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
This International Standard specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This International Standard 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 International Standard are applicable to tubing packs labelled as "sterile".This International Standard 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.
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