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BS EN ISO 29701:2010

Current
Current

The latest, up-to-date edition.

Nanotechnologies. Endotoxin test on nanomaterial samples for in vitro systems. Limulus amebocyte lysate (LAL) test
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-31-2010

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Abbreviated terms
4 Pre-test considerations
5 Test sample
6 Preparation of test sample
7 Test methods
8 Assessment of results
9 Test report
Annex A (informative) - Examples of potential interferences
        to LAL test
Annex B (informative) - Gel-clot method
Annex C (informative) - Endpoint photometric method
Annex D (informative) - Kinetic method
Bibliography

Specifies the application of a test using Limulus amebocyte lysate (LAL) reagent for the evaluation of nanomaterials intended for cell-based in vitro biological test systems.

This International Standard describes the application of a test using Limulus amebocyte lysate (LAL) reagent for the evaluation of nanomaterials intended for cell-based in vitro biological test systems. The test is suitable for use with nanomaterial samples dispersed in aqueous media, e.g. water, serum or reaction medium, and to such media incubated with nanomaterials for an appropriate duration at 37 °C.

This International Standard is restricted to test samples for in vitro systems, but the methods can also be adapted to nanomaterials to be administered to animals by parenteral routes.

Committee
NTI/1
DevelopmentNote
Supersedes 09/30175345 DC. (11/2010)
DocumentType
Standard
Pages
32
PublisherName
British Standards Institution
Status
Current
SupersededBy
Supersedes

ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO/TS 80004-1:2015 Nanotechnologies — Vocabulary — Part 1: Core terms

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