CSA Z23500-3:2020 pdf download.Preparation and quality management of fluids for haemodialysis and related therapies
4 Requirements
Table 2 - Maximum allowable levels of other trace elements in dialysis water [Add the following note]
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 of contaminants allowable in dialysis water.
4.3 Dialysis water microbiological requirements[Replace the first two paragraphs with the following]
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 [Replace the second, third, and fourth paragraphs with the following]
In addition to bacteria and endotoxins, yeasts and filamentous fungi can also be present, and their presence implies a potential risk to the patient[65][66]. Further studies are required to investigate the organism's ability to persist, their role in biofilm formation and their clinical significance. In view of this, no limits in respect of yeasts and filamentous fungi have been set in this revision. In cases where the presence of yeasts and filamentous fungi in fluids is of clinical concern, Malt Extract Agar (MEA) can be used to identify the species rather than Sabouraud Agar which is less effective. For mould, Corn Meal Agar or Czapek-Dox Agar are suitable growth media.CSA Z23500-3 pdf download.