Standard: AAMI RD17
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS—EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS, AND HEMOFILTERS
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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,
- 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|
|Most Recent Revision:||YES|
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