I.S. EN ISO 22442-2:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING (ISO 22442-2:2015)
Hardcopy , PDF
30-06-2021
English
01-01-2015
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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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Sourcing
6 Collection
7 Handling
8 Storage and transport
Annex A (normative) - Additional requirements relating
to the application of this part of ISO 22442
to bovine-sourced materials
Annex B (informative) - Certification and attestation
Annex C (informative) - Veterinary services
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Provides 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.
| DevelopmentNote |
Supersedes I.S. EN 12442-2. (02/2008)
|
| DocumentType |
Standard
|
| Pages |
34
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 22442-2 : 2016 | Identical |
| DIN EN ISO 22442-2:2016-05 | Identical |
| ISO 22442-2:2015 | Identical |
| BS EN ISO 22442-2:2015 | Identical |
| NEN EN ISO 22442-2 : 2015 | Identical |
| EN ISO 22442-2:2015 | Identical |
| NF EN ISO 22442-2 : 2016 | Identical |
| NBN EN ISO 22442-2 : 2015 | Identical |
| NS EN ISO 22442-2 : 2007 | Identical |
| SN EN ISO 22442-2 : 2016 | Identical |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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