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About This Item

 

Full Description

This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document does not apply to:
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
— reprocessing procedures and equipment.

NOTE 1: Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.

NOTE 2: Requirements for plasmafilters are specified in ISO 8637-3.
 

Document History

  1. ISO 8637-1:2024

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    Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Most Recent
  2. ISO 8637-1:2017


    Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Historical Version
  3. ISO 8637:2010


    Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Historical Version
  4. ISO 8637:2004


    Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Historical Version