ANSI/AAMI/ISO 23500-2:2024—Hemodialysis Water Treatment
Healthy kidneys continuously filter waste products, excess fluids, and toxins from the bloodstream. When kidneys fail, hemodialysis (i.e., a life-saving treatment for kidney failure) performs this essential function by circulating blood through a dialysis machine where waste products are removed. For patients undergoing hemodialysis, high purity water becomes part of a life-sustaining medical treatment. ANSI/AAMI/ISO 23500-2:2024, Preparation and quality management of fluids for hemodialysis and related therapies—Part 2: Water treatment equipment for hemodialysis applications and related therapies establishes requirements and recommendations for the water treatment equipment that helps assure dialysis water is consistently safe and suitable for patient care.
Why Water Quality Is Essential for Safe Hemodialysis
Patients receiving in-center hemodialysis are typically treated three times per week, and over the course of a year, a single patient can be exposed to tens of thousands of liters of water through dialysis treatment. During a single hemodialysis session, a patient can be exposed to 300-600 liters of water that are purified and mixed with dialysis concentrates to create dialysis fluid: a specialized cleansing solution used in kidney dialysis to remove waste products, extra water, and balance chemicals in the blood. This fluid passes alongside the patient’s blood across a semi-permeable membrane, allowing waste products and excess fluids to be removed while helping maintain proper electrolyte balance.
Because dialysis patients are repeatedly exposed to such large volumes of water, even trace amounts of chemical contaminants, bacteria, microorganisms, or bacterial endotoxins can pose serious health risks. Water used in hemodialysis must undergo extensive treatment to meet stringent purity requirements. As a result, water treatment systems are among the most critical components of every dialysis facility, helping protect patient safety and assure reliable delivery of life-sustaining kidney replacement therapy.
What Is ANSI/AAMI/ISO 23500-2:2024?
ANSI/AAMI/ISO 23500-2:2024 specifies the requirements for water treatment devices and systems used in hemodialysis and related therapies. This American National Standard is meant to be used by the individual or company that specifies the complete water treatment system and the supplier who assembles and installs the system.
ANSI/AAMI/ISO 23500-2:2024 is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water.
Ultimately, ANSI/AAMI/ISO 23500-2:2024 helps protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminants found in water supplies. The standard is critical for assuring that the water purification and distribution systems used to treat tap water for dialysis are safe and effective.
What Is Not in the Scope of ANSI/AAMI/ISO 23500-2:2024
ANSI/AAMI/ISO 23500-2:2024 does not apply to the following:
- Equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients
- Dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid
- Sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid
- Dialysis concentrates
- Hemodiafiltration or hemofiltration systems
- Systems that process dialyzers for multiple uses
- Peritoneal dialysis systems
Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3.
Importance of Safe, Reliable Dialysis Care
The need for dialysis continues to grow worldwide. More than 850 million people worldwide are affected by kidney disease, and millions progress to kidney failure (due to chronic conditions like diabetes and high blood pressure) requiring dialysis or transplantation. Chronic kidney disease has become one of the fastest-growing causes of death globally, increasing demand for safe, reliable dialysis care.
Patients undergoing dialysis place extraordinary trust in the technology supporting their treatment. ANSI/AAMI/ISO 23500-2:2024 helps assure that dialysis facilities begin every treatment with properly designed water purification equipment capable of delivering the high-quality water required for safe hemodialysis.
Where to Find ANSI/AAMI/ISO 23500-2:2024
ANSI/AAMI/ISO 23500-2:2024, Preparation and quality management of fluids for hemodialysis and related therapies—Part 2: Water treatment equipment for hemodialysis applications and related therapies is available on the ANSI Webstore, the best place to buy AAMI and ISO standards.
ANSI/AAMI/ISO 23500-2:2024 was developed by the Association for the Advancement of Medical Instrumentation (AAMI) and the International Standards Organization (ISO).
Please direct any technical questions relating to this American National Standard to the developer. You can find the contact information for all ANSI-accredited standards developers here: List of ANSI-Accredited Standards Developers (ASDs).
For further information, please refer to: Who to Contact for Standards Related Questions.
