ISO/FDIS 8637-1
u
ISO/FDIS 8637-1
86613

Status : Under development

Abstract

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.

General information

  •  : Under development
    : Proof sent to secretariat or FDIS ballot initiated: 8 weeks [50.20]
  •  : 2
     : 31
  • ISO/TC 150/SC 2
    11.040.40 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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