EN ISO 11607-2:2020/A11:2022
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
06-15-2022
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.
| Committee |
CEN/TC 102
|
| DocumentType |
Amendment
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN ISO 11607-2:2022 | Identical |
| UNI EN ISO 11607-2:2023 | Identical |
| BS EN ISO 11607-2:2020+A11:2022 | Identical |
| ÖNORM EN ISO 11607-2:2022 12 01 | Identical |
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