CAN/CSA-Z8638-08:2008 Edition

Preface

This is the first edition of CAN/CSA-Z8638, Cardiovascular implants and artificial organs – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 8638 (second edition, 2004-10-01). It replaces the previous edition published in 1994 as CAN/CSA-Z364.1.2, Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators (adopted ISO 8638:1989). At the time of publication, ISO 8638:2004 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 single-use extracorporeal blood circuits (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 is not applicable 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 dialysing fluid, – systems intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.

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