ISO 23500-3-2024 PDF

Full title and description

ISO 23500-3:2024 — Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies. This part specifies minimum chemical and microbiological quality requirements for water used to prepare dialysis fluids and concentrates and for reprocessing haemodialysers, and provides guidance on ongoing monitoring and conformity actions for dialysis facilities and water-treatment stakeholders.

Abstract

This international standard defines the required quality characteristics and monitoring approach for dialysis water used in haemodialysis, haemodiafiltration and haemofiltration, and for water used to prepare concentrates. It describes microbiological and chemical quality expectations, sampling and testing guidance, and clarifies that operation of water treatment equipment and final mixing of treated water with concentrates are responsibilities of dialysis professionals. The document excludes dialysis fluid regenerating systems.

General information

• Status: Published.
• Publication date: April 2024 (Edition 2, 2024-04).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (medical devices / haemodialysis).
• Edition / version: 2 (second edition, 2024).
• Number of pages: 18 pages (official PDF/ePub/paper formats available).

Scope

Applies to: water used for preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration; water used in the preparation of concentrates; and water used in reprocessing haemodialysers where applicable. The standard does not apply to dialysis fluid regenerating systems. It provides requirements and guidance for monitoring, testing and maintaining water purity from the facility treatment point up to final mixing with concentrates.

Key topics and requirements

• Microbiological quality requirements and monitoring (examples: total viable count and endotoxin limits are specified as part of microbiological control; action levels are typically set at around 50% of the maximum allowable level).
• Chemical quality requirements for inorganic contaminants and routine guidance on which chemical parameters to monitor (metals, major ions, and key anions), with test methods and limits referenced in the standard.
• Sampling points, sampling frequency and recommended laboratory methods for microbiological and chemical analyses, including guidance for interpreting results and when to act.
• Guidance on validation and ongoing surveillance of water treatment systems and distribution loops; responsibilities of dialysis professionals for operation and final mixing of treated water with concentrates.
• Notes on limitations: the document does not set routine numeric limits for some emerging organic contaminants (pharmaceuticals, endocrine disruptors) and advises using appropriate treatment/validation (RO, NF, GAC) where relevant.

Typical use and users

Primary users: dialysis clinicians and clinical engineering teams, hospital and clinic water-quality managers, medical device and water-treatment equipment manufacturers, laboratory personnel performing dialysis-water analyses, and regulatory/compliance officers in healthcare facilities. Typical use cases include setting facility water-quality specifications, designing monitoring programmes, validating water-treatment systems, and training dialysis staff on sampling and action-level responses.

Related standards

ISO 23500 is a multipart series. Closely related parts include: - ISO 23500-1:2024 — General requirements for preparation and quality management of fluids for haemodialysis and related therapies (Part 1). - ISO 23500-2:2024 — Water treatment equipment for haemodialysis applications and related therapies (Part 2). - ISO 23500-4:2024 — Concentrates for haemodialysis and related therapies (Part 4). - See also ISO 23500-5 and other parts in the series for dialysis fluid and substitution fluid topics as they are published or updated.

Keywords

haemodialysis, dialysis water, dialysis fluid, water quality, microbiology, endotoxin, total viable count, water treatment, concentrates, ISO 23500, clinical engineering, dialysis monitoring.

FAQ

Q: What is this standard?

A: ISO 23500-3:2024 is the part of the ISO 23500 series that specifies minimum chemical and microbiological quality requirements and monitoring guidance for water used in haemodialysis and related therapies.

Q: What does it cover?

A: It covers water quality criteria (microbiological and chemical), sampling and testing guidance, monitoring frequency and action/response recommendations for dialysis facilities, and clarifies responsibilities for operation and final mixing of treated water with concentrates. It explicitly excludes dialysis fluid regenerating systems.

Q: Who typically uses it?

A: Dialysis clinicians, biomedical/clinical engineers, water-treatment system suppliers, laboratory analysts, facility quality and compliance staff, and manufacturers of dialysis-related concentrates and equipment.

Q: Is it current or superseded?

A: ISO 23500-3:2024 is the current published edition (second edition, April 2024). It replaces the 2019 edition ISO 23500-3:2019 and is the active document to use unless a later revision is published.

Q: Is it part of a series?

A: Yes — ISO 23500 is a multipart series addressing fluids for haemodialysis and related therapies (Part 1: general requirements; Part 2: water treatment equipment; Part 3: water; Part 4: concentrates; additional parts cover dialysis fluid and related topics). Practitioners should consult the relevant parts together for a complete compliance and quality-management approach.

Q: What are the key keywords?

A: haemodialysis, dialysis water, microbiological limits (total viable count), endotoxin, water-treatment validation, concentrates, monitoring and sampling, ISO 23500.