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I.S. EN 12442-2:2000

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

02-12-2008

Language(s)

English

Published date

01-01-2000

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; 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
Pages
20
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK

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