ANSI/AAMI/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
English
24-05-2019
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized.
| Committee |
TC 198
|
| DevelopmentNote |
New child AMD 1 2023 is now added
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-720-4
|
| Pages |
44
|
| ProductNote |
THIS STANDARD ALSO REFERS TO GAMP 5, New child AMD 1 2023 is now added
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ANSI/AAMI ST91:2021 | Flexible and semi-rigid endoscope processing in health care facilities |
| AAMI TIR14:2016(R2024) | Contract sterilization using ethylene oxide |
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