NF EN 12442-3 : 2000

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.