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    I.S. EN 12180:2000

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  16-03-2007

    Language(s):  English

    Published date:  01-01-2000

    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)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Intended performance
    5 Design attributes
    6 Materials
    7 Design evaluation
    8 Manufacturing
    9 Sterilization
    10 Packaging
    11 Information supplied by the manufacturer
    Annex A (normative) Surface characteristics
    Annex B (normative) Tests for shell integrity
    Annex C (normative) Test requirements for valve competence
             and injection site competence
    Annex D (normative) Tests for silicone gel cohesion
    Annex E (normative) Mechanical tests on mammary implant
             in its implantable state
    Annex ZA (informative) Clauses of this European Standard
             addressing essential requirements or other
             provisions of EU Directives
    Bibliography

    Abstract - (Show below) - (Hide below)

    Explains specific requirements for mammary implants for clinical practice.

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

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    Status Superseded
    Superseded By

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

    NFT 46 007 : 1978 VULCANIZED RUBBERS - DETERMINATION OF THE TEAR STRENGTH (ANGLE TESTPIECES, WITH OR WITHOUT NICK AND CRESCENT TESTPIECES)
    ISO 14630:2012 Non-active surgical implants General requirements
    NFT 46 002 : 1988 VULCANIZED OR THERMOPLASTIC RUBBER - TENSILE TEST
    ASTM D 3389 : 2016 : REDLINE Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    NFS 99 401 : 1994 MEDICAL DEVICES - SILICONE ELASTOMETER OF MEDICAL GRADE
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
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