Radiation Criteria for Acceptability of Medical Radiological Equipment Used in Diagnostic Radiology, Nuclear Medicine and Radiotherapy, update of European Commission publication Radiation Protection 91, 1997
Consultation period: 25/01/2010 - 30/06/2010
Objectives of the consultation
Council Directive 97/43/EURATOM on health protection of individuals against the dangers from ionizing radiation in relation to medical exposure stipulates that the EU Member States' competent authorities shall adopt specific criteria of acceptability for equipment in order to indicate when appropriate remedial action is necessary, including, if appropriate, taking the equipment out of service. In order to facilitate the implementation of this requirement in the EU Member States, in 1997 the Commission published Radiation Protection 91: Criteria for acceptability of radiological (including radiotherapy) and nuclear medicine installations (RP 91) [104 KB] All available translations.. This publication specified minimum criteria for acceptability and has been used to this effect in legislation, codes of practice and by individual professionals throughout the member states and elsewhere in the world.
However, development of new radiological systems and technologies, improvements in traditional technologies and changing clinical/social needs have created circumstances where the criteria of acceptability need to be reviewed to ensure the principles of justification and optimization are upheld. To give effect to this, in 2007 the Commission initiated a study* aimed at reviewing and updating RP 91, which in due course has led to the development of the present publication.
The final results of the study initiated in 2007 have been presented to the Commission and to the EURATOM Article 31 Group of Experts in mid-2009 and have been judged to be of a very high quality and fully satisfactory to the objectives of the update study. However, following advice from Article 31 Group of Experts, the Commission decided to do not proceed with the immediate publication of the document in its Radiation Protection series but to allow for a public consultation of the draft document, followed by a European workshop. This decision has been motivated by the quite expanded scope of the equipment covered by the document, the very detailed technical information included and the possible difficulties that the Member States may have to implement these new recommendations.
In view of the European Workshop planned for the last quarter of 2010, the Commission is launching this public consultation of the draft publication Radiation Protection 162: Radiation Criteria for Acceptability of Medical Radiological Equipment Used in Diagnostic Radiology, Nuclear Medicine and Radiotherapy. Comments are expected from Member States' competent authorities, relevant professional bodies, industry, standardization organizations and international organizations. To submit your comments, please use the comment form below. Comments should be sent to TREN-LUX-H4-RADIATION-CRITERIA@ec.europa.eu prior to 30 June 2010.
* Dr Keith Faulkner coordinated the overall project and Professor Jim Malone (Introduction and Diagnostic Radiology Lead), Dr Stelios Christofides (Nuclear Medicine Lead) and Professor Stephen Lillicrap (Radiotherapy Lead) coordinated the work in the specialist areas indicated.