ISO 18242:2016规定了无菌一次性体外离心血泵的要求，无论是涂层、非表面改性还是表面改性，用于在体外循环期间产生血流。在体外膜肺氧合术中，这种血流最常用于提供全身灌注，但也有静脉转流、动力辅助静脉引流或体外膜氧合的应用。 它不适用于 -用作心室辅助装置的离心泵，以及 -体外循环回路的其他部件（例如，血管、泵控制台/驱动器）。

ISO 18242:2016 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. It does not apply to - centrifugal pumps used as ventricular assist devices, and - other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).