Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviations
5 Overall demands in endotoxin work
5.1 Demands on operator
5.2 Demands on equipment
5.3 Demands on glassware
5.4 Demands on extraction liquids, water and detergents
5.5 Demands on filters
5.6 Transportation of samples
5.7 Storage of samples at the laboratory
5.8 Test for contamination
5.9 Sampling documentation
6 Extraction
6.1 Equipment
6.2 How to extract
6.3 Storage
6.4 Extraction documentation
7 Analytical methods
7.1 Equipment
7.2 Procedure
7.3 Validation
7.4 Protocol
8 Expression of results
9 Precision
10 Report
Annex A (informative) Properties of endotoxin
and sources of exposure
Annex B (informative) Principle of LAL-assays
Bibliography