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CAN/CSA-ISO 8638:12:2012 Edition

$24.70

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

Published By Publication Date Number of Pages
CSA 2012-03-27 30
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Preface

This is the first edition of CAN/CSA-ISO 8638, Cardiovascular implants and extracorporeal systems – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters, which is an adoption, without modification, of the identically titled ISO (International Organization for Standardization) Standard 8638 (third edition, 2010-07-01). It replaces the previous edition published in 2008 as CAN/CSA-Z8638, Cardiovascular implants and artificial organs – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (adopted ISO 8638:2004).

Scope

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as the 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;
  • 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 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.

CAN/CSA-ISO 8638:12
$24.70