Maximum allowable levels of bacteria and endotoxin in standard and ultrapure dialysis fluid[1]
Maximum allowable levels of bacteria and endotoxin in standard and ultrapure dialysis fluid[1]
Standard dialysis fluid
Ultrapure dialysis fluid
Bacterial count
<100 CFU/mL
<0.1 CFU/mL
Endotoxin
<0.5 EU/mL
<0.03 EU/mL*
CFU: colony-forming unit; EU: endotoxin unit. * Less than 0.001 EU/mL in Japan.[2]
References:
International Organization for Standardization. Preparation and quality management of fluids for haemodialysis and related therapies. Part 5: Quality of dialysis fluid for haemodialysis and related therapies. ISO 23500-5. Geneva, International Organization for Standardization, 2019.
Kawanishi H, Masakane I, Tomo T. The new standard of fluids for hemodialysis in Japan. Blood Purif 2009; 27 Suppl 1:5.
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