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

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/Amd 1:2023)

General information

Valid from 01.11.2023
Base Documents
EN ISO 11607-2:2020/A1:2023; ISO 11607-2:2019/Amd 1:2023

Standard history

Status
Date
Type
Name
15.11.2023
Main + amendment
01.11.2023
Amendment
01.07.2022
Main + amendment
03.02.2020
Main

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.

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