Medical Certifications

Master Bond EP3HTSDA-2Med is a true one component epoxy that is not pre-mixed and frozen. It offers an easy dispensing profile with an exceptionally long working life at room temperature, making it ideal for streamlining automated assembly. As a silver filled system, it exhibits high electrical conductivity (volume resistivity < 0.001 ohm-cm) and excellent thermal conductivity. This epoxy passes ISO 10993-5 for cytotoxicity and is designed for high-speed medical device manufacturing. EP3HTSDA-2Med cures quickly with heat. Cure schedule options include heating at 250°F for 20-30 minutes or 300°F for 5-10 minutes, with an optional post cure to optimize overall performance properties. The system bonds well to many substrates, including but not limited to metals, ceramics, plastics, and silicon dies. EP3HTSDA-2Med has an excellent physical strength profile. It provides a tensile strength of 3,000-4,000 psi and a tensile modulus of 200,000-250,000 psi. It has a thermal conductivity of 45-49 BTU•in/(ft2•hr•°F) [6.5-7 W/(m·K)]. The filler particles used in this epoxy are exceptionally small, averaging 2-3 microns, and no larger than 25 microns. This allows for very thin bond lines, thereby providing effective heat transfer since it can offer a very low thermal resistance of 2-3 x 10-6 K•m2/W. This epoxy resists many sterilization methods such as glutaraldehyde, ethylene oxide (EtO) and gamma radiation. The system is available in EFD® syringes for automated dispensing or glass jars in 20 grams, 50 grams, 100 grams, 1 pound and multiple pounds.

Master Bond and STERIS collaborated in research to determine the compatibility of Master Bond’s specialty epoxies with Vaporized Hydrogen Peroxide (VHP™) using V-PRO® s2 Low Temperature Sterilization System. This study was recently published in a peer-reviewed journal Polymer-Plastics Technology and Materials. As medical devices have evolved through technological advancements, they have become more complex in both their design and materials of construction. Medical grade biocompatible epoxies are widely used in reusable medical devices. Choosing an epoxy that maintains its performance characteristics when subjected to repeated sterilization throughout the reusable medical device’s lifespan is a known challenge for medical device manufacturers. This study evaluated the material compatibility of seven cured two part and one part epoxies used in medical devices following exposure to 100 cycles in a low temperature vaporized hydrogen peroxide sterilizer. Six of the seven epoxies tested were found to be compatible with vaporized hydrogen peroxide sterilization based on qualitative, hardness and weight measurements conducted post exposure to 100 VHP cycles. The epoxies deemed to be compatible displayed no visual signs of physical defects, minimal reduction in hardness (≤2%) and total weight gain (≤2.9%). This study highlights the importance of conducting material compatibility studies, and continued collaborations (among medical device manufacturers, sterilizer manufacturers and epoxy manufacturers) during the early stages of medical device development to ensure a successful reusable medical device that will withstand repeated sterilization Key Findings from the Study about Master Bond Medical Adhesive Systems The Master Bond EP42HT-2Med, EP42HT-4AOMed Black, EP62-1HTMed, EP41S-5Med, EP4CL-80Med and UV10TKMed epoxies are compatible with low temperature vaporized hydrogen peroxide, as they maintained their surface texture, exhibited less than 2% change in hardness, and displayed less than a 2.5% weight gain post exposure to 100 VHP cycles. To read the experiment and results in its entirety please go to https://www.tandfonline.com/doi/full/10.1080/25740881.2024.2376209 or contact technical support to discuss your application.

Master Bond LED415DC90Med is a one component, dual cure adhesive system designed for high-speed manufacturing of medical electronic devices. It cures rapidly without oxygen inhibition upon exposure to 405 nm LED light, followed by a short 30-45 minute heat cure at 90-95°C, making it well-suited for bonding heat sensitive components. LED415DC90Med passes ISO 10993-5 requirements for non-cytotoxicity and resists common medical sterilants, including glutaraldehyde, peracetic acid, ethylene oxide, and gamma radiation. Unlike conventional dual cure adhesives that limit light penetration to approximately 1 mm, LED415DC90Med can partially cure or fixture sections up to 6 mm deep when exposed to 405 nm LED light at the appropriate intensity and for a sufficient duration. This deeper cure capability enables the fixturing of opaque components by allowing light penetration through the adhesive from the sides. A subsequent cure at 90-100°C for 30-60 minutes is recommended to optimize strength and overall performance. LED415DC90Med has a thixotropic index of 5.53 at room temperature. It exhibits a tensile strength of 5,500-6,500 psi, a tensile modulus of 450,000-550,000 psi, and a lap shear strength exceeding 1,000 psi (aluminum to aluminum). This rigid system cures to a Shore D hardness of 85-90 with an elongation of 1-3% at 75°F. It is serviceable from -80°F to +350°F, electrically non-conductive (volume resistivity > 1014 ohm-cm), and bonds well to a variety of substrates, including plastics, glass, and metals. LED415DC90Med is available in syringes, ½ pint, pint, and quart containers.

Epoxies are known to be resistant to water. A good way to conceptualize this would be to expose the epoxy to water over time and measure its change in weight. This tends to be a good benchmark for feasibility in terms of its resistance to saline and other body fluids.

Manufacturers of wearables and other medical devices can find suitable solutions among a number of medically safe adhesive systems, which are available in a wide variety of chemistries including epoxies, silicones and UV/LED-curable compounds. The use of biocompatible, non-toxic materials to avoid negative effects on skin and tissue, drives a fundamental need for safe adhesive, sealant, coating, and encapsulant compounds. Designed to address these concerns, a class of compounds combines proven biocompatibility and non-cytotoxic characteristics with performance properties required for the manufacture of medical devices and wearables intended for contact with the human body.