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)

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.
This document does not apply to:
—     haemodialysers, haemodiafilters or haemofilters;
—     plasmafilters;
—     haemoperfusion devices;
—     vascular access devices.
NOTE 1        Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2        Requirements for plasmafilters are specified in ISO 8637-3.

Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blut- und Flüssigkeitskreislauf bei Hämodialysatoren, Hämodiafiltern, Hämofiltern und Hämokonzentratoren (ISO 8637‑2:2024)

Dieses Dokument legt Anforderungen an extrakorporale Blut- und Flüssigkeitskreisläufe und Zubehör für den einmaligen Gebrauch fest, die in Kombination mit Hämodialysegeräten für extrakorporale Blutbehandlungstherapien wie z. B. Hämodialyse, Hämodiafiltration und Hämofiltration verwendet werden, jedoch nicht darauf beschränkt sind.
Dieses Dokument ist nicht anwendbar für:
-   Hämodialysatoren, Hämodiafilter oder Hämofilter;
-   Plasmafilter;
-   Hämoperfusionsgeräte;
-   Geräte für den vaskulären Zugang.
ANMERKUNG 1   Die Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren sind in ISO 8637 1 festgelegt.
ANMERKUNG 2   Die Anforderungen an Plasmafilter sind in ISO 8637 3 festgelegt.

Systèmes extracorporels pour la purification du sang - Partie 2: Circuits sanguins extracorporels et liquidiens pour les hémodialyseurs, les hémodiafiltres, les hémofiltres et les hémoconcentrateurs (ISO 8637-2:2024)

Le présent document spécifie les exigences relatives aux circuits sanguins extracorporels et liquidiens jetables et aux accessoires utilisés conjointement avec un appareil d’hémodialyse destiné aux thérapies avec traitement du sang extracorporel, notamment, entre autres, l’hémodialyse, l’hémodiafiltration et l’hémofiltration.
Le présent document ne s’applique pas aux:
—     hémodialyseurs, hémodiafiltres ou hémofiltres;
—     filtres pour plasma;
—     dispositifs d’hémoperfusion;
—     dispositifs d’accès vasculaire.
NOTE 1        Les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs sont spécifiées dans l’ISO 8637-1.
NOTE 2        Les exigences relatives aux filtres pour plasma sont spécifiées dans l’ISO 8637-3.

Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni in tekočinski obtok za hemodializatorje, hemodiafiltre, hemofiltre in hemokoncentratorje (ISO 8637-2:2024)

Ta dokument določa zahteve za zunajtelesni krvni in tekočinski obtok ter dodatno opremo za enkratno uporabo, ki se uporabljata skupaj z opremo za hemodializo, namenjeno za zunajtelesno zdravljenje krvi, kot je med drugim hemodializa, hemodiafiltracija in hemofiltracija.
Ta dokument se ne uporablja za:
–    hemodializatorje, hemodiafiltre in hemofiltre;
–    plazmafiltre;
–    hemoperfuzijske pripomočke;
–    žilne dostopovne pripomočke.
OPOMBA 1:    Zahteve za hemodializatorje, hemodiafiltre, hemofiltre in hemokoncentratorje so določene v standardu ISO 8637-1.
OPOMBA 2:    Zahteve za plazmafiltre so določene v standardu ISO 8637-3.

General Information

• Status: Published
• Publication Date: 16-Apr-2024
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• 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: 17-Apr-2024
• Completion Date: 17-Apr-2024
• Ref Project: 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)

Relations

• Replaces: EN ISO 8637-2:2018 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
• Effective Date: 25-Dec-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2024
Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni in
tekočinski obtok za hemodializatorje, hemodiafiltre, hemofiltre in
hemokoncentratorje (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)
Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blut- und
Flüssigkeitskreislauf bei Hämodialysatoren, Hämodiafiltern, Hämofiltern und
Hämokonzentratoren (ISO 8637-2:2024)
Systèmes extracorporels pour la purification du sang - Partie 2: Circuits sanguins
extracorporels et liquidiens pour les hémodialyseurs, les hémodiafiltres, les hémofiltres
et les hémoconcentrateurs (ISO 8637-2:2024)
Ta slovenski standard je istoveten z: EN ISO 8637-2:2024
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 8637-2
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8637-2:2018
English Version
Extracorporeal systems for blood purification - Part 2:
Extracorporeal blood and fluid circuits for haemodialysers,
haemodiafilters, haemofilters and haemoconcentrators
(ISO 8637-2:2024)
Systèmes extracorporels pour la purification du sang - Extrakorporale Systeme zur Blutreinigung - Teil 2:
Partie 2: Circuits sanguins extracorporels et liquidiens Extrakorporaler Blut- und Flüssigkeitskreislauf bei
pour les hémodialyseurs, les hémodiafiltres, les Hämodialysatoren, Hämodiafiltern, Hämofiltern und
hémofiltres et les hémoconcentrateurs (ISO 8637- Hämokonzentratoren (ISO 8637-2:2024)
2:2024)
This European Standard was approved by CEN on 15 December 2023.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8637-2:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 8637-2:2024) 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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
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 8637-2:2018.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 8637-2:2024 has been approved by CEN as EN ISO 8637-2:2024 without any
modification.
International
Standard
ISO 8637-2
Second edition
Extracorporeal systems for blood
2024-04
purification —
Part 2:
Extracorporeal blood and fluid
circuits for haemodialysers,
haemodiafilters, haemofilters and
haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 2: Circuits sanguins extracorporels et liquidiens pour
les hémodialyseurs, les hémodiafiltres, les hémofiltres et les
hémoconcentrateurs
Reference number
ISO 8637-2:2024(en) © ISO 2024

ISO 8637-2:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 8637-2:2024(en)
Contents  Page
Foreword .v
Introduction .vi
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
4  Requirements . 6
4.1 General .6
4.2 Biological safety and haemocompatibility .6
4.3 Sterility .6
4.4 Non-pyrogenicity .7
4.5 Mechanical characteristics .7
4.5.1 Structural integrity.7
4.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter.7
4.5.3 Connectors to vascular access device.10
4.5.4 Connectors to ancillary components .10
4.5.5 Colour coding .10
4.5.6 Access ports .10
4.5.7 Blood pathway volume .11
4.5.8 Air capture chamber fill level .11
4.5.9 Transducer protectors .11
4.6 Functional characteristics .11
4.6.1 General .11
4.6.2 Blood pump system performance .11
4.6.3 Dialysis fluid pump performance . 12
4.6.4 Net fluid removal . 12
4.6.5 Substitution fluid flow rate . 12
4.6.6 Dialysis fluid composition . . 12
4.6.7 Dialysis fluid temperature . 12
4.6.8 Substitution fluid temperature . 12
4.6.9 Fluid path occlusion. 12
4.6.10 Prevention of air infusion . 13
4.6.11 Pressure monitoring . 13
4.6.12 Blood leak detection . 13
4.7 Expiry date . 13
5 Test methods .13
5.1 General . 13
5.2 Biological safety and haemocompatibility .14
5.3 Sterility .14
5.4 Non-pyrogenicity .14
5.5 Mechanical characteristics .
...