Test And Analysis Of Electromagnetic Compatibility Of Medical Electrical Equipment Based On YY 0505-2012 Standard

With the development of science and technology, electrical equipments are emerging constantly. But it is accompanied by the increasingly harsh electromagnetic environment. At present, electromagnetic pollution has already been considered as the fourth major pollution after water pollution, air pollution and noise pollution. Electromagnetic compatibility of medical electrical equipment has attracted international attention due to the relationship of people's health and safety. In worldwide, how to test and analysis according to the related standard before product's permission, discussion and research are considered as hotspots on these EMC problems of medical devices.Considering the diversity and complexity of medical devices, the industry standard YY0505-2012 was considered as the foundation in this thesis, the key analysis and interpretation of the standard requirements were explained, and examples were given for the special requirements of EMC in the standards of medical electrical equipment. Combined with the criterion of the EMS test's phenomena, radio-frequency equipments, which took the third management degree with high risk category, were taken as an example. The output power was considered as the essential performance of radio-frequency equipment. Meanwhile, two different types of monitoring methods were designed and ten different radio-frequency equipments were selected as EUT. The data of two different running modes(monopole cut mode and bipolar coagulation) were recorded separately when the tests were in radiated EMS test and conducted EMS test. As a result, this thesis illuminated two types of monitoring methods with evaluation and improvement. In radiated EMS test, there was no significant difference among the monitoring methods. In conducted EMS test, the longer the length of the power cord, the less the volatility of the test results. According to the statistical analysis of test results by ANOVA method and paired T-test method, in radiated EMS test, there was no significant difference among the monitoring methods. However, in conducted EMS test, test device with lower precision could not apply for lower output power of EUT.Combined with the EMC design principle and design method, this thesis took high-frequency equipment as an example under the radiated EMS test and conducted EMS test. Through the test result and product design principle analysis, this thesis found the relevant reasons and showed improvement design. Finally, the effect was evaluated.The results of this research could provide a reference and an inspiration for electromagnetic compatibility test of the medical electrical products on the essential performance and monitoring method, and provide a reference for the development and design for manufacturers on EMC of medical device products later on.