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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
01.07.2022
Amendment
01.07.2022
Main + amendment
03.02.2020
Main
EN ISO 11607-2:2020/A11:2022 modifies the European standard EN ISO 11607-2:2020.

EN ISO 11607-2 sets out requirements for the development and validation of processes for packaging medical devices that are terminally sterilized.

The main text and the consolidated version which consists of main text and the amendment can be found from the standard’s history.

In this amendment you can find:

— relationship between EN ISO 11607-2 and the requirements of Directive 93/42/EEC,

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

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