• I.S. 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:  01-01-2010

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

    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
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