CSA Z23500-5:2020 pdf download.Preparation and quality management of fluids for haemodialysis and related therapies
1 Scope
This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 23500-1, Preparation and quality management of fluids for haemodialysis and related therapies一Part 1: General requirements
ISO 23500-3, Preparation and quality management of fluids for haemodialysis and related therapies一Part 3: Quality of water for haemodialysis and related therapies
ISO 23500-4, Preparation and quality management of fluids for haemodialysis and related therapies 一Part 4: Concentrates for haemodialysis and related therapies
4.1.2 Microbiological requirements for standard dialysis fluid
Standard dialysis fluid shall contain a total viable microbial count of less than 100 CFU/ml (when tested in accordance with Clause 5) and an endotoxin concentration of less than 0,5 EU/ml (when tested in accordance with Clause 5).
Action levels for the total viable microbial count and endotoxin concentration in dialysis fluid should also be set based on knowledge of the microbial dynamics of the system. Typically, the action levels are set at 50 % of the maximum allowable levels for total viable microbial count and endotoxin; other levels can be set.
If microbial counts exceeding the action levels are observed in the dialysis fluid, corrective measures,such as disinfection and retesting, should be taken promptly to reduce the levels.
Associated with the presence of bacteria and endotoxin in dialysis fluid is the likely presence of fungi (yeasts and filamentous fungi). After extensive discussion, the working group has not recommended maximum limits, for such contaminants.
Tests for bacterial growth and endotoxins are not required if the dialysis machine fluid pathway is fitted with an appropriate capacity bacteria-retentive and endotoxin-retentive filter validated by the manufacturer and operated and surveilled according to the manufacturer's instructions, unless the manufacturer requires such tests in the instructions for use.CSA Z23500-5 pdf download.