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NS EN ISO 22442-3 : 1ED 2007
Current
The latest, up-to-date edition.
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MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
12-01-2013
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Risk management
4.2 Sourcing and manufacturing process
4.3 General requirements related to validation
5 Literature review
5.1 Conduct of the literature review
5.2 Application of literature review output
5.3 Viruses
5.4 TSE agents
6 Elimination and/or inactivation study of viruses and TSE
agents
6.1 General
6.2 Protocol
6.3 Conduct of the study
6.4 Interpretation of data
7 Final report
8 Review of final report
9 Routine monitoring and control of critical process parameters
Annex A (normative) - Requirements related to literature review
Annex B (informative) - Guidance on the elimination and/or
inactivation study for viruses
Annex C (informative) - Guidance on the elimination and/or
inactivation study for TSE agents
Annex D (informative) - Guidance on scaling down
Annex E (informative) - Statistical evaluation of virus titres
and reduction factors and assessment of
their validity
Annex F (informative) - Calculation of reduction factors
Annex G (informative) - Probability of detection of agents at
low concentrations
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of Directive 93/42/EEC as amended by
Commission Directive 2003/32/EC
Bibliography
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