|Publication Date:||1 January 2003|
This standard covers the dialysis machine used to proportion and monitor dialysate and the accessories normally found on the dialysis machine.
This standard covers apparatus for preparing dialysate; monitors of the dialysate including blood leak detectors, ultrafiltration monitors, and controllers; integral blood pumps and heparin infusion pumps; and extracorporeal blood circuit monitors such as air detectors and pressure and flow monitors that are customarily supplied as a single comprehensive system. Some systems include monitors of patient blood pressure, blood volume, and online clearance, and others have the capability for computer interface with automated data systems. Where applicable, the monitoring for hemodiafiltration, hemofiltration, and home hemodialysis systems are also included. The requirements established by this standard will, at a minimum, help ensure the effective, safe performance of hemodialysis systems, devices, and related materials.
Excluded from the scope of this standard are sorbent dialysate regeneration systems that regenerate and recirculate small volumes of dialysate (although their monitors should meet this standard); peritoneal dialysis systems; central delivery systems; water treatment systems; concentrates and concentrate preparation and distribution systems; hemodialyzers; blood tubing; individual infusion pumps; and blood access devices. Some of these devices, such as hemodialyzers and blood tubing, along with water treatment equipment and concentrates, are addressed in other American National Standards.
NOTE-For an explanation of the need for this standard and the rationale for its specific provisions, see annex A.