指定体外循环和体外膜肺氧合（ECMO）的一次性使用管包的要求。适用于所有用于体外循环（CPB体外循环）和体外膜肺氧合（ECMO）的医用管，但在用于（6小时）即CPB手术或（长期，即24小时）ECMO过程中，用于蠕动泵的管材包括特定的要求和试验。本文件的无菌和非热原性规定适用于标有“无菌”标签的管道包装。

Specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). 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. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as "sterile".