ISO 23500 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies

The “ISO 23500 Preparation and quality management of fluids for haemodialysis and related therapies” standard published by the International Standards Organization (ISO) consists of several sections published under the same title:

• ISO 23500-1 Part 1: General requirements. This standard describes the general requirements for dialysis practitioners for the preparation of fluids for haemodialysis and related therapies and for replacement fluid for use in on-line treatments such as haemodiafiltration and haemofiltration. This standard provides guidance on user responsibility for fluids used in haemodialysis and related therapies once the equipment used in their preparation has been delivered and installed. Since the dialysis water used to prepare the dialysis fluid can also be used to reprocess dialyzers that are not marked as single-use, this aspect of water use is also within the scope of this standard.

This standard also covers the quality management of equipment used to treat and distribute water used in the preparation of dialysis fluid and replacement fluid (from the point where municipal water enters the dialysis facility to the point where the final dialysis fluid enters the dialyzer or the replacement fluid is infused). It also covers the quality management of equipment used in the dialysis facility to prepare acid and bicarbonate concentrates from dust or other highly concentrated media and the preparation of final dialysis fluid or replacement fluid from dialysis water and concentrates.

However, this standard does not cover sorbent-based dialysis fluid regeneration systems that renew and recirculate small volumes of dialysate, continuous renal replacement therapy systems using prepackaged solutions, and systems and solutions for peritoneal dialysis. This standard does not address clinical problems associated with the inappropriate use of such fluids.

• ISO 23500-2 Part 2: Water treatment equipment for haemodialysis applications and related therapies. This standard is intended for manufacturers or suppliers of water treatment systems or devices used to provide water for haemodialysis or related therapies.

This standard covers devices for the treatment of drinking water designed for use in the administration of haemodialysis and related therapies. These include: preparation of concentrates from dust or other highly concentrated media in the dialysis facility, preparation of dialysis fluid (including dialysis fluid that may be used to prepare replacement fluid), reprocessing of single-use dialyzers where multiple uses are permitted, and reprocessing of dialyzers not specifically marked for single use.

This standard includes all devices, piping and fittings between the point where drinking water is delivered to the water treatment system and the point of use of dialysis water. Examples of devices include water purifiers, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of dialysis water.

However, this standard excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that renew and recirculate small volumes of dialysis fluid, dialysis concentrates, hemodiafiltration systems, hemofiltration systems, systems that process dialyzers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid distribution systems and concentrates, are covered in other standards.

• ISO 23500-3 Part 3: Water for haemodialysis and related treatments. This standard specifies the minimum chemical and microbiological quality requirements for water used in the preparation of dialysis fluids, concentrates and reprocessing of haemodialysers, and the steps required to ensure compliance with the requirements. This standard also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.

This standard applies to: water used in the preparation of dialysis fluids for hemodialysis, hemodiafiltration and hemofiltration, and for water used in the reprocessing of hemodialyzers, and for water used in the preparation of concentrates. However, this standard does not apply to dialysis fluid regeneration systems. The operation of water treatment equipment and the final mixing of purified water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.

• ISO 23500-4 Part 4: Concentrates for haemodialysis and related therapies. This standard describes the minimum requirements for concentrates used for haemodialysis and related therapies. This standard is intended for manufacturers of such concentrates. In several examples throughout this document, reference is made to the end user dialysis fluid to clarify the requirements for the production of concentrates. Since the manufacturer of the concentrate has no control over the final dialysis fluid, any reference to the dialysis fluid is for illustrative purposes and is not a requirement of the manufacturer.

This standard includes concentrates in both liquid and powder forms. It also includes spike additives, which are chemicals that can be added to the concentrate to support or increase the concentration of one or more ions present in the concentrate and thus in the final dialysis fluid. This standard also specifies requirements for equipment used at the user's facility to mix acid and bicarbonate powders into the concentrate.

• ISO 23500-5 Part 5: Quality of dialysis fluids for haemodialysis and related therapies. This standard describes the minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. This standard covers dialysis fluids used for haemodialysis and haemodiafiltration, including replacement fluid for haemodiafiltration and haemofiltration. However, this standard excludes water and concentrates used to prepare the dialysis fluid or the equipment used in its preparation. These areas are covered by other standards.

Sorbent-based dialysis fluid regeneration systems that renew and recirculate small volumes of dialysate, continuous renal replacement therapy systems using prepackaged solutions, and systems and solutions for peritoneal dialysis are outside the scope of this standard.

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