AAMI and ANSI/AAMI/ISO Standards

COMPARISON: AAMI vs. ANSI/AAMI/ISO

Maximum Allowable Levels and Action Limits Of Bacteria and Endotoxin In Dialysate (AAMI RD52:2004 VS. ANSI/AAMI/ISO 11663:2014) and Water (AAMI RD62:2006 VS. ANSI/AAMI/ISO 13959:2014)**

Colony Count & LAL Table Current AAMI Standards used by CMS New “ANSI/AAMI/ISO” Standards adopted by AAMI
Dialysate (AAMI RD52:2004) (ISO 11663:2014)
Colony Count (CFU/mL) 200 (max) and 50 (action limit) 100 (max) and 50 (action limit)**
LAL (EU/mL) 2.0 (max) and 1.0 (action limit) 0.5 (max); and 0.25 (action limit)**
Water (AAMI RD62:2006) (ISO 13959:2014)
Colony Count (CFU/mL) 200 (max) and 50 (action limit) 100 (max); and 50 (action limit)**
LAL (EU/mL) 2.0 (max) and 1.0 (action limit) 0.25 (max); and 0.125 (action limit)**
**Action limit not specified but typically set at 50% of the maximum allowable.