2017/745 MDR Harmonized Standards

What are the 2017/745 MDR Harmonized Standards?

In this article, we are going to give you the list of 2017/745 MDR Harmonized Standards and their latest updates.

First of all, we would like to give you the basic definitions about this harmonization system. This list is going to be updated day by day but before getting started check from the official page for the latest list of harmonized standards.

What is Harmonized Standard?

Harmonized standards are the European Standards created by European Standard Organizations (CEN, CENELEC) in reaction to a order allowed by the European Commission after interview with the Member States. They are distributed within Official Journal of the European Union They take into consideration the essential requirements of mandates and controls, and they are the best degree for a manufacturer/importer to demonstrate suggested similarity of their item with the pertinent directive/regulation.

List of 2017/745 MDR Harmonized Standards

  • EN 285:2015+A1:2021 – Sterilization – Steam sterilizers – Large sterilizers
  • EN ISO 10993-9:2021 – Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
  • EN ISO 10993-10:2023 – Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021)
  • EN ISO 10993-12:2021 – Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021) 
  • EN ISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
  • EN ISO 11135:2014, EN ISO 11135:2014/A1:2019 – 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)
  • EN ISO 11137-1:2015, EN ISO 11137- 1:2015/A2:2019 – 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)
  • EN ISO 11737-1:2018, EN ISO 11737- 1:2018/A1:2021 – Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
  • EN ISO 11737-2:2020 – 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) 
  • EN ISO 13408-6:2021 – Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)
  • EN ISO 13485:2016, EN ISO 13485:2016/A11:2021 – Medical devices – Quality management systems – Requirements for regulatory purposes (ISO
    13485:2016)
  • EN ISO 14160:2021 – Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)
  • EN ISO 14971:2019, EN ISO 14971:2019/A11 :2021 – Medical devices – Application of risk management to medical devices (ISO 14971:2019)
  • EN ISO 15223-1:2021 – Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021)
  • EN ISO 17664-1:2021 – 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 (ISO 17664-1:2021)
  • EN ISO 25424:2019, 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 (ISO 25424:2018)
  • EN IEC 60601-2-83:2020, EN IEC 60601-2- 83:2020/A11:2021 – Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

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