SS ISO 11607-2:+A1:2025
Packaging for terminally sterilised medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
OVERVIEW
This standard specifies requirements for the 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | +A1:2025 |
| No. of Pages | 35 |
| ICS Classification | 11.080.30 Sterilized packaging |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 11607-2 : 2019+A1:2025 IDT |