FprEN ISO 8637-2

Name: FprEN ISO 8637-2
Brand: CEN
SKU: FprEN ISO 8637-2
Price: 29.1 EUR
Availability: InStock
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Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/FDIS 8637‑2:2026) FprEN ISO 8637-2

Publication date: Sep 24, 2026

General information

Current stage: 50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks Sep 24, 2026

Originator: CEN

Owner: CEN/TC 205 Non-active medical devices

Type: European Norm

ICS: 11.040.20 Transfusion, infusion and injection equipment

Buying

Status: Draft

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
EN ISO 8637-2:2024

NOW

IN_DEVELOPMENT
FprEN ISO 8637-2
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Sep 24, 2026