DANSK DSF/FPREN ISO 8637-1 PDF

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This International Standard does not apply to: <br />— extracorporeal blood circuits; <br />— plasmafilters; <br />— haemoperfusion devices; <br />— vascular access devices; <br />— blood pumps; <br />— pressure monitors for the extracorporeal blood circuit; <br />— air detection devices; <br />— systems to prepare, maintain or monitor dialysis fluid; <br />— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. <br />— reprocessing procedures and equipment. NOTE – Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.