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.
PUBLISHED
ISO 8637-2:2024
PROJECT
ISO/FDIS 8637-2
50.20
Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Sep 21, 2026
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/FDIS 8637‑2:2026)
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
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