Tubing, Silicone Tubing
Bio-Sil® 1465 Tubing
Bio-Sil® 1465 is a unique platinum-cured silicone formulation developed by Saint-Gobain. This 65 durometer (shore A) tubing is extruded and packaged in a certified clean room. Bio-Sil® 1465 tubing has met the criteria of various ISO 10993 and USP tests, making it well-suited for many medical applications. The physical properties of Bio-Sil® 1465 make it an ideal choice for drug delivery, enteral nutrition, minimally invasive surgery, and various fluid transfer.
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Bio-Sil® 1465 Tubing Product Details
Features & Benefits
- Platinum-cured tubing
- 65 Shore A hardness
- Ultra-flexible
- Autoclavable, EtO and gamma stable
- Temperature range of -80°F (-62°C) to 500°F (260°C)
- Tubing has met the requirements of various ISO 10993 and USP tests
Biocompatibility
| Method Description | Reference Standard | Result |
|---|---|---|
| Genotoxicity | ISO 10993-3 | Meets Criteria |
| Hemolysis – Direct Contact | ASTM F756-00 | Meets Criteria |
| Hemolysis – Indirect Contact | ASTM F756-00 | Meets Criteria |
| Irritation and Skin Sensitization: Kligman Maximization Test | ISO 10993-10 | Meets Criteria |
| Systemic Toxicity: Systemic Injection | ISO 10993-11 | Meets Criteria |
| Biological Reactivity Tests, In Vitro | USP <87> | Meets Criteria |
| Biologic Reactivity Tests, In Vivo: | USP <88> | Meets Criteria |
| As Manufactured Irradiation Samples | ||
| Biologic Reactivity Tests, In Vivo: | USP <88> | Meets Criteria |
| Post-Gamma Irradiation Samples | ||
| Biologic Reactivity Tests, In Vivo: | USP <88> | Meets Criteria |
| Post-Autoclave Samples | ||
| Particulate Matter | USP <788> | <1 particle/mL for each category |
| LAL Gel Clot Endotoxin | USP <85> | Meets Criteria |
| Systemic Toxicity: Rabbit Pyrogen | ISO 10993-11 & USP <151> | Meets Criteria |
| Bacteriostasis & Fungistasis | USP <71> | Meets Criteria |
| Bioburden Enumeration | ANSI/AAMA/ISO 11737-1 | 19 CFU/Device (Average) |
| Elastomeric Closures for Injection | USP <381> | Meets Criteria |
| Physicochemical Tests for Plastics | USP <661> | Meets Criteria |
| Rubber Closure for Aqueous Infusions | JP 59 | Meets Criteria |
| Silicone Elastomer for Closures and Tubing | EP 3.1.9 | Meets Criteria |
| Total Extractables in Rubber Articles Intended for Repeated Use | 21CFR Part 177.2600 | Meets Criteria |
| Extractables Data | Saint-Gobain Protocol | N/A |
Physical Properties
| Property | ASTM Method | Value or Rating (metric) |
|---|---|---|
| Durometer Hardness, Shore A | D2240 | 65 |
| Color | Translucent | |
| Tensile Strength, psi (MPa) | D412 | 1373 (9.47) |
| Ultimate Elongation, 100% | D412 | 608 |
| Tear Resistance, Die B, ppi (kN/m) | D624 | 179 (31.3) |
| Specific Gravity | D792 | 1.17 |
| Tensile Modulus at 200% Elongation, psi (MPa) | D412 | 302 (2.08 Mpa) |
*Unless otherwise noted, all tests were conducted at room temperature (73°F).
**Values shown were determined on 0.075" thick extruded strips, 0.075" thick molded ASTM plaques, or molded ASTM durometer buttons.
Specifications
| Part Number | ID (in) | OD (in) | Wall (in) | Length (ft) | ID (mm) | OD (mm) | Wall (mm) |
|---|---|---|---|---|---|---|---|
| BS1465-012-025 | 0.012 | 0.025 | 0.007 | 25 | 0.305 | 0.635 | 0.178 |
| BS1465-020-037 | 0.020 | 0.037 | 0.009 | 25 | 0.508 | 0.940 | 0.229 |
| BS1465-020-083 | 0.020 | 0.083 | 0.031 | 50 | 0.508 | 2.108 | 0.794 |
| BS1465-025-047 | 0.025 | 0.047 | 0.011 | 50 | 0.635 | 1.194 | 0.279 |
| BS1465-030-065 | 0.030 | 0.065 | 0.018 | 50 | 0.762 | 1.651 | 0.457 |
| BS1465-031-094 | 0.031 | 0.094 | 0.031 | 50 | 0.794 | 2.381 | 0.794 |
| BS1465-040-085 | 0.040 | 0.085 | 0.023 | 50 | 1.016 | 2.159 | 0.584 |
| BS1465-058-077 | 0.058 | 0.077 | 0.010 | 50 | 1.473 | 1.956 | 0.254 |
| BS1465-063-095 | 0.063 | 0.095 | 0.017 | 50 | 1.588 | 2.413 | 0.432 |
| BS1465-063-125 | 0.063 | 0.125 | 0.031 | 50 | 1.588 | 3.175 | 0.794 |
| BS1465-078-125 | 0.078 | 0.125 | 0.023 | 50 | 1.981 | 3.175 | 0.584 |
| BS1465-094-156 | 0.094 | 0.156 | 0.031 | 50 | 2.381 | 3.969 | 0.794 |
| BS1465-104-192 | 0.104 | 0.192 | 0.044 | 50 | 2.642 | 4.877 | 2.642 |
| BS1465-125-188 | 0.125 | 0.188 | 0.031 | 50 | 3.175 | 4.763 | 0.794 |
| BS1465-125-250 | 0.125 | 0.250 | 0.063 | 50 | 3.175 | 6.350 | 1.588 |
| BS1465-132-183 | 0.132 | 0.183 | 0.026 | 50 | 3.353 | 4.648 | 0.660 |
| BS1465-156-219 | 0.156 | 0.219 | 0.031 | 50 | 3.969 | 5.556 | 0.794 |
| BS1465-188-250 | 0.188 | 0.250 | 0.031 | 50 | 4.763 | 6.350 | 0.794 |
| BS1465-188-313 | 0.188 | 0.313 | 0.063 | 50 | 4.763 | 7.938 | 1.588 |
| BS1465-188-375 | 0.188 | 0.375 | 0.094 | 50 | 4.763 | 9.525 | 2.381 |
| BS1465-188-438 | 0.188 | 0.438 | 0.125 | 50 | 4.763 | 11.113 | 3.175 |
| BS1465-250-313 | 0.250 | 0.313 | 0.031 | 50 | 6.350 | 7.938 | 0.794 |
| BS1465-250-375 | 0.250 | 0.375 | 0.063 | 50 | 6.350 | 9.525 | 1.588 |
| BS1465-250-438 | 0.250 | 0.438 | 0.094 | 50 | 6.350 | 11.113 | 2.381 |
| BS1465-250-500 | 0.250 | 0.500 | 0.125 | 50 | 6.350 | 12.700 | 3.175 |
| BS1465-313-438 | 0.313 | 0.438 | 0.063 | 50 | 7.938 | 11.113 | 1.588 |
| BS1465-313-500 | 0.313 | 0.500 | 0.094 | 50 | 7.938 | 12.700 | 2.381 |
| BS1465-313-563 | 0.313 | 0.563 | 0.125 | 50 | 7.938 | 14.300 | 3.175 |
| BS1465-375-500 | 0.375 | 0.500 | 0.063 | 50 | 9.525 | 12.700 | 1.588 |
| BS1465-375-563 | 0.375 | 0.563 | 0.094 | 50 | 9.525 | 14.288 | 2.381 |
| BS1465-375-625 | 0.375 | 0.625 | 0.125 | 50 | 9.525 | 15.875 | 3.175 |
| BS1465-500-625 | 0.500 | 0.625 | 0.063 | 50 | 12.700 | 15.875 | 1.588 |
| BS1465-500-688 | 0.500 | 0.688 | 0.094 | 25 | 12.700 | 17.463 | 2.381 |
| BS1465-500-750 | 0.500 | 0.750 | 0.125 | 25 | 12.700 | 19.050 | 3.175 |
| BS1465-625-875 | 0.625 | 0.875 | 0.125 | 25 | 15.875 | 22.225 | 3.175 |
| BS1465-750-1000 | 0.750 | 1.000 | 0.125 | 10 | 19.050 | 25.400 | 3.175 |
| BS1465-1000-1250 | 1.000 | 1.250 | 0.125 | 10 | 25.400 | 31.750 | 3.175 |
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