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Item Information   Holdings     Summary       More by this author     International Electrotechnical Commission.     Subjects     Medical instruments and apparatus -- Standards     Medical instruments and apparatus -- Quality control -- Safety regulations.     User-centered system design     Biomedical engineering     Browse Catalog     by author:      International Electrotechnical Commission.       by title:      Medical devices : ap...         MARC Display

Medical devices : application of usability engineering to medical devices / International Electrotechnical Commission = Dispositifs médicaux : application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux / Commission Electrotechnique Internationale. by International Electrotechnical Commission. International Electrotechnical Commission, 2007. Subjects Medical instruments and apparatus -- Standards   Medical instruments and apparatus -- Quality control -- Safety regulations.   User-centered system design   Biomedical engineering Description:  209 p. : ill.; 30 cm. Edition:  Ed. 1.0 Series:  International standard (International Electrotechnical Commission) ; IEC 62366. Contents:  "2007-10." NOTE: Contains Amendment 1.0 , 2014. "International Standard IEC 62366 has been prepared by a joint working group of subcommittee 62A: Common aspects of electrical medical equipment used in medical practice, of IEC technical committee 62: Electrical medical equipment in medical practice and technical committee ISO/TC 210: Quality management and corresponding general aspects for medical devices"--P. 4. "This International Standard specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device." -- p. 7   Copy/Holding information Location Collection Call No. Status   Walter Schroeder Library Reference R856.6 .I58 2007-2014 Available Add Copy to MyList Format: HTMLPlain textDelimited Subject:   Email to:

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