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EN ISO 11607-2:2020/A1:2023 Standard

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  Keywords:

#eu #regulation #requirements #can #performance

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Tuesday 8th of April 2025

  Description:

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

  Purpose

EN ISO 11607-2 sets out requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. EN ISO 11607-2:2020/A1:2023 modifies the European standard EN ISO 11607-2:2020. The main text can be found in the standard’s history.In this amendment you can find the following:— the relationship between EN ISO 11607-2 and the General Safety and Performance Requirements of Regulation (EU) 2017/745,— the relationship between EN ISO 11607-2 and the General Safety and Performance Requirements of Regulation (EU) 2017/746,— Annex B (normative) which covers risk management topics.

  Publication

Friday 8th of March 2024

  Amendment

This standard is an amendment for "EN ISO 11607-2:2020"

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