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ANSI/AAMI/ISO 11607-2:2019/A1:2023

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management

Summary

This amendment adds Annex B on risk management and related modifications to the text. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2019
Page Count 18
Themes Sterilization—Industrial
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