• ONORM EN ISO 14607 : 2009

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS

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    Withdrawn date:  22-11-2018

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

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    Abstract - (Show below) - (Hide below)

    Diese ÖNORM legt besondere Anforderungen an Mammaimplantate zur klinischen Anwendung fest. Im Hinblick auf die Sicherheit legt sie Anforderungen an die beabsichtigte Funktion, Konstruktions- merkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und vom Hersteller zu liefernde Informationen fest.

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

    Development Note Supersedes ONORM EN 12180. (05/2007)
    Document Type Standard
    Publisher Osterreichisches Normungsinstitut/Austrian Standards
    Status Withdrawn
    Superseded By

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

    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 37:2017 Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
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