STANDARD

Current

ÖNORM EN ISO 23500-2

Issue date: 2024 11 01

Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)

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.

General information on ÖNORM EN ISO 23500-2

Format
Digital | 48 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN ISO 23500-2 from 2016 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art Link
Dokumentnummer
ISO 23500-1:2019
Titel
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
Ausgabedatum
2019 02 15
Art
Standard
Dokumentnummer
ISO 23500-3:2019
Titel
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
Ausgabedatum
2019 02 15
Art
Standard

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