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AAMI ST72 : 2011 : R2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING
Hardcopy , PDF
25-11-2019
English
01-01-2016
Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality management system elements
5 Non-pyrogenic labeling
6 Selection of product units
7 Selection of technique
8 Validation of methodology
9 Use of technique
10 Alternatives to batch testing
Annex A - Background on the bacterial endotoxins test
Annex B - Guidance on test methods, routine monitoring, and
alternatives to batch testing
Annex C - Guidance on out of specification (OOS) and failure
investigation
Annex D - Bibliography
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