ISO 8637-1:2024

Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

ISO 8637-1:2024

Name:ISO 8637-1:2024   Standard name:Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Standard number:ISO 8637-1:2024   language:English language
Release Date:30-May-2024   technical committee:ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
Drafting committee:ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems   ICS number:11.040.40 - Implants for surgery, prosthetics and orthotics
International
Standard
ISO 8637-1
Second edition
Extracorporeal systems for blood
2024-05
purification —
Part 1:
Haemodialysers, haemodiafilters,
haemofilters and
haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et
hémoconcentrateurs
Reference number
ISO 8637-1:2024(en) © ISO 2024

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ISO 8637-1:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland

© ISO 2024 – All rights reserved
ii

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ISO 8637-1:2024(en)
Contents  Page
Foreword .v
Introduction .vi
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
4  Requirements . 5
4.1 Biological safety and haemocompatibility .5
4.2 Sterility .5
4.3 Non-pyrogenicity .5
4.4 Mechanical characteristics .6
4.4.1 Structural integrity.6
4.4.2 Blood compartment integrity .6
4.4.3 Blood compartment connectors of haemodialysers, haemodiafilters and
haemofilters . .6
4.4.4 Dialysis fluid compartment connectors of haemodialysers and haemodiafilters .7
4.4.5 Filtrate connectors of haemofilters .8
4.4.6 Blood and filtrate connectors of haemoconcentrators.8
4.5 Performance characteristics .9
4.5.1 Solute clearance for haemodialysers and haemodiafilters .9
4.5.2 Sieving coefficients for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators .
...

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