AAMI Report on Useability Engineering


AAMI (Association for the Advancement of Medical Instrumentation) BSR/AAMI/IEC TIR62366-2-2016, Medical devices – Part 2: Guidance on the application of usability engineering to medical devices (TECHNICAL REPORT) (technical report) Contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a usability engineering (human factors engineering) process, both as defined in IEC 62366-1:2015 and as supporting goals other than safety. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information. Single copy price: $243.00 (list price)/$146.00 (AAMI member price) Order from: AAMI Webstore, www.aami.org Send comments (with copy to psa@ansi.org) to: Jennifer Moyer, (703) 253 -8274, jmoyer@aami.org

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