Webinars: Medical

Establishing Maximum Acceptable Dose


Manufacturers utilizing ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes need to establish the maximum acceptable dose for the specified product. Compliance to the ISO 11137 standard requires an experimental program that demonstrates that a product treated with the maximum acceptable dose meets its specified functional requirements throughout its defined lifetime.

This 30-minute Webinar focuses on radiation interaction with materials and the proper design of experiments to establish a product’s maximum acceptable dose. It examines why manufacturers should be cognizant of the possible impact of radiation to the product’s mechanical properties and how this may influence performance following sterilization. It also discusses the product manufacturer’s responsibility to show that the product meets its intended performance requirements while being safe and effective.

An audience Q&A follows the technical presentation.


Mike Flanagan, Expert Advisor, Sterigenics