EN ISO 22442-3:2007

Foreword
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

ISO 22442-3:2007 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.