EN ISO 13959:2015

Water for haemodialysis and related therapies (ISO 13959:2014)

ISO 13959:2014 specifies minimum requirements for water to be used in haemodialysis and related therapies.
ISO 13959:2014 includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.

Wasser für Hämodialyse und verwandte Therapien (ISO 13959:2014)

Diese Internationale Norm legt Mindestanforderungen an das für die Hämodialyse und verwandte Therapien einzusetzende Wasser fest.
Diese Internationale Norm behandelt Wasser für die Herstellung von Konzentraten und Dialysierflüssigkeit für Hämodialyse, Hämodiafiltration und Hämofiltration sowie für die Wiederaufbereitung von Hämodialysatoren.
Der Betrieb der Wasseraufbereitungsausrüstung und das abschließende Mischen des aufbereiteten Wassers mit Konzentraten zur Herstellung der Dialysierflüssigkeit werden nicht von dieser Internationalen Norm abgedeckt. Diese Arbeitsschritte liegen in der alleinigen Verantwortung der professionellen Dialysefachkräfte. Die vorliegende Internationale Norm gilt nicht für Dialysierflüssigkeits-Wiederaufbereitungssysteme.

Eau pour hémodialyse et thérapies apparentées (ISO 13959:2014)

L'ISO 13959:2014 spécifie les exigences minimales pour l'eau utilisée dans le cadre d'hémodialyses et de thérapies apparentées.
L'ISO 13959:2014 inclut l'eau utilisée pour préparer les concentrés et les fluides de dialyse pour hémodialyse, hémodiafiltration et hémofiltration et pour retraiter les hémodialyseurs.

Voda za hemodializo in podobne terapije (ISO 13959:2014)

Ta mednarodni standard določa minimalne zahteve glede vode, uporabljene pri hemodializi in podobnih terapijah. Ta mednarodni standard zajema vodo za pripravo koncentratov, dializnih tekočin za hemodializo, hemodiafiltracijo in hemofiltracijo ter ponovno obdelavo v hemodializatorjih.  Postopek uporabe opreme za pripravo vode in končno mešanje pripravljene vode s koncentrati za proizvodnjo dializne tekočine ne spadata v področje uporabe tega mednarodnega standarda. Za takšne postopke so izključno odgovorni strokovnjaki za dializo. Ta mednarodni standard se ne uporablja za sisteme za regeneracijo dializne tekočine.

General Information

• Status: Withdrawn
• Publication Date: 01-Dec-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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 13959:2016 - Water for haemodialysis and related therapies (ISO 13959:2014)

Relations

• Replaced By: 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)
• Effective Date: 27-Mar-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13959:2016
01-februar-2016
Voda za hemodializo in podobne terapije (ISO 13959:2014)
Water for haemodialysis and related therapies (ISO 13959:2014)
Wasser für Hämodialyse und ähnliche Therapien (ISO 13959:2014)
Eau pour hémodialyse et thérapies apparentées (ISO 13959:2014)
Ta slovenski standard je istoveten z: EN ISO 13959:2015
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN ISO 13959:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13959:2016

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SIST EN ISO 13959:2016


EN ISO 13959
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version

Water for haemodialysis and related therapies (ISO
13959:2014)
Eau pour hémodialyse et thérapies apparentées (ISO Wasser für Hämodialyse und ähnliche Therapien (ISO
13959:2014) 13959:2014)
This European Standard was approved by CEN on 23 November 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 13959:2015 E
worldwide for CEN national Members.

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SIST EN ISO 13959:2016
EN ISO 13959:2015 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 4

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SIST EN ISO 13959:2016
EN ISO 13959:2015 (E)
European foreword
The text of ISO 13959:2014 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 13959:2015 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 June 2016, and conflicting national standards shall be
withdrawn at the latest by June 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.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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 13959:2014 has been approved by CEN as EN ISO 13959:2015 without any modification.
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SIST EN ISO 13959:2016
EN ISO 13959:2015
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