標準號：ANSI/AAMI AT6-2013
中文標準名稱：自體輸血裝置
英文標準名稱：Autologous transfusion devices
標準類型：C31
發布日期：2013/8/27 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C31
適用范圍：This standard establishes labeling and performance requirements, test methods, and terminology that will help define a reasonable level of safety and efficacy for autologous transfusion devices. Specifically, it includes requirements for sterile, disposable systems and associated electromechanical hardware designed to collect and filter or process, or both, extravasated blood for reinfusion of erythrocytes or filtered whole blood into the patient's circulation. Aspects of these systems related to collection, anticoagulation (systemic and device), storage, processing and filtration, and reinfusion are within the scope of this standard.