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
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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