RADIATION PROTECTION N° 162 - European Commission

1 European Commission . RADIATION PROTECTION N 162. Criteria for Acceptability of Medical Radiological Equipment used in Diagnostic Radiology, Nuclear Medicine and Radiotherapy Directorate-General for Energy Directorate D Nuclear Safety & Fuel Cycle Unit D4 RADIATION PROTECTION 2012. This report was prepared by Quality Assurance Reference Centre for the European Commission under contract N . ENER/10/ and represents those organisations' views on the subject matter. The views and opinions expressed herein do not necessarily state or reflect those of the European Commission and should not be relied upon as a statement of the Commission 's views.

2 The European Commission does not guarantee the accuracy of the data included in this report, nor does it accept responsibility for any use made thereof. Europe Direct is a service to help you find answers to your questions about the European Union Freephone number (*): 00 800 6 7 8 9 10 11. (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed. More information on the European Union is available on the Internet ( ). Luxembourg: Publications Office of the European Union, 2012.

3 ISBN 978-92-79-27747-4. doi: European Union, 2012. Reproduction is authorised provided the source is acknowledged. Printed in Luxembourg 2. FOREWORD. Luxembourg, October 2012. The work of the European Commission in the field of RADIATION PROTECTION is governed by the Euratom Treaty and the secondary legislation adopted under it. Council Directive 97/43/Euratom (the Medical Exposure Directive, MED) is the legal act defining the Euratom requirements on RADIATION PROTECTION of patients and of other individuals submitted to medical exposure.

4 The MED requires the adoption of criteria of acceptability for equipment in order to indicate when remedial action is necessary (including, if appropriate, taking the equipment out of service). In 1997 the Commission issued publication RADIATION PROTECTION 91 (RP91) containing a non-binding set of criteria for acceptability of radiological installations. Later Commission guidance on transposition of the MED into national legislation notes that RP91 "gives only the absolute minimum requirements" and that "holders of installations should make effort(s).

5 To adopt more stringent criteria.. The present report (RP162) updates and considerably expands the scope of RP91. The recommended approach to the establishment and the use of criteria for acceptability of radiological equipment, as well as the technical parameters and values contained in the document, have been extensively reviewed and discussed between 2007 and 2012. This was done in many technical meetings involving specialists in different areas, through an open public consultation from January to June 2010 and in a dedicated workshop held in Dublin in September 2011.

6 The final result is a quite extensive set of non-binding criteria that will help holders of radiological installations assess the (continuing) acceptability of the equipment they use and undertake appropriate remedial action, if indicated. The report should also be useful for regulators when deciding on the adoption of national criteria for acceptability of radiological equipment. However, the Commission does not recommend the direct adoption of the RP162 suspension levels in national regulations, as this may pose unnecessarily stringent limitations on the use of equipment.

7 The adoption of regulatory restrictions on equipment use should be based on careful and thorough evaluation of national circumstances. Hence, RP162 should be used by regulators only as an example of criteria to be considered. While primarily intended for holders of radiological equipment in clinical use and for regulators dealing with safety of such equipment, this report could also be useful for wider audiences. These include designers, manufacturers and suppliers of equipment as well as other players involved in different stages of the equipment lifecycle.

8 The publication of this report in the Commission 's RADIATION PROTECTION series of publications has been recommended by the Group of Experts established under Article 31 of the Euratom Treaty. It is our hope that it will contribute to a continuous improvement of the PROTECTION of the health of the European citizens against the risks accompanying the growing and generally beneficial use of ionising RADIATION in medicine. Augustin Janssens Head of RADIATION PROTECTION Unit Directorate General for Energy 3. CONTENTS.

9 FOREWORD .. 3. CONTENTS .. 5. 1 INTRODUCTION .. 9. Background and purpose .. 9. Basis for criteria for acceptability in the European directives .. 11. Requirements of the Medical Exposure Directive (MED) .. 11. Requirements of the Medical Devices Directives (MDD) and equipment standards .. 13. To whom this document is addressed .. 14. Clarification of terminology and equipment lifecycle .. 14. Criteria for acceptability .. 16. Approaches to criteria .. 16. Identifying and selecting suspension levels .. 17. Special considerations, exceptions and exclusions.

10 19. Special considerations .. 19. Old equipment .. 19. Rapidly evolving technologies .. 19. Exclusions .. 20. Establishing conformity with criteria for acceptability .. 21. Wider issues for the hospital, the MPE and the regulator .. 22. Conclusions .. 22. 2 Diagnostic Radiology .. 23. Introduction .. 23. X-ray generators and equipment for general radiography .. 23. Introductory remarks and qualitative criteria .. 23. Suspension levels for X-ray generators and general 25. Radiographic image receptors .. 29. Introductory remarks.