AAMI 8638

AAM 8638 2010-JAN-01 Cardovascular mplants and extracorporeal systems — Extracorporeal blood crcut for hemodalyzers hemodaflters and hemoflters

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This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration and hemofiltration.

This International Standard does not apply to:

— hemodialyzers, hemodiafilters or hemofilters;

— plasmafilters;

— hemoperfusion devices;

— vascular access devices;

— blood pumps;

— pressure monitors for the extracorporeal blood circuit;

— air detection devices;

— systems to prepare, maintain or monitor dialysis fluid;

— systems or equipment intended to perform hemodialysis, hemodiafiltration, hemofiltration or hemoconcentration.

NOTE Requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators are specified in ISO 8637.

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