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
28-12-2020
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.
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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
This document 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.
| Committee |
TC 194
|
| DocumentType |
Standard
|
| Pages |
46
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 22442-1:2020 | Identical |
| EN ISO 22442-1:2020 | Identical |
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