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CAN/CSA-ISO 8637:12:2012 Edition

$28.60

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

Published By Publication Date Number of Pages
CSA 2012-03-28 34
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Preface

This is the first edition of CAN/CSA-ISO 8637, Cardiovascular implants and extracorporeal systems – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which is an adoption, without modification, of the identically titled ISO (International Organization for Standardization) Standard 8637 (third edition, 2010-07-01).

It replaces the previous edition published in 2008 as CAN/CSA-Z8637, Cardiovascular implants and artificial organs – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (adopted ISO 8637:2004).

Scope

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as the device, for use in humans.

This International Standard is not applicable to:

  • extracorporeal blood circuits;
  • 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 used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
  • reprocessing procedures and equipment.

NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8638.

CAN/CSA-ISO 8637:12
$28.60