ISO 23500-2:2019
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:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 34
- Дата публикации:
- 15 февраля 2019 г.
- Издание:
- ISO IS 23500 edition 1 version 1
- ICS:
- 11.040.40
1.1 General This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies. 1.2 Inclusions This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for: a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; b) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid; c) the reprocessing of dialysers intended for single use where permitted for multiple uses, d) the reprocessing of dialysers not specifically marked as intended for single use. This document includes all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of the devices are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water. 1.3 Exclusions This document excludes 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 systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500‑5, This document also excludes the on-going surveillance of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500‑1.
Abstract
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 applications. It is intended for manufacturers and suppliers of water purification systems and components used to produce dialysis-quality water. The standard covers devices, piping and fittings from the potable water inlet up to the point of use for dialysis water, and focuses on chemical and microbiological safety to protect patients.
Key topics and requirements
- Scope and intended use: Applies to systems that treat potable water for dialysis, concentrate preparation, dialysis fluid production, and dialyser reprocessing where applicable.
- Device types covered: Water purification devices, online water quality monitors (e.g., conductivity monitors), piping and distribution systems, and component units such as sediment and cartridge filters, softeners, carbon media, deionization, reverse osmosis (RO), and bacteria/endotoxin-retentive filters.
- Water quality: Sets out requirements related to chemical contaminants, organic carbon and pesticides, and microbiological parameters relevant to dialysis water quality. (Maximum allowable levels and analytical details are cross-referenced to ISO 23500-3 and Annex B.)
- Equipment requirements: Design and functional requirements for backflow prevention, tempering valves, chemical injection, storage and distribution, and other system components.
- Testing and conformity: Guidance on tests to demonstrate conformity with water quality and equipment requirements, including microbiological testing and verification of component performance.
- Labelling and documentation: Requirements for device marking and product literature to support safe installation, operation, testing and maintenance.
Applications and who uses it
- Manufacturers and suppliers of dialysis water treatment systems and individual components use ISO 23500-2:2019 to design, validate and label products intended for haemodialysis applications.
- Clinical engineers, dialysis facility managers and procurement teams reference the standard when specifying, installing and commissioning water treatment and distribution systems.
- Regulatory and quality teams use the document to evaluate conformity and to develop maintenance and testing protocols that help protect patient safety.
- Practical applications include selection and installation of RO systems, carbon adsorption stages, distribution piping for dialysis centers, and integration of online monitors for continuous water quality control.
Related standards
- ISO 23500-1: General principles for preparation and quality management of dialysis fluids
- ISO 23500-3: Chemical and microbiological requirements and test methods for dialysis water
- ISO 23500-4 and ISO 23500-5: Related requirements for dialysis fluid delivery systems and concentrate handling
Keywords: ISO 23500-2:2019, water treatment equipment, haemodialysis, dialysis water quality, reverse osmosis, conductivity monitors, dialysis water distribution, medical device standard.
Технические детали
- Технический комитет
- ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
- SKU
- ISO 23500-2:2019
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