AAMI and ANSI/AAMI/ISO Standards

AAMI
MAXIMUM ALLOWABLE CHEMICAL CONTAMINANT LEVELS IN WATER USED TO PREPARE DIALYSATE, CREATE CONCENTRATES FROM POWDER AND REPROCESS DIALYZERS FOR MULTIPLE USE*

Contaminants with documented
toxicity in hemodialysis

Contaminants normally included
in dialysate

Other contaminants

Contaminant Max Concentration;in mg/L (ppm) unless otherwise noted
Aluminum 0.01
Chloramines 0.1
Free Chlorine 0.5
Copper 0.1
Fluoride 0.2
Lead 0.005
Nitrate(as N) 2
Sulfate 100
Zinc 0.1
Calcium 2 (0.1 mEq/L)
Magnesium 4 (0.3 mEq/L)
Potassium 8 (0.2 mEq/L)
Sodium 70 (3.0 mEq/L)
Antimony 0.006
Arsenic 0.005
Barium 0.1
Beryllium 0.0004
Cadmium 0.001
Chromium 0.014
Mercury 0.0002
Selenium 0.09
Silver 0.005
Thallium 0.002

*The physician has the ultimate responsibility for ensuring the quality of water used for dialysis.

 

COMPARISON: AAMI VERSUS 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)**

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.