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UNI EN 12442-3 : 2002

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OR VIRUSES AND TRANSMISSIBLE AGENTS
Superseded date

06-12-2008

Published date

01-12-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Literature search
6 Elimination and/or inactivation study of viruses and
      transmissible agents
7 Final report
8 Review of final report
9 Routing monitoring and control of critical process
      parameters
Annex A (normative) Requirements related to literature search
Annex B (informative) Guidance on scaling down
Annex C (informative) Guidance on the elimination and/or
                      inactivation study for viruses and
                      transmissible agents ('agents')
Annex D (informative) Statistical evaluation of virus titres
                      and reduction factors and assessment of
                      their validity
Annex E (informative) Calculation of reduction factors
Annex F (informative) Probability of detection of agents at
                      low concentrations
Annex ZA (informative) Clauses of this standard addressing
                       Essential Requirements or other
                       provisions of EU Directives
Bibliography

Defines the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices utilizing materials of animal origin (excluding in-vitro diagnostic medical devices). Not applicable to moulds, yeasts and bacteria.

DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy

Standards Relationship
EN 12442-3 : 2000 Identical
I.S. EN 12442-3:2000 Identical
BS EN 12442-3:2000 Identical
DIN EN 12442-3:2001-01 Identical
DIN EN 12442-3:1998-05 (Draft) Identical
UNE-EN 12442-3:2001 Identical

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