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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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

24-05-2019

€132.80
Excluding VAT

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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