Validation and Process Control for Electron Beam Sterilization (course)

Validation and Process Control for Electron Beam Sterilization

21 – 25 May 2012 
3 - 7 September 2012

Risø High Dose Reference Laboratory
Risø – DTU, Technical University of Denmark
DK 4000 Roskilde, Denmark



It is necessary to comply with the requirements of the international radiation sterilization standard EN ISO 11137 in order for medical devices to be approved. In Europe this concerns CE-marking in accordance with the Medical Device Directive, and other national regulatory agencies, such as the FDA in USA, also use this standard for approval of medical devices.

This Risø course gives background for understanding the requirements of EN ISO 11137.

The emphasis of this course is on high energy (10 MeV) electron beam sterilization, but aspects of low energy (100 keV) electron beam and of gamma sterilization will also be discussed.

The focus of the course is on two aspects:

        1. Dosimetry as required in

            - IQ/OQ, Installation / Operational Qualification  
            - PQ, Performance Qualification  
            - Routine monitoring and Process Control

        2. Establishing the sterilization dose


Using the methods described in EN ISO 11137, part 2

Validation and process control for electron beam sterilization course information

Validation and process control for electron beam sterilization course week plan 

Validation and process control for electron beam sterilization course registration forms

Page updated  by   19.12.2011


Arne Miller
Professor
Radiation Research (NUK)
Dir tel+45 46774224


Jakob Helt-Hansen
Senior scientist
Radiation Research (NUK)
Dir tel+45 46774908