Medical device manufacturers using ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the maximum acceptable dose for the specified product. Compliance with the ISO 11137 standard requires an experimental program to demonstrate that, when treated with the maximum acceptable dose, the product meets its specified functional requirements throughout its defined lifetime. This whitepaper will focus on radiation interaction with materials and the proper design of experiments to establish a product’s maximum acceptable dose.
Readers will learn about the different aspects of radiation interaction with materials and how these interactions may influence the mechanical properties and performance of the product post-sterilization. The whitepaper will cover the critical steps involved in designing and executing experiments to determine the maximum acceptable dose, ensuring that the product remains safe and functional over its intended lifespan.
Professionals involved in quality assurance, R&D, sterility assurance, and validation will gain valuable insights into optimizing their radiation sterilization processes. This knowledge will help them comply with regulatory requirements and ensure that their products are safe, effective, and reliable.