ISO 23500-4-2024 PDF

Full title and description

Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies. This international standard specifies chemical and microbiological requirements, labelling and marking, and requirements for concentrates (liquid and powder), additives (spikes) and equipment used to mix concentrates for haemodialysis and related therapies.

Abstract

This document specifies minimum chemical and microbiological requirements for concentrates used to prepare dialysis fluids for haemodialysis and related therapies, and provides requirements and guidance for manufacturers of such concentrates. It covers concentrates supplied as liquids or powders, adds guidance for additives (spikes) and for equipment intended to mix powder concentrates into usable concentrate at the user site. The document excludes concentrates prepared at a dialysis facility from pre‑packaged salts and water, pre‑packaged sterile dialysis fluid, sorbent regeneration systems that recycle small fluid volumes, and clinical treatment equipment (covered by IEC 60601‑2‑16).

General information

• Status: Published.
• Publication date: 17 April 2024 (Edition 2, 2024‑04).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthopaedics; health/medical devices related classification).
• Edition / version: 2nd edition (2024).
• Number of pages: 22 pages.

Scope

The standard applies to manufacturers of concentrates for haemodialysis and related therapies and specifies chemical and microbiological limits, labelling and information requirements, and requirements for additives (spikes) and for mixing equipment provided for use at the customer site. It is applicable to both liquid and powder concentrates. It does not apply to concentrates prepared from pre‑packaged salts and water at a dialysis facility, pre‑packaged sterile dialysis fluid, sorbent dialysis fluid regeneration systems that recirculate small volumes, or to haemodialysis treatment equipment (the latter is covered by IEC 60601‑2‑16). Dialysis fluid quality itself is addressed in ISO 23500‑5.

Key topics and requirements

• Chemical composition limits for concentrate formulations (ions and components relevant to dialysis fluid preparation).
• Microbiological quality limits and guidance for microbiological control of concentrates.
• Applicability to liquid concentrates and powder concentrates (including instructions for reconstitution where relevant).
• Requirements for additives ("spikes") used to change or supplement ionic concentrations in the final dialysis fluid.
• Labelling and information to be provided on concentrate packaging (composition, instructions, warnings and user responsibilities).
• Requirements and guidance for equipment intended to mix powders into concentrate at the user's facility (design, instructions, and safety considerations).
• Clear exclusions and interface requirements with dialysis water, dialysis fluid (see ISO 23500‑3 and ISO 23500‑5) and medical device standards (e.g., IEC 60601‑2‑16).

Typical use and users

Primary users are manufacturers and suppliers of haemodialysis concentrates and related additives. Secondary users include regulatory bodies, notified bodies, dialysis clinic procurement and quality assurance teams, clinical engineering departments, and laboratories performing product release testing or incoming quality control. The standard is used to define product specification, labelling, manufacturing QC limits, and to inform facility procurement and acceptance testing.

Related standards

ISO 23500 is a multipart series; closely related parts include ISO 23500‑1 (General requirements), ISO 23500‑3 (Water for haemodialysis and related therapies), ISO 23500‑5 (Quality of dialysis fluid). The standard interfaces with medical electrical equipment requirements (IEC 60601‑2‑16) and with national/regional adoptions or endorsements of the ISO 23500 series.

Keywords

haemodialysis, concentrates, dialysis concentrates, dialysis fluid, dialysis additives, spikes, powder concentrate, liquid concentrate, microbiological limits, chemical limits, water treatment, dialysis QA, ISO 23500.

FAQ

Q: What is this standard?

A: ISO 23500‑4:2024 is the part of the ISO 23500 series that specifies requirements for concentrates used to prepare dialysis fluids for haemodialysis and related therapies, addressing chemical and microbiological quality, labelling and related manufacturer responsibilities.

Q: What does it cover?

A: It covers concentrates in liquid and powder form, additives (spikes), and equipment intended to mix powder concentrates into concentrate at the user's facility. It sets chemical and microbiological requirements and information/label requirements for manufacturers. It excludes concentrates prepared on‑site from pre‑packaged salts and water, pre‑packaged sterile dialysis fluid, sorbent recirculation systems, and haemodialysis treatment devices.

Q: Who typically uses it?

A: Manufacturers of dialysis concentrates and additives, quality and regulatory teams, dialysis clinic procurement and QA staff, clinical engineers, and agencies assessing product conformity.

Q: Is it current or superseded?

A: This is the current (2nd) edition published in April 2024; it replaces ISO 23500‑4:2019. The ISO lifecycle entry lists the 2024 edition as published (to be reviewed in ISO's review cycle).

Q: Is it part of a series?

A: Yes — ISO 23500 is a multipart series addressing preparation and quality management of fluids for haemodialysis and related therapies; other relevant parts include ISO 23500‑1 (general requirements), ISO 23500‑3 (water), and ISO 23500‑5 (dialysis fluid quality).

Q: What are the key keywords?

A: Haemodialysis, concentrates, concentrate formulation, dialysis fluid, spikes/additives, microbiological control, chemical contaminants, laboratory testing, mixing equipment, labelling.