This International Standard specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and
transducer protectors (integral and non-integral) intended for use in such circuits.
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 8637-1, and requirements for plasmafilters are specified in ISO 8637-3
NOTE Extracoproreal blood tubing sets may also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.
Required fields are indicated with *
