Historical
ANSI/AAMI RD16:2007 (ANSI/AAMI RD 16:2007)
Cardiovascular implants and artificial organs - Hemodialysers, hemodiafilters, hemofilters and hemoconcentrators
Specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators for use for humans; includes biological safety, sterility, nonpyrogenicity, mechanical and performance characteristics, and labeling.
Association for the Advancement of Medical Instrumentation [aami]