CSA Z23500-3:20 Preparation and quality management offluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies.
4 Requirements
Table 2 — Maximum allowable levels ofother trace elements in dialysis water
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NOTE 1A: Canadian provincial and territorial drinking water standards differ and are unique to specific geographical areas within Canada. In some cases, the limits defined within a local Canadian jurisdiction might be lower than the limit set in Tables 1 and 2. Selenium and antimony are some examples where the Canadian drinking water standards are lower or equivalent to the ISO standard for dialysis water. In cases where the ISO limit is above the Canadian local jurisdiction limit, the user should use the lower of the two limits as the maximum acceptable concentration for the contaminant. The reader is cautioned to periodically review their local drinking water limits as they compare to Tables 1 and 2 to determine the maximum level ofcontaminants allowable in dialysis water.
4.3 Dialysis water microbiological requirements
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Total viable microbial counts in standard dialysis water shall be less than 100 CFU/mL, or lower if required by national legislation or regulations. If the water treatment system allows the production of ultrapure dialysis water, total viable microbial counts shall be less than 0.1 CFU/mL. An action level shall be set based on knowledge of the microbial dynamics of the system. Typically, the action level will be 50% of the maximum allowable level.
Endotoxin content in standard dialysis water shall be less than 0.25 EU/mL, or lower if required by national legislation or regulations. An action level shall be set, typically at 50% of the maximum allowable level. In ultrapure dialysis water, endotoxin content shall be less than 0.03 EU/mL.
5 Tests for microbiological and chemical requirements
5.2 Microbial contaminant test methods
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Recommended methods and cultivation conditions can also be found in CSA Z23500-4 and CSA Z23500-5 as well as this Standard. (See Table 3.) The methodology detailed uses Tryptone Glucose Extract Agar (TGEA) and Reasoner’s Agar No. 2 (R2A) incubated at 17 to 23 °C for a period of 7 days. Table 3 — Culture techniques [Delete the fourth row and footnote b ].CSA Z23500-3 pdf download.