DIN EN ISO 7199:2017-05

This standard specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. This International Standard also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. This International Standard also applies to external equipment unique to the use of the oxygenator. This document does not apply to - implanted oxygenators, - liquid oxygenators, - extracorporeal circuits (blood tubing), - separate heat exchangers, - separate ancillary devices, and - separate arterial line filter. This document has been prepared by Technical Committee ISO/TC 150 "Implants for surgery" of the International Organization for Standardization (ISO) and adopted as prEN ISO 7199:2015 by Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN (Germany). The responsible German standardization committee is Working Committee NA 063-01-03 AA "Extrakorporaler Kreislauf, Apparate und Einmalartikel" ("Extracorporeal circuits, equipment and disposables") at DIN Standards Committee Medicine (NAMed).