95.99 Withdrawal of Standard Jun 28, 2010
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
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.
WITHDRAWN
ISO 13960:2003
95.99
Withdrawal of Standard
Jun 28, 2010
WITHDRAWN
ISO 13960:2010