ISO-11607-2 Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes

ISO-11607-2 - 1ST EDITION - CURRENT -- See the following: ISO-11607-2-AM1

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 1ST EDITION - April 15, 2006
 FOR 1ST EDITION AMENDMENT 1 - July 15, 2014

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.




To find similar documents by classification:

11.080.30 (Sterilized packaging)

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Document Number

ISO 11607-2:2006

Revision Level




Publication Date

April 15, 2006

Committee Number

ISO/TC 198