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EVS-EN ISO 11607-2:2020/A11:2022

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

General information
Valid from 01.07.2022
Base Documents
EN ISO 11607-2:2020/A11:2022
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.11.2023
Main + amendment
01.07.2022
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/A11:2022 modifies the European standard EN ISO 11607-2:2020. The main text and the consolidated version which consists of the main text and the amendment 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 requirements of Directive 93/42/EEC,

— the relationship between EN ISO 11607-2 and the requirements of Directive 90/385/EEC,

— the relationship between EN ISO 11607-2 and the requirements of Directive 98/79/EC,
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