ISO 23500-2:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 33
- Дата публикации:
- 25 июля 2024 г.
- Издание:
- ISO IS 23500 edition 2 version 1
- ICS:
- 11.040.40
This document specifies requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies. This document is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water. This document does not apply to — equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients, — dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, — sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, — dialysis concentrates, — haemodiafiltration or haemofiltration systems, — systems that process dialysers for multiple uses, and — peritoneal dialysis systems. Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3.
Abstract
Overview - ISO 23500-2:2024 (haemodialysis water treatment)
ISO 23500-2:2024 specifies requirements and recommendations for water treatment devices and assembled water treatment systems used to produce purified water for haemodialysis and related therapies. It applies to components and piping from the inlet to the point of use, and is directed at system specifiers, suppliers who assemble/install systems, and manufacturers of devices intended for dialysis water applications. The document complements other parts of the ISO 23500 series and excludes equipment such as dialysis concentrate preparation, dialysis fluid proportioning systems, sorbent regeneration systems, haemodiafiltration/haemofiltration systems, dialyser reprocessing systems and peritoneal dialysis systems.
Key topics and technical requirements
ISO 23500-2 covers both water quality and device/system requirements, including:
- Dialysis water quality: chemical contaminant limits, organic carbon and pesticide considerations, and microbiological quality (linked to ongoing monitoring requirements in ISO 23500-3).
- Water treatment equipment requirements: design and safety expectations for individual devices and multi-component systems, including:
- backflow prevention and tempering valves
- sediment and cartridge filters
- water softeners and anion exchange resin tanks
- carbon media and chemical injection systems
- reverse osmosis and deionization technologies (and alternatives such as RO pre-treatment with ultrafiltration)
- bacteria and endotoxin retentive filters
- storage and distribution systems for dialysis water
- Electrical safety for water treatment equipment used in haemodialysis applications.
- Testing and conformity assessment: procedures for verifying microbiological and chemical purity, and tests to validate device-level features (e.g., filter performance, RO systems).
- Labelling and product literature: marking, instructions and documentation required for devices and systems.
- Informative annexes provide rationale and reference tables to support implementation.
Practical applications and who uses this standard
ISO 23500-2 is used by:
- Clinical engineers, dialysis facility managers and medical directors specifying safe water systems for patient treatment.
- Manufacturers and suppliers designing, assembling, installing or validating water purification devices and distribution systems for dialysis.
- Regulators and auditors evaluating compliance with internationally-recognized dialysis water equipment requirements.
- Contractors and maintenance providers responsible for installation, testing and ongoing verification of dialysis water systems.
This standard supports safe haemodialysis care by defining robust requirements for water purification equipment, system design and testing - essential for protecting patients from chemical and microbial contaminants.
Related standards
- ISO 23500-1, ISO 23500-3, ISO 23500-4, ISO 23500-5 - other parts of the ISO 23500 series (notably ISO 23500-3 for ongoing monitoring of chemical and microbiological water purity).
Технические детали
- Технический комитет
- ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
- SKU
- ISO 23500-2:2024
Похожие стандарты
Стандарты, упомянутые в описании
ISO 23500-2:2019
ОтменёнPreparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatmen…
Overview ISO 23500-2:2019 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 2 defines requirements for water treatment equipment for haemodialysis applicat…