ISO 8637-2:2024

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Publication date: Apr 8, 2024

General information

Current stage: 90.92 Effective date: Oct 13, 2025

Originator: ISO

Owner: ISO/TC 150/SC 2

Type: International Standard

ICS: 11.040.40

Languages: English French

Buying

Status: Published

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CD - ALL 17,978

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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

WITHDRAWN
ISO 8637-2:2018

NOW

PUBLISHED
ISO 8637-2:2024
90.92 Standard to be revised
Oct 13, 2025

REVISED BY

IN_DEVELOPMENT
ISO/DIS 8637-2

National adoptions

SSH EN ISO 8637-2:2024

DPS

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)

60.60 Standard published

DPS/KT 205 more