HelixMark® Standard Tubing
Technical Features
Materials
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| 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 50 ft coil (15.24 m) |
| Materials | Silicone |
| CAD Model Available | No |
| Packaging | 50 ft coil (15.24 m) |
| Manufacturing Environment Classification | ISO Class 8 / 100,000 / Grade D |
| Manufacturing Aids - Mold Release - Lubricant used | No |
| Colorant in Part | No |
| Regrind Used to Manufacture This Part | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 60 |
| Animal Derived Ingredients (BSE/TSE) | Animal Derived Component Free (ADCF) |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| EU MDR 10.4.1 (CMR/ED) | No Substance(s) Present Above Threshold |
| European Pharmacopoeia (EP) 3.1.X | Pass 3.1.9 Silicone |
| 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 |
| Medicinal Substances | Does NOT intentionally contain medicinal substances |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| Pyrogens | Not tested for pyrogens |
| REACH SVHC | No Substance(s) Present Above Threshold |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| USP Biocompatibility 87 | Information Not Available |
| USP Biocompatibility 88 | Information Not Available |
| Residual Solvents: Tested via ICH Q3C Standard | Contains NO ICH Q3C Class 1 or 2 Residual Solvents |
| Elemental Impurities: Tested via ICH Q3D Standard | Contains NO ICH Q3D Class 1, 2, 2B or 3 Elemental Impurities |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | No Extractables Testing Performed |
| Visible-Subvisible Particulate Claim | Information Not Available |
| Bioburden USP 61 62 | Bioburden values available |
| Tested via USP 661.1 | No |
| Integrity Tested? | Yes, routine random samples are tested |
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