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About This Item

 

Full Description

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.

This document does not apply to:

— haemodialysers, haemodiafilters or haemofilters;

— 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.

NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3.

NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

 

Document History

  1. ISO 8637-2:2018

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    Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

    • Most Recent
  2. ISO 8637:2010


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

    • Historical Version
  3. ISO 8638:2010


    Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

    • Historical Version
  4. ISO 8637:2004


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

    • Historical Version
  5. ISO 8638:2004


    Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

    • Historical Version