【问】医疗器械可用性的法规要求有哪些？

 

【答】中国：

YY/T 1474-2016医疗器械 可用性工程对医疗器械的应用

-医疗器械人因设计技术审查指导原则

 

欧盟：

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

 

美国：

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

 

来源：易倍医学

关键词： 医疗器械可用性