CAN3-Z364.1.1-M84

Specifies minimum performance requirements and test procedures to asses compliance to those requirements, for hemodialysers, hemofilters and hemoconcentrators used for kidney dialysis and associated procedures. The Standard includes requirements for hemodialysers of coil, hollow fibre and parallel, plate design. It does not apply to the extracorporeal circuit, plasma filters, hemoperfusion devices, vascular access devices, blood pumps, pressure monitors of the extracorporeal circuit, air detection devices and hemodialysis or hemofiltration systems to prepare, maintain and monitor dialysis solutions.