• BS EN ISO 29701:2010

    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:  31-10-2010

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee NTI/1
    Development Note Supersedes 09/30175345 DC. (11/2010)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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