EN ISO 23500:2015

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)

ISO 23500:2014 provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, ISO 23500:2014 functions as a recommended practice.
ISO 23500:2014 addresses the user's responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of ISO 23500:2014, the dialysis fluid includes dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user's facility, as well as concentrates and the final dialysis fluid and substitution fluid.

Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die Hämodialyse und verwandte Therapien (ISO 23500:2014)

Directives concernant la préparation et le management de la qualité des fluides d'hémodialyse et de thérapies annexes (ISO 23500:2014)

L'ISO 23500:2014 fournit aux médecins dialyseurs des lignes directrices relatives à la préparation du liquide de dialyse pour des applications en hémodialyse et thérapies apparentées à utiliser pour des traitements en ligne, tels que l'hémodiafiltration et l'hémofiltration. En tant que telle, l'ISO 23500:2014 se veut une pratique recommandée.
L'ISO 23500:2014 traite de la responsabilité de l'utilisateur vis-à-vis du liquide de dialyse une fois que l'équipement utilisé pour sa préparation a été délivré et installé. Pour les besoins de l'ISO 23500:2014, le liquide de dialyse comprend l'eau pour dialyse (voir 3.18 pour la définition) utilisée pour préparer le liquide de dialyse et le liquide de substitution, l'eau pour dialyse utilisée pour préparer les concentrés dans l'installation de l'utilisateur, ainsi que les concentrés et le liquide de dialyse final et le liquide de substitution.

Smernice za pripravo in vodenje kakovosti tekočin za hemodializo in podobne terapije (ISO 23500:2014)

Ta mednarodni standard zagotavlja zdravnikom, ki predpišejo zdravljenje z dializo, smernice za pripravo tekočine za hemodializo in podobne terapije ter nadomestne tekočine za hemodiafiltracijo in hemofiltracijo za uporabo pri terapijah »on-line«, kot so hemodiafiltracija in hemofiltracija. Ta mednarodni standard se tako uporablja kot priporočena praksa.

General Information

• Status: Withdrawn
• Publication Date: 13-Oct-2015
• Withdrawal Date: 19-Mar-2019
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 20-Mar-2019
• Ref Project: SIST EN ISO 23500:2015 - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)

Relations

• Replaced By: EN ISO 23500-1:2019 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
• Effective Date: 15-Feb-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 23500:2015
01-december-2015
6PHUQLFH]DSULSUDYRLQYRGHQMHNDNRYRVWLWHNRþLQ]DKHPRGLDOL]RLQSRGREQH
WHUDSLMH,62
Guidance for the preparation and quality management of fluids for haemodialysis and
related therapies (ISO 23500:2014)
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die
Hämodialyse und verwandte Therapien (ISO 23500:2014)
Directives concernant la préparation et le management de la qualité des fluides
d'hémodialyse et de thérapies annexes (ISO 23500:2014)
Ta slovenski standard je istoveten z: EN ISO 23500:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 23500:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23500:2015

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SIST EN ISO 23500:2015


EN ISO 23500
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version

Guidance for the preparation and quality management of
fluids for haemodialysis and related therapies (ISO
23500:2014)
Directives concernant la préparation et le management Leitfaden für die Vorbereitung und das
de la qualité des fluides d'hémodialyse et de thérapies Qualitätsmanagement von Konzentraten für die
annexes (ISO 23500:2014) Hämodialyse und verwandte Therapien (ISO
23500:2014)
This European Standard was approved by CEN on 27 September 2015.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23500:2015 E
worldwide for CEN national Members.

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SIST EN ISO 23500:2015
EN ISO 23500:2015 (E)
Contents Page
European foreword . 3

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SIST EN ISO 23500:2015
EN ISO 23500:2015 (E)
European foreword
The text of ISO 23500:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for
surgery” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
23500:2015 by 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 April 2016, and conflicting national standards shall be
withdrawn at the latest by April 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 23500:2014 has been approved by CEN as EN ISO 23500:2015 without any modification.
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SIST EN ISO 23500:2015

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