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| YY 0989.7-2017 Implants for surgery—Active implantable medical devices—Part 7:Particular requirements for cochlear implant systems (English Version) |
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Detail of YY 0989.7-2017
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Introduction of YY 0989.7-2017
本标准规定了适用于预期通过电刺激听觉通路来治疗听力障碍的有源植入式医疗器械的专用要求，本标准同样适用于器械的某些非植入部分和附件。
本标准不适用于通过非电刺激方式治疗听力障碍的器械。植入部分的电特性应通过本部分中列述的适当方法或其他方法进行验证，其他方法的准确度应能被证明是等于或优于规定的方法。
如有争议，应采用本部分规定的方法。
Contents of YY 0989.7-2017