Z364.2.1-M1986

1. Scope 1.1 General This Standard applies to (a) reagents and apparatus for preparing dialysing fluid; (b) monitors of the dialysing fluid; (c) accessories for monitoring the extracorporeal blood circuit; and (d) blood pumps, infusion, and single needle systems. Notes: (1) Examples of reagents and devices included within the Scope of this Standard are dialysis concentrate and sanitizing agents as well as dialysing fluid supply systems, on-line dialysing fluid quality monitors (such as conductivity monitors), blood pressure monitors, blood leak detectors, and air detectors. (2) Specific requirements for single needle systems are under consideration and will be included in a future edition. 1.2 Exclusions This Standard does not include requirements for (a) systems that regenerate the dialysing fluid; (b) dialysers; (c) blood tubings: (d) blood access devices; (e) hemoperfusion devices; (f) hemofiltration systems; and (g) the frequency of monitoring of the purity of water used for dialysing fluid. Notes: (1) For requirements for hemodialysers, hemofilters, hemoconcentrators, and the associated extracorporeal circuits, users are invited to consult CSA Standards CAN3-Z364.1.1 and Standard CAN3-Z364.2.2. 1.3 SI Units The values given in SI (metric) units are to be considered the standard values. The values given in parentheses are for information only.