What is Medical Grade Epoxy?
Medical devices undergo rigorous testing to determine biocompatibility, particularly for components and assemblies that come into direct or indirect contact with the human body. Manufacturers of these devices typically seek medical grade adhesives—such as epoxies and light-curing systems—that have undergone thorough screening to ensure they meet the requirements for biocompatible adhesives. This ensures the final product will pass all necessary compatibility testing.
ISO 10993 is a series of evaluations designed to assess various aspects of biocompatibility, with ISO-10993-5 being the standard test for polymers and medical adhesives, evaluating cytotoxicity. Another widely recognized standard is USP Class VI, which ensures that no harmful reactions or long-term effects occur from chemicals that may leach from materials. USP Class VI adhesives are tested under standards developed by the United States Pharmacopeia and National Formulary (USP-NF), the governing body responsible for the quality and safety of medical devices and materials. In recent years, ISO-10993 has become the more commonly used benchmark in the industry.
Epoxyset offers a range of medical epoxy adhesives and UV light curable medical adhesives that have passed ISO-10993-5 and USP Class VI testing. Below are products that meet these standards and are suitable for use in medical device assembly.
