ISO 8637-1:2017
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ISO 8637-1:2017
69843

Abstract

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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.


General information 

  •  :  Published
     : 2017-11
  •  : 1
     : 22
  •  : ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
  •  :
    11.040.40 Implants for surgery, prosthetics and orthotics

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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