ISO 11607-2:2006
Withdrawn
View Superseded by
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Hardcopy , PDF
04-07-2006
04-09-2025
ISO 11607-2:2006 specifies the requirements for 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.
ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO 11607 (04/2006) DRAFT ISO/DIS 11607-2 is also available for this standard. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
11
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DS EN ISO 11607-2 : 2017 | Identical |
| DIN EN ISO 11607-2:2006-07 | Identical |
| JIS T 0841-2:2019 | Identical |
| BS EN ISO 11607-2 : 2006 | Identical |
| NBN EN ISO 11607-2 : 2006 AMD 1 2014 | Identical |
| I.S. EN ISO 11607-2:2017 & LC:2017 | Identical |
| DIN EN ISO 11607-2:2014-11 | Identical |
| NS EN ISO 11607-2 : 2017 | Identical |
| SAC GB/T 19633.2 : 2015 | Identical |
| EN ISO 11607-2:2006 | Identical |
| EN ISO 11607-2:2017 | Identical |
| I.S. EN ISO 11607-2:2006 | Equivalent |
| NBR ISO 11607-2 : 2013 | Identical |
| UNE-EN ISO 11607-2:2017 | Identical |
| AAMI ISO 11607-2:2006 | Identical |
| NF EN ISO 11607-2:2018 | Identical |
| PN EN ISO 11607-2 : 2017 | Identical |
| JIS T 0841-2:2009 | Identical |
| UNE-EN ISO 11607-2:2007 | Identical |
| BS EN ISO 11607-2:2017 | Identical |
| AAMI ISO 11607-2 : 2006 : R2010 | Identical |
| UNE-EN ISO 11607-2:2006 | Identical |
| NEN EN ISO 11607-2 : 2017 + COR 2017 | Identical |
A newer version of this standard is available.
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