Analysis of Key Points Should be Paid Attention in GB 9706.1-2020 Inspection of Ultrasonic Diagnostic Equipment
This paper compared the differences between GB 9706.1-2020 and GB 9706.1-2007 as a whole,and taking ultrasonic diagnostic equipment as an example,analyzed the risk points that should be paid attention to in risk management activities,expounded the reference basis for formulating basic performance and the specific tests to verify basic performance,compared the difference between the measurement of patient leakage current and total patient leakage current,described the special treatment of transducer assembly before dielectric strength test,analyzed the key points of battery safety detection,and summarized the usability engineering process and the key points that should be paid attention.This paper provides guidance and reference for the design,production and management of ultrasonic diagnostic equipment.
国家科技期刊平台
NSTL
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