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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
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ISO 8637-2:2024(en)
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Published in Switzerland
© ISO 2024 – All rights reserved
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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 .
...