Regulatory & Licensing Requirements

International standards for product, process and installation qualification for electron beam systems are established and set forth in ANSI/AAMI/ISO 11137 (1994) and EN 552. The site license process for electron beam systems is similar to that associated with other common machine-generated radiation equipment such as medical x-ray machines and oncology therapy equipment. The license is typically issued through a state agency associated with radiological health issues for the given jurisdiction. The license process can be completed within a relatively short time period without need for public notice or special or conditional use permits. Additionally, electron beam equipment does not involve the use of any radioactive materials or isotopes requiring nuclear materials handling licenses from agencies such as the US Nuclear Regulatory Commission.