ANSI AAMI RD62 pdf free download

ANSI AAMI RD62 pdf free download.Water treatment equipment for hemodialysis applications.
3.9 disinfection: Destruction of pathogenic and other kinds of microorganisms by thermal or chemical means.
NOTE—Disinfection is a less lethal process than sterilization, since it destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms. This definition of disinfection is equivalent to low-level disinfection in the Spalding classification.
3.10 empty bed contact time (EBCT): Empty bed contact time is a measure of how much contact occurs between particles, such as activated carbon, and water as the water flows through a bed of the particles.
NOTE—EBCT (minutes) is calculated from the following equation:
EBCT = (7.48 x V)/Q
where
V is the volume of particles in the bed (ft3), 0 is the flow rate of water through the bed (gal/mm), and 7.48 is the conversion factor for
gallons to ft3.
3.11 endotoxin: Endotoxins, which are lipopolysaccharides consisting of a polysaccharide chain covalently bound
to lipid A, are the major component of the outer cell wall of gram-negative bacteria
NOTE—Endotoxins can acutely activate both humoral and cellular host defenses, leading to a syndrome characterized by fever, shaking chills, hypotension, multiple organ failure, and even death if allowed to enter the circulation in a sufficient dose. Long-term exposure to low levels of endotoxin has been implicated in a chronic inflammatory response, which may contribute to some of the long-term complications seen in hemodialysis. However, the mechanisms of this process remain incompletely understood. (See also 3.23 pyrogen.)
3.12 endotoxin-retentive filter: Membrane filter specifically proven to remove bacteria and endotoxin.
NOTE—Endotoxin removal is accomplished by size exclusion and/or adhesion to the membrane surface of the filter. Endotoxinretentive filters are used in the treated water distribution system. (See also 3.20 microfilter and 3.26 ultrafilter.)
3.13 EU: Endotoxin units as assayed by the Limulus Amebocyte Lysate (LAL) method when testing for endotoxins.
NOTE 1—Because endotoxins differ in their activity on a mass basis, their activity is referred to a standard endotoxin. The relationship between mass of endotoxin and its activity varies with both the lot of LAL and the lot of control standard endotoxin being used. Since standards for endotoxin were harmonized in 1983, the relationship between mass and activity of endotoxin has been approximately 10 EU/ng.
NOTE 2—In some countries, endotoxin concentrations are expressed in international units (lU). Since the 1983 harmonization of endotoxin assays, EU and IU are equivalent.
3.14 feed water: Water supplied to a water treatment system or individual component thereof.
3.15 germicide: Agent that kills microorganisms.
3.16 hemodiafiltration: Form of renal replacement therapy in which waste solutes are removed from blood by a combination of diffusion and convection through a high-flux membrane.
NOTE—Diffusive solute removal is achieved using a dialysate stream as in hemodialysis. Convective solute removal is achieved by adding ultrafiltration in excess of that needed to obtain the desired weight loss; fluid balance is maintained by infusing replacement solution into the blood either before (pre-dilution hemodiafiltration) or after (post-dilution hemodiafiltration) the dialyzer.
3.17 hemofiltration: Hemofiltration is a form of renal replacement therapy in which waste solutes are removed from blood by convection.
NOTE—Convective transport is achieved by ultrafiltration through a high-flux membrane. Fluid balance is maintained by infusing replacement solution into the blood either before (pre-dilution hemofiltration) or after (post-dilution hemofiltration) the hemofilter. (Note that there is no dialysate stream in hemofiltration.)
3.18 manufacturer: Person who designs, manufactures, fabricates, assembles, or processes a finished device.
NOTE—Manufacturers include, but are not limited to, those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking or specification development, and initial distributors of foreign entities performing these functions.ANSI AAMI RD62 pdf download.