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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)
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Published in Switzerland
© ISO 2024 – All rights reserved
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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 .
...