I.S. EN 14031:2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
08-04-2021
English
01-01-2003
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Overall demands in endotoxin work
5.1 General
5.2 Demands on operator
5.3 Demands on equipment
5.4 Demands on glassware
5.5 Demands on extraction liquids, water and
detergents
5.6 Demands on filters
5.7 Transportation of samples
5.8 Storage of samples at the laboratory
5.9 Test for contamination
5.10 Sampling documentation
6 Extraction
6.1 General
6.2 Equipment
6.3 How to extract
6.4 Storage
6.5 Extraction documentation
7 Analytical methods
7.1 General
7.2 Equipment
7.3 Procedure
7.4 Validation
7.5 Analytical protocol
8 Expression of results
9 Precision
10 Test report
Annex A (informative) Properties of endotoxins and
sources of exposure
A.1 Identity and physical and chemical properties
A.2 Sources of occupational exposure
Annex B (informative) Principle of LAL-assays
B.1 General
B.2 Detection of inhibition or enhancement of measured
endotoxins using spiked samples
B.3 Detection of inhibition or enhancement of measured
endotoxins using parallel line assay
Bibliography
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