AAMI/ISO TIR22442-4:2011(R2016)
Current
The latest, up-to-date edition.
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 4: PRINCIPLES FOR ELIMINATION AND/OR INACTIVATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS AND VALIDATION ASSAYS FOR THOSE PROCESSES
Hardcopy , PDF
English
11-12-2016
Glossary of equivalent standards
Committee representation
Background of US adoption of ISO/TR 22442-4:2010
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Elimination of TSE agents: basic considerations
5 Potential methods to eliminate TSE agents
6 Experimental validation of methods for eliminating
TSE agents from medical devices utilizing non-viable
animal tissues
Bibliography
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