Standard: AAMI RD16
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS-HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS, AND HEMOCONCENTRATORS
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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,
- 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|
|Most Recent Revision:||YES|
This Standard References
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