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ISO 11607-2:2019

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes

General information

Valid from 31.01.2019
Directives or regulations
None

Standard history

Status
Date
Type
Name
13.09.2023
Amendment
31.01.2019
Main
07.07.2014
Amendment
07.04.2006
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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