Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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1 Scope 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 is not applicable to:
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— pressure monitors for the extracorporeal blood circuit;
— air detection devices;
— systems to prepare, maintain or monitor dialysis fluid ;
— systems used to perform haemodialysis , haemodiafiltration , haemofiltration or haemoconcentration ;
Другие стандарты BS