oSIST prEN ISO 8637-2:2025

SLOVENSKI STANDARD
01-september-2025
Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni in
tekočinski obtok za hemodializatorje, hemodiafiltre, hemofiltre in
hemokoncentratorje (ISO/DIS 8637-2:2025)
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid
circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
(ISO/DIS 8637-2:2025)
Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blut- und
Flüssigkeitskreislauf bei Hämodialysatoren, Hämodiafiltern, Hämofiltern und
Hämokonzentratoren (ISO/DIS 8637-2:2025)
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/DIS 8637-2:2025)
Ta slovenski standard je istoveten z: prEN ISO 8637-2
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.

DRAFT
International
Standard
ISO/DIS 8637-2
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
Part 2: 2025-07-07
Extracorporeal blood and fluid
Voting terminates on:
2025-09-29
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
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
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This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 8637-2:2025(en)
DRAFT
ISO/DIS 8637-2:2025(en)
International
Standard
ISO/DIS 8637-2
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
Part 2:
2025-07-07
Extracorporeal blood and fluid
Voting terminates on:
2025-09-29
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
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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Published in Switzerland Reference number
ISO/DIS 8637-2:2025(en)
ii
ISO/DIS 8637-2:2025(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 .7
4.3 Sterility .7
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 .14
5.5.1 Structural integrity.14
5.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter. 15
5.5.3 Connectors to vascular access device. 20
5.5.4 Connectors to ancillary components . 20
5.5.5 Colour coding .21
5.5.6 Access ports .21
5.5.7 Blood pathway volume .21
5.5.8 Air capture chamber fill level .21
5.5.9 Transducer protectors . 22
5.6 Functional characteristics . 22
5.6.1 General .
...