AAMI 8637

AAM 8637 2010-JAN-01 Cardovascular mplants and extracorporeal systems — Hemodalyzers hemodaflters hemoflters and hemoconcentrators

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This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.

This International Standard is not applicable to:

— extracorporeal blood circuits;

— 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 used to perform hemodialysis, hemodiafiltration, hemofiltration or hemoconcentration;

— reprocessing procedures and equipment.

NOTE Requirements for the extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters are specified in ISO 8638.

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