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About This Item

 

Full Description

ISO 13960:2003 specifies requirements for sterile, single-use plasmafilters, intended for use on humans.

ISO 13960:2003 is not applicable to the extracorporeal circuits used for plasmapheresis or other extracorporeal blood exchange devices, such as haemodialysers, haemodiafilters, haemofilters, haemoperfusion devices, vascular access devices, oxygenators or active medical devices.

ISO 13960:2003 does not address the replacement fluid.

 

Document History

  1. ISO 8637-3:2018


    Extracorporeal systems for blood purification - Part 3: Plasmafilters

    • Most Recent
  2. ISO 13960:2010


    Cardiovascular implants and extracorporeal systems - Plasmafilters

    • Historical Version
  3. ISO 13960:2003

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    Cardiovascular implants and artificial organs - Plasmafilters

    • Historical Version