This standard specifies the classification, composition, functions, requirements, etc. of the basic equipment and material configuration that medical institutions that carry out cardiopulmonary extracorporeal circulation technology should have. The standard classifies cardiopulmonary extracorporeal circulation equipment and materials, artificial heart-lung machines, variable temperature equipment, air-oxygen mixers, fixed stents, blood recovery machines (optional), negative pressure auxiliary venous drainage devices (optional), emergency power supplies, etc. Special equipment for circulation, coagulation and anticoagulation testing, oxygen metabolism and tissue perfusion testing, blood gas electrolyte analyzer, blood glucose meter, colloid osmotic pressure detector, free hemoglobin measuring instrument, cardiac defibrillator, temporary pacemaker and other cardiopulmonary extracorporeal circulation Corresponding regulations have been made on supporting instruments and extracorporeal circulation consumables.
T/CSBME 004-2018 history
2018T/CSBME 004-2018 Configuration list of equipment and materials for extracorporeal circulation (heart and lung)