CSA Group Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (Adopted ISO 8638:2010, third edition, 2010-07-01)

Preface This is the first edition of CAN/CSA-ISO 8638, Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters, which is an adoption, without modification, of the identically titled ISO (International Organization for Standardization) Standard 8638 (third edition, 2010-07-01). It replaces the previous edition published in 2008 as CAN/CSA-Z8638, Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (adopted ISO 8638:2004). Scope This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (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 does not apply 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 dialysis fluid; systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.