AAMI AT6:2005/(R)2011

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Establishes labeling and performance requirements, test methods, and terminology that will help establish a reasonable level of safety and efficacy for autologous transfusion devices. Specifically, includes requirements for sterile, disposable systems and associated electromechanical hardware designed to collect and filter or process, or both, extravasated blood for reinfusion into the patient’s circulation. Aspects of these systems related to collection, anticoagulation (systemic and regional), storage, processing and filtration, and reinfusion are within the scope of this standard.

Product Details

Published:

12/06/2005

ISBN(s):

1570202494

ANSI:

ANSI Approved

Number of Pages:

32

File Size:

1 file , 460 KB