Standard: AAMI RD17

CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS—EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS, AND HEMOFILTERS

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Scope:

This lnternational Standard specifies requirements for single-use extracorporeal blood circuit (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration, and hemofiltration.

This lnternational 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 dialyzing fluid,

- systems intended to perform hemodialysis, hemodiafiltration, hemofiltration, or hemoconcentration.

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

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami rd17
Publish Date: 2007-01-01
Page Count: 37
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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