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
International Standard
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ISO 8637-1:2024
Published (Edition 2, 2024)

ISO 8637-1:2024

ISO 8637-1:2024
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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;


     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

  •  : Published
     : 2024-05
    : International Standard published [60.60]
  •  : 2
     : 31
  • ISO/TC 150/SC 2
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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