Standard: AAMI RD16

CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS-HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS, AND HEMOCONCENTRATORS

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Scope:

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.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami rd16
Publish Date: 2007-01-01
Page Count: 44
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: NO
Status: Inactive

Standards That Reference This Standard

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