SS ISO 11607-2:2019
Packaging for terminally sterilised medical devices – Part 2 : Validation requirements for forming, sealing and assembly processes
OVERVIEW
Specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilised. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
Applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilised.
Does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2019 |
| No. of Pages | 23 |
| ICS Classification | 11.080.30 Sterilized packaging |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 11607-2 : 2019 IDT |