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ISO 11607-2:2019

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ISO 11607-2:2019

Packaging for terminally sterilized medical devices —Part 2:Validation requirements for forming, sealing and assembly processes

International Organization for Standardization

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Abstract

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized.

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Document Type Standard
Status Current
Publisher International Organization for Standardization
ProductNote THIS STANDARD ALSO REFERS TO EN 13795-1,ANSI/AAMI ST65,ANSI/AAMI ST77,ANSI/AAMI ST90,ISO 11607-1:2018
Committee TC 198
Supersedes
  • ISO 11607-2 : 2006(R 2015)