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Homepage>CSN Standards>85 HEALTH SERVICE>8552 General regulations and directions for articles for health service>CSN EN ISO 11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
FREE SHIPPINGReleased: 2006
CSN EN ISO 11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

CSN EN ISO 11607-2

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

CURRENCY
LANGUAGE
English
Category:855280
Released:2006
Released:2017
Number of Standard:CSN EN ISO 11607-2
DESCRIPTION

EN ISO 11607-2


EN ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - ISO 11607-2:2006 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. ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. ISO 11607-2:2006 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.
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