Prerequisites for a safety licence

In practices subject to a safety licence, the undertaking shall carry out a safety assessment concerning the radiation practice. The Radiation and Nuclear Safety Authority (STUK) confirms the safety assessment either as part of granting the safety licence or separately. The safety assessment shall be prepared in writing and kept up to date. 

The undertaking using radiation shall identify and estimate the radiation exposure caused to workers, the general public and, in health care, to patients. The resulting radiation exposure is assessed not only in terms of normal practice, but also in terms of possible deviations. In addition, an assessment has to be made on how the identified radiation safety deviations could cause exposure. With regard to radiation safety deviations, the undertaking must identify in advance the means for preventing the deviations and limiting the resulting radiation exposure. The undertaking must also assess how to return to safe practice after a deviation.   

Radiation exposure and estimated potential exposure are used to determine categories for workers, the general public and for medical exposure. The undertaking also determines the categories of the radiation sources used in the practice. The undertaking draws this information together in a written safety assessment of the radiation practice, which STUK will validate as part of the granting of the safety licence.  

The undertaking must regularly update the safety assessment after its validation. The updated safety assessment shall be sent to STUK for validation if any changes take place in the previously validated category of workers, members of the public or medical exposure. In addition, the updated safety assessment shall be sent to STUK along with an application for a change of the safety licence if the radiation practices change in a way that changes the category of the workers, members of the public or medical exposure. 

For more information and assistance in preparing a safety assessment, please refer to the following instruction prepared by STUK: Näin laadit turvallisuusarvion (How to prepare a safety assessment, in Finnish and Swedish, pdf) 

To ensure radiation-safe operating methods, the responsibilities and tasks of the parties involved in the practice must be clearly defined. In addition, the flow of information between the parties must be effective. 

Responsibility for the safety of radiation practice lies with the undertaking. In practice, the undertaking is the party with the highest decision-making authority in the organization. The undertaking can be a natural person, but can also be a limited liability company, a foundation or a wellbeing services county, for example.  

The undertaking is responsible for the radiation safety of its practice, but may assign tasks and responsibilities both within the organization and to external experts. The management system of a radiation practice defines the organization's structure, authority and procedures related to decision-making and the flow of information.  

The management system must include the following information: 

• Who has been appointed as the radiation safety officer (RSO) and what are his/her responsibilities and duties? Eligibility to act as a radiation safety officer varies depending on the way radiation is used and what is the target of the radiation. Furthermore, a deputy RSO has to be appointed in demanding operations if the operations have been classified as class 1 on the basis of the resulting or potential exposure. 
• Which persons or occupational groups are involved in the use of radiation, and what education and qualification requirements apply to them? The organization must also state what kind of training they have received and how the tasks and responsibilities are divided. 
• What measures and methods are used to ensure a smooth flow of information within the organization? This is particularly important in cases in which the radiation user's organization is large and daily or other regular interaction might not take place naturally. 
• How to ensure a good safety culture, i.e. that the whole organization commits to radiation-safe operating methods? This is particularly true for large organizations that have several uses of radiation in different locations and possibly also several safety licences. 
• How and under what circumstances will experts be used if the radiation user's organization does not have a radiation safety expert or a medical physics expert? This is particularly important in situations where experts are used regularly and frequently. It is important to identify situations in which the use of an external expert is necessary. 

Considering the variation in the size and form of organizations 

The use of radiation is often a part of wider operations. In these cases, it is often sensible to integrate radiation safety matters into the overall operations management system. Undertakings like these might not have a separate management system for radiation practices, but the requirement of the Radiation Act can nevertheless be interpreted as being met. Undertakings like these must submit sufficient information to STUK in connection with the application for a safety licence. 

If only a few persons are involved in the use of radiation, the safety licence only needs to specify the duties and responsibilities of the radiation safety officer and any other persons involved in the use of radiation, including their qualification and training requirements. In this case, it can be assumed that the radiation safety officer is responsible for radiation safety and takes care of the related duties and obligations, unless otherwise indicated. This does not remove the obligation use external experts when necessary. 

As the size of an organization grows, special attention should also be paid to the flow of information in addition to the division of tasks and responsibilities. This must also be reflected in the information provided to STUK about the management system. Similarly, the commitment of the entire organization to radiation-safe operating methods is particularly important in large organizations whose use of radiation may be divided into several safety licences. 

If the people and occupational groups involved in a radiation practice change substantially, it may be necessary to update and expand the information in the management system. The information may need to be updated, especially with regard to the information submitted to STUK. If the number of personnel changes, but the occupational groups and the described responsibilities remain unchanged, no changes need to be made to the management system.  

Quality assurance refers to all planned and systematic actions necessary to provide adequate confidence that quality requirements are fulfilled. The undertaking determines the desired and necessary level of quality targets that ensures safe practice. Quality assurance also allows the undertaking to determine whether the applicable regulatory requirements have been met. However, this level does not usually guarantee the high quality of operations.

Quality assurance aims to anticipate possible operational weaknesses and to ensure that radiation safety is not compromised under any circumstances. There can be many quality assurance measures. Drawing them together into a single quality assurance programme allows the undertaking to determine the adequacy of the measures while avoiding unnecessary repetition.

Quality assurance methods must monitor both operational and technical aspects. An example of operational quality assurance is a systematic verification that the relevant instructions are up-to-date. Technical quality is typically ensured by carrying out tests and checks. The quality assurance programme must contain instructions on how to perform technical testing and checking of radiation sources and of any equipment, software and supplies that have an effect on safety. 

