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EVS-EN ISO 11607-2:2020

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

General information
Valid from 03.02.2020
Base Documents
ISO 11607-2:2019; EN ISO 11607-2:2020
Standard history
Status
Date
Type
Name
03.02.2020
Main
02.08.2017
Main
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
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