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现行 ISO/TR 19024:2016
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Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass Cpb装置相对于降低肺动脉旁路气管微血管(Gme)向病人传播能力的评估
发布日期: 2016-08-12
ISO/TR 19024:2016推荐了可接受的气体微栓子(GME)测试方法,并讨论了当前测试方法的局限性。ISO/TR 19024:2016中描述的试验仅限于使用体外循环系统进行的试验。 适用于体外循环(CPB)期间用于体外循环支持的所有设备。它概述了目前用于评估CPB设备处理GME能力的方法。
ISO/TR 19024:2016 recommends acceptable methodology for conducting gaseous microemboli (GME) testing and discusses limitations of current test methods. Tests described in ISO/TR 19024:2016 are limited to those conducted using an in vitro circulatory system. It is applicable to all devices intended for extracorporeal circulatory support during cardiopulmonary bypass (CPB). It outlines approaches currently used to assess the ability of CPB devices to handle GME.
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归口单位: ISO/TC 150/SC 2
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