Z364.2.2-03 (R2008)

1 Scope 1.1 This Standard applies to a) acute, chronic, and home-based hemodialysis; b) water for preparing dialyzing fluid and concentrate for hemodialysis; c) all water intended for contact with the dialyzing fluid pathway; d) the baseline quality of the feed water and any other input water; e) water treatment and monitoring equipment; f) water distribution systems; and g) product water used for flushing blood pathways before sterilization (but not afterwards). Note: Users of this Standard are invited to consult the other Standards in the Z364 series dealing with kidney dialysis, i.e., CAN/CSA-Z364.1.1/CAN/CSA-Z364.1.2, CAN/CSA-Z364.1.3, and Z364.2.1. 1.2 This Standard's requirements related to the chemical and microbiological quality of water apply to all settings, regardless of whether a single patient or many patients are being treated. 1.3 In CSA Standards, "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.