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.
| ANSI : | ANSI Approved |
| File Size : | 1
file
, 310 KB |
| ISBN(s) : | 1570205035 |
| Note : | This product is unavailable in Belarus, Russia, Ukraine |
| Number of Pages : | 27 |
| Published : | 08/27/2013 |
