scope:

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.

This International Standard does not apply to:

⎯ haemodialysers, haemodiafilters or haemofilters;

⎯ 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 or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.

NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.