SIST EN ISO 8637-2:2018

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)

WARNING — Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this document.
This document specifies requirements for the blood circuit for devices used in extracorporeal blood
filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and
transducer protectors (integral and non-integral) intended for use in such circuits.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— pressure monitors for the extracorporeal blood circuit;
— air detection devices;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or
haemoconcentration.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are
specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3.
NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as
haemoperfusion, plasmafiltration and plasma adsorption.

Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8637-2:2018)

Diese Internationale Norm spezifiziert die Anforderungen an den Blutkreislauf für Geräte, die in extrakorporalen Blutfiltrationstherapien wie Hämodialyse, Hämodiafiltration, Hämofiltration, Schutzvorrichtungen für Messwandler (integral und nicht integral) oder ähnlichen Verfahren verwendet werden und die für den Gebrauch in derartigen Kreisläufen vorgesehen sind.
Diese Internationale Norm gilt nicht für:
   Hämodialysatoren, Hämodiafilter, Hämofilter;
   Plasmafilter;
   Hämoperfusionsgeräte;
   Geräte für den vaskulären Zugang;
   Blutpumpen;
   Druckaufzeichnungsgeräte für extrakorporale Blutkreisläufe;
   Luftnachweisgeräte;
   Systeme für die Herstellung, Aufbewahrung oder Überwachung der Dialyseflüssigkeit;
   Systeme oder Vorrichtungen für die Durchführung von Hämodialyse, Hämodiafiltration, Hämofiltration oder Hämokonzentration.
ANMERKUNG 1   Die Anforderungen an Hämodialysatoren, Hämodiafilter Hämofilter und Hämokonzentratoren sind in ISO 8637-1 spezifiziert, und Anforderungen an Plasmafilter sind in ISO 8637-3 spezifiziert.
ANMERKUNG 2   Extrakorporale Blutschlauchsets dürfen auch für andere extrakorporale Therapien wie Hämoperfusion, Plasmafiltration und Plasmaadsorption verwendet werden.

Systèmes extracorporels pour la purification du sang - Partie 2: Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8637-2:2018)

Le présent document spécifie les exigences relatives au circuit sanguin des dispositifs utilisés dans le cadre de thérapies avec filtration du sang extracorporelle, notamment, entre autres, pour l'hémodialyse, l'hémodiafiltration et l'hémofiltration, et pour les protecteurs de transducteur (intégrés et non intégrés) destinés à être utilisés dans de tels circuits.
Le présent document ne s'applique pas aux:
—          hémodialyseurs, hémodiafiltres ou hémofiltres;
—          filtres pour plasma;
—          dispositifs d'hémoperfusion;
—          dispositifs d'accès vasculaire;
—          pompes sanguines;
—          moniteurs de pression du circuit sanguin extracorporel;
—          dispositifs de détection d'air;
—          systèmes de préparation, de conservation ou de contrôle du liquide de dialyse;
—          systèmes ou à l'équipement destinés à effectuer une hémodialyse, une hémodiafiltration, une hémofiltration ou une hémoconcentration.
NOTE 1    Les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs sont spécifiées dans l'ISO 8637‑1, et les exigences concernant les filtres pour plasma sont indiquées dans l'ISO 8637‑3.
NOTE 2    Des tubulures de transfusion extracorporelles peuvent également être utilisées pour d'autres thérapies extracorporelles telles que l'hémoperfusion, la plasmafiltration et l'adsorption de plasma.

Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni obtok za hemodializatorje, hemodiafiltre in hemofiltre (ISO 8637-2:2018)

OPOZORILO: Za proizvode, ki sodijo na področje uporabe tega dokumenta, lahko veljajo tudi druge zahteve in druge direktive EU.
Ta dokument določa zahteve za krvni obtok za pripomočke, ki se uporabljajo pri zdravljenjih z zunajtelesnimi pretočnimi sistemi za čiščenje krvi, ki med drugim vključujejo hemodializo, hemodiafiltracijo, hemofiltracijo in pretvorniška varovala (integrirana in neintegrirana), ki se uporabljajo v takšnih obtokih.
Ta dokument se ne uporablja za:
– hemodializatorje, hemodiafiltre in hemofiltre;
– plazmafiltre;
– hemoperfuzijske pripomočke;
– žilne dostopovne pripomočke;
– črpalke krvi;
– monitorje tlaka za zunajtelesni obtok;
– pripomočke za zaznavanje prisotnosti zraka;
– sisteme za pripravo, ohranjanje in spremljanje dializne tekočine;
– sisteme ali opremo za izvajanje hemodialize, hemodiafiltracije, hemofiltracije ali hemokoncentracije.
OPOMBA 1: Zahteve za hemodializatorje, hemodiafiltre, hemofiltre in hemokoncentratorje so podane v standardu ISO 8637-1, zahteve za plazmafiltre pa v standardu ISO 8637-3.
OPOMBA 2: Sklopi cevk za zunajtelesni obtok se lahko uporabljajo za druga zunajtelesna zdravljenja, kot so hemoperfuzija ter filtracija in absorpcija plazme.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 29-Jun-2016
• Publication Date: 12-Nov-2018
• Withdrawal Date: 06-May-2024
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 06-May-2024
• Due Date: 29-May-2024
• Completion Date: 07-May-2024
• 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: EN ISO 8637-2:2018 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)

