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EN ISO 11607-2:2020 Standard

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  Keywords:

#eu #can #relationship #regulation #performance

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  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

Wednesday 14th of April 2021

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EN ISO 13485:2016

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