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dnaSRPS EN ISO 8637-2:2025

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

General information

50.20     Sep 24, 2026

50.60    Nov 16, 2026

ISS

Z076

European Norm

11.040.20  

English  

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
SRPS EN ISO 8637-2:2024

NOW

PROJECT
dnaSRPS EN ISO 8637-2:2025
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Sep 24, 2026

Related project

Adopted from FprEN ISO 8637-2 IDENTICAL

Adopted from ISO/FDIS 8637-2 IDENTICAL

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