Evaluation of potential induced activity in medical devices sterilized with electron beam irradiation as a function of maximum electron energy

Commercial sterilization of medical devices may be performed using electron beam irradiators, which operate at various electron energies. The potential for activating components of the devices has been discussed, with current standards stating that an electron energy greater than 10 MeV requires assessment of potential induced radioactivity. There does not appear to be a literature citation for this energy limit, but it is the accepted default assumption within the industry.

This research was directed at evaluating potential activation in medical products sterilized in electron beam as a function of the electron maximum energy. Monte Carlo simulation of a surrogate medical device was used to calculate photon and neutron fields resulting from electron irradiation, which were used to calculate concentrations for several radionuclides.

The predominant mechanism for inducing radioactivity is photoneutron production in metal elements. Other mechanisms, including photoneutron production in deuterium with subsequent neutron capture, neutron capture of the photoneutrons produced in metal elements, and isomeric excitation, are all possible means of inducing radioactivity in similar conditions, but none made a perceptible contribution to activation in these experiments.

The experiments confirmed that 10 MeV is a conservative assumption that any lower energy does not create significant activation. However, in the absence of a limited number of elements, the amount of induced radioactivity at 11 MeV and 12 MeV could also be considered insignificant. When based on an estimate of the amount of metal present in a medical device, the sum-of-fractions comparison to the US Nuclear Regulatory Commission exempt concentration limits is less than unity for all energies below 12.1 MeV, which suggests that there is minimal probability of significant induced activity at energies above the generally-accepted standard 10 MeV upper energy limit.