BS EN 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices
BS EN 62366-1:2015 pdf free. Medical devices Part 1: Application of usability engineering to medical devices. 5 USABILITY ENGINEERING PROCESS 5.1 Prepare USE SPECIFICATION The MANUFACTURER shall prepare a USE SPECIFICATION. The USE SPECIFICATION shall include: — intended medical indication; NOTE I This can include conditions(s) or disease(s) to be screened, monitored. treated, diagnosed, or prevented — intended PATIENT population: […]
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