Gives guidelines for the minimum performance requirements and test procedures to assess compliance to the requirements, for hemodialyers, hemofilters and hemoconcentrators used for kidney dialysis and associated procedures. Requirements for hemodialysers of coil, hollow fibre and parallel, plate design are given but it does not apply to the extracorporeal circuit, plasma filters, hemoperfusion devices, vascular access devices, pressure monitors of the extracorporeal circuit, blood pumps, air detection devices and hemodialysis or hemofiltration systems to prepare maintain and monitor dialysis solutions.