ISO 23500-1:2024 PDF

Overview

ISO 23500-1:2024 - "Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements" sets out the general requirements and quality-management framework for preparing dialysis fluids and online substitution fluids used in haemodialysis, haemodiafiltration and haemofiltration. The second edition (2024) addresses responsibilities of dialysis practitioners after water-treatment and concentrate-preparation equipment are installed, covering the process from municipal water entry to the point the final dialysis or substitution fluid enters the dialyser or is infused.

It does not apply to sorbent-based fluid-regeneration systems, continuous renal replacement systems using pre-packaged solutions, or peritoneal dialysis solutions, and it does not address clinical misuse of fluids.

Key topics and technical requirements

• Quality requirements for dialysis water, concentrates and final dialysis/substitution fluids, including chemical and microbiological contaminants.
• System design and technical considerations for water treatment, distribution and concentrate-preparation equipment.
• Validation of system performance: validation plans, installation/operational qualification, performance qualification, initial and periodic validation and revalidation.
• Surveillance and monitoring: routine sampling, heterotrophic plate counts, bacterial endotoxin testing, and surveillance of components such as sediment/cartridge filters, softeners, carbon media, reverse osmosis and deionization systems.
• Microbiological control strategies: disinfection frequency, device-level microbiological design aspects, and sampling/analysis methods.
• Record retention, personnel competency, environmental impact and access/location requirements.
• Informative annexes cover rationale, equipment, surveillance guidelines, validation, home and acute haemodialysis considerations, and risk-assessment guidance.

Practical applications and users

ISO 23500-1:2024 is intended for organizations and professionals responsible for dialysis fluid quality and water-treatment systems, including:

• Dialysis practitioners and clinical managers
• Biomedical engineers and facility maintenance teams
• Water-treatment technicians and laboratory personnel performing surveillance
• Manufacturers and installers of dialysis water-treatment equipment
• Regulatory bodies and quality/compliance officers

Practical benefits include improved patient safety through standardized water and fluid quality management, clear validation and monitoring procedures, and guidance for preventing microbiological contamination and chemical exposure during haemodialysis and online therapies.

Related standards

• Other ISO documents developed by ISO/TC 150 (implants and extracorporeal systems) and relevant national healthcare regulations may apply. Users should consult ISO’s catalogue and local regulatory requirements for complementary standards and conformity guidance.

Keywords: ISO 23500-1, dialysis water, haemodialysis, dialysis fluid preparation, substitution fluid, haemodiafiltration, quality management, microbiological control, water treatment, validation.