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Item Information   Holdings       More by this author     International Organization for Standardization     Subjects     Medical instruments and apparatus Standards.     Browse Catalog     by author:      International Organization for Standardization       by title:      Medical devices - ap...         MARC Display

Medical devices - application of risk management to medical devices = Dispositifs médicaux - application de la gestion des risques aux dispositifs médicaux. by International Organization for Standardization International Organization for Standardization, 2007. Subjects Medical instruments and apparatus Standards. Description:  82 p. : ill. ; 30 cm. Edition:  2nd. ed., corrected. Series:  International Organization for Standardization. International standard ; ISO 14971. Contents:  Reference number ISO 14971:2007(E). Scope -- Terms and definitions -- General requirements for risk management -- Risk analysis -- Risk evaluation -- Risk control -- Evaluation of overall residual risk acceptability -- Risk management report -- Production and post-production information -- A: Rationale for requirements -- B: Overview of the risk management process for medical devices -- C: Questions that can be used to identify medical device characteristics that could impact on safety -- D: Risk concepts applied to medical devices -- E: Examples of hazards, foreseeable sequences of events and hazardous situations -- F: Risk management plan -- G: Information on risk management techniques -- H: Guidance on risk management for in vitro diagnostic medical devices -- I: Guidance on risk analysis process for biological hazards -- J: Information for safety and information about residual risk.   Copy/Holding information Location Collection Call No. Copy Status   Walter Schroeder Library Reference R856.6 .M4 2007   Available Add Copy to MyList Walter Schroeder Library Reference R856.6 .M4 2007 .2 2 Available Add Copy to MyList Format: HTMLPlain textDelimited Subject:   Email to:

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