$74
AAMI/ISO 11607-2: 2019
2019
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
- Format:
- Language(s) :
- Published :
- English
- 2019
Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems.
| AAMI/ISO 11607-2: 2019 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | AAMI/ISO 11607-2: 2019 |
| Scope | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
| Publisher | AAMI - Association for the Advancement of Medical Instrumentation/International Org. for Standardization |
| Languages | English |
| State | |
| Publication Year | 2019 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| ANSI | ANSI Approved |
| Edition | 2nd |
| File Size | 1 file , 510 KB |
| ISBN(s) | 9781570207204 |
| Note | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages | 26 |
| Published | 2019 |
| AAMI/ISO 11607-2: 2019 | ||
|---|---|---|
| History | Publisher Year | |
| AAMI/ISO 11607-2: 2019 | 2019 | Current |
| AAMI/ISO 11607-2:2006/(R)2015 | 2006 | |
| AAMI/ISO 11607:2000 | 2000 | |
| AAMI 11607:1997 | 1997 |
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