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  • ONORM EN ISO 10993-11 : 2009

    Current The latest, up-to-date edition.

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY

    Available format(s): 

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

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

    Committees responsible
    National foreword
    Foreword
    Introduction
    Method
    1 Scope
    2 Normative references
    3 Definitions
    4 Test sample requirements and recommendations
    5 Method for extraction from medical devices
    6 Selection of test procedures for systemic toxicity
    7 Selection of test procedures for pyrogenicity
    8 Assessment of results
    9 Test report
    Annex
    A (informative) Addresses
    ZA (normative) Normative references to international
        publications with their relevant European
        publications

    Abstract - (Show below) - (Hide below)

    Specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

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

    Committee TC 179
    Document Type Standard
    Publisher Osterreichisches Normungsinstitut/Austrian Standards
    Status Current

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

    OVE/ONORM EN 60601-1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)

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

    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    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
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