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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
ISO 11607-2:2019; EN ISO 11607-2:2020; EN ISO 11607-2:2020/A11:2022
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.11.2023
Main + amendment
01.11.2023
Amendment
01.07.2022
Main + amendment
01.07.2022
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. The standard can be used in the medical industry, health care facilities or wherever medical devices are packaged and sterilized.

ISO 11607-2 helps to ensure that the medical device can be sterilized and remain sterile in storage or transport conditions. It is also important that medical devices delivered in a sterile state are manufactured, packed and sterilized by validated methods. The main text and the amendment can be found in the standard’s history.

In this consolidated version you can also find:

— the relationship between the standard and the requirements of Directive 93/42/EEC,

— the relationship between the standard and the requirements of Directive 90/385/EEC,

— the relationship between the standard and the requirements of Directive 98/79/EC,

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