The purpose of this standard is to establish the requirements that the blood lines that constitute the extracorporeal circuit for hemodialysis, hemofiltration, hemoconcentration and their accessories must meet, as well as the tests that allow their verification. Other test methods may be used if their equivalence to the reference methods reflected in this standard is demonstrated. This standard applies to different types of sterile, non-pyrogenic and single-use blood lines and accessories, which act by external action with extracorporeal circulation of blood. Hemodialyzers, hemofilters, hemoconcentrators, vascular accesses, blood pumps, pressure monitors, air detection devices, and dialysis machines are excluded from the content of this standard.