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  • ANSI/AAMI/ISO 10993-10:2010(R2014)

    Current The latest, up-to-date edition.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  08-10-2014

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of ISO 10993-10:2010
    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

    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 WG 08
    Development Note Supersedes AAMI BE78 and AMD 1 TO AAMI BE78. (10/2010)
    Document Type Standard
    Product Note Reconfirmed 2014
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    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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