BS EN ISO 8637:2014

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.