AST's NATA accreditation now includes the Bacterial Endotoxins test.
The Bacterial Endotoxins test used at AST is a limulus amoebocyte lysate (LAL) gel formation method of assessing endotoxin concentration by kinetic turbidimetric reaction time. It is currently the analytical method of choice in Australia for quantitative endotoxin analysis.
Endotoxins cause a fever-like reaction and other adverse effects (septic shock). They are not readily inactivated at the temperatures used for disinfection or sterilisation, hence monitoring of Reusable Medical Devices (RMDs) is vitally important.
AST provides NATA accredited analytical results that meet the requirements of AS/NZ 4187:2014 Reprocessing of reusable medical devices in health service organisations.
This includes routine monitoring and control of the cleaning process
for washer disinfectors and manual chemical cleaning in accordance with
Table 7.2 of the standard. Water quality monitoring testing is required
monthly in accordance with the standard (Table 8.1).
Testing against other standards or other analytical suites is also available:
- EN 285 table B1 – water (feedwater) supplied to steam generator
- EN 285 table 10.1 and table E2 Steam purity tests
- section 220.127.116.11 of AS/NZ 4187:2014
AST is able to provide NATA accredited tests to comply with your water monitoring obligations.
The following table shows AST's reporting limits are much lower than those required for compliance with the standard, giving you confidence that your test water is clean and compliant:
|Analyte||Maximum concentration levels ||AST limit of reporting|
| ||Cleaning process||Final Rinse|||
|Appearance||Clear, colourless||Clear, colourless|
|pH|| ||5.5 - 8.0||0.1 pH units|
|Conductivity 25ºC|| ||30 µS/cm||5 µS/cm|
|Total Dissolved Solids (TDS)|| ||40 mg/L||20 mg/L|
|Total Hardness (CaCO3)||60 mg/L||50 mg/L||1 mg/L|
|Chloride (Cl)||120 mg/L||10 mg/L||0.05 mg/L|
|Lead (Pb)|| ||10 mg/L||0.5 µg/L|
|Iron (Fe)|| ||2 mg/L||0.02 mg/L|
|Phosphate|| ||0.2 mg P2O5/L||0.003 mgP/L|
|Silica (SiO2)||2 mg/L||0.2 mg/L||0.1 mg/L|
|Total Viable Count (cfu/100mL)|| |
100 cfu/100 mL
|Endotoxin (EU/mL)|| ||0.25 EU/mL||0.1 EU/mL|
Monitoring steriliser water on a regular basis ensures:
- the steriliser water is not too hard that it impairs the activity of detergents or causes deposits
- the steriliser water will not cause scaling or corrosion of items processed
- the steriliser water is not re-contaminating disinfected items with microorganisms or toxins.
For information about sampling RMD steriliser water and how to submit samples to AST, please see our RMD steriliser water information sheet:
RMD Steriliser Water Sampling (475Kb)
Please contact us for further information or if you require compliance monitoring testing services.