Standard

NS-EN ISO 8637-1:2020

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ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.ISO 8637-1:2017 does not apply 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 dialysis fluid;- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;- reprocessing procedures and equipment.NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2020-04
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.40
  • National Committee CEN/TC 205

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