International Standard
ISO 8637-1:2024
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Reference number
ISO 8637-1:2024
Edition 2
2024-05
© ISO 2025
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Published (Edition 2, 2024)

ISO 8637-1:2024

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Abstract

This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document does not apply to:

—     extracorporeal blood circuits;

—     plasmafilters;

—     haemoperfusion devices;

—     vascular access devices;

—     blood pumps;

—     systems to prepare, maintain or monitor dialysis fluid;

—     systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;

—     reprocessing procedures and equipment.

NOTE 1       Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.

NOTE 2       Requirements for plasmafilters are specified in ISO 8637-3.

General information

  • Status
     : Published
    Publication date
     : 2024-05
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 31
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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