SIST EN ISO 23500-5:2024
(Main)Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
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 Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und verwandte Therapien (ISO 23500-5:2024)
Dieses Dokument legt die Mindestanforderungen an die chemische und mikrobiologische Qualität von Dialysierflüssigkeiten fest, die bei der Hämodialyse und verwandten Therapien zum Einsatz kommen.
Dieses Dokument gilt für:
Dialysierflüssigkeiten, die für die Hämodialyse und die Hämodiafiltration eingesetzt werden;
online-hergestellte Substitutionsflüssigkeit für die Hämodiafiltration und die Hämofiltration, basierend auf Dialysierflüssigkeit.
Dieses Dokument gilt nicht für:
das Wasser und die Konzentrate oder die Ausrüstung zur Herstellung der Dialysierflüssigkeit;
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; und
Systeme und Lösungen für die Peritonealdialyse.
Die Anlieferung und Überwachung der Zusammensetzung der Dialysierflüssigkeiten und ihrer erlaubten Abweichungen von festgelegten Punkten ist in IEC 60601 2 16 festgelegt.
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 23500-5:2024)
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 23500-5:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 23500-5:2024
01-julij-2024
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 5. del:
Kakovost tekočin za hemodializo in podobne terapije (ISO 23500-5:2024)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-
5:2024)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und
verwandte Therapien (ISO 23500-5:2024)
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 23500-5:2024)
Ta slovenski standard je istoveten z: EN ISO 23500-5:2024
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 23500-5:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 23500-5:2024
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SIST EN ISO 23500-5:2024
EN ISO 23500-5
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 23500-5:2019
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
23500-5:2024)
Préparation et management de la qualité des liquides Herstellung und Qualitätsmanagement von
d'hémodialyse et de thérapies annexes - Partie 5: Flüssigkeiten für die Hämodialyse und verwandte
Qualité des liquides de dialyse pour hémodialyse et Therapien - Teil 5: Qualität von Flüssigkeiten für die
thérapies apparentées (ISO 23500-5:2024) Hämodialyse und verwandte Therapien (ISO 23500-
5:2024)
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 23500-5:2024 E
worldwide for CEN national Members.
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SIST EN ISO 23500-5:2024
EN ISO 23500-5:2024 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 23500-5:2024
EN ISO 23500-5:2024 (E)
European foreword
This document (EN ISO 23500-5:2024) 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 23500-5:2019.
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 E
...
SLOVENSKI STANDARD
oSIST prEN ISO 23500-5:2023
01-januar-2023
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 5. del:
Kakovost tekočin za hemodializo in podobne terapije (ISO/DIS 23500-5:2022)
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-
5:2022)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und
verwandte Therapien (ISO/DIS 23500-5:2022)
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/DIS 23500-5:2022)
Ta slovenski standard je istoveten z: prEN ISO 23500-5
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 23500-5:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 23500-5:2023
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oSIST prEN ISO 23500-5:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-5
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 5:
Quality of dialysis fluid for haemodialysis and related
therapies
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
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
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 23500-5:2023
ISO/DIS 23500-5:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-5
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 5:
Quality of dialysis fluid for haemodialysis and related
therapies
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
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 23500-5:2023
ISO/DIS 23500-5:2022(E)
Contents Page
Foreword .
...
Questions, Comments and Discussion
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