Implants cardiovasculaires et organes artificiels — Systèmes réservoirs de cardiotomie/veineux à paroi dure (avec/sans filtre) et sacs réservoirs veineux mous

ISO 15674:2016 specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.

It applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.