Title 21
SECTION 870.4240
870.4240 Cardiopulmonary bypass heat exchanger.
§ 870.4240 Cardiopulmonary bypass heat exchanger.(a) Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.
(b) Classification. Class II (performance standards).