BS EN ISO 8637:2014

This standard BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

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.