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ANSI/AAMI/ISO 8637:2010
Cardiovascular implants and extracorporeal systems - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
Specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators, hereinafter collectively referred to as ôthe deviceö, for use in humans.T
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Association for the Advancement of Medical Instrumentation [aami]