AAMI ISO 22442-3 : 2007 : R2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
Hardcopy , PDF
08-05-2020
English
01-01-2011
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
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