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EN ISO 11607-1:2020/A1:2023 Standard

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  Keywords:

#covers #management #risk #can #eu

  Directive

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

  Last Official Journal reference

Monday 15th of June 2026

  Description:

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

  Purpose

ISO 11607-1 describes requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. EN ISO 11607-1:2020/A1:2023 modifies the European standard EN ISO 11607-1:2020. The main text of this standard can be found in the standard’s history. In this amendment you can find: — the relationship between EN ISO 11607-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/745, — the relationship between EN ISO 11607-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/746, — Annex F (normative) which covers risk management topics, — Annex G (informative) which covers risk management for medical device packaging and gives rationale for the requirements.

  Publication

Friday 8th of March 2024

  Amendment

This standard is an amendment for "EN ISO 11607-1:2020"

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