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