Z364.2.1-94 (R2011)

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 may 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) haemoperfusion devices; (f) haemofiltration systems; and (g) the frequency of monitoring of the purity of water used for dialysing fluid. Notes: (1) For requirements for haemodialysers, haemofilters, haemoconcentrators, and the associated extracorporeal circuits, users are invited to consult CSa Standard Z364.1.1 and Z364.1.2. (2) The recommendations of this Committee for monitoring water quality are contained in CSA Standard Z364.2.2.