NEN EN 12442-3 : 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
01-17-2008
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 |
Netherlands Standards
|
| Status |
Superseded
|
| 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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