Table of contents
- Chapter 1 General provisions
- Section 2 Exposures to be accounted for in the justification assessment and the optimization of radiation protection
- Section 3 Assessment of overall benefit
- Section 4 Individual justification assessment of medical exposure
- Section 5 Justification of non-medical imaging exposure
- Section 6 Justification for consumer goods
- Section 7 Statements and other reports on the justification of practices
- Section 8 Limitation of exposure in the optimization of radiation protection
- Section 9 Optimization of the radiation protection of a research subject taking part in medical research
- Section 10 Optimization of carer’s and comforter’s radiation protection
- Section 11 Release of a patient who emits radiation
- Section 12 Calculation and determination grounds for radiation exposure
- Chapter 3 Dose limits
Obligations of the undertaking
- Section 16 Categorization of radiation practices
- Section 17 Use of a radiation safety expert
- Section 18 Areas of radiation safety expert’s use
- Section 19 Use of a medical physics expert
- Section 20 Areas of medical physics expert’s use
- Section 21 Co-operation between experts
- Section 22 Human resources
Safety licence and security
- Section 23 Information to be provided in the application for a safety licence
- Section 24 Inquiries and notifications concerning the import and export of a high-activity sealed source
- Section 25 Amending a safety licence
- Section 26 Notification of changes to a practice subject to a safety licence
- Section 27 Practices exempt from a safety licence
- Section 28 Prerequisites for exemption from a safety licence
- Section 29 Furnishing security
- Chapter 6 Waste and discharges
- Section 34 Classification of radiation workers
- Section 35 Classification of working areas
- Section 36 Requirements for controlled areas
- Section 37 Requirements for supervised areas
- Section 38 Recording the results of radiological surveillance
- Section 39 Outside worker working in a controlled area
- Section 40 Storing the results of radiological surveillance and individual monitoring
- Section 41 Protection during pregnancy and breastfeeding
- Section 42 Information to be stored in workers’ dose register
- Section 43 Requirements applicable to monitoring document
- Chapter 8 Non-medical imaging exposure
- Chapter 9 Emergency exposure situations
- Chapter 10 Existing exposure situations
- Chapter 11 Natural radiation
- Chapter 12 Approval of dosimetry service and other radiation measurements
- Chapter 13 Inspection programme of STUK
- Chapter 14 Advisory Committee on Radiation Safety
- Chapter 15 Entry into force
Translation from Finnish
Legally binding only in Finnish and Swedish
Ministry of Social Affairs and Health, Finland
Government Decree on Ionizing Radiation 1034/2018
By the decision of the Government, the following is enacted under the Radiation Act (859/2018):
Chapter 1 General provisions
Section 1 Limitation of scope of application
This Decree does not apply to non-ionizing radiation.
Chapter 2 General principles
Section 2 Exposures to be accounted for in the justification assessment and the optimization of radiation protection
The justification assessment of a radiation practice and the optimization of radiation protection within a radiation practice shall take into account occupational exposure, public exposure and medical exposure.
The justification assessment of individual medical exposure shall not take into account occupational exposure and public exposure.
In an emergency exposure situation and an existing exposure situation, the justification assessment of protective actions and the optimization of radiation protection must take into account occupational exposure and public exposure prior to, during and after the protective actions.
The justification assessment and optimization of radiation protection referred to in subsections 1 and 3 must also take into account the waste generated as well as the radiation exposure arising from the related waste management.
Section 3 Assessment of overall benefit
An assessment of the overall benefit referred to in section 5 of the Radiation Act (859/2018) must consider the health benefit to the individual being exposed and the benefits to the society.
An assessment of detriments must account for radiation exposure and the resultant health detriments, environmental detriments as well as detriments to property and the functionality of society.
Section 4 Individual justification assessment of medical exposure
The justification of medical exposure arising from an examination, a procedure or treatment must be assessed individually in advance. The assessment must account for the purpose and specific objectives of the examination, procedure or treatment as well as the characteristics of the person subject to it. An assessment of the benefits and detriment must take into account the alternative methods available for achieving the purpose of the examination, procedure or treatment as well as the effectiveness, benefits and risk factors of these methods.
For the purposes of medical research as referred to in the Medical Research Act (488/1999), the medical exposure caused to the research subject must be assessed and justified in advance.
Section 5 Justification of non-medical imaging exposure
The grounds for the justification of the method and individual application of exposure as referred to in Chapter 14 of the Radiation Act must be provided. The grounds must account for, in addition to what is provided in section 4, subsection 1, societal values and ethical considerations.
Section 6 Justification for consumer goods
The justification assessment concerning the manufacture, import and transfer of consumer goods causing exposure to ionizing radiation must consider:
1) the applicability of the consumer goods’ characteristics and performance for the intended use;
2) the consumer goods’ design and technical characteristics with which the radiation exposure and potential exposure attributable to the goods can be minimized in normal use and in any possible misuse;
3) the need for a safety license concerning the use of the consumer goods and a possible exemption from a safety licence;
4) the consumer goods’ compliance with requirements;;
5) the need for rendering harmless any radioactive waste arising from the consumer goods;
6) the appropriateness of the consumer goods’ markings;
7) information and instructions to be provided to the consumer on the consumer goods’ safe and appropriate use and on rendering radioactive waste harmless.
Section 7 Statements and other reports on the justification of practices
As part of the justification assessment of a new type of radiation practice as referred to in section 24 of the Radiation Act, the Radiation and Nuclear Safety Authority (hereinafter STUK) requests, unless it is clearly not necessary for the resolution of the matter, a statement from:
1) the Advisory Committee on Radiation Safety;
2) the Data Protection Ombudsman, if the practice involves factors related to data protection;
3) key stakeholders, as necessary, on whom the intended practice may have an impact.
In addition, STUK requests, when necessary, a report from an expert institution or some other expert on the technology and safