What Is the Dialysate Endotoxin Acceptable Limit

Conventional dialysis requires the endotoxin concentration in the dialysis water and dialysate to be <2 EU/ml with an action level of 1 EU/ml (Table 2) (5,6). However, the 2011 AAMI recommendations lowered the acceptable endotoxin concentration to <0.25 EU/ml in dialysis water and <0.5 EU/ml in the dialysate (8).

What is the AAMI allowable level for endotoxin in water?

Reference DocumentAllowable water Total Viable Count (TVC)Action Level water Endotoxin Unit (EU)AAMI RD52:2004 (Minimum regulatory requirement)<200≥1ANSI/AAMI/ISO 13959:2014 (Preferred recommendation)<100≥0.125

What are AAMI standards for water quality in hemodialysis?

[7] [8][9] The Association for the Advancement of Medical Instrumentation (AAMI) recommends the following as maximum allowable chemical levels in HD water: Calcium 2.0 mg/L, magnesium 4.0 mg/L, potassium 8.0 mg/L, sodium 70 mg/L, chlorine 0.5 mg/L, fluoride 0.2 mg/L, aluminum 0.01 mg/L, copper 0.1 mg/L, chloramines 0.1 …