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  • SN EN ISO 14971 : 2012

    Current The latest, up-to-date edition.

    Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

    Available format(s):  Hardcopy

    Language(s): 

    Published date:  01-09-2012

    Publisher:  Swiss Standards

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    Abstract - (Show below) - (Hide below)

    ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

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    Committee INB/NK 410
    Document Type Standard
    Publisher Swiss Standards
    Status Current
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