Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management process
Annex A (informative) - Guidance on the application
        of this part of ISO 22442
Annex B (informative) - Graphical representation of part
        of the risk management process for medical devices
        utilizing animal material
Annex C (normative) - Special requirements for some
        animal materials considering the risk
        management for TSE agents
Annex D (informative) - Information relevant to the
        management of TSE risk
Bibliography

Abstract

This part of ISO 22442 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
ProductNote	this standard also refers to ISO 10993-20
Pages
ISBN
Committee	TC 194
Supersedes	ISO/DIS 22442-1 : 60.00 (2015)
Superseded By	ISO/DIS 22442-1:2018