)

  • 19/30378069 DC BS ISO 17664-2. Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 2. Non-critical medical devices
  • 09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
  • 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
  • BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
  • BS EN ISO 14971:2019 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 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 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
  • BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
  • 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

Gosstandart of Russia

Spanish Association for Standardization (UNE)

  • UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • 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)

Kingdom of Bahrain Testing and Metrology Directorate

  • BH GSO 2628:2022 Medical devices and supplies classification criteria
  • BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
  • BH GSO ISO 15225:2017 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

European Committee for Standardization (CEN)

  • EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • 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 14971:2000 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
  • 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

Danish Standards Foundation

  • DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • 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 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
  • DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
  • DS/EN 62366:2008 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

Lithuanian Standards Office

  • LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

International Organization for Standardization (ISO)

Korean Agency for Technology and Standards (KATS)

  • 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 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure

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

Association for Electrical, Electronic & Information Technologies (VDE)

Code of Federal Regulations (CFR)

  • CFR 31-560.533-2014 Money and Finance: Treasury. Part560:Iranian transactions and sanctions regulations. Section560.533:Brokering commercial sales of agricultural commodities, medicine, and medical devices.

Standards Norway

  • NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
  • NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements

Comitato Elettrotecnico Italiano

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

Standard Association of Australia （SAA）

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

Association for the Advancement of Medical Instrumentation

  • 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/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • 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
  • 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
  • AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs

The Directorate General of Specifications and Metrology (DGSM)

American National Standards Institute （ANSI)

  • 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

European Committee for Electrotechnical Standardization（CENELEC）

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

Military Standards (MIL-STD)

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