标准摘要
[中文适用范围]： 本文件规定了在心肺转流 (CPB) 过程中，持续时间长达 6 小时、体外肺辅助（采用 VV、VAV 或 AV 插管策略的 ECLA）、左侧或右侧用于取出和输送患者血液的无菌一次性插管的要求心脏搭桥术（LHB、RHB）、心肺支持（CPS）、体外生命支持（采用 VA 插管策略的 ECLS）、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 11070 中规定的导引器（例如导丝）， — 离体器官灌注插管，和 — ISO 10555-3 中规定的血管内导管。 [外文原描述]： 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 (ECCO 2 R), 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.
英文名称Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation