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

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  Keywords:

#eu #can #relationship #regulation #performance

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Wednesday 28th of January 2026

  Description:

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

  Purpose

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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