This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters, and
hemoconcentrators, hereinafter collectively referred to as "the dewce, fo use for humans.
This International Standard does not apply to
__ extracorporeal blood circuits,
__ plasmafilters,
__ hemoperfusion devices,
__ vascular access devices,
-- blood pumps,
__ pressure monitors for the extracorporeal blood circuit,
air detection devices,
__ systems to prepare, maintain, or monitor dialysate,
__ systems used to perform hemodialysis, hemodiafiltration, hemofiltration, or hemoconcentration,
__ reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters are
specified in ISO 8638.