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EU Commission Updates Harmonized Standards for In Vitro Devices

The Commission of the European Union (EU) has updated its list of harmonized standards applicable to in-vitro medical devices to reflect the latest available technical and scientific information.

According to Commission Implementing Decision (EU) 2021/1195, two new standards can now be used to demonstrate compliance with applicable requirements of the EU’s In Vitro Diagnostic Device Regulation, (EU) 2017/745. These are:

  • 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 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)”

In addition, the Commission’s Implementing Decision designated amendments to current harmonized standards, as follows:

  • EN ISO 11135:2014/A1:2019, amendment to “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/A2:2019, amendment to “Sterilization of healthcare 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)”

Under Commission rules, compliance with an EU harmonized standard confers a presumption of conformity with the corresponding essential requirements in EU harmonization legislation once the standard has been published in the Official Journal of the European Union.

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Read the text of the Commission’s Implementing Decision updating its list of harmonized standards for in vitro devices as published in the Official Journal.

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