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  • DIN EN ISO 10993-10 E : 2003

    Current The latest, up-to-date edition.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2003

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    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
    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
    Bibliography

    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)

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

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    DIN EN ISO 11979-5 E : 2010 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
    DIN EN ISO 9394 E : 2013 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES (ISO 9394:2012)

    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
    DIN EN ISO 14155-1 E : 2003 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
    DIN EN ISO 10993-18 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    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
    DIN EN ISO 10993-14 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
    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
    DIN EN ISO 10993-13 E : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
    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
    DIN EN ISO 10993-12 E : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
    DIN EN ISO 14155-2 E : 2003 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    DIN EN ISO 10993-15 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
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