TABLE III

Guidelines on the Quality of Pure Water

AMMI TIR34:2007 Water for the Reprocessing Medical Devices RO WaterEN 285, 2006 Boiler Feed WaterJapanese Pharmacopoeia Water for Injection
Colony counts (CFU/100mL)≤1,000NA≤10
Endotoxin (EU/mL)<10NA<0.25
pHNA5.0 to 7.5NA
Water hardness (ppm CaCO3)<1.0≤2.0NA
Conductivity (μS/cm)<1.0≤5 to 15* at 25 °C≤1.0 at 20 °C
Inonic contaminants
    Chloride (mg/L)<0.2≤2NA
    Iron (mg/L)<0.2≤0.2NA
  • * Empirical threshold. NA: not available (3, 8, 22).