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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

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

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

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