UNI EN 12442-2 : 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - CONTROL AND SOURCING, COLLECTION AND HANDLING
12-06-2008
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Sourcing; general; species and strain
6 Sourcing of animal materials: Inspection,
certification and traceability
7 Collection
8 Handling
9 Storage and transport
10 Derivatives and other specialized cases
Annex A (normative) Additional requirements relating to
the application of EN 12442-2 to
bovine sourced materials
Annex B (informative) Certification and attestation
Annex C (informative) Veterinary services
Annex ZA (informative) Clauses of this European Standard
addressing Essential Requirements
or other provisions of EC Directives
Bibliography
Defines requirements for controls on sourcing, collection and handling of animals and tissues (including storage and transport) of animals and tissues for manufacture of medical devices using materials of animal origin other than in vitro diagnostic medical devices.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| BS EN 12442-2:2000 | Identical |
| I.S. EN 12442-2:2000 | Identical |
| DIN EN 12442-2:1998-05 (Draft) | Identical |
| UNE-EN 12442-2:2001 | Identical |
| DIN EN 12442-2:2001-01 | Identical |
| EN 12442-2 : 2000 | Identical |
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