| Materials | PSU |
| CAD Model Available | Yes |
| Manufacturing Environment Classification | ISO Class 7 / 10,000 / Grade C |
| Colorant in Part | Yes |
| Regrind Used to Manufacture This Part | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 36 |
| Product Shelf Life Post-Irradiation (months) | 36 |
| Animal Derived Ingredients (BSE/TSE) | Certified Animal Derived Component Free (ADCF) |
| California Prop. 65 | SOME Substances on the California Proposition 65 list have been knowingly or intentionally added |
| California Prop. 65 List Date | 1/10/2022 12:00:00 am |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| EU MDR 10.4.1 (CMR/ED) | No Substance(s) Present Above Threshold |
| EU MDR 10.4.1 (CMR/ED) Substance List | Annex VI to CLP_ATP17 - 17 December 2022 |
| European Pharmacopoeia (EP) 3.1.X | Information Not Available |
| Human Derived Ingredients | Does NOT intentionally contain human derived ingredients |
| Latex | Does NOT intentionally contain natural latex |
| Latex in Packaging | Does NOT intentionally contain natural latex |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| Pyrogens | Pyrogen free - Tested via USP <85> |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 50 |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Raw Material |
| USP Biocompatibility 87 | Raw materials pass USP <87> |
| USP Biocompatibility 88 | passes USP <88>, temperature not stated |
| USP Biocompatibility Claim Based On | Raw Material |
| Residual Solvents: Tested via ICH Q3C Standard | Contains ICH Q3C Class 1 or 2 Residual Solvents |
| Elemental Impurities: Tested via ICH Q3D Standard | Contains ICH Q3D Class 1, 2, 2B or 3 Elemental Impurities |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | Other Report |
| Visible-Subvisible Particulate Claim | USP <788> |
| Tested via USP 661.1 | Yes |
| Integrity Tested? | Yes, routine random samples are tested |
The products in our inventory are intended solely for use as components for further manufacturing, processing or incorporation into a finished device. These products are not intended for use as finished devices. Customers are solely responsible for determining whether a Qosina component product is appropriate for customer’s intended use and for ensuring that the use of the component product is in compliance with applicable laws. Our components are not available for sale to hospitals, physicians, and pharmacists.
