BS EN 1283:1996- Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
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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.
