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  • EN ISO 14607:2018

    Current The latest, up-to-date edition.

    Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

    Available format(s): 

    Language(s): 

    Published date:  16-05-2018

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and 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) - Determination of octamethylcyclotetrasiloxane
            (D4) and decamethylcyclopentasiloxane (D5)
            in silicone gels
    Annex B (normative) - Tests for shell integrity
    Annex C (normative) - Mechanical tests on a mammary
            implant in its implantable state
    Annex D (normative) - Test method for valve competence
            and injection site competence
    Annex E (normative) - Test for silicone gel cohesion (silicone
            filling materials only)
    Annex F (normative) - Test for silicone gel penetration
            (silicone filling materials only)
    Annex G (informative) - Assessment of silicone diffusion
            from mammary implants using an in vitro method
    Annex H (informative) - Test for surface characteristics
    Annex I (normative) - Information for the user
    Annex J (normative) - Information for the patient
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC [OJ L 169]
             aimed to be covered

    Abstract - (Show below) - (Hide below)

    ISO 14607:2018 specifies particular requirements for mammary implants.With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.

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

    Committee CEN/TC 285
    Development Note Supersedes EN 12180. (04/2007)
    Document Type Standard
    Product Note THIS STANDARD ALSO IDENTICAL TO ISO 14607:2018
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
    ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 16054:2000 Implants for surgery Minimum data sets for surgical implants
    CR 14060:2000 Medical device traceability
    ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    ISO 34-1:2015 Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO/TR 14283:2004 Implants for surgery Fundamental principles
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 37:2017 Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 25178-2:2012 Geometrical product specifications (GPS) Surface texture: Areal Part 2: Terms, definitions and surface texture parameters
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