This International Standard specifies requirements for single-use extracorporeal blood circuit (hereafter
referred to as "the device") and (integral and non-integral) transducer protectors which are intended for
use in hemodialysis, hemodiafiltration, and hemofiltration.
This International Standard does not apply to
__ hemodialyzers, hemodiafilters, or hemofilters,
__ plasmafilters,
__ hemoperfusion devices,
-- vascular access devices,
-- blood pumps,
-- pressure monitors for the extracorporeal blood circuit,
-- air detection devices,
-- systems to prepare, maintain, or monitor dialyzing fluid,
-- systems intended to perform hemodialysis, hemodiafiltration, hemofiltration, or hemoconcentration.
NOTE Requirements for hemodialyzers, hemodiafilters, hemofiiters, and hemoconcentrators are specified in ISO
8637.