Résumé

ISO 8637:1989 specifies requirements for haemodialysers, including those of coil, hollow-fibre and parallel-plate design, haemofilters and haemoconcentrators for single use for humans. Requirements for materials of construction and test methods for biocompatibility, validation of sterility, non-pyrogenicity and certain performance characteristics are not included.

ISO 8637:1989 does not apply to devices assembled and sterilized by the user, nor to devices for the extracorporeal blood circuit, plasma filters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors of the extracorporeal circuit, air detection devices or systems to prepare, maintain or monitor dialysing fluid.


Informations générales 

  • État actuel
     : Annulée
    Date de publication
     : 1989-07
  • Edition
     : 1
    Nombre de pages
     : 18
  • Comité technique
     : ISO/TC 150/SC 2 Implants cardiovasculaires et circuits extra-corporels
  • ICS
     :
    11.040.40 Implants chirurgicaux, prothèses et orthèses

Cycle de vie

Vous avez une question?

Consulter notre FAQ

Service à la clientèle
+41 22 749 08 88

Horaires d’ouverture:
De lundi à vendredi - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Store
  3. Catalogue de normes
  4. TC
  5. ISO/TC 150/SC 2
  6. ISO 8637:1989