Abstract Preview
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.
General information
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Status : PublishedPublication date : 2019-02
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Edition : 2Number of pages : 13
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- ICS :
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Sterilized packaging
Buy this standard
Format | Language | |
---|---|---|
PDF + ePub | ||
Paper |
- CHF88
Life cycle
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Previously
WithdrawnISO 11607-2:2006
WithdrawnISO 11607-2:2006/Amd 1:2014
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Now
Corrigenda / Amendments
Under developmentISO 11607-2:2019/CD Amd 1
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