I.S. EN ISO 22442-2:2020
Current
The latest, up-to-date edition.
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
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.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Sourcing
6 Collection
7 Handling
8 Storage, transport and labelling
Annex A (normative) Additional requirements relating to the application of this document to bovine-sourced materials and other TSE relevant animal species
Annex B (informative) Certification and attestation
Bibliography
This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
34
|
| 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 22442-2:2020 | Identical |
| EN ISO 22442-2:2020 | Identical |
| ISO 22442-2:2020 | Equivalent |
| BS EN ISO 22442-2:2020 | Equivalent |
| EN ISO 22442-2:2020 | Equivalent |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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