Norm

NEN-ISO 8638:2004 en

Hartimplantaten en kunstmatige organen - Buiten het lichaam gelegen bloedcircuit voor hemodialysetoestellen,hemodiafilters, hemofilters

  • Deze norm is ingetrokken sinds 12-07-2010

48,19

Over deze norm

Status Ingetrokken
Aantal pagina's 12
Commissie Chirurgische implantaten
Gepubliceerd op 01-10-2004
Taal Engels
This International Standard 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. This International Standard 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, - systems intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.

Details

ICS-code 11.040.40
Nederlandse titel Hartimplantaten en kunstmatige organen - Buiten het lichaam gelegen bloedcircuit voor hemodialysetoestellen,hemodiafilters, hemofilters
Engelse titel Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
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