| Technical Detail | 60A Durometer; 1/8 inch ID x 1/4 inch OD (0.125 inch x 0.25 inch, 3.18 mm x 6.35 mm) x 328 ft coil (100 m) |
| Materials | Silicone |
| CAD Model Available | No |
| Packaging | 328 ft coil (100 m) |
| Manufacturing Environment Classification | ISO Class 7 / 10,000 / Grade C |
| Colorant in Part | No |
| Regrind Used to Manufacture This Part | Information Not Available |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 60 |
| Product Shelf Life Post-Irradiation (months) | 36 |
| Animal Derived Ingredients (BSE/TSE) | Conforms with EMA/410/01 rev. 3 |
| California Prop. 65 | Information Not Available |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| European Pharmacopoeia (EP) 3.1.X | Pass 3.1.9 Silicone |
| Human Derived Ingredients | Information Not Available |
| Latex | Information Not Available |
| Latex in Packaging | Information Not Available |
| Medicinal Substances | Information Not Available |
| Nanomaterials | Information Not Available |
| Pyrogens | Pyrogen free - Tested via USP <85> |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2023 June 14 (235 Substances) |
| RoHS3 (2015/863) | Information Not Available |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 50 |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Finished Component |
| USP Biocompatibility 87 | Finished component passes USP<87> |
| USP Biocompatibility 88 | passes USP <88>, temperature not stated |
| USP Biocompatibility Claim Based On | Finished Component |
| Residual Solvents: Tested via ICH Q3C Standard | No ICH Q3C Testing Performed |
| Elemental Impurities: Tested via ICH Q3D Standard | No ICH Q3D Testing Performed |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | Other Report |
| Visible-Subvisible Particulate Claim | USP <788> |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | No |
| Integrity Tested? | No |
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.
