CSA Z364.2.2-03 (R2008)

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 Standards requirements related to the chemical and microbiologicalquality 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.