ISO 15676:2005 心血管植入物和人造器官-心肺分流术和体外隔膜充氧处理（ECMO）用一次性使用导管装的指南

标准编号：ISO 15676:2005

中文名称：心血管植入物和人造器官-心肺分流术和体外隔膜充氧处理（ECMO）用一次性使用导管装的指南

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：2005-07

标准范围

体外膜肺氧合（ECMO）的使用要求。体外膜肺氧合（ECPO）和体外膜肺氧合（ECMO）的所有医用管都适用，但在用于（短期，即，6小时）CPB手术或（长期的，即，24小时）ECMO程序中，使用与蠕动泵一起使用的管包括特定的要求和试验。ISO 15676:2005的无菌和非热原性规定适用于标有“无菌”标签的管包。ISO 15676:2005仅适用于多功能系统的管道方面，这些系统可能具有完整的组件，如血气交换器（氧合器）、储气罐、血液过滤器、消泡剂、血液泵等。

ISO 15676:2005 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). ISO 15676:2005 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 ISO 15676:2005 are applicable to tubing packs labelled as "sterile".ISO 15676:2005 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