ISO 11607-2:2019
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
31-01-2019
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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 |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
13
|
| ProductNote |
THIS STANDARD ALSO REFERS TO EN 13795-1,ANSI/AAMI ST65,ANSI/AAMI ST77,ANSI/AAMI ST90,ISO 11607-1:2018
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SS-EN ISO 11607-2:2020 | Identical |
| EN ISO 11607-2:2020 | Identical |
| I.S. EN ISO 11607-2:2020 | Identical |
| BS EN ISO 11607-2:2020 | Identical |
| NEN-EN-ISO 11607-2:2020 | Identical |
| UNI EN ISO 11607-2:2020 | Identical |
| ÖNORM EN ISO 11607-2:2020 04 15 | Identical |
| IS/ISO 11607 : Part 2 : 2019 | Identical |
| DS/EN ISO 11607-2:2020 | Identical |
| DS/ISO 11607-2:2019 | Identical |
| DS/ISO 11607-2:2019/Amd 1:2023 | Identical |
| ÖNORM EN ISO 11607-2:2022 12 01 | Identical |
| PN-EN ISO 11607-2:2020-06 | Identical |
| NS-EN ISO 11607-2:2020/A11:2022 | Identical |
| UNI EN ISO 11607-2:2022 | Identical |
| NF EN ISO 11607-2:2020 | Identical |
| EN ISO 11607-2:2017 | Identical |
| UNI EN ISO 11607-2:2023 | Identical |
| ABNT NBR ISO 11607-2:2024 | Identical |
| UNE-EN ISO 11607-2:2020 | Identical |
| DIN EN ISO 11607-2:2020-05 | Identical |
| NS-EN ISO 11607-2:2020 | Identical |
| BS EN ISO 11607-2:2017 | Identical |
| SA HB 13485:2020 | AS ISO 13485:2017 - Medical devices - A practical guide |
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