ISO 23500-1-2024 PDF

Full title and description

St ISO 23500-1:2024 — Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements. This part defines general requirements and responsibilities for the preparation, handling and quality management of fluids used in haemodialysis and related therapies (including substitution fluid for online therapies) at the point from municipal water entry to the point of final dialysis fluid or substitution fluid delivery.

Abstract

This document specifies general requirements for the preparation and quality management of dialysis water, concentrates and the final dialysis or substitution fluids used in haemodialysis, haemodiafiltration and haemofiltration. It provides guidance on user/facility responsibilities after delivery and installation of preparation equipment, and covers aspects such as water treatment and distribution, concentrate preparation, final mixing and the use of dialysis water for dialyser reprocessing. Exclusions include sorbent-based regeneration systems, CRRT using pre-packaged solutions and peritoneal dialysis; clinical treatment decisions are not addressed.

General information

• Status: Published.
• Publication date: 16 August 2024 (Edition 2, 2024).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (implants for surgery, prosthetics and orthotics / therapy equipment and extracorporeal systems).
• Edition / version: Edition 2 (2024).
• Number of pages: 104 pages.

Key bibliographic and lifecycle details above are taken from the ISO bibliographic entry for ISO 23500-1:2024.

Scope

Specifies the quality-management requirements for equipment and processes used to treat and distribute water for dialysis, to prepare acid and bicarbonate concentrates (from powdered or other highly concentrated media) and to prepare final dialysis fluid or substitution fluid. The scope covers the flow of water from municipal supply entry through treatment and distribution to the point where final fluid enters the dialyser or substitution fluid is infused. It excludes sorbent-based dialysis fluid regeneration systems, CRRT with pre-packaged solutions and peritoneal dialysis systems; clinical treatment issues are outside the scope.

Key topics and requirements

• Definitions and roles — responsibilities of equipment suppliers, facility personnel and dialysis practitioners for preparation, validation and ongoing management of fluids.
• Quality management for water treatment and distribution systems, including monitoring, sampling and maintenance practices.
• Requirements and guidance for preparation and safe handling of acid and bicarbonate concentrates at the facility.
• Procedures for preparing final dialysis fluid and online substitution fluid, and for verifying correct proportioning and composition.
• Guidance on re-use / reprocessing of dialysers when dialysis water is used, including risk considerations.
• Exclusions and interfaces with other standards (e.g., equipment safety and monitoring standards and other parts of the ISO 23500 series).
• Documentation, validation, corrective action and routine surveillance as elements of a facility quality-management approach.

These topics reflect the general-requirements approach of Part 1 and its interface with the other parts of the ISO 23500 series.

Typical use and users

Intended users include dialysis facility managers, nephrology clinicians, clinical engineers, infection-control teams, medical device and water-treatment equipment manufacturers, laboratory personnel performing water and fluid testing, and regulatory or accreditation bodies. The standard is used when specifying, installing, commissioning and operating water treatment and dialysis fluid-preparation systems, and when establishing facility-level quality-management procedures and surveillance programmes.

Related standards

ISO 23500-1 is part of a multi-part series addressing fluids for haemodialysis and related therapies; closely related parts published in the 2024 revision include:

• ISO 23500-2 — Water treatment equipment for haemodialysis applications and related therapies.
• ISO 23500-3 — Water for haemodialysis and related therapies (water quality requirements and monitoring).
• ISO 23500-4 — Concentrates for haemodialysis and related therapies (chemical and microbiological requirements for concentrates).
• ISO 23500-5 — Quality of dialysis fluid for haemodialysis and related therapies (minimum dialysis-fluid quality requirements).

Keywords

dialysis water, dialysis fluid, haemodialysis, haemodiafiltration, haemofiltration, substitution fluid, water treatment, concentrates, quality management, surveillance, ISO 23500.

FAQ

Q: What is this standard?

A: ISO 23500-1:2024 is the part of the ISO 23500 series that sets general requirements and user/facility responsibilities for preparing and managing the quality of fluids used in haemodialysis and related therapies.

Q: What does it cover?

A: It covers quality-management requirements for water treatment and distribution systems, preparation of acid and bicarbonate concentrates at the facility, preparation and delivery of final dialysis or substitution fluids, monitoring and documentation, and interfaces with other technical standards; it explicitly excludes sorbent-based regeneration systems, CRRT pre-packaged solutions and peritoneal dialysis.

Q: Who typically uses it?

A: Dialysis clinics, nephrology teams, clinical engineers, equipment manufacturers and testing laboratories use it to specify, validate and operate water and fluid-preparation systems and to establish facility-level quality and monitoring programmes.

Q: Is it current or superseded?

A: ISO 23500-1:2024 is the current (second) edition published in 2024, superseding the 2019 edition. The standard is listed as published and scheduled for periodic review per ISO lifecycle procedures.

Q: Is it part of a series?

A: Yes — it is Part 1 of the ISO 23500 series; other parts (e.g., Parts 2–5) cover water-treatment equipment, water quality, concentrates and dialysis-fluid quality respectively.

Q: What are the key keywords?

A: Key keywords include dialysis water, dialysis fluid, haemodialysis, haemodiafiltration, haemofiltration, substitution fluid, water treatment, concentrates and quality management.