SR EN ISO 11607-2:2006

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

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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General information

Status : Withdrawn
Approval date : 10/30/2006
Publish date : 11/1/2006
Withdrawal date : 1/31/2018
Number of pages : 20
ICS : 11.080.30 Steriliyed packaging
Technical Committee : 377 - Medical devices

Relations with other standards:

Normative reference SR EN ISO 11607-1:2006
Replaced by SR EN ISO 11607-2:2017
Amended by SR EN ISO 11607-2:2006/A1:2014