ISO/FDIS 8637-2

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

General information

50.20   Proof sent to secretariat or FDIS ballot initiated: 8 weeks   Sep 21, 2026

ISO

ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems

International Standard

11.040.20   Transfusion, infusion and injection equipment

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

PUBLISHED
ISO 8637-2:2024

NOW

IN_DEVELOPMENT
ISO/FDIS 8637-2
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Sep 21, 2026




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