AAMI ISO 22442-3 : 2007 : R2011

Glossary of equivalent standards
Committee representation
Background of AAMI Adoption of
ISO 22442-3:2007
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Literature review
6 Elimination and/or inactivation study
  of viruses and TSE agents
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
Bibliography

Defines requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding invitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable.