877-259-1669 info@resinlab.com Adhesives Encapsulants Services Resources About Contact Us Request a Quote Medical Device Assembly Medical devices undergo rigorous testing to determine their biocompatibility whenever they are expected to have contact with the human body. In order to improve medical device security, a series of standards were developed by the International Standards Organization called ISO 10993. The most common screening test for the biocompatibility of a medical device adhesive is the cytotoxicity test specified under ISO 10993-5. This is a relatively fast and inexpensive test where a sample of the cured adhesive in placed in vitro with animal tissue cells without exposing live animals to testing. After a specified length of time and conditions, the cells are examined for any toxic effects and have a high correlation with actual animal testing. If little or no bioreactivity is observed, the adhesive is deemed safe for medical device assembly. ISO 10993-5 Certified Adhesives ResinLab has submitted several products for ISO 10993-5 testing that have shown no cytotoxic effect and are therefore approved for medical device assembly. Test reports are available upon request. Other ResinLab adhesives have the potential for this approval but have not been tested to date. ResinLab is willing to invest in ISO 10993-5 testing for adhesives with the likelihood of approval and opportunities for use in medical device assembly applications. Product Color Viscosity (cps) Specific Gravity Shear Strength (psi) Cure Speed (fixture/full cure) CA5011 Clear 40 - 80 1.10 400 - 2,000 5 - 30s/24h CA5013 Clear 120 - 170 1.10 580 - 2,000 5 - 30s/24h CA5015 Clear 735 - 775 1.10 435 - 2,030 5 - 30s/24h EP750LV Clear 2,500 1.09 1,500 24 - 72h UR6060 Clear 1,050 1.34 400 - UR7001 Clear 10,500 1.17 1,000 - 2,500 - UV7818M Clear 385 1.02 285 10 - 20s with UV light exposure Adhesives Encapsulants Services Resources Request a Quote About Careers Terms & Conditions Privacy Policy GHS Statement 877-259-1669 info@resinlab.com N109 W13300 Ellsworth Drive Germantown, WI 53022 © 2021 RESINLAB LLC, ALL RIGHTS RESERVED This site uses cookies to provide you with the best possible experience. By clicking 'Accept', you read our Privacy Policy and consent to our terms, including the use of cookies. ACCEPT