Research On The Fine Management Of EMC Testing And Management Process Transformation Project

Electromagnetic compatibility(EMC)refers to the ability of a device or system to operate in its electromagnetic environment without causing unacceptable electromagnetic interference to any device in its environment.The International Electrotechnical Commission(IEC)standard IEC defines electromagnetic compatibility as follows: The system or equipment can work normally in the electromagnetic environment in which it is located,without causing interference to other systems and equipment.In recent years,with the rapid development of science and technology,new electronic information technology has been widely applied and penetrated into the field of medical electrical equipment.Therefore,the electromagnetic environment for using medical electronic devices is also more complicated.On the one hand,when certain medical devices are used,electromagnetic interference from other surrounding electrical devices may be received,which may be detrimental to the patient.On the other hand,if the EMC specifications of a medical device do not comply with national regulations,it may also affect the normal operation of other surrounding electrical equipment or surrounding wireless communication services.Therefore,the EMC index has attracted the attention of the public and has gradually become an important safety indicator for medical electrical equipment.Countries have begun to implement EMC testing standards for medical electronic devices.In order to better ensure the safety of the public use of medical devices,the State Food and Drug Administration has organized the National Medical Electrical Standardization Technical Committee,drafted the international medical electrical equipment electromagnetic compatibility testing standard IEC60601-1-2,drafted and 2012 medical devices.Industry Standard YY0505-2012 “Medical Electrical Equipment Part 1-2: General Requirements for EMC Requirements and Tests Related to Safety-Related Standards” was issued on December 17 th.This standard is a mandatory standard for the medical electrical equipment industry.All medical device companies and enterprises must strictly implement the standards implemented from January 1,2014.Due to the enforcement of standards,tens of thousands of domestic medical electrical equipment manufacturers are affected by 30,000 medical device manufacturers.All of these devices must be sent to a test facility that can detect electromagnetic compatibility as needed.As a nationwide medical device province,Guangdong Province is among the best in the country's EMC inspection every year.At present,the detection and management processes of domestic electromagnetic compatibility laboratories are generally single and cannot be adapted to the quality inspection.Stress and challenges are great..In view of the problems in the above analysis,this paper analyzes the research status of EMC detection management processes and refinement management at home and abroad,and understands the characteristics of EMC detection management processes at home and abroad.It also intends to use the EMC laboratory of the G test as a research object.Analyze the status and problems of EMC testing laboratory detection management process from two aspects of theory and practice.Through the introduction of refined management concepts,methods,etc.,combined with related theories of project management,the project started and ended in the process of transformation.Solve related problems and propose solutions,and conduct detailed argumentation and analysis of these solutions,and make recommendations on how to further optimize China's EMC testing and management process.