ANSI/AAMI/RD5-2003 pdf download.Hemodialysis systems.
This standard covers the dialysis machine used to proportion and monitor dialysate and the accessories normally found on the dialysis machine.
1.2 Inclusions
This standard covers apparatus for preparing dialysate; monitors of the dialysate including blood leak detectors, ulrafiltration 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 capabilty for computer interface with automated data systems. Where applicable, the monitoring for hemodiafilration, hemofiltration, and home hemodialysis systems are also included. The requirements established by this standard will, at a minimum, help ensure the effective, safe performance 0 hemodialysis systems, devices, and related materials.
1.3 Exclusions
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 tor this standard and the rationale tor its specific provisions, see annex A.
2 Normative references
The fllowing standards contain provisions that, through reference in this text, constitute provisions of this standard.
At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. The Association for the Advancement of Medical Instrumentation (AAMI) maintains a register of currently valid AAM/American National Standards.
2.1 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Hemodialyzers. ANSI/AAMI RD16:1996. Arlington (VA): AAMI, 1996. As amended, 2002. American National Standard.
2.2 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Hemodialyzer blood tubing. ANSI/AAMI RD17:1994. Arlington (VA): AAMI, 1994. As amended, 2002. American National Standard.
2.3 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Concentrates for hemodialysis. ANSI/AAMI RD61 :2000. Arlington (VA): AAMI, 2000. American National Standard.
2.4 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Water treatment equipment for hemodialysis applications. ANSI/AAMI RD62:2001. Arlington (VA): AAMI, 2001. American National Standard.
2.5 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Safe current limits for electromedical apparatus. ANSIAAMI ES1:1993. Arlington (VA): AAMI, 1993. American National Standard
2.6 ECRI. Hemodialysis machines. Health Devices 20:6. Plymouth Meeting (PA): ECRI, 1991.
2.7 U.S. PHARMACOPEIAL CONVENTION. United States Pharmacopeia XXIV. Easton (PA): Mack Publishing, 2000 or subsequent version.ANSI/AAMI/RD5 pdf download.