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MS ISO 11607-2:2009 (CONFIRMED:2015)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (First revision) (ISO 11607-2:2006, IDT)
This Malaysian Standard 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 Malaysian Standard is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
This Malaysian Standard does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
1st Revision
• (none) / (none) / MS 1927: PART 2:2007• (none) / (none) / MS 1927: P
PDF
04/06/2019
23
NSC 18 - Medical Devices and Facilities for Healthcare
11.080.30
30.00