BS EN ISO 11607-2:2017

SKU: 1482199
Stock Status: Out of Print
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Description

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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.
Product Information
ISBN 9780580964343
Publication Status Out Of Print
Publication Date 15/05/2018
Format (Paperback, Hardback etc) A4
Total Pages 26
Brand / Publisher BSI
Publisher BSI
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