Table 3.
Testing Thresholds for Microbial Contaminants
Contaminant | Maximum Allowable Level | Typical Action Level |
---|---|---|
Bacteria water and dialysate | <200 CFU/mL | 50 CFU/mL |
Endotoxin water and dialysate | <2 EU/mL | 1 EU/mL |
Abbreviations: EU, endotoxin unit; CFU, colony-forming unit
Information based on American National Standards Institute/Association of the Advancement of Medical Instrumentation RD52:2004 and current Centers for Medicare & Medicaid Services standards.