2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

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14 - Draft standards 24 - View all published standards related to this directive 0 - Withdrawn standards

Harmonised Standards or standards supporting the application of the EU legislation

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

60.60 Standard published

L 258 Official journal reference
Jul 20, 2021 Official journal publication date

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

60.60 Standard published

L 258 Official journal reference
Jul 20, 2021 Official journal publication date

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2022 Official journal publication date

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2022 Official journal publication date

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

60.60 Standard published

L 258 Official journal reference
Jul 20, 2021 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

L 135 Official journal reference
May 12, 2022 Official journal publication date

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

60.60 Standard published

L 258 Official journal reference
Jul 20, 2021 Official journal publication date

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

60.60 Standard published

L 258 Official journal reference
Jul 20, 2021 Official journal publication date

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2022 Official journal publication date

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)

60.60 Standard published

L 258 Official journal reference
Jul 21, 2021 Official journal publication date

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2021 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2022 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

L 135 Official journal reference
May 12, 2022 Official journal publication date

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2021 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2022 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2022 Official journal publication date

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2022 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 4 Official journal reference
Jan 7, 2022 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

L 135 Official journal reference
May 12, 2022 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

L 135 Official journal reference
May 12, 2022 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 135 Official journal reference
May 12, 2022 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 135 Official journal reference
May 12, 2022 Official journal publication date