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ANSI/AAMI RD17:2007
Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialyzers, haemodiafilters and haemofilters
Specifies requirements for the single-use extracorporeal blood circuit and non-integral transducer protectors which are intended for use in hemodialysis, hemodiafiltration, hemofiltration and hemoconcentration; includes biological safety, sterility, nonpyrogenicity, mechanical and physical characteristics, and labeling.
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Association for the Advancement of Medical Instrumentation [aami]