This is the first edition of CAN/CSA-ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11607-1 (first edition, 2006-04-15), including Amendment 1:2014.
For brevity, this Standard will be referred to as CAN/CSA-ISO 11607-1 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.
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.