60.60 Standard published Jul 31, 2024
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.40 Implants for surgery, prosthetics and orthotics
Published
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.
WITHDRAWN
EN ISO 23500-2:2019
PUBLISHED
EN ISO 23500-2:2024
60.60
Standard published
Jul 31, 2024
