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Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps 心血管植入物和体外系统 体外循环系统 静脉气泡捕集器
发布日期: 2019-12-31
该文件规定了体外循环需要的体外膜肺氧合(CPB)、体外膜肺氧合(ECMO)或静脉转流术中,用于无菌循环、一次性使用的静脉气泡捕捉器的要求,目的是清除进入静脉管道的空气。交叉引用:ISO 11607-1ISO 14937ISO 594-2ISO 11607-2ISO 10993-11ISO 10993-1ISO 17665-1ISO 10993-7ISO 11135-1ISO 10993-4ISO 11137-1ISO 8637:2010包含以下内容:修订,2019年12月
This document specifies requirements for sterile, single-use, venous bubble traps intended to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support, which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or venovenous bypass for liver transplantation.Cross References:ISO 11607-1ISO 14937ISO 594-2ISO 11607-2ISO 10993-11ISO 10993-1ISO 17665-1ISO 10993-7ISO 11135-1ISO 10993-4ISO 11137-1ISO 8637:2010Incorporates the following:Amendment, December 2019
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发布单位或类别: 英国-英国标准学会
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