SIST EN ISO 23500-3:2024
(Main)Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)
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 23500-3:2024)
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 23500-3:2024)
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 23500-3:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 23500-3:2024
01-julij-2024
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 3. del:
Voda za hemodializo in podobne terapije (ISO 23500-3:2024)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 3: Wasser für die Hämodialyse und verwandte Therapien
(ISO 23500-3:2024)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 3: Eau pour hémodialyse et thérapies apparentées (ISO 23500-3:2024)
Ta slovenski standard je istoveten z: EN ISO 23500-3:2024
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 23500-3:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 23500-3:2024
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SIST EN ISO 23500-3:2024
EN ISO 23500-3
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 23500-3:2019
English Version
Preparation and quality management of fluids for
haemodialysis and related therapies - Part 3: Water for
haemodialysis and related therapies (ISO 23500-3:2024)
Préparation et management de la qualité des liquides Herstellung und Qualitätsmanagement von
d'hémodialyse et de thérapies annexes - Partie 3: Eau Flüssigkeiten für die Hämodialyse und verwandte
pour hémodialyse et thérapies apparentées (ISO Therapien - Teil 3: Wasser für die Hämodialyse und
23500-3:2024) verwandte Therapien (ISO 23500-3:2024)
This European Standard was approved by CEN on 18 April 2024.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23500-3:2024 E
worldwide for CEN national Members.
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SIST EN ISO 23500-3:2024
EN ISO 23500-3:2024 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 23500-3:2024
EN ISO 23500-3:2024 (E)
European foreword
This document (EN ISO 23500-3:2024) 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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
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 23500-3:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
I
...
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.
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oSIST prEN ISO 23500-3:2023
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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
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THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
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ISO/DIS 23500-3:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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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
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ii
© ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 23500-3:2023
ISO/DIS 23500-3:2022(E)
Contents Page
Foreword .iv
Introduction .
...
Questions, Comments and Discussion
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