SIST EN ISO 23500-3:2019
(Main)Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
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.
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die Hämodialyse und verwandte Therapien - Teil 3: Wasser für die Hämodialyse und verwandte Therapien (ISO 23500-3:2019)
Dieses Dokument legt Mindestanforderungen an Wasser fest, das in der Hämodialyse und in verwandten Therapien verwendet werden soll.
Dieses Dokument erfasst Wasser, das in der Herstellung von Konzentraten, Dialysierflüssigkeiten für die Hämodialyse, die Hämodiafiltration, die Hämofiltration und die Wiederaufbereitung von Hämodialysatoren verwendet werden soll.
Dieses Dokument gilt nicht für den Betrieb von Wasseraufbereitungsanlagen und die endgültige Mischung von aufbereitetem Wasser mit Konzentraten, um Dialysierflüssigkeit herzustellen. Dafür ist allei¬nig das Dialyse Fachpersonal verantwortlich. Dieses Dokument gilt nicht für Dialysierflüssigkeits-Aufbereitungssysteme.
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 3: Eau pour hémodialyse et thérapies apparentées (ISO 23500-3:2019)
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 23500-3:2019)
Ta dokument vključuje vodo za pripravo koncentratov, dializnih tekočin za hemodializo, hemodiafiltracijo in hemofiltracijo ter ponovno obdelavo v hemodializatorjih. Ta dokument ne zajema postopka uporabe opreme za pripravo vode in končno mešanje pripravljene vode s koncentrati za proizvodnjo dializne tekočine. Za takšne postopke so izključno odgovorni strokovnjaki za dializo. Ta dokument se ne uporablja za sisteme za regeneracijo dializne tekočine.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 23500-3:2019
01-maj-2019
1DGRPHãþD
SIST EN ISO 13959:2016
3ULSUDYDLQYRGHQMHNDNRYRVWLWHNRþLQ]DKHPRGLDOL]RLQSRGREQHWHUDSLMHGHO
9RGD]DKHPRGLDOL]RLQSRGREQHWHUDSLMH ,62
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die
Hämodialyse und verwandte Therapien - Teil 3: Wasser für die Hämodialyse und
verwandte Therapien (ISO 23500-3:2019)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 3: Eau pour hémodialyse et thérapies apparentées (ISO 23500-3:2019)
Ta slovenski standard je istoveten z: EN ISO 23500-3:2019
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN ISO 23500-3:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 23500-3:2019
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SIST EN ISO 23500-3:2019
EN ISO 23500-3
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 13959:2015
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 3: Water for
haemodialysis and related therapies (ISO 23500-3:2019)
Préparation et management de la qualité des liquides Leitfaden für die Vorbereitung und das
d'hémodialyse et de thérapies annexes - Partie 3: Eau Qualitätsmanagement von Konzentraten für die
pour hémodialyse et thérapies apparentées (ISO Hämodialyse und verwandte Therapien - Teil 3:
23500-3:2019) Wasser für die Hämodialyse und verwandte Therapien
(ISO 23500-3:2019)
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 23500-3:2019 E
worldwide for CEN national Members.
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SIST EN ISO 23500-3:2019
EN ISO 23500-3:2019 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 23500-3:2019
EN ISO 23500-3:2019 (E)
European foreword
This document (EN ISO 23500-3:2019) 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 13959:2015.
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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portu
...
SLOVENSKI STANDARD
oSIST prEN ISO 23500-3:2017
01-junij-2017
6PHUQLFH]DSULSUDYRLQYRGHQMHNDNRYRVWLWHNRþLQ]DKHPRGLDOL]RLQSRGREQH
WHUDSLMHGHO 9RGD]DKHPRGLDOL]RLQSRGREQHWHUDSLMH ,62',6
Guidance for the preparation and quality management of fluids for haemodialysis and
related therapies - Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500
-3:2017)
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die
Hämodialyse und verwandte Therapien - Teil 3: Wasser für die Hämodialyse und
verwandte Therapien (ISO/DIS 23500-3:2017)
Document d'orientation pour la préparation et le management de la qualité des liquides
d'hémodialyse et de thérapies annexes - Partie 3: Eau pour hémodialyse et thérapies
apparentées (ISO/DIS 23500-3:2017)
Ta slovenski standard je istoveten z: prEN ISO 23500-3
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
oSIST prEN ISO 23500-3:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 23500-3:2017
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oSIST prEN ISO 23500-3:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-3
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 3:
Water for haemodialysis and related therapies
Directives concernant la préparation et le management de la qualité des fluides d’hémodialyse et de
thérapies annexes —
Partie 3: Eau 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 23500-3:2017(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
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oSIST prEN ISO 23500-3:2017
ISO/DIS 23500-3:2017(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
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ii © ISO 2017 – All rights reserved
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oSIST prEN ISO 23500-3:2017
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oSIST prEN ISO 23500-3:2017
ISO/DIS 23500-3
Contents Page
Foreword . iii
Introduction . iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3 Dialysis water requirements . 1
4 Requirements . 1
5 Tests for compliance with microbiological and chemical requirements . 4
Annex A (informative) Rationale for the development and provisions of this International
Standard .
...
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