EN ISO 11607-2:2006

Superseded

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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

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Superseded date: 23-01-2020

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Published date: 15-04-2006

Publisher: Comite Europeen de Normalisation

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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.

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Committee	CEN/TC 102
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 11607-2:2017

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Equivalent Standard(s)	Relationship
ISO 11607-2:2006	Identical
DIN EN ISO 11607-2:2006-07	Identical
UNE-EN ISO 11607-2:2006	Identical
UNE-EN ISO 11607-2:2007	Identical

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