International Standard
ISO 8637-1
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Reference number
ISO 8637-1
Edition 2
2024-05
© ISO 2024
Under publication
Under publication (Edition 2, 2024)
Final production steps (up to seven weeks).
Will replace ISO 8637-1:2017

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

  • Status
     : Under development
    Publication date
     : 2024-05
    Stage
    : International Standard under publication [60.00]
  • Edition
     : 2
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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