ISO 23500-2-2024 PDF

Full title and description

ISO 23500-2:2024 — Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies. This part specifies requirements and recommendations for individual water treatment devices and for water treatment systems assembled from one or more devices intended to supply water for haemodialysis and related therapies.

Abstract

This document defines requirements and guidance for the specification, assembly, installation and use of water treatment devices and complete water treatment systems used to produce water for haemodialysis and related therapies. It covers devices, piping and fittings from the point water is delivered to the water purification system up to the point of use of the purified water. The standard is directed at system specifiers, suppliers, manufacturers and installers and complements the water-quality and monitoring requirements given in ISO 23500-3.

General information

• Status: Published
• Publication date: July 2024 (Edition 2, 2024)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.40
• Edition / version: Edition 2 (2024)
• Number of pages: 33

Scope

Applies to individual water treatment devices and assembled water treatment systems intended to supply water for haemodialysis and related therapies. It covers all devices, piping and fittings between the point where municipal/potable water is delivered to the water purification system and the point of use of the purified water (examples: water purification units, online monitors such as conductivity monitors, distribution piping). Exclusions include equipment used to prepare concentrates from powder at the dialysis facility, dialysis fluid proportioning systems, sorbent dialysis fluid regeneration systems, dialysis concentrates, haemodiafiltration/haemofiltration systems, dialyser reprocessing systems beyond the stated scope, and peritoneal dialysis systems. Ongoing water purity monitoring requirements are addressed in ISO 23500-3.

Key topics and requirements

• Requirements and recommendations for design, assembly and installation of water treatment devices and systems intended for dialysis applications.
• Scope of covered components: water purification devices, online water-quality monitors (e.g., conductivity), distribution piping, fittings and connections up to the point of use.
• Expectations for manufacturers and system suppliers regarding intended use, documentation, marking and instructions for installation, commissioning and maintenance.
• Materials compatibility and hygienic construction to minimise chemical and microbiological contamination risk.
• Commissioning, validation and acceptance testing of installed systems; verification of performance characteristics.
• Requirements for alarms, fail-safe features and interfaces with clinical equipment where relevant.
• Recommendations for routine maintenance, cleaning/disinfection procedures and lifecycle management of system components.
• Clarification of responsibilities between equipment suppliers, installers and dialysis practitioners; linkages to water quality requirements in ISO 23500-3 and dialysis fluid quality in ISO 23500-5.

Typical use and users

Used by manufacturers of water treatment devices, system integrators, suppliers and installers of dialysis water systems, dialysis clinic managers and biomedical engineering teams, hospital procurement and compliance staff, and regulatory or accreditation bodies. The standard supports design/specification of new systems, procurement, installation acceptance, and lifecycle maintenance programs for dialysis water treatment.

Related standards

Part of the ISO 23500 series. Closely related documents include ISO 23500-1 (General requirements), ISO 23500-3 (Water for haemodialysis and related therapies — chemical and microbiological quality and monitoring), ISO 23500-4 (Concentrates for haemodialysis and related therapies) and ISO 23500-5 (Quality of dialysis fluid for haemodialysis and related therapies). Relevant medical-device and electrical safety standards (for example IEC standards covering dialysis equipment) should be consulted where device interfaces or safety systems overlap.

Keywords

haemodialysis, dialysis water, water treatment, water purification, dialysis fluid, water system installation, water distribution piping, conductivity monitoring, equipment commissioning, ISO 23500 series

FAQ

Q: What is this standard?

A: ISO 23500-2:2024 is the second part of the ISO 23500 series providing requirements and guidance for water treatment equipment and systems used to produce water for haemodialysis and related therapies.

Q: What does it cover?

A: It covers requirements and recommendations for individual water treatment devices and assembled systems, including devices, distribution piping and online monitoring up to the point of use. It does not set the chemical/microbiological water-quality limits (those are in ISO 23500-3) and excludes certain systems such as proportioning systems, sorbent regenerators and peritoneal dialysis systems.

Q: Who typically uses it?

A: Manufacturers, system suppliers and integrators, installers, dialysis clinic biomedical engineers, facility managers, procurement and compliance teams, and regulators or accreditation agencies involved with haemodialysis water systems.

Q: Is it current or superseded?

A: Current. ISO 23500-2:2024 (Edition 2, published July 2024) replaces the earlier ISO 23500-2:2019.

Q: Is it part of a series?

A: Yes — it is part of the ISO 23500 series (guidance for preparation and quality management of fluids for haemodialysis and related therapies). Other parts include ISO 23500-1 (general requirements), ISO 23500-3 (water), ISO 23500-4 (concentrates), ISO 23500-5 (dialysis fluid quality), etc.

Q: What are the key keywords?

A: haemodialysis, dialysis water, water treatment equipment, water purification, water distribution, conductivity monitoring, equipment commissioning, ISO 23500.