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

Class II medical device gel

Class II medical device gel, Total:200 items.

The international standard classification for "Class II medical device gel" includes: Implants for surgery, prosthetics and orthotics , Medical equipment in general , Medical equipment .

The Chinese standard classification for "Class II medical device gel" includes: Extracorporeal circulation, artificial organ and prosthesis device , 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

Professional Standard - Medicine

  • YY/T 0316-2008 Medical devices - Application of risk management to medical devices
  • YY/T 1911-2023 Test method of coagulation for medical devices
  • YY/T 1474-2016 Medical devices－Application of risk management to medical devices
  • 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/T 1574-2017 Tissue engineering medical device products—Standard guide for immobilization or encapsulation in alginate gels
  • YY/T 1985-2025 Tissue Engineering Medical Devices / Collagen
  • YY/T 1955-2025 Tissue Engineering Medical Devices Collagen Terminology
  • YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
  • 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 1435-2016 Tissue engineering medical device products―Standard guide for characterization of hydrogels

Group Standards of the People's Republic of China

  • T/CAMDI 076-2022 Gel chromatography method for molecular weight and distribution of polysulfone specialty for medical devices

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

Canadian Standards Association (CSA)

US Federal Contractor Registration (USFCR)

German Institute for Standardization

National Standardisation Body (ASRO)

Ente Nazionale Italiano di Unificazione

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 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 14971:2019 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 S99-012:2010 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)

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

Gosstandart of Russia

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 ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • 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 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

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

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

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)

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 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

Finnish Standards Institute

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

Association for Electrical, Electronic & Information Technologies (VDE)

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 14971:2007 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 14971:2019 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)
  • 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'

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)

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

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

Standard Association of Australia （SAA）

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

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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