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.
ISO 8638:2004 history
2010ISO 8638:2010 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
2004ISO 8638:2004 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
1989ISO 8638:1989 Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators