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【問】醫(yī)療器械可用性的法規(guī)要求有哪些？

【答】中國：

YY/T 1474-2016醫(yī)療器械 可用性工程對醫(yī)療器械的應(yīng)用

-醫(yī)療器械人因設(shè)計(jì)技術(shù)審查指導(dǎo)原則

歐盟：

IEC 62366-1:2015+AMD1:2020 Medical devices - Part 1: Application of usability engineering to medical devices

IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

IEC60601-1-6:2010+AMD1:2013+AMD2:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

美國：

Applying Human Factors and Usability Engineering to Medical Devices 2016-2-3