Norm

NEN-ISO 8637:2010 en

Hartimplantaten en kunstmatige organen - Hemodialysetoestellen, hemodiafilters, hemofilters en hemoconcentratoren

  • Deze norm is ingetrokken sinds 21-01-2014

79,70

Over deze norm

Status Ingetrokken
Aantal pagina's 18
Commissie Chirurgische implantaten
Gepubliceerd op 01-07-2010
Taal Engels
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This International Standard 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 dialysis fluid; - systems used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; reprocessing procedures and equipment.

Details

ICS-code 11.040.40
Nederlandse titel Hartimplantaten en kunstmatige organen - Hemodialysetoestellen, hemodiafilters, hemofilters en hemoconcentratoren
Engelse titel Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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