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BS EN ISO 11607-2:2017

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Packaging for terminally sterilized medical devices
More Information
ISBN9780580964343
Publication StatusCurrent
Publication Date15/05/2018
Format (Paperback, Hardback etc)A4
Total Pages26
Brand / PublisherBSI
PublisherBSI

Official BSI Distributor

What is this standard about?

This part of ISO 11607 specifies the requirements for 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.

Who is this standard for?

This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
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