Summary

Applies to medical devices other than in vitro diagnostic devices manufactured utilizing animal tissues or their derivatives that are non-viable at the point of use. Specifies the application of risk management for controlling biological hazards.

Standard Details

Standard Number: ISO 22442-1:2020
Type: ISO Standard
Published by: ISO
Official Link: https://www.iso.org/standard/74280.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.

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ISO 22442-1:2020 — Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

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