DIN EN ISO 8638:2014-03

This standard specifies requirements for the extracorporeal blood circuit manufactured for single use and intended for use in conjunction with haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereinafter collectively referred to as 'the device') and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, heamodiafiltration and haemofiltration. This standard is not applicable to: - haemodialysers, haemodiafilters, 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 used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE: Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in EN ISO 8637.