Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2022)

This document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.

Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 3: Wasser für die Hämodialyse und verwandte Therapien (ISO/DIS 23500-3:2022)

Dieses Dokument legt die Mindestanforderungen an die chemische und mikrobiologische Qualität von Wasser fest, das für die Zubereitung von Dialysierflüssigkeiten und -konzentraten sowie für die Wiederaufbereitung von Hämodialysatoren verwendet wird, sowie die notwendigen Schritte, um die Einhaltung der Anforderungen zu gewährleisten. Das Dokument gibt auch einen Leitfaden für die laufende Überwachung der Reinheit dieses Wassers in Bezug auf die chemische und mikrobiologische Qualität.
Dieses Dokument gilt für
   Wasser für die Zubereitung von Dialyseflüssigkeiten für die Hämodialyse, Hämodiafiltration und Hämofiltration sowie für die Wiederaufbereitung von Hämodialysatoren, und
   Wasser, das zur Herstellung von Konzentraten verwendet wird.
Dieses Dokument gilt nicht für Systeme zur Regeneration von Dialyseflüssigkeit.
Der Betrieb von Wasseraufbereitungsanlagen und die abschließende Vermischung von behandeltem Wasser mit Konzentraten zur Herstellung von Dialyseflüssigkeit liegen in der alleinigen Verantwortung der Dialysefachkräfte.

Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes — Partie 3: Eau pour hémodialyse et thérapies apparentées (ISO/DIS 23500-3:2022)

Le présent document spécifie les exigences minimales pour l'eau utilisée dans le cadre d'hémodialyses et de thérapies apparentées.
Le présent document inclut l'eau utilisée pour la préparation des concentrés et des liquides de dialyse pour hémodialyse, hémodiafiltration et hémofiltration, ainsi que pour le retraitement des hémodialyseurs.
Le présent document exclut le fonctionnement de l'équipement de traitement de l'eau et le mélange final de l'eau traitée avec les concentrés pour produire le liquide de dialyse. Ces opérations relèvent de l'entière responsabilité des néphrologues. Le présent document ne concerne pas les systèmes de régénération des liquides de dialyse.

Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 3. del: Voda za hemodializo in podobne terapije (ISO/DIS 23500-3:2022)

General Information

Status
Not Published
Public Enquiry End Date
30-Jan-2023
Technical Committee
Current Stage
5020 - Formal vote (FV) (Adopted Project)
Start Date
13-Feb-2024
Due Date
02-Apr-2024

Relations

Buy Standard

Draft
prEN ISO 23500-3:2023
English language
25 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 23500-3:2023
01-januar-2023
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 3. del:
Voda za hemodializo in podobne terapije (ISO/DIS 23500-3:2022)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2022)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 3: Wasser für die Hämodialyse und verwandte Therapien
(ISO/DIS 23500-3:2022)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes Partie 3: Eau pour hémodialyse et thérapies apparentées (ISO/DIS 23500-
3:2022)
Ta slovenski standard je istoveten z: prEN ISO 23500-3
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 23500-3:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 23500-3:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 23500-3:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-3
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-11-18 2023-02-10
Preparation and quality management of fluids for
haemodialysis and related therapies —
Part 3:
Water for haemodialysis and related therapies
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes —
Partie 3: Eau pour hémodialyse et thérapies apparentées
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23500-3:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 3 ----------------------
oSIST prEN ISO 23500-3:2023
ISO/DIS 23500-3:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-3
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:

Preparation and quality management of fluids for
haemodialysis and related therapies —
Part 3:
Water for haemodialysis and related therapies
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes —
Partie 3: Eau pour hémodialyse et thérapies apparentées
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 23500-3:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 4 ----------------------
oSIST prEN ISO 23500-3:2023
ISO/DIS 23500-3:2022(E)
Contents Page
Foreword .iv
Introduction .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.