SIST EN ISO 23500-2:2024

Overview

EN ISO 23500-2:2024 (ISO 23500-2:2024) specifies requirements and recommendations for water treatment equipment for haemodialysis and related therapies. The standard covers individual water treatment devices and complete water treatment systems assembled from such devices, including devices, piping and fittings from the point water is delivered to the purification system up to the point of use. It is intended for those who specify, supply, assemble or manufacture water treatment solutions for dialysis applications.

Key topics and technical requirements

• Scope and applicability: Applies to water purification devices, online water quality monitors (e.g., conductivity), storage and distribution piping systems used to supply dialysis-quality water.
• Excluded systems: Does not apply to preparation of concentrates, dialysis fluid proportioning systems, sorbent regeneration systems, haemodiafiltration/haemofiltration systems, dialyser reprocessing systems, dialysis concentrates or peritoneal dialysis systems.
• Water quality principles: Outlines dialysis water quality requirements for chemical contaminants, organic carbon and microbiological parameters (detailed ongoing monitoring requirements are covered in ISO 23500-3).
• Equipment requirements: Addresses component-level requirements and recommendations for backflow prevention, tempering valves, sediment and cartridge filters, water softeners, anion exchange resin tanks, carbon media, chemical injection systems, reverse osmosis units, deionization, and bacteria/endotoxin-retentive filters.
• Storage & distribution: Specifies requirements for storage tanks, distribution piping and fittings to maintain water purity and minimize biofilm and contamination risks.
• Testing and conformity: Includes test methods and conformity checks for chemical and microbiological quality, and performance verification for specific equipment types.
• Safety and labelling: Covers electrical safety of water treatment equipment, product markings and required product literature for safe installation and use.

Practical applications

• Ensures safe, standardized water purification systems for haemodialysis centres, hospital dialysis units, and satellite dialysis clinics.
• Guides design, selection and installation of reverse osmosis systems, carbon filters, deionization units and distribution loops used to produce dialysis-quality water.
• Supports procurement specifications, acceptance testing, commissioning and maintenance procedures to reduce patient risk from chemical or microbiological contaminants.

Who should use this standard

• Medical device manufacturers and component suppliers of water treatment equipment
• Hospital engineers, dialysis facility managers and infection control teams
• System integrators, installers and commissioning agents specifying or assembling dialysis water systems
• Regulators and accreditation bodies assessing compliance with safe dialysis water practices

Related standards

• ISO 23500-3 (ongoing monitoring of water purity - chemical and microbiological)
• Relevant national and regional medical device and electrical safety regulations

Keywords: EN ISO 23500-2:2024, ISO 23500-2, water treatment equipment, haemodialysis, dialysis water, reverse osmosis, water purification, microbiological quality, chemical contaminants.