Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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Number of Standard:
CSN EN ISO 11607-2
Category:
855280
Pages:
32
Released:
01.03.2018
Catalog number:
503768
DESCRIPTION
CSN EN ISO 11607-2
CSN EN ISO 11607-2 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. 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. Original English text of CSN EN Standard. The price of the Standard included all amendments and correcturs.