心血管植入物和体外系统. 离心式血液泵

[中文适用范围]： 本文件 specifications requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass but also has applications for veno-venous bypass, kinetic-assisted venous drainage, or extracorporeal membrane oxygenation. This document does not apply to — centrifugal pumps used as ventricular assist devices and — other components of extracorporeal circuits (e.g. blood tubing, pump console/driver). [外文原描述]： ISO 18242:2016 specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, or extracorporeal membrane oxygenation. It does not apply to - centrifugal pumps used as ventricular assist devices, and - other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).