ANSI/AAMI/ISO 11607-2:2019
Current
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
24-05-2019
Important note : All end users must be registered with an Account prior to user licenses being assigned.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 |
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