Table 23. Microbiological quality standards of different regulatory agencies.
| ANSI/AAMI/ISO763, 764, 765 | ERA-EDTA guidelines765a | |
|---|---|---|
| Water for dialysis | ||
| Bacteria (CFU/ml) | <100 (action level at 50) | <100 |
| Endotoxin (EU/ml) | <0.5 | <0.25 |
| Dialysate | ||
| Bacteria (CFU/ml) | <100 (action level at 50) | <100 |
| Endotoxin (EU/ml) | <0.5 | <0.25 |
| Ultrapure dialysate | ||
| Bacteria (CFU/ml) | <0.1 | <0.1 |
| Endotoxin (EU/ml) | <0.03 | <0.03 |
| Substitution fluid for infusion | ||
| Bacteria (CFU/ml) | Sterile | <10−6 |
| Endotoxin (EU/ml) | Undetectable | <0.03 |
AAMI, Association for the Advancement of Medical Instrumentation; ANSI, American National Standards Institute; CFU, colony-forming units; ERA-EDTA, European Renal Association—European Dialysis and Transplant Asssociation; EU, endotoxin units; ISO, International Organization for Standardization.