Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Pretest considerations
4.1 Storage of nanomaterials
4.2 Storage containers
4.3 Handling of nanomaterials
5 Test sample
5.1 Aqueous dispersion
5.2 Aqueous extract
6 Preparation of test sample
6.1 Dispersion method
6.2 Extraction method
6.3 Concentration
6.4 Storage of test sample
6.5 Laboratory environment
6.5.1 Air cleanliness
6.5.2 Equipment and laboratory-ware
6.5.3 Rinse water
7 Test methods
7.1 Principle
7.2 Alternative test methods
7.2.1 Endpoint photometric methods
7.2.2 Kinetic methods
7.3 Selection and validation of test method
7.3.1 Considerations of minimum required
sensitivity
7.3.2 Inhibition/enhancement potential to
test by test sample
7.3.3 Validation of test method
7.4 Test procedures
8 Assessment of results
8.1 General
8.2 Guidance on application of test
9 Test report
Annex A (informative) - Examples of potential
interferences to LAL test
A.1 Inhibition
A.2 Enhancement
Annex B (informative) - Gel-clot method
B.1 General
B.2 Reagents
B.3 Equipment
B.4 Preparation of standard endotoxin solution
B.5 Preparation of inhibition/enhancement
control (IEC)
B.6 Dilution of test sample
B.7 Experimental procedures
Annex C (informative) - Endpoint photometric method
C.1 General
C.2 Reagents
C.3 Equipment
C.4 Preparation of standard curve
C.5 Preparation of inhibition/enhancement
control (IEC)
C.6 Experimental procedure
C.7 Assay acceptance criteria
C.8 Calculation of endotoxin concentration in
the test sample
C.9 Validation of test method
Annex D (informative) - Kinetic method
D.1 General
D.2 Reagents
D.3 Equipment
D.4 Preparation of standard curve
D.5 Preparation of inhibition/enhancement
control (IEC)
D.6 Experimental procedure
D.7 Assay acceptance criteria
D.8 Calculation of endotoxin concentration
in the test sample
D.9 Validation of test method
Bibliography