SAMIRA study on criteria for acceptability of medical radiological equipment (CARE). Survey results on European Union national legislations/regulations.

PURPOSE: The objective of this study was to understand how the European Commission (EC) publication RP 162: Radiation Criteria for Acceptability of Medical Radiological Equipment is currently implemented at the national level in European legislations/regulations and to gather information on national standards related to acceptability criteria since the publication of RP 162.

METHODS

A survey was designed to gather information on the application of RP 162 and the existing formal national regulations on acceptability criteria in Europe. The survey was addressed to the presidents or secretary generals of the 37 national member organizations belonging to the European Federation of Organisations for Medical Physics.

RESULTS

Overall, 31 answers from the 37 contacted organisations were received (84%). Considering European Union (EU) countries, the response rate was 96%. Seven EU countries declared to use RP 162 as the main source of acceptability criteria, and 12 countries use it in part and in conjunction with other sources. On the contrary, 7 EU countries reported not using RP 162. A synoptic table with the national regulation regarding acceptability criteria was compiled.

CONCLUSIONS

The results of this survey indicate that RP 162 is still in total or partial use in almost three-quarters of EU countries, despite the significant time elapsed since publication. An updated RP 162 will ensure that the criteria reflect the latest technological capabilities and regulatory requirements, maintaining high standards of safety and effectiveness in medical radiological practices and possibly improving the homogeneity in suspension levels throughout the EU.