FDA 21 CFR 177.1550 DM 21/03/1973 and amendments USP Class VI requirements ISO 10993-5:2009, 11:2006 Regulation 1935/2004/CE, 10/2011/CE, 1245/2020/CE 3-A RPSCQC (62-02) for hose assemblies
Manufacturing
Manufacturedin a Class 8 Cleanroom environment
Packaging
Manufactured, tested and packed in a controlled environment