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This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as .the device., for use in humans.

This document does not apply to:

.     extracorporeal blood circuits;

.     plasmafilters;

.     haemoperfusion devices;

.     vascular access devices;

.     blood pumps;

.     systems to prepare, maintain or monitor dialysis fluid;

.     systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;

.     reprocessing procedures and equipment.

NOTE 1       Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.

NOTE 2       Requirements for plasmafilters are specified in ISO 8637-3.