Cardiovascular implants and artificial organs -- Plasmafilters
ISO 13960:2003 specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
ISO 13960:2003 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.
ISO 13960:2003 does not address the replacement fluid.
A standard is reviewed every 5 years
Revisions / Corrigenda