Normalization of Risk Management Documents for Electromagnetic Compatibility of Medical Electrical Equipment
Objective To provide a reference for manufacturers to carry out the risk management on electromagnetic compatibility(EMC)in the design and production process of medical electrical(ME)equipment products.Methods A comprehensive analysis was conducted on the"17 EMC of ME Equipment and ME Systems"in the Medical Electrical Equipment-Part 1:General Requirements for Basic Safety and Essential Performance(GB 9706.1-2020),as well as the relevant requirements for EMC risk management of ME equipment or ME systems in the latest international standards.The writing thoughts of EMC risk management documents for ME equipment were put forward.Results and Conclusion The risk management of EMC in ME equipment can be approached from the aspects of electromagnetic disturbance existing at the location of the use of ME equipment/systems and electromagnetic disturbance emitted.This study can provide a reference for the electromagnetic compatibility risk management process and documentation of ME equipment/systems.
medical electrical equipmentmedical electrical systemelectromagnetic compatibilityrisk management
万方数据
维普
