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CEN

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.

Herstellung und Qualitätsmanagement von Flüssigkeiten 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

Status
Published
Publication Date
19-Mar-2019
Withdrawal Date
29-Sep-2019
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
20-Mar-2019
Completion Date
20-Mar-2019
Ref Project
SIST EN 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)

Relations

Replaces
EN ISO 13959:2015 - Water for haemodialysis and related therapies (ISO 13959:2014)
Effective Date
27-Mar-2019
Revised
FprEN ISO 23500-3 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/FDIS 23500-3:2024)
Effective Date
22-Dec-2021

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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

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

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
...

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b)     dialysis water used for the preparation of concentrates at the user's facility,
c)    concentrates,
d)    the final dialysis fluid and substitution fluid.
The scope of this document includes
a)    the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused,
b)    equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and
c)    preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
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1.1 General
This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
1.2 Inclusions
This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for:
a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
b) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid;
c) the reprocessing of dialysers intended for single use where permitted for multiple uses,
d) the reprocessing of dialysers not specifically marked as intended for single use.
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1.3 Exclusions
This document excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500‑5,
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