Final Draft
International Standard
ISO/FDIS 8637-2
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Reference number
ISO/FDIS 8637-2
Edition 3
© ISO 2026
Final Draft International Standard
Under development
This draft is in the approval phase.
Will replace ISO 8637-2:2024

Abstract

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.

General information

  • Status
     : Under development
    Stage
    : Final text received or FDIS registered for formal approval [50.00]
  • Edition
     : 3
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.20 
  • RSS updates

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