EN ISO 11663:2015

Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)

ISO 11663:2014 specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
ISO 11663:2014 includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.

Qualität von Konzentraten für die Hämodialyse und verwandte Therapien (ISO 11663:2014)

Qualité des fluides de dialyse pour hémodialyse et thérapies apparentées (ISO 11663:2014)

ISO 11663:2014 spécifie des exigences de qualité minimales pour les fluides de dialyse dans le cadre d'hémodialyses et de thérapies apparentées.
Elle inclut les fluides de dialyse utilisés pour l'hémodialyse et l'hémofiltration, notamment le fluide de substitution pour hémodiafiltration et hémofiltration.
Elle n'aborde pas les exigences relatives à l'eau et aux concentrés utilisés pour préparer le fluide de dialyse ou l'équipement utilisé lors de sa préparation. Ces domaines sont traités par d'autres Normes internationales.
Les systèmes de régénération des fluides de dialyse à base de sorbant qui régénèrent et remettent en circulation de petits volumes de fluide de dialyse, les systèmes pour traitements continus de suppléance rénale qui utilisent des solutions préemballées et les systèmes et solutions pour dialyse péritonéale sont exclus de la présente Norme internationale.

Kakovost tekočin za hemodializo in podobne terapije (ISO 11663:2014)

Ta mednarodni standard določa zahteve glede minimalne kakovosti za tekočine za hemodializo in podobne terapije. Ta mednarodni standard vključuje tekočine za hemodializo in hemodiafiltracijo, vključno z nadomestno tekočino za hemodiafiltracijo in hemofiltracijo. Ta mednarodni standard ne obravnava zahtev za vodo in koncentrate, ki se uporabljajo za pripravo dializne tekočine, ali za opremo, ki se uporablja za njeno pripravo. Te vidike obravnavajo drugi mednarodni standardi. Sistemi za regeneracijo dializne tekočine na osnovi sorbenta za regeneracijo in recirkulacijo majhnih količin dializne tekočine, sistemi za neprekinjeno nadomestno ledvično zdravljenje, pri katerih se uporabljajo predpakirane raztopine, ter sistemi in raztopine za peritonealno dializo so izključeni iz tega mednarodnega standarda.

General Information

• Status: Withdrawn
• Publication Date: 03-Nov-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 11663:2016 - Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)

Relations

• Replaced By: EN ISO 23500-5:2019 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
• Effective Date: 15-Feb-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11663:2016
01-januar-2016
.DNRYRVWWHNRþLQ]DKHPRGLDOL]RLQSRGREQHWHUDSLMH,62
Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
Qualität von Konzentraten für die Hämodialyse und verwandte Therapien (ISO
11663:2014)
Qualité des fluides de dialyse pour hémodialyse et thérapies apparentées (ISO
11663:2014)
Ta slovenski standard je istoveten z: EN ISO 11663:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 11663:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11663:2016

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SIST EN ISO 11663:2016


EN ISO 11663
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version

Quality of dialysis fluid for haemodialysis and related
therapies (ISO 11663:2014)
Qualité des fluides de dialyse pour hémodialyse et Qualität von Konzentraten für die Hämodialyse und
thérapies apparentées (ISO 11663:2014) verwandte Therapien (ISO 11663:2014)
This European Standard was approved by CEN on 10 October 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 11663:2015 E
worldwide for CEN national Members.

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SIST EN ISO 11663:2016
EN ISO 11663:2015 (E)
Contents Page
Foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 5
2

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SIST EN ISO 11663:2016
EN ISO 11663:2015 (E)
Foreword
The text of ISO 11663:2014 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 11663:2015 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 May 2016, and conflicting national standards shall be
withdrawn at the latest by May 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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this
...