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.
Document identifier
AAMI AT6:2013
Title
Autologous transfusion devices
AAMI Category
General Surgery / General Hospital Use
Publication date
2013-08-27
International Relationship
History of version
AAMI AT6:2013 * AAMI AT6:2005/(R)2011 * AAMI AT6-91(R1996)
Price |
131 vnd |