AAMI AT6 – Autologous transfusion devices
This standard establishes labeling and performance requirements test methods and terminologythat will help define a reasonable level of safety and efficacy for autologous transfusion devices.Specifically it includes requirements for sterile disposable systems and associatedelectromechanical hardware designed to collect and filter or process or both extravasated bloodfor reinfusion of erythrocytes or filtered whole blood into the patient’s circulation. Aspects of thesesystems related to collection anticoagulation (systemic and device) storage processing andfiltration and reinfusion are within the scope of this standard.
Product Details
- Published:
- 08/27/2013
- ISBN(s):
- 1570205035
- ANSI:
- ANSI Approved
- Number of Pages:
- 27
- File Size:
- 1 file 310 KB
- Note:
- This product is unavailable in Belarus Russia Ukraine
