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ANSI/AAMI/ISO 8638 (R2015)
Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters.
Specifies requirements for the single-use extracorporeal blood circuit and (integral and nonintegral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration and hemofiltration. (Revision of ANSI/AAMI RD17:2007.)
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Association for the Advancement of Medical Instrumentation [aami]