Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (First revision) (ISO 11607-1:2006, IDT)
This Malaysian Standard 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 standard is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
This standard 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 standard does not describe a quality assurance system for control of all stages of manufacture.
Published
• (none) / (none) / MS 1927: PART 2:2007• (none) / (none) / MS 1927: P
PDF
04/06/2019
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NSC 18 - Medical Devices and Facilities for Healthcare
