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  • SN EN ISO 10993-11 : 2009

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY

    Available format(s): 

    Withdrawn date:  01-11-2018

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Swiss 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)

    Development Note Supersedes SN 119800. (06/2006)
    Document Type Standard
    Publisher Swiss Standards
    Status Withdrawn
    Superseded By
    Supersedes
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