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

31-10-2010

Publisher

British Standards Institution

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	BS ISO 19007:2018
Supersedes	09/30175345 DC : 0

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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BS EN ISO 29701:2010

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

Table of Contents

Abstract

Scope

General Product Information

Standards Referencing This Book

Category

Subcategory