ISO 15676:2016 心血管植入物及人工器官 心肺旁路和体外膜肺氧合（ECMO）使用的一次性使用管道套包的要求

标准编号：ISO 15676:2016

中文名称：心血管植入物及人工器官 心肺旁路和体外膜肺氧合（ECMO）使用的一次性使用管道套包的要求

英文名称：Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

发布日期：2016-08

标准范围

This document specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as “sterile”.This document is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.

标准预览图