心血管植入物和人工器官血气交换器（氧合器

[中文适用范围]： 本文件规定了适用于心脏-肺脏旁路（CPB）供氧、二氧化碳清除以及体外肺辅助（ECLA，采用静脉-静脉（VV）、静脉-动脉（VA）或静脉-动脉-静脉（VAV）插管策略）、心脏-肺脏支持（CPS）、体外生命支持（ECLS，采用 VA 插管策略）、体外二氧化碳清除（ECCO,R）和其他需要血液气体交换的体外循环技术所用的一次性无菌体外血液气体交换器（氧合器）。本文件还适用于作为氧合器整体部分的热交换器和动脉滤过器，以及用于氧合器的独特外部设备。本文件不适用于——植入式氧合器，——液体氧合器，——体外回路（血液管路），——单独使用的热交换器，——辅助设备，以及——单独的动脉线路滤过器。 [外文原描述]： This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO 2 R), and other extracorporeal circulation techniques requiring blood-gas exchange. This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. This document also applies to external equipment unique to the use of the oxygenator. This document does not apply to — implanted oxygenators, — liquid oxygenators, — extracorporeal circuits (blood tubing), — separate heat exchangers, — separate ancillary devices, and — separate arterial line filters.