本文件规定了用于在体外循环(CPB)期间清除和输送患者血液的无菌一次性套管的要求，最多可达6？h持续时间、体外肺辅助（ECLA采用VV、VAV或AV插管策略）、左心或右心旁路（LHB、RHB）、心肺支持（CPS）、体外生命支持（ECLS采用VA插管策略）、体外二氧化碳清除（ECCO2R）和其他体外循环技术。本标准不适用于: —？ISO中提及的导引器（如导丝）？11070, —？分离的器官灌注套管，和 —？ISO中提到的血管内导管？10555-3.

This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6？h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO₂R), and other extracorporeal circulation techniques. This standard does not apply to: —？introducers (e.g., guidewires) as addressed in ISO？11070, —？isolated organ perfusion cannulae, and —？intravascular catheters as addressed in ISO？10555-3.