AAMI Standards RD52-2004
AAMI Standards & RD52-2004 Recommendations - Print PDF
Test |
Usage |
Where Used |
Test Goals |
Product Used |
Endotoxin |
Weekly, until a pattern of consistent compliance is demonstrated (recommended monthly thereafter) |
1st and last outlets of water
loop + reprocessing and bicarb mixing points |
Action Limit: <2EU/mL / 200CFU/mL Alert Limit: <1EU.mL / <50CFU/mL |
Pyrosate |
pH |
Daily as part of RO |
Prior to water entering RO pre-treatment system |
Around neutral pH 7.0 |
Serim Water pH Test Kit #5154 |
Total Chlorine |
Daily, as part of RO system validation. Also prior to 2nd and 3rd shifts (if applicable) |
Between and after carbon beds |
<0.1 ppm |
|
Water Hardness |
Daily, as part of RO system validation |
After water softener |
At or <10 ppm |
Test |
Usage |
Where Used |
Test Goals |
Product Used |
| Endotoxin | Monthly, rotated. Test at least 2 machines / month. Each machine is tested at least once / year. |
From dialysate port of the dialyzer or a sampling from which samples can be collected using a pyrogen-free container |
Action Limit: <2EU/mL / <200CFU/mL Alert Limit: <1EU/mL / <50CFU/mL Ultrapure dialysate: <0.03EU/mL / <0.1CFU/mL Infusion dialysate: <0.03EU/mL / <1CFU/1000mL |
Pyrosate |
| Bicarbonate- acid mixed solution pH |
Before each treatment in addition to machine reading (must have 2 separate tests) |
After dialysis equipment has diluted bicarb & acid concentrates. Sample from port entering dialyzer |
7.0 - 8.0 | Serim Bicarb pH Test Kit #5116A |
| Replaces the Phoenix meter (and their associated calibrations and repairs) Conductivity can be done with a less expensive MyronL. |
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Other Tests
Test |
Usage |
Where Used |
Test Goals |
Product Used |
| Residual Chlorine |
When using chlorine to
clean dialysis equipment concentrate containers, etc. |
Final rinse water | <0.5 ppm | Serim Residual Chlorine Test Kit #5100A or 5100C |
| Blood Leak in dialysate |
When blood leak detector alarms |
Test dialysate exiting dialyzer or waste fluid from drain line |
<0.35 mL/min | Serim Blood Leak Test Kit #5119 or #5119A |
| Replaces Hemastix® or urine multiple test strips | ||||