CSA Preface This is the first edition of CAN/CSA-ISO 11607-2, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11607-2 (first edition, 2006-04-15), including Amendment 1:2014. For brevity, this Standard will be referred to as "CAN/CSA-ISO 11607-2" throughout.
This Standard is one of two Standards developed by the Canadian Mirror Committee to ISO/TC 198 that are being adopted by CSA Group under the series Packaging for terminally sterilized medical devices, which consists of the following: a) ISO 11607-1, Part 1: Requirements for materials, sterile barrier systems and packaging systems; and b) ISO 11607-2, Part 2: Validation requirements for forming, sealing and assembly processes.
Scope This part of ISO 11607 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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 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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