The quality assurance programme specifies: 

• the quality assurance measures 
• procedures for performing the quality assurance measures 
• intervals for performing the quality assurance measures 
• action limits 
• actions to take when the action limits are exceeded 
• responsibilities for the implementation of measures and actions under the programme. 

The undertaking must also document the results of the quality assurance measures. This can be as simple as a tick-a-box form. The up-to-dateness of the quality assurance programme has to be regularly assessed. 

The regulations lay down some requirements for the frequency of quality assurance measures. However, the undertaking must consider whether the statutory frequencies are sufficient for their practice or whether quality assurance should be carried out more frequently or more comprehensively. It is also a good idea to use a radiation safety expert to help with this. If organisation operates in the field of health care, also a medical physics expert should be involved. 

STUK's instructions and manuals and the applicable ISO standards can help to create a quality assurance programme for a radiation practice. The documents can provide hints and tips for your practice, even if the practice on the whole is not compliant with the standard or accredited. Some examples of useful documents are ISO 9001 Quality Management and the ISO 17025 General requirements for the competence of testing and calibration laboratories. If the quality management of the practice is compliant with the ISO standard, the requirements of the Radiation Act are also met in practice.

When an undertaking intends to start a new type of radiation practice subject to a safety licence, it has to demonstrate that a justification exists for the practice. In many cases, the intended use of radiation is similar to what has already been practised in Finland and what is still considered to be justified. The purpose of the lists below is to help the undertaking to consider whether a justification assessment is necessary for a new use of radiation.

Generally justified use of radiation

The following describes the generally justified uses of radiation. “Generally” means that the use of radiation does not involve any unusual features concerning the intended use of radiation, sources of radiation, working methods, radiation safety, security arrangements or radioactive waste or emissions generated by the operations.

If the use of radiation is “generally justified”, it is not necessary to determine whether the practice is justified when commencing the practice. However, the use of radiation has to meet all the conditions laid down in the Radiation Act for granting a safety licence.

The generally justified uses of radiation are as follows:

• use of radiation exempt from a safety licence (section 49 of the Radiation Act)
• the use of radiation sources (sealed and unsealed sources and equipment containing them, as well as equipment that generates radiation electrically)
  • in research, when the radiation is not targeted at people
  • calibration and inspection of radiation meters
  • in education as a teaching, demonstration and training tool

• trade, import, export and shipment of radiation sources
• installation, maintenance, repair and manufacture of radiation sources
• transport of radiation sources

• the use of sealed sources and equipment that generates radiation electrically
  • for controlling and monitoring of industrial processes
  • for quality control of raw materials, products and waste
  • in analyses of properties of substances
  • industrial imaging and similar imaging, when the radiation is not targeted at people
  • irradiation of products, except foodstuffs

• use of unsealed sources in tracer tests for industrial processes, except in water supply networks that supply household water 

• treatment and rendering harmless of radioactive waste¹⁾
• use of equipment that generates radiation electrically
  • in the manufacture of radioisotopes
  • in ion implantation
  • in veterinary imaging
  • in security checks when the radiation is not targeted at people.

¹⁾ The assessment of the justification of a radiation practice must also take into account any waste generated and the exposures arising from its management. When a radiation practice is justified, the treatment and rendering harmless of the radioactive waste generated by that practice is also justified.

Unjustified uses of radiation

The unjustified practices presented below are based directly on the Radiation Act (section 68, Prohibitions of Use) and on individual decisions made by STUK.

Unjustified uses of radiation are as follows:

• deliberate use of radioactive substances²⁾ in the following products and the import, export and shipment of such products (Radiation Act, section 68):
  • foodstuffs as referred to in the Food Act
  • animal feed as referred to in the Feed Act
  • cosmetic products as referred to in Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products
  • jewellery and other equivalent personal accessories
  • toys as referred to in the Toy Safety Act (1154/2011)
  • in the tracer tests carried out in water supply systems, the water of which is used as household water

• the use of a high-activity sealed source without assessing the possibility of substituting it with a an appliance generating radiation electrically or some other alternative technology (section 75, subsection 2 of the Radiation Act).

²⁾ this also applies to practices in which the increase of radioactivity derives from the activation of consumer goods or the material used in the manufacture of the consumer goods.

In addition, STUK has refused to grant a safety licence for the following uses of radiation because STUK has considered them to be unjustified:

The lists of justified and unjustified practices are updated on the basis of the justification assessments carried out.

Sometimes people can have x-rays for non-medical reasons. In non-medical imaging, the examination is carried out practically in the same way as in a medical examination, but the imaging unit must have a safety licence that also covers these examinations. In practice, this means that the operator must apply for a licence amendment. As a result, a single safety licence for health care x-ray practices would apply to two separate exposure categories: medical imaging exposure and non-medical imaging exposure.

Non-medical imaging causing exposure may include:

• health examinations using a method involving the use of radiation for immigration purposes
• age assessment with a method using radiation
• the use of ionizing radiation to identify objects concealed in the human body
• health examinations using a method involving the use of radiation for recruitment purposes.

When the operator applies for a licence amendment, they must provide a report on the practice and its justification assessment, unless the justification of the examination in question has already been established in general. The table below lists the examinations which lead to non-medical exposure deemed justified by STUK to date. There is no need to carry out a separate justification assessment for these examinations in connection with the licence application. However, a justification assessment must be carried out if the practice results in non-medical exposure and involves examinations other than those listed in the table. A justification assessment must also be carried out if the examinations listed in the table are carried out by methods other than those indicated in the table.

The operator must assess whether the non-medical exposure is justified at least every five years.

Table: Examinations which lead to non-medical exposure deemed justified by STUK.