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  • BS EN ISO 10993-10:2013

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Biological evaluation of medical devices Tests for irritation and skin sensitization

    Available format(s):  Hardcopy, PDF

    Superseded date:  08-02-2023

    Language(s):  English

    Published date:  28-02-2014

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General principles - Step-wise approach
    5 Pretest considerations
    6 Irritation tests
    7 Skin sensitization tests
    8 Key factors in interpretation of test results
    Annex A (normative) - Preparation of materials for
            irritation/sensitization testing
    Annex B (normative) - Special irritation tests
    Annex C (normative) - Human skin irritation test
    Annex D (informative) - In vitro tests for skin
            irritation
    Annex E (informative) - Method for the preparation of
            extracts from polymeric test materials
    Annex F (informative) - Background information
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on Medical Devices
    Annex ZB (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 90/385/EEC
             on Active Implantable Medical Devices

    Abstract - (Show below) - (Hide below)

    Specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

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

    Committee CH/194
    Development Note Supersedes BS 5736-6(1983), BS 5736-7(1983), BS 5736-8(1984) and BS 5736-9(1986) Supersedes 00/560455 DC & 92/53864 DC. (10/2002) Supersedes 08/30170164 DC. (10/2010)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 9394:2012 Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
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