BS EN ISO 11607-2:2020+A11:2022

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

standard by British Standard / European Standard / International Organization for Standardization , 09/13/2022

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Full Description

BS EN ISO 11607-2:2020 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.

Product Details

Published:: 09/13/2022
ISBN(s):: 9780539231694
Number of Pages:: 32
File Size:: 1 file , 1.3 MB
Product Code(s):: 30459118, 30459118
Note:: This product is unavailable in Ukraine, Russia, Belarus

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