BS EN ISO 23500-3-2024 PDF

Full title and description

STB BS EN ISO 23500-3:2024 — Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies. This document specifies minimum chemical and microbiological quality requirements, monitoring guidance and steps to ensure conformity for water used to prepare dialysis fluids, concentrates and for reprocessing haemodialysers; it is published as an updated second edition in 2024 and is available as an EN/BS adoption of the ISO text.

Abstract

This part of ISO 23500 sets out the minimum chemical and microbiological quality requirements for water used in the preparation of dialysis fluids and concentrates and for reprocessing haemodialysers, and provides guidance for ongoing monitoring of water purity (chemical and microbiological). It excludes dialysis fluid-regenerating systems and leaves the operation of water-treatment equipment and final mixing of treated water with concentrates to dialysis professionals.

General information

• Status: Published (active international standard and adopted as EN/BS variants).
• Publication date: ISO edition published 17 April 2024; BS EN ISO adoption published 24 April 2024 (national adoption dates can vary by member body).
• Publisher: ISO (original international standard); also published/adopted by national bodies as BS EN ISO (BSI) and by other national standards bodies.
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics / dialysis fluids and related therapies).
• Edition / version: Edition 2 (2024).
• Number of pages: ISO text: 18 pages (ISO PDF); BS/EN national publications include additional front matter and can show a larger page count (examples: BS edition listed as 28 pages).

Scope

This standard applies to water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, to water used in the preparation of concentrates, and to water used for reprocessing haemodialysers. It specifies minimum chemical and microbiological quality requirements, monitoring and sampling guidance and the actions needed to demonstrate conformity. It does not apply to dialysis fluid-regenerating systems; the operation of water-treatment equipment and final mixing of treated water with concentrates remain the responsibility of dialysis professionals.

Key topics and requirements

• Minimum chemical and microbiological quality criteria for dialysis water (sets the framework for contaminants to control and monitor).
• Guidance for sampling, testing frequency and ongoing monitoring to demonstrate continued conformity.
• Recommendations on suitable analytical approaches and verification (including options referenced in the 2024 edition for analytical alternatives).
• Clarification of responsibilities: operation of water-treatment systems and final mixing are user/dialysis-professional responsibilities.
• Exclusions and interfaces with other parts of the ISO 23500 series (e.g., water-treatment equipment, concentrates and dialysis fluid composition addressed in other parts).

Typical use and users

This document is intended for dialysis practitioners and clinical teams, clinical engineers and biomedical staff in dialysis centres, manufacturers and suppliers of water-treatment equipment and dialysis concentrates, regulatory bodies and accreditation organisations, and laboratories performing water and dialysis-fluid testing. It supports procurement, validation, routine monitoring and quality-management activities in facilities that provide haemodialysis and related therapies.

Related standards

ISO 23500 is a multi-part series; closely related parts include ISO 23500-1 (General requirements and quality-management framework), ISO 23500-2 (Water treatment equipment), ISO 23500-4 (Concentrates) and ISO 23500-5 (Quality of dialysis fluid). Users should consult the series together to cover the full chain from municipal water to final dialysis fluid.

Keywords

dialysis water, haemodialysis, haemodiafiltration, haemofiltration, water quality, microbiological quality, chemical contaminants, monitoring, dialysis concentrates, water treatment, ISO 23500.

FAQ

Q: What is this standard?

A: It is Part 3 of the ISO 23500 series (Edition 2, 2024) providing minimum chemical and microbiological quality requirements and monitoring guidance for water used in haemodialysis-related applications.

Q: What does it cover?

A: It covers water used to prepare dialysis fluids and concentrates and for reprocessing haemodialysers, including guidance on monitoring and steps to demonstrate conformity; it excludes dialysis fluid-regeneration systems and leaves operation of water-treatment equipment and final mixing to dialysis professionals.

Q: Who typically uses it?

A: Dialysis clinical teams, hospital clinical engineers, water-treatment equipment suppliers, concentrate manufacturers, clinical laboratories and regulators—any organisation responsible for providing, testing or validating water and fluids for haemodialysis and related therapies.

Q: Is it current or superseded?

A: The 2024 edition (Edition 2) is the current version of ISO 23500-3 and replaces the 2019 edition; national adoptions (EN / BS / STB variants) were published shortly after the ISO release in 2024. Check the national body (BSI or the STB national catalog) for the exact adoption date in a specific country.

Q: Is it part of a series?

A: Yes — ISO 23500 is a multi-part series addressing the preparation and quality management of fluids for haemodialysis and related therapies; other parts cover general requirements (Part 1), water-treatment equipment (Part 2), concentrates (Part 4) and dialysis fluid quality (Part 5). Users should refer to the whole series for comprehensive guidance.

Q: What are the key keywords?

A: dialysis water, haemodialysis, haemodiafiltration, haemofiltration, water treatment, microbiology, chemical contaminants, monitoring, concentrates, quality management.