Requirements during the use of radiation devices
In addition to the EEC Treaty and product Directives, radiation-producing devices and radioactive materials fall within the scope of the European Atomic Energy Community (EURATOM) Treaty. On the basis of this treaty, Directives are given on the use of radiation devices and radioactive materials.
The most important directives adopted on the basis of the EURATOM treaty are the Directive 96/29/Euratom (so-called Basic Safety Standards (BSS) Directive), which covers the protection of labour and population, and the Directive 97/43/Euratom (so-called Medical Exposure (MED) Directive), which covers the use of radiation for medical purposes.
The BSS Directive establishes a regime of control including prior authorisation of the use of devices which produce radiation and of radioactive materials. The MED Directive also sets requirements on the use and regulation of radiological equipment. The BSS Directive has been transposed to Finnish legislation with amendments to the Radiation Act (1142/1998) and to the Radiation Decree (1143/1998). The MED Directive is transposed by the decree of the Ministry of Social Affairs and Health (423/2000). Details instructions are also given in STUK’s ST Guides.
According to the Radiation Act (592/1991), the use of radiation requires a safety licence issued by STUK, unless the use is specifically exempted. The Radiation Act authorises STUK to give general instructions concerning the safety of radiation practices and operations involving radiation. These instructions are given in a set of guides know as Radiation Safety Guides (ST Guides). The operator is responsible for safety of a radiation practice. The operator has a duty to ensure that radiation legislation and associated instructions are adhered to, and that the level of safety spesified by them is attained and maintained.
STUK sets acceptability requirements for radiation devices as safety requirements for their use. These refer to the set of minimum performance requirements whose values are applied as action levels in the use of radiation. If an action level is exceeded, measures shall be taken to repair the device or, if necessary, the device has to be taken out of use.
Acceptability requirements are not limit values for optimum performance capability and are not principally the tolerance values given in international standards. In context of purchasing new equipment, making acceptance tests and performing quality control measures, the users should use more stringent requirements which can be based on device specifications or tolerance values given in the standards.
Regulatory control of use of radiation
