ISO 13960:2003

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.

Edition	2003
Published Date	2003
Published By	International Standardization Organisation
Page Count	9