Z364.2.1-13(R2018)

Scope 1.1 General This Standard specifies requirements for the safe use, disinfection, testing, and maintenance of monitoring systems for hemodialysis. It is intended for use by dialysis providers, including health care workers and professionals who perform technical and operational functions associated with hemodialysis. This Standard applies to a) quality management; b) monitoring of fluid quality systems; c) maintenance requirements; d) biocompatibility of material components; e) disinfection of the hydraulic fluid path and blood tubing transducer protectors; f) dialysing fluid and blood circuit systems; and g) equipment testing electrical safety. 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 that do not produce on-line fluid; and g) the frequency of monitoring of the purity of water used for dialyzing fluid. Notes: 1) For requirements for hemodialysers, hemodiafilters, hemofilters, hemoconcentrators, and the associated extracorporeal circuits, users should consult CAN/CSA-ISO 8637 and CAN/CSA-ISO 8638. 2) For requirements for monitoring water quality, users should consult CAN/CSA-ISO 11663, CAN/CSA-ISO 13959, and CAN/CSA-ISO 26722. 1.3 Terminology In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (nonmandatory) to define their application.