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.
Status: PublishedPublication date: 2019-02
Edition: 2Number of pages: 13
Technical Committee: ISO/TC 198 Sterilization of health care products
- ICS :
- 11.080.30 Sterilized packaging
This standard contributes to the following Sustainable Development Goal:
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|std 1 92||PDF + ePub|
|std 2 92||Paper|
ISO 11607-2:2006/Amd 1:2014
ISO 11607-2:2019Stage: 60.60
Corrigenda / AmendmentsUnder development
ISO 11607-2:2019/FDAmd 1
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