CSA Z23500-2:20 Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies.
4 Requirements
4.2 Water treatment equipment requirements Water treatment system
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A bypass valve should have a physical lockout installed prior to its activation. The bypass valve should be labelled with a warning notifying the user of the result of its removal. Bypass valves should not be used on deionization tanks, carbons, and other critical components. Bypass valves should not be used on ultra filters that are being used in conjunction with deionization tanks for patient treatment.
4.2.2 Backflow prevention device
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Installation should be based on local plumbing codes and should be designed, where possible, to allow for redundancy when servicing and testing. Design and installation should allow for servicing and testing without interruption of the dialysis water purification process or during after-hour periods.
Consideration should be made for a parallel installation on each water source and can include domestic hot, domestic cold, and back-up water sources where applicable.
NOTE 1A: The installation and testing frequency of backflow prevention devices in Canada might vary based on jurisdiction.
4.2.8 Carbon media
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Empty-bed-contact-time of 10 min should be maintained for portable water treatment system installations in Canada due to the prevalent use of chlorine and chloramines, the increase in home therapies, and the use of portable water systems in critical care settings for sustained low efficiency dialysis (SLED) and other acute therapies.
NOTE 1A: The design of parallel carbon beds can incorporate a flow regulation device to ensure balanced flow through each parallel branch. Flow rates can be used as an assessment tool to apply corrective measures when deemed appropriate.
5 Testing
5.1 Conformity with dialysis water quality requirements
5.1.2 Microbiology of dialysis water
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Recommended methods and cultivation conditions are Tryptone Glucose Extract Agar (TGEA) and Reasoner’s Agar No. 2 (R2A) incubated at 17 to 23° C for a period of 7 days. (See CSA Z23500-3, Table 3.)CSA Z23500-2pdf download.