AAMI ISO 23500-5:2019 pdf download – Preparation and quality management of fluids 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.
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 0,03 EU/ml (when tested in accordance with Clause 5). 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 be 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 haemodiafiltration 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. Conformity of online produced fluid with the requirements of this document cannot be demonstrated with traditional test procedures. For this reason, conformity with this document shall be ensured by proper operation of a validated system, verified according to the manufacturer’s instructions at the time of installation, and confirmed by the user with a regular surveillance and maintenance schedule. The user shall follow the manufacturer’s instructions for use of the validated system, and the user’s surveillance and maintenance schedule shall be designed to confirm that the water and concentrates used to prepare the substitution fluid continue to meet the specifications of ISO 23500-3 and ISO 23500-4.