AAMI AT6:2013

This standard establishes labeling and performance requirements, test methods, and terminologythat will help define a reasonable level of safety and efficacy for autologous transfusion devices.Specifically, it includes requirements for sterile, disposable systems and associatedelectromechanical hardware designed to collect and filter or process, or both, extravasated bloodfor reinfusion of erythrocytes or filtered whole blood into the patient's circulation. Aspects of thesesystems related to collection, anticoagulation (systemic and device), storage, processing andfiltration, and reinfusion are within the scope of this standard.