CAN/CSA-Z8638-08

This National Standard of Canada is based on International Standard ISO 8638:2004. 1 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.