Medical device manufacturers using ionizing radiation (gamma, electron beam or X-Ray) for sterilization purposes should establish the maximum acceptable dose for the specified product. Manufacturers must comply with the ISO 11137 standard, which 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.
Quality Assurance, Project Management, R&D, Sterility Assurance, Engineering and Validation personnel will benefit from this whitepaper that includes a “Sample Use Case”.
