DIN EN 12442-2:1998-05 (Draft)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
Hardcopy , PDF
01-03-2008
English
01-01-1998
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 |
Draft
|
Pages |
20
|
PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
NF EN 12442-2 : 2000 | Identical |
NBN EN 12442-2 : 2000 | Identical |
NEN EN 12442-2 : 2000 | Identical |
NS EN 12442-2 : 1ED 2000 | Identical |
I.S. EN 12442-2:2000 | Identical |
SN EN 12442-2 : 2000 | Identical |
UNI EN 12442-2 : 2002 | Identical |
UNE-EN 12442-2:2001 | Identical |
BS EN 12442-2:2000 | Identical |
EN 12442-2 : 2000 | Identical |
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