Criteria for acceptability of medical radiological equipment in Euratom legislation

The treaty establishing the European Atomic Energy Community ('Euratom Treaty') is binding primary law for 27 member states of the European Union (EU) with about 500 million inhabitants. Council Directive 96/29/Euratom is a secondary EU law establishing the Basic Safety Standards (BSS) for protection of the health of workers and the general public. The BSS Directive is supplemented by other binding instruments, medical exposure being regulated under Council Directive 97/43/Euratom ('Medical Exposures Directive', MED). MED, Article 8 (3), stipulates that the EU member states shall adopt criteria of acceptability for medical radiological equipment in order to indicate when action is necessary, including taking the equipment out of service. A few years ago, the European Commission ('the Commission', EC) started a revision of the Euratom BSS encompassing, among others, a codification of similar legal acts including MED. The draft legal proposal contains a number of changes on medical exposure and, while no amendments have been made on the criteria for acceptability, some of them (e.g. those concerning the requirements for equipment in use and the involvement of the medical physics expert) may have a direct influence in this area. The Commission submitted the revised Directive to the Council of the European Union in September 2011; the adoption depends on the procedures in the Council. In order to facilitate the implementation of MED, Article 8 (3), in 1997 the Commission published 'Radiation Protection 91: Criteria for acceptability of radiological (including radiotherapy) and nuclear medicine installations'; an update of RP 91 was launched in 2007 and planned for publication in early 2012 (as RP 162).