Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)

This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.

Herstellung und Qualitätsmanagement von Konzentraten für die Hämodialyse und verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und verwandte Therapien (ISO 23500-5:2019)

Dieses Dokument legt Mindestanforderungen an die Qualität von Dialysierflüssigkeiten fest, die bei der Hämodialyse und verwandten Therapien zum Einsatz kommen.
Dieses Dokument umfasst Dialysierflüssigkeiten, die für die Hämodialyse und die Hämodiafiltration eingesetzt werden, einschließlich der Substitutionsflüssigkeit für die Hämodiafiltration und die Hämofiltration.
Dieses Dokument behandelt nicht die Anforderungen an das Wasser und die Konzentrate sowie die Ausrüstung zur Herstellung der Dialysierflüssigkeit. Diese Aspekte werden durch weitere Internationale Normen abgedeckt.
Sorbent basierte Dialysierflüssigkeits-Wiederaufbereitungssysteme, in denen kleine Volumina der Dialysierflüssigkeit wiederaufbereitet und wieder in Umlauf gebracht werden, Systeme für die kontinuierliche Nierenersatztherapie, bei denen vorverpackte Lösungen zum Einsatz kommen, sowie Systeme und Lösungen für die Peritonealdialyse sind vom Anwendungsbereich dieses Dokuments ausgenommen.

Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies apparentées (ISO 23500-5:2019)

Le présent document spécifie des exigences de qualité minimales pour les liquides de dialyse dans le cadre d'hémodialyses et de thérapies apparentées.
Le présent document inclut les liquides de dialyse utilisés pour l'hémodialyse et l'hémofiltration, y compris le liquide de substitution pour hémodiafiltration et hémofiltration.
Le présent document exclut l'eau et les concentrés utilisés pour préparer le liquide de dialyse ou l'équipement utilisé lors de sa préparation. Ces domaines sont traités par d'autres Normes internationales.
Les systèmes de régénération des liquides de dialyse à base de sorbant qui régénèrent et remettent en circulation de petits volumes de liquide de dialyse, les systèmes d'épuration extra-rénale continue qui utilisent des solutions prêtes à l'emploi et les systèmes et solutions utilisés en dialyse péritonéale sont exclus du présent document.

Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 5. del: Kakovost tekočin za hemodializo in podobne terapije (ISO 23500-5:2019)

Ta dokument določa minimalne zahteve glede kakovosti za tekočine za hemodializo in podobne terapije.
Ta dokument vključuje tekočine za hemodializo in hemodiafiltracijo, vključno z nadomestno tekočino za hemodiafiltracijo in hemofiltracijo.
Ta dokument ne zajema vode in koncentratov, ki se uporabljajo za pripravo dializne tekočine, ali opreme,
ki se uporablja za njeno pripravo. Te vidike obravnavajo drugi mednarodni standardi.
Sistemi za regeneracijo dializne tekočine na osnovi sorbenta za regeneracijo in recirkulacijo majhnih količin
dializne tekočine, sistemi za neprekinjeno nadomestno ledvično zdravljenje, pri katerih se uporabljajo vnaprej pakirane raztopine, ter sistemi in raztopine za peritonealno dializo so izključeni iz tega dokumenta.

General Information

Status
Published
Publication Date
19-Mar-2019
Withdrawal Date
29-Sep-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
20-Mar-2019
Completion Date
20-Mar-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 23500-5:2019
01-maj-2019
1DGRPHãþD
SIST EN ISO 11663:2016
3ULSUDYDLQYRGHQMHNDNRYRVWLWHNRþLQ]DKHPRGLDOL]RLQSRGREQHWHUDSLMHGHO
.DNRYRVWWHNRþLQ]DKHPRGLDOL]RLQSRGREQHWHUDSLMH ,62
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-
5:2019)
Vorbereitung und Qualitätsmanagement von Konzentraten für die Hämodialyse und
verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und
verwandte Therapien (ISO 23500-5:2019)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies
apparentées (ISO 23500-5:2019)
Ta slovenski standard je istoveten z: EN ISO 23500-5:2019
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN ISO 23500-5:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23500-5:2019

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SIST EN ISO 23500-5:2019


EN ISO 23500-5
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2019
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 11663:2015
English Version

Preparation and quality management of fluids for
haemodialysis and related therapies - Part 5: Quality of
dialysis fluid for haemodialysis and related therapies (ISO
23500-5:2019)
Préparation et management de la qualité des liquides Vorbereitung und Qualitätsmanagement von
d'hémodialyse et de thérapies annexes - Partie 5: Konzentraten für die Hämodialyse und verwandte
Qualité des liquides de dialyse pour hémodialyse et Therapien - Teil 5: Qualität von Flüssigkeiten für die
thérapies apparentées (ISO 23500-5:2019) Hämodialyse und verwandte Therapien (ISO 23500-
5:2019)
This European Standard was approved by CEN on 14 January 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23500-5:2019 E
worldwide for CEN national Members.

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SIST EN ISO 23500-5:2019
EN ISO 23500-5:2019 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 23500-5:2019
EN ISO 23500-5:2019 (E)
European foreword
This document (EN ISO 23500-5:2019) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" in collaboration with Technical Committee CEN/TC 205 “Non-active medical
devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2019, and conflicting national standards
shall be withdrawn at the latest by September 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11663:2015.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece,
...

SLOVENSKI STANDARD
oSIST prEN ISO 23500-5:2017
01-junij-2017
6PHUQLFH]DSULSUDYRLQYRGHQMHNDNRYRVWLWHNRþLQ]DKHPRGLDOL]RLQSRGREQH
WHUDSLMHGHO.DNRYRVWWHNRþLQ]DKHPRGLDOL]RLQSRGREQHWHUDSLMH ,62',6

Guidance for the preparation and quality management of fluids for haemodialysis and
related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
(ISO/DIS 23500-5:2017)
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die
Hämodialyse und verwandte Therapien - Teil 5: Qualität von Konzentraten für die
Hämodialyse und verwandte Therapien (ISO/DIS 23500-5:2017)
Document d'orientation pour la préparation et le management de la qualité des liquides
d'hémodialyse et de thérapies annexes - Partie 5: Qualité des liquides de dialyse pour
hémodialyse et thérapies apparentées (ISO/DIS 23500-5:2017)
Ta slovenski standard je istoveten z: prEN ISO 23500-5
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
oSIST prEN ISO 23500-5:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 23500-5:2017

---------------------- Page: 2 ----------------------
oSIST prEN ISO 23500-5:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-5
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-04-07 2017-06-29
Guidance for the preparation and quality management of
fluids for haemodialysis and related therapies —
Part 5:
Quality of dialysis fluid for haemodialysis and related
therapies
Directives concernant la préparation et le management de la qualité des fluides d’hémodialyse et de
thérapies annexes —
Partie 5: Qualité des fluides de dialyse pour hémodialyse et thérapies apparentées
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 23500-5:2017(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 2017

---------------------- Page: 3 ----------------------
oSIST prEN ISO 23500-5:2017
ISO/DIS 23500-5:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

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oSIST prEN ISO 23500-5:2017

---------------------- Page: 5 ----------------------
oSIST prEN ISO 23500-5:2017
ISO/DIS 23500-5
Contents Page
Foreword .iii
Introduction . iv
1 Scope . 2
2 Normative references . 2
3 Terms and definitions . 2
4 Requirements . 3
5 Tests for compliance with microbiological requirements . 4
Annex A (informative) Rationale for the development and provisions of this International
Standard .
...

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