CAN/CSA-Z8637-08:2008 Edition

Preface

This is the first edition of CAN/CSA-Z8637, Cardiovascular implants and artificial organs – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 8637 (second edition, 2004-10-01). It replaces the previous edition published in 1994 as CAN/CSA-Z364.1.1, Haemodialysers, Haemofilters and Haemoconcentrators (adopted ISO 8637:1989). At the time of publication, ISO 8637:2004 is available from ISO in English only. CSA will publish the French version when it becomes available from ISO.

Scope

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

This lnternational 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 dialysate,
• 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.