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I.S. EN ISO 22442-2:2020

Current

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)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-28-2020

Preview

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 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
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

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