Relations

• Replaces: SIST EN ISO 8638:2014 - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 8638:2014 - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
• Effective Date: 01-Dec-2018
• Revised: SIST EN ISO 8637-2:2024 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
• Effective Date: 25-Dec-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8637-2:2018
01-december-2018
1DGRPHãþD
SIST EN ISO 8638:2014
=XQDMWHOHVQLSUHWRþQLVLVWHPL]DþLãþHQMHNUYLGHO=XQDMWHOHVQLNUYQLREWRN]D
KHPRGLDOL]DWRUMHKHPRGLDILOWUHLQKHPRILOWUH,62
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blutkreislauf bei
Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8637-2:2018)
Systèmes extracorporels pour la purification du sang - Partie 2: Circuit sanguin
extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8637-
2:2018)
Ta slovenski standard je istoveten z: EN ISO 8637-2:2018
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8637-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8637-2:2018

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SIST EN ISO 8637-2:2018


EN ISO 8637-2
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2018
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 8638:2014
English Version

Extracorporeal systems for blood purification - Part 2:
Extracorporeal blood circuit for haemodialysers,
haemodiafilters and haemofilters (ISO 8637-2:2018)
Systèmes extracorporels pour la purification du sang - Kardiovaskuläre Implantate und extrakorporale
Partie 2: Circuit sanguin extracorporel pour les Système - Teil 2: Extrakorporaler Blutkreislauf bei
hémodialyseurs, les hémodiafiltres et les hémofiltres Hämodialysatoren, Hämodiafiltern und Hämofiltern
(ISO 8637-2:2018) (ISO 8637-2:2018)
This European Standard was approved by CEN on 17 June 2018.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 26 September 2018.

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 NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8637-2:2018 E
worldwide for CEN national Members.

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SIST EN ISO 8637-2:2018
EN ISO 8637-2:2018 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 4
2

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SIST EN ISO 8637-2:2018
EN ISO 8637-2:2018 (E)
European foreword
This document (EN ISO 8637-2:2018) 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 February 2019, and conflicting national standards
shall be withdrawn at the latest by August 2021.
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 8638:2014.
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
...

SLOVENSKI STANDARD
oSIST prEN ISO 8637-2:2016
01-junij-2016
=XQDMWHOHVQLSUHWRþQLVLVWHPL]DþLãþHQMHNUYLGHO=XQDMWHOHVQLNUYQLREWRN]D
KHPRGLDOL]DWRUMHKHPRGLDILOWUHLQKHPRILOWUH,62',6
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters (ISO/DIS 8637-2:2016)
Kardiovaskuläre Implantate und extrakorporale Système - Teil 2: Extrakorporaler
Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO/DIS 8637-
2:2016)
Systèmes extracorporels pour la purification du sang - Partie 2: Hémodialyseurs,
hémodiafiltres, hémofiltres et hémoconcentrateurs (ISO/DIS 8637-2:2016)
Ta slovenski standard je istoveten z: prEN ISO 8637-2
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 8637-2:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 8637-2:2016

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oSIST prEN ISO 8637-2:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8637-2
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2016-04-21 2016-07-20
Extracorporeal systems for blood purification —
Part 2:
Extracorporeal blood circuit for haemodialysers,
haemodiafilters and haemofilters
Systèmes extracorporels pour la purification du sang
ICS: 11.040.40
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8637-2:2016(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2016

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oSIST prEN ISO 8637-2:2016
ISO/DIS 8637-2:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2016 – All rights reserved

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oSIST prEN ISO 8637-2:2016
ISO 8637-2:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope.1
2 Normative references .1
3 Terms and definitions.2
4 Requirements .3
4.1 Biological safety .3
4.2 Sterility.3
4.3 Non-pyrogenicity .
...