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DIN EN 12442-2:1998-05 (Draft)

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING

Available format(s)

Hardcopy , PDF

Superseded date

01-03-2008

Language(s)

English

Published date

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Superseded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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