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.
