Overview
EN ISO 23500-3:2024 - "Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies" is the CEN-endorsed version of ISO 23500-3:2024. The standard specifies the minimum chemical and microbiological quality requirements for water used to prepare dialysis fluids and concentrates and for reprocessing haemodialysers. It also gives guidance on the necessary steps and ongoing monitoring to ensure and verify conformity with those requirements.
Key facts:
- Applies to water for haemodialysis, haemodiafiltration, haemofiltration and concentrate preparation.
- Excludes dialysis fluid regenerating systems.
- Assumes feed water is potable; special considerations are needed for non-potable sources (e.g., private wells).
- Supersedes EN ISO 23500-3:2019 and incorporates technical updates (e.g., WHO drinking water guidelines as references, removal of thallium from trace-element list, and acceptance of recombinant Factor C for endotoxin testing).
Key Topics and Requirements
- Chemical contaminant requirements: Defines maximum permissible concentrations for specified inorganic and trace elements (referenced in the standard’s tables). Note: no universal threshold for organic contaminants is specified due to analytical and toxicological uncertainties.
- Microbiological requirements: Sets minimum requirements for bioburden control and endotoxin limits for dialysis water and provides methods for sampling and microbial testing.
- Testing and monitoring methods: Describes recommended analytical methods for chemical and microbiological testing, including accepted alternatives to classic endotoxin assays (e.g., rFC).
- Installation and verification: Requires verification of water quality upon installation of water treatment systems and regular surveillance thereafter.
- Responsibility and limits: Clarifies that operation of water treatment equipment and final mixing with concentrates are the responsibility of dialysis professionals.
Applications and Practical Use
EN ISO 23500-3:2024 is used to:
- Validate and commission water treatment systems for dialysis clinics and hospitals.
- Establish quality control programs, sampling plans, and routine monitoring for dialysis water.
- Define acceptance criteria for suppliers of dialysis concentrates and treated water systems.
- Support infection control, patient safety and risk management by reducing exposure to chemical and microbial contaminants.
- Inform procurement specifications for water treatment equipment and testing services.
Who Should Use This Standard
- Dialysis facility managers and clinical engineers
- Water treatment system manufacturers and installers
- Clinical microbiology and laboratory personnel conducting dialysis water testing
- Medical device and concentrate producers (ISO 23500 series)
- Regulators and accreditation bodies setting dialysis water safety requirements
Related Standards
- ISO 23500-1: General requirements for preparation and quality management of dialysis fluids
- ISO 23500-4: Requirements for concentrates, salts and mixing (referenced for final fluid production)
- WHO Drinking Water Guidelines (used as a reference benchmark in this edition)
EN ISO 23500-3:2024 is essential for ensuring safe dialysis water quality, guiding monitoring programs, and protecting patients from chemical and microbiological risks associated with haemodialysis and related therapies.