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AAMI TIR72 pdf free download

AAMI TIR72 pdf free download.Dialysis fluid chemical composition.
2.11 endotoxin major component of the outer cell wall of gram-negative bacteria. NOTE Endotoxins are lipopolysaccharides, which consist of a polysaccharide chain covalently bound to lipid A. 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. [See also pyrogen.] 2.12 endotoxin units (EU) units assayed by the Limulus Amebocyte Lysate (LAL) test for endotoxins NOTE 1 Because the activity of endotoxins depends on the bacteria from which they are derived, their activity is referred to as “standard endotoxin.” NOTE 2 In some countries, endotoxin concentrations are expressed in international units (IU). Since the 1 983 harmonization of endotoxin assays, EU and IU are equivalent. 2.13 hemodialysis form of renal replacement therapy in which waste solutes are removed primarily by diffusion from blood flowing on one side of a membrane into dialysis fluid flowing on the other side. NOTE Fluid removal that is sufficient to obtain the desired volume loss is achieved by establishing a hydrostatic pressure gradient across the membrane. This fluid removal provides some additional waste solute removal, particularly for solutes with higher molecular weight. 2.14 Limulus Amebocyte Lysate test (LAL test) assay used to detect endotoxin NOTE 1 The detection method uses the chemical response of an extract from blood cells of a horseshoe crab, Limulus polyphemus , to endotoxins. NOTE 2 Amebocyte lysate from a second horseshoe crab, Tachypleus tridentatus, may also be used to detect endotoxin.2.15 manufacturer entity that designs, makes, fabricates, assembles, or processes a particular item or object. (21 CFR 820.3(o), Quality System Regulation, Design Control, Definitions) NOTE 1 “Manufacturer” includes, but is 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. NOTE 2 “Manufacturer” does not cover the preparation of concentrates from prepackaged dry chemicals at a dialysis facility or the handling of bulk concentrates at a dialysis facility after responsibility for the concentrate is transferred from the manufacturer to the user. 2.16 proportioning system apparatus that proportions dialysis water and hemodialysis concentrate to prepare dialysis fluid 2.17 pyrogen fever-producing substance NOTE Pyrogens are most often lipopolysaccharides of gram-negative bacterial origin [see also endotoxin]. 2.18 storage tank tank at the user’s facility for storage of dialysis water, for storage of concentrate from bulk deliveries, or for concentrate prepared in bulk at the user’s facility from powder and dialysis water.3 Rationale for the control of chemical composition of dialysis fluid The chemical composition of the dialysis fluid can be influenced by cumulative variation throughout the process leading up to patient treatment. The stakeholders in the dialysis process include manufacturers, dialysis providers, and laboratories responsible for testing dialysis fluids. The manufactured goods required for dialysis include concentrates, concentrate mixers, purified water systems, fluid distribution systems, and dialysis equipment. Industry standards have established tolerances for particular steps in the delivery of final dialysis fluid, as well as limits for the chemical and microbial content of the final dialysis fluid. It is unclear to the stakeholders in the process flow how to apportion the designated variance limit value between the phases leading to the delivery and measurement of dialysis treatment. Furthermore, the sensitivity and specificity of laboratory test methods affect the outcome and interpretation of data measured throughout the process from manufacture to patient delivery. Given these constraints, the stakeholders have established process controls intended to limit variation within their scope in order to ensure that the final dialysis fluid will perform as intended.AAMI TIR72 pdf download.

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