ISO 8637:2004

Cardiovascular implants and artificial organs -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

ISO 8637:2004 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as 'the device', for use for humans.

ISO 8637:2004 is not applicable to extracorporeal blood circuits, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors for the extracorporeal blood circuit, air detection devices, systems to prepare, maintain or monitor dialysate, systems used to perform haemofiltration or haemoconcentration, reprocessing procedures and equipment.

Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters are specified in ISO 8638.


General information

  • Status :  Withdrawn
    Publication date : 2004-10
  • Edition : 2
  • :
    ISO/TC 150/SC 2
    Cardiovascular implants and extracorporeal systems
  • 11.040.40
    Implants for surgery, prosthetics and orthotics

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