ISO 23500-5-2024 PDF

Full title and description

Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024). This part of ISO 23500 specifies minimum chemical and microbiological quality requirements for dialysis fluid used in haemodialysis and related therapies, and provides guidance on dialysis fluid intended for haemodialysis, haemodiafiltration and related substitution fluids produced online.

Abstract

ISO 23500-5:2024 defines the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies. It covers dialysis fluid produced at the point of use (bedside) or by central delivery systems and includes guidance for substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid. The document clarifies exclusions (water and concentrates used to prepare dialysis fluid, equipment for fluid production, sorbent regeneration systems, certain continuous renal replacement systems and peritoneal dialysis solutions) and describes the relationship between dialysis-fluid composition control and the protective systems defined in IEC 60601-2-16.

General information

• Status: Published
• Publication date: 17 April 2024
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.40 (Implants for surgery; extracorporeal and related therapies)
• Edition / version: Edition 2 (2024)
• Number of pages: 12

Scope

This document specifies minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies. It applies to dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid. It does not apply to the water and concentrates used to prepare dialysis fluid or to the equipment used to produce dialysis fluid; sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid; systems for continuous renal replacement therapy that use pre-packaged solutions; and systems and solutions for peritoneal dialysis. The standard also notes that delivery and monitoring of dialysis fluid composition and permitted deviations are governed by protective systems defined in IEC 60601-2-16.

Key topics and requirements

• Minimum chemical composition and permitted deviations for dialysis fluid (electrolyte composition, pH and conductivity considerations).
• Microbiological quality requirements and monitoring expectations (microbial counts, endotoxin control and methods for sampling/testing).
• Requirements and guidance for substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid.
• Exclusions and interfaces: clarifies that water treatment, concentrates and production equipment are covered in other parts of the ISO 23500 series.
• Relationship with medical-device safety standards (notably IEC 60601-2-16) for delivery, monitoring and protective system limits.
• Recommendations for quality assurance, routine monitoring and corrective actions when limits are exceeded.

Typical use and users

ISO 23500-5 is intended for clinical and technical professionals involved in dialysis fluid quality: dialysis clinic staff, nephrologists, clinical engineers, microbiology and quality‑assurance teams, hospital infection control, manufacturers of dialysis machines and concentrate suppliers, water-treatment system designers and regulatory bodies. It is used to define acceptable fluid quality for treatment planning, procurement specifications, routine monitoring programmes and manufacturer instructions for use.

Related standards

ISO 23500-5 is part of the ISO 23500 series on preparation and quality management of fluids for haemodialysis and related therapies. Closely related documents include ISO 23500-1 (general requirements), ISO 23500-2 (water treatment equipment), ISO 23500-3 (water for haemodialysis), ISO 23500-4 (concentrates for haemodialysis). It also interfaces with IEC 60601-2-16 (particular requirements for the safety of haemodialysis equipment) and builds on principles from earlier standards that were consolidated into the 23500 series.

Keywords

dialysis fluid, haemodialysis, haemodiafiltration, substitution fluid, microbiological quality, endotoxin, electrolyte composition, conductivity, water treatment, concentrates, IEC 60601-2-16, quality assurance

FAQ

Q: What is this standard?

A: ISO 23500-5:2024 specifies minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies and gives guidance on substitution fluid produced online.

Q: What does it cover?

A: It covers the required quality attributes of dialysis fluid (chemical composition, pH, conductivity and microbiological/endotoxin control), monitoring and quality-assurance recommendations for dialysis fluid used in haemodialysis and haemodiafiltration. It excludes water-treatment equipment, concentrates and certain other dialysis modalities addressed in other standards.

Q: Who typically uses it?

A: Dialysis clinics and hospitals, clinical engineers, nephrologists, manufacturers of dialysis equipment and concentrates, water-treatment suppliers, quality and infection-control teams, and regulatory authorities.

Q: Is it current or superseded?

A: ISO 23500-5:2024 is the current published edition (Edition 2, published April 2024). It replaces the earlier 2019 edition.

Q: Is it part of a series?

A: Yes. It is part of the ISO 23500 series addressing preparation and quality management of fluids for haemodialysis and related therapies (notably Parts 1–4 and others covering water, equipment and concentrates).

Q: What are the key keywords?

A: Dialysis fluid, haemodialysis, haemodiafiltration, substitution fluid, microbiological quality, endotoxin, concentrates, water treatment, quality assurance.