ISO 23500-5:2019 pdf free.Preparation and quality management of fluids for haemodialysis and related therapies -Quality of dialysis fluid for haemodialysis and related therapies.
4 Requirements
4.1 Microbiological contaminants in dialysis fluid
4.1.1 General
The requirements contained in this clause apply to a sample of the dialysis fluid collected at the inlet to the dialyser or the reinfusion point.
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 ClauseS) and an endotoxin concentration of less than 05 EU/mI (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.
4.1.3 MicrobiologIcal requirements for ultrapure dialysis fluid
Ultrapure dialysis fluid shall contain a total viable microbial count of less than 0,1 CFU/ml (when tested in accordance with Clause 5) and an endotoxin concentration less than 003 EU/mI (when tested in accordance with ClauseS). If those limits are exceeded in ultrapure dialysis fluid, corrective measures should be taken to reduce the levels to an acceptable level. The user is responsible for surveilling the dialysis fluid bacteriology of the system following installation. It is incumbent on the user to establish a regular surveillance routine.
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.
4.1.4 Microbiological requirements for online prepared substitution fluid
The requirements contained in this clause apply to online prepared fluid intended to he infused into the patient as it enters the patient’s blood.
This fluid shall be sterile and nonpyrogenic.
Substitution fluid for convective therapies, such as haernodiafiltration and haemofiltration, can be produced online by a process of ultrafiltration with bacteria-retentive and endotoxin-retentive filters. This online process shall be validated to produce fluid that is sterile and nonpyrogenic.
Dialysis fluid shall be prepared from water meeting the requirements of Iso 23500-3 and acid and bicarbonate concentrates meeting the requirements of ISO 23500-4. The water and concentrates shall be combined using individual dialysis fluid delivery systems or a central dialysis fluid delivery system constructed from materials that do not contribute chemical contaminants to the final dialysis fluid.
The maximum levels of chemical contaminants permitted in water used to prepare dialysis fluid and concentrates are given in ISO 23500-3 and are also shown in informative Annex B of this document (Tables 13.1 and 132) together with methods of determination (Table 133). Other equivalent analytical methods can he used. Where testing for the individual trace elements listed in Table B.2 is not available, an analysis for total heavy metals can be used with a maximum allowable level of at 0,1 mg/I.ISO 23500-5 pdf download.