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AAMI RD16

2007 Edition, January 1, 2007

Complete Document

Cardiovascular implants and artificial organs-Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators



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Superseded By: AAMI 8637

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W/D S/S BY AAMI 8637
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Description / Abstract:

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

This lnternational Standard does not apply 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 dialysate,

- 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.