摘要 目的：在同樣標(biāo)準(zhǔn)、尺度下進(jìn)行有源植入醫(yī)療器械“MR兼容”性評(píng)價(jià)，確保有源植入醫(yī)療器械
的使用安全和有效。方法：本文依據(jù)ISO/TS 10974：2018標(biāo)準(zhǔn)，結(jié)合中國(guó)食品藥品檢定研究院的工作，
針對(duì)標(biāo)準(zhǔn)中要求的各個(gè)試驗(yàn)的試驗(yàn)依據(jù)、試驗(yàn)方法、接收準(zhǔn)則進(jìn)行了研究。結(jié)果：標(biāo)準(zhǔn)共涉及6項(xiàng)已知
或可預(yù)見的風(fēng)險(xiǎn)，分別為溫升、振動(dòng)、力、力矩、非預(yù)期的刺激以及器械故障。為了評(píng)價(jià)這些風(fēng)險(xiǎn)，本文介紹了和6項(xiàng)風(fēng)險(xiǎn)相對(duì)應(yīng)的9個(gè)試驗(yàn)項(xiàng)目，以此評(píng)價(jià)有源植入醫(yī)療器械的核磁兼容性。結(jié)論：目前國(guó)內(nèi)
針對(duì)有源植入醫(yī)療器械核磁兼容性的評(píng)價(jià)剛剛起步，一些檢測(cè)手段和方法處在借鑒和摸索之中，本文系
統(tǒng)性介紹了評(píng)價(jià)項(xiàng)目的考慮角度和方法，為國(guó)內(nèi)從事有源植入物核磁兼容性設(shè)計(jì)及評(píng)價(jià)者提供參考。
關(guān)鍵詞： 有源植入性醫(yī)療器械；核磁兼容；ISO/TS 10974:2018
中圖分類號(hào)：R28 文獻(xiàn)標(biāo)識(shí)碼：A 文章編號(hào)：1002-7777(2019)10-1109-07
doi:10.16153/j.1002-7777.2019.10.005
Study on Safety Evaluation Methods for Magnetic Resonance Imaging of Active
Implantable Medical Devices
Li Shu, Hao Ye, Wang Quan, Ren Haiping*
(National Institutes for Food and Drug Control, Beijing 102629,
China)
Abstract Objective: To evaluate the "MR compatibility" of active implantable medical devices under the
same standards and scales to ensure the safe and effective use of active implantable medical devices. Methods:
According to the ISO/TS 10974: 2018 standard and the work of National Institutes for Food and Drug Control,
the test basis, test methods and acceptance criteria of each test required by the standard were studied. Results:
Six known or predictable risks which were involved in the standard were found out, namely temperature
rise, vibration, force, moment, unexpected stimulus and device failure. In order to evaluate these risks, nine
experiments corresponding to six risks were introduced in the paper to evaluate the MR compatibility of active
implantable medical devices. Conclusion: At present, the evaluation of MR compatibility of active implantable
medical devices in China has just started, and some testing methods are still in the process of exploration. This
paper systematically introduces the considerations and methods of evaluation in order to provide references for the
design and evaluation of MR compatibility of active implantable medical devices in China.
Keywords： active implantable medical devices; MR compatibility; ISO/TS 10974:2018
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