ISO 11607-2:2019
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
This standard has an identical version adopted as a Singapore Standard. The adopted Singapore version has the same content as this version and is available at an affordable price. To view and/or purchase the adopted Singapore Version, click here .
OVERVIEW
This document 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.
It 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 | 13 |
| ICS Classification | 11.080.30 Sterilized packaging |
| Committee | ISO/TC 198 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |