ISO/FDIS 8637-1
u
ISO/FDIS 8637-1
86613
No disponible en español

Estado : En desarrollo

Resumen

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.

Informaciones generales

  •  : En desarrollo
    : Envío de la prueba a la secretaría o inicio de la votación del FDIS: 8 semanas [50.20]
  •  : 2
     : 31
  • ISO/TC 150/SC 2
    11.040.40 
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