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  • ISO 14607:2007

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Non-active surgical implants Mammary implants Particular requirements

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  23-02-2019

    Language(s):  English, French, Russian

    Published date:  29-01-2007

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.

    With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

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

    Development Note Supersedes ISO/DIS 14607. (04/2018)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    ISO/TS 13907:2012 Soil quality — Determination of nonylphenols (NP) and nonylphenol-mono- and diethoxylates — Method by gas chromatography with mass selective detection (GC-MS)
    BS EN ISO 14630:2012 Non-active surgical implants. General requirements
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    UNE-EN 16372:2015 Aesthetic surgery services
    12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
    UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
    EN 16372:2014 Aesthetic surgery services
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
    BS EN 16372:2014 Aesthetic surgery services
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    ISO 14630:2012 Non-active surgical implants General requirements

    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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