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SSH EN ISO 8637-2:2024

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)

Jul 28, 2025

General information

60.60     Jul 28, 2025

95.99   

DPS

DPS/KT 205

European Norm

11.040.20     11.040.40  

English  

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Scope

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.
This document does not apply to:
—     haemodialysers, haemodiafilters or haemofilters;
—     plasmafilters;
—     haemoperfusion devices;
—     vascular access devices.
NOTE 1        Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2        Requirements for plasmafilters are specified in ISO 8637-3.

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 8638:2014

NOW

PUBLISHED
SSH EN ISO 8637-2:2024
60.60 Standard published
Jul 28, 2025

Related project

Adopted from EN ISO 8637-2:2024 IDENTICAL

Adopted from ISO 8637-2:2024 IDENTICAL