This Standard specifies requirements for sterile, single use haemodialysers, haemodiafilters, haemofilters, haemocontrators 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.
DS/EN 1283:1997 history
1997DS/EN 1283:1997 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits