本文件规定了一次性使用无菌动脉血管过滤器的要求，该过滤器用于在体外循环手术期间过滤和清除人体血液中的栓子、碎屑、血块和其他潜在危险的固体和气体物质。交叉引用:ISO 11607-2ISO 10993-7ISO 17665-1ISO 10993-4:2017ISO 11607-1ISO 11135ISO 10993-11ISO 10993-1ISO 594-2ISO 14937ISO 80369-7ISO 11137-1AAMI AT6ISO 10993-10ISO 7199ISO 14971ISO 15223-2ISO 13485ISO 15223-1ISO/TS 23810:2018PD ISO/TS 23810:2018ISO 8637-1:2017包含以下内容:修订，2020年2月

This document specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.Cross References:ISO 11607-2ISO 10993-7ISO 17665-1ISO 10993-4:2017ISO 11607-1ISO 11135ISO 10993-11ISO 10993-1ISO 594-2ISO 14937ISO 80369-7ISO 11137-1AAMI AT6ISO 10993-10ISO 7199ISO 14971ISO 15223-2ISO 13485ISO 15223-1ISO/TS 23810:2018PD ISO/TS 23810:2018ISO 8637-1:2017Incorporates the following:Amendment, February 2020