BSI BS EN ISO 8638:2014

Withdrawn Revision
Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

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A newer publication replaces it: BSI BS EN ISO 8637-2


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BSI BS EN ISO 8638:2014

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

PUBLISH DATE 2014
PAGES 26
BSI BS EN ISO 8638:2014

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as β€œthe device”) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.

This International Standard does not apply to:

  • haemodialysers, haemodiafilters or haemofilters;
  • plasmafilters;
  • vascular access devices;
  • blood pumps;
  • pressure monitors for the extracorporeal blood circuit;
  • air detection devices;
  • systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.

NOTE: Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.

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