ISO 8638:2004
Implants cardiovasculaires et organes artificiels — Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres
Numéro de référence
ISO 8638:2004
Edition 2
ISO 8638:2004
Annulée (Edition 2, 2004)


ISO 8638:2004 specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.

ISO 8638:2004 is not applicable to haemodialysers, haemodiafilters or haemofilters, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors for the extracorporeal blood circuit, air detection devices, systems to prepare, maintain or monitor dialysing fluid, or systems intended to perform haemofiltration or haemoconcentration.

Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.

Informations générales

  •  : Annulée
     : 2004-10
    : Annulation de la Norme internationale [95.99]
  •  : 2
  • ISO/TC 150/SC 2
  • RSS mises à jour

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