BS EN ISO 8637:2014 - Page 2

Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. | Status: Superseded, Withdrawn

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;
• — reprocessing procedures and equipment.

NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8638.