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    I.S. EN 30993-6:1995

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 LOCAL EFFECTS AFTER IMPLANTATION

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-10-2007

    Language(s):  English

    Published date:  01-01-1995

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Committees responsible
    National foreword
    Foreword
    Introduction
    Method
    1. Scope
    2. Normative references
    3. Common provisions for implantation test methods
    4. Test method for implantation in subcutaneous tissue
    5. Test method for implantation in muscle
    6. Test method for implantation in bone
    Annexes
    A. (informative) Control materials
    B. (informative) Cylindrical specimen
    C. (information) Bibliography
    ZA. (normative) Normative references to international
         publications with their relevant European publications
    Tables
    1. Selection of test periods for short-term implantation
         in subcutaneous tissue and muscle
    2. Selection of test periods for long-term implantation
         in subcutaneous tissue, muscle and bone
    Figure
    B.1 Special cylinder with grooves

    Abstract - (Show below) - (Hide below)

    Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level.

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    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
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