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目的的探讨制定数字化脑电图机的安全性和有效性的技术参数和测试方法。方法通过对该类产品文献调研、相关安全标准的研究,总结了10家国内外知名脑电图机生产厂商的产品技术参数等方法,提出一系列适合我国实际情况的数字化脑电图机标准细则。结果与结论研究提出了数字化脑电图机安全性应执行的标准和有效性的具体参数和测试方法,为制定我国的数字化脑电图机国家标准或行业标准提供参考。
Objective To explore the technical parameters and test methods for establishing the safety and effectiveness of digital EEG. Methods Based on the literature research and safety standards research of such products, the methods of product technical parameters of 10 well-known domestic and foreign EEG manufacturers were summarized, and a series of standard EEG standard rules that fit the actual situation of our country . RESULTS AND CONCLUSIONS The specific parameters and test methods for the standard and validity of digital EEG machine safety should be put forward, which will provide references for the development of national standard or industry standard of digital EEG machine in our country.