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
English, French
31-01-2019
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 |
| 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 |
| NF EN ISO 11607-2:2020 | Identical |
| EN ISO 11607-2:2017 | Identical |
| ABNT NBR ISO 11607-2:2024 | Identical |
| DIN EN ISO 11607-2:2020-05 | Identical |
| UNE-EN ISO 11607-2:2020 | Identical |
| NS-EN ISO 11607-2:2020 | Identical |
| BS EN ISO 11607-2:2017 | Identical |
| I.S. EN ISO 11135:2014&A1:2019/LC:2019 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)<br> |
| CEI UNI EN ISO 15223-1:2022-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements |
| I.S. EN ISO 11137-1:2015/A2:2019 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137- 1:2006/Amd 2:2018) |
| ANSI/AAMI/ISO 11140-1:2014 | Sterilization of health care products - Chemical indicators - Part 1: General requirements. |
| SA HB 13485:2020 | AS ISO 13485:2017 - Medical devices - A practical guide |
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