This International Standard specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
This International Standard is not applicable to the extracorporeal circuits used for plasmapheresis or other extracorporeal blood exchange devices, such as haemodialysers, haemodiafilters, haemofilters, haemoperfusion devices, vascular access devices, oxygenators or active medical devices.
This International Standard does not address the replacement fluid.
ISO 13960:2003 history
2010ISO 13960:2010 Cardiovascular implants and extracorporeal systems - Plasmafilters
2003ISO 13960:2003 Cardiovascular implants and artificial organs - Plasmafilters