ISO-11607-2 › Historical Revision Information
Amendment 1: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management

ISO-11607-2 - FOR 2ND EDITION AMENDMENT 1 SEE - CURRENT -- See the following: ISO-11607-2-AM1
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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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Document Number

ISO-11607-2

Revision Level

FOR 2ND EDITION AMENDMENT 1 SEE

Status

Current

Publication Date

Sept. 1, 2023

Committee Number

ISO/TC 198