This European Standard specifies requirements for sterile, single use haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and the extracorporeal circuits for these devices (including any integral accessory lines, such as fluid and infusion lines and lines for connection to pressure monitors) intended for renal care and cardiovascular use on humans.

This European Standard does not apply to extracorporeal circuits for cardiovascular use or to other extracorporeal blood exchange devices, such as plasmafilters, haemoperfusion devices, vascular access devices, oxygenators, active medical devices or devices for peritoneal dialysis.