Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Also Known As:
SKU117478132
Published by
International Organization for Standardization
ISO
Publication Date2019-02
Pages CountPages20
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.
Details
History and complementary documents
History
| Edition | 2 |
| ICS Codes | 11.080.30 - Sterilized packaging |
| Language(s) | English |
| File Size | 1.2 MB |
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