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Full Description

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 History

  1. AAMI AT6:2013

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    Autologous transfusion devices

    • Most Recent
  2. AAMI AT6:2005/(R)2011


    Autologous transfusion devices

    • Historical Version
  3. AAMI AT6-91(R1996)


    Autologous Transfusion Devices

    • Historical Version