ANSI AAMI RD5 pdf free download

ANSI AAMI RD5 pdf free download.Hemodialysis systems.
2.8 INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC). Medical electrical equipment—Part 1-4:
General requirements for safety—Collateral standard: Programmable electrical medical systems IEC 60601-1-4:
2000. Geneva: lEG, 2000.
2.9 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Medical electrical equipment, Part 1-2: General requirements for safety—Collateral standard: Electromagnetic compatibility— Requirements and tests. ANSI/AAMI/IEC 60601-1-2:2001. Arlington (VA): AAMI, 2002. American National Standard.
2.10 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Manual, electronic, or automated sphygmomanometers. ANSI/AAMI SP1 0:2002. Arlington (VA): AAMI, 2002. American National Standard.
2.11 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Biological evaluation of medical devices—Part 1: Evaluation and testing. ANSI/AAMI/lSO 10993-1:1997. Arlington (VA): AAMI, 1997. American National Standard.
3 Definitions
For the purposes of this standard, the following definitions apply.
3.1 air detector: Device (sensor) that detects air or foam in the extracorporeal circuit.
3.2 blood line, arterial: Blood line leading from the patient to the hemodialyzer.
3.3 blood line, venous: Blood line leading from the hemodialyzer to the patient.
3.4 batch system: Apparatus in which the dialysate is prepared in bulk before each dialysis session.
3.5 dialysate: Aqueous fluid containing electrolytes and usually dextrose, which is intended to exchange solutes with blood during hemodialysis. The word “dialysate” is used throughout this document to mean the fluid made from water (see normative reference 2.4) and concentrate(s) that is delivered to the dialyzer by the dialysate supply system. It does not include peritoneal dialysate. Such phrases as “dialyzing fluid” or “dialysis solution” may be used in place of dialysate.
3.6 dialysate supply system: Devices that prepare dialysate online from water and dialysis concentrate(s) or store and distribute premixed dialysate; circulate the dialysate through the dialyzer; monitor the dialysate for temperature, conductivity (or equivalent), pressure, flow, and blood leaks; and prevent dialysis during disinfection or cleaning modes. The term includes reservoirs, conduits, proportioning devices for the dialysate, and monitors and associated alarms and controls assembled as a system for the characteristics listed above. The dialysate supply system is often an integral part of single-patient dialysis machines (see normative reference 2.6).
3.7 dialysis concentrate: Fluid containing high concentrations of electrolytes. It is intended to be diluted with purified water to form dialysate. Dialysis concentrate comes in various formulations and concentrations (dilution ratios). It comes in liquid form or can be mixed at the point of use from powder or cartridges containing powder (see normative reference 2.3). It is referred to as “concentrate” throughout this document.
3.8 transmembrane pressure: As related to the dialysis machine, transmembrane pressure is the pressure difference between the blood compartment and dialysate compartment of the dialyzer. In some dialysis machines, the transmembrane pressure (TMP) is approximated as the difference between the pressure measured at the outlet of the blood compartment (P) and outlet of the dialysate compartment (Pdo), or TMP = P — Pdo.
3.9 labeling: Any written material accompanying the hemodialysis machine or instructions or control feature markings attached to the machine.
3.10 manufacturer: Entity that designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and foreign distributors performing these functions.
3.11 proportioning system: Apparatus that proportions water and dialysate concentrate(s) to prepare dialysate.
3.12 user: Physician (medical director) or his or her representative (i.e., the clinical team responsible for installing, using, or repairing the equipment).ANSI AAMI RD5 pdf download.