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Standard
ISO 8637-3
Second edition
Extracorporeal systems for blood
2024-05
purification —
Part 3:
Plasmafilters
Systèmes extracorporels pour la purification du sang —
Partie 3: Filtres pour plasma
Reference number
ISO 8637-3:2024(en) © ISO 2024
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ISO 8637-3:2024(en)
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© ISO 2024 – All rights reserved
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ISO 8637-3:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Biological safety and haemocompatibility .3
4.2 Sterility .3
4.3 Non-pyrogenicity .3
4.4 Mechanical characteristics .3
4.4.1 Structural integrity.3
4.4.2 Blood compartment integrity .3
4.4.3 Connectors .4
4.5 Performance characteristics .5
4.5.1 Plasma filtration rate .5
4.5.2 Sieving coefficient .6
4.5.3 Blood compartment volume .6
4.5.4 Blood compartment pressure drop .6
4.5.5 Haemolytic characteristics .
...