ISO 13959:2009 Water Quality Standards

    A New Water Quality Standard for Better Patient Outcomes

    The recent adoption of ISO 13959:2009 by AAMI means the quality of water used in dialysis treatment will increase. The new standard has 2 important aspects to it. First, acceptable microbiological levels have been reduced by more than 50%, as noted in the chart below. Second, the testing protocol used to determine bacteria levels is a much more sensitive cultivation technique. The net result is that existing water system designs may or may not consistently produce water that meets the new standards.

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  • New ISO Water Standards
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AAMI Microbiological Standards for Dialysis Water
 
  Microbiological Level Previous Standards New Standards Previous Action Level New Action Level
  Colony Forming Units < 200 CFU/mL < 100 CFU/mL ≥ 100 CFU/mL ≥ 50 CFU/mL
Endotoxin Units < 2 EU/mL < 0.25 EU/mL ≥ 1 EU/mL ≥ 0.125 EU/mL
 

What Can You or Your Facility Do?
For existing water systems, you should perform testing using the new ISO standard to ensure that your water system is producing water that meets the new requirements. As a result, you may need to increase the disinfection frequency, or add additional filtration or a combination of both in order to meet the new standard. Mar Cor Purification can help you evaluate the options.

 

 

 

Iso Water Stantdards


Please download our ISO 13959:2009 Water Standards Informational Brochure for more information

Heat Disinfection Technologies Proven to Meet ISO Water Standards Worldwide
Mar Cor Purification is the leading manufacturer and service provider of portable and central heat disinfection hemodialysis water systems in the United States. Mar Cor Purification continually strives to develop innovative technologies designed to improve patient safety and increase provider productivity.

dialysis water system CWP
Double Pass Dialysis Water System w/ Heat Disinfection
This feed double pass water system is designed specially to meet stringent international hemodialysis water requirements.
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Dialysis Water System w/ Heat Loop Disinfection
The CWP 100 offers cost-effective, consistent delivery of AAMI grade water according to ANSI/AMMI/ISO 13959:2009.
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Dialysis Water System w/ Isolated Automated Heat
This 510(k) Portable RO Systems with Heat Disinfection is FDA Cleared for Use in Hospital Acute Settings.
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Hot Water Disinfection Reverse Osmosis System
The ability to hot water disinfect the 4400 HX can help in reducing bacteria related problems.
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