FprEN ISO 23500-2

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

Publication date:   Feb 29, 2024

General information

50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks   Feb 29, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

Buying

Draft

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 23500-2:2019

NOW

IN_DEVELOPMENT
FprEN ISO 23500-2
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Feb 29, 2024