I.S. EN ISO 22442-1:2020
Current
The latest, up-to-date edition.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
Hardcopy , PDF
English
12-28-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management process
Annex A (informative) Guidance on the application of this document
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
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