ANSI/AAMI AT6-2013 自体输血装置

标准号：ANSI/AAMI AT6-2013
中文标准名称：自体输血装置
英文标准名称：Autologous transfusion devices
标准类型：C31
发布日期：2013/8/27 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C31
适用范围：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.