ISO 11663:2014 pdf free

ISO 11663:2014 pdf free.Quality of dialysis fluid for haemodialysis and related therapies
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 may 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.
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 range. The user is responsible for monitoring the dialysis fluid bacteriology of the system following installation. It is incumbent on the user to establish a regular monitoring routine.
Dialysis fluid shall be prepared from water meeting the requirements of ISO 13959 and acid and bicarbonate concentrates meeting the requirements of ISO 13958. 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 Tables B.1 and B.2.
Microbial analysis of water and dialysis fluid samples should be conducted as soon as possible after collection to avoid unpredictable changes in the microbial population. If samples cannot be analysed within 4 h of collection, follow the laboratory’s instructions for sample storage and shipping. Samples intended for colony counts should not be frozen.ISO 11663 pdf free download.