PREN ISO 29701 : DRAFT 2009

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

Defines a test using Limulus amebocyte lysate (LAL) reagent for detecting and quantifying endotoxins, which can contaminate test samples of nanomaterials intended for cell-based in vitro biological test systems.