FprEN ISO 8637-2

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/FDIS 8637‑2:2026)

Publication date:   Sep 24, 2026

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.