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现行 AAMI PC76:2021
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Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging 有源植入式医疗器械.接触磁共振成像的起搏器和ICD患者的安全性要求和试验协议
发布日期: 2021-04-01
提供植入式起搏器和ICD暴露于磁共振成像的要求和测试协议。医生越来越多地使用磁共振成像作为鉴别诊断工具,从而使起搏器和ICD患者接触到此类设备。植入式起搏器和ICD的当前产品标准不包括植入式起搏器和ICD的要求和测试协议,这将确保此类程序期间患者的安全。
Provides requirements and test protocols for implantable pacemakers and ICDs exposed to magnetic resonance imaging. Physicians are increasingly using magnetic resonance imaging as tool for differential diagnostic, thus exposing pacemakers and ICD patients to such equipment. Current product standards for implantable pacemakers and ICDs do not include requirements and test protocols for implantable pacemakers and ICDs, which would ensure patient safety during such procedures.
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