AAMI & ANSI/AAMI/ISO Standards for Colony Count & LAL
Colony Count and LAL Testing Datasheet - DOWNLOAD
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 23500-5: 2019) and Water (AAMI RD62:2006 vs. ANSI/AAMI/ISO 23500-3: 2019)**
Colony Count & LAL Table | Current AAMI Standards used by CMS | New “ANSI/AAMI/ISO” Standards adopted by AAMI |
---|---|---|
Dialysate | (AAMI RD52:2004) | (ISO 23500-5: 2019) |
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 23500-3: 2019) |
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. |