标准编号:ISO 18242:2016
中文名称:心血管植入物和体外系统 离心式血泵
英文名称:Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
发布日期:2016-09
标准范围
This document 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.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).