Medical devices must undergo rigorous biocompatibility testing to help ensure patient safety, particularly when components or assemblies come into direct or indirect contact with the human body. Selecting the right medical-grade adhesive is therefore an important consideration in the design and manufacture of medical devices. Epoxyset medical grade adhesives undergo rigorous testing and many of them have been tested and pass ISO 10993 and USP Class VI.
| Product | Viscosity (cPs) | Work Life | Service Temperature | Chemistry | Hardness | Datasheet |
|---|---|---|---|---|---|---|
| EB-107LP-1 | 100-300 | 2 hrs | -55°C-150°C | Epoxy | D-85 | Download |
| EB-107LP-2 | 200-500 | 8 hrs | -55°C-150°C | Epoxy | D-82 | Download |
| EB-130M-1 | 500-800 | 40 min | -55°C-200°C | Epoxy | D-85 | Download |
| EB-177 | 200-300 | 12 hrs | -55°C-250°C | Epoxy | D-92 | Download |
| EB-153 | 3,000-5,000 | 4-6 hrs | -55°C-250°C | Epoxy | D-87 | Download |
| EB-135 | 4000-7000 | 30-40 min | -55°C-135°C | Epoxy | D-86 | Download |
| Setworx 60 | 20,000-30,000 | 60-70 min | -55°C-120°C | Epoxy | D-78 | Download |
| Setworx 1510 | 20,000-30,000 | 10-12 min | -55°C-125°C | Epoxy | D-80 | Download |
| UV-8504E | 500-800 | NA | -55°C-200°C | Epoxy | D-78 | Download |
| UV-8300LV | 2,000-4,000 | NA | -55°C-250°C | Epoxy | D-78 | Download |
| UV-8701E | 5,000 – 9,000 | NA | -55°C-250°C | Epoxy | D-78 | Download |
| UB-21 | 750-850 | 2-3 hrs | -55°C-125°C | Urethane | A-88 | Download |
| Setworx U47MP | 12,000-15,000 | 40-60 min | -55°C-120°C | Urethane | D-68 | Download |
1. What makes an epoxy “medical grade”?
A medical-grade epoxy is formulated and tested for use in medical devices. Depending on the application, it may be evaluated for biocompatibility under ISO 10993 or USP Class VI standards. The completed device must still undergo the required regulatory testing.
2. Are medical-grade epoxies biocompatible?
Many medical-grade epoxies have passed specific biocompatibility tests. However, suitability depends on the type and duration of patient contact, the cured formulation, and the device’s intended use.
3. What are medical-grade epoxies used for?
Common applications include bonding needles, catheters, sensors, housings, diagnostic equipment, surgical instruments, and other medical-device components. They may also be used for encapsulation, sealing, and electrical insulation.
4. Can medical-grade epoxies withstand sterilization?
Certain formulations can tolerate sterilization methods such as ethylene oxide, gamma radiation, electron beam, or steam autoclaving. Compatibility should be verified through testing because sterilization can affect adhesion, color, flexibility, and other properties.
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