For MedFlex 360 TPE weldbale tubing; we offer full documents on biological certification and validation as bellow:  

FDA 21 CFR 177.2600

USP 85,87,88,381,643&661

ISO10993-3, 5, 10 &11

European Pharmacopeia 3.2.9

E&L report based on BPOG & USP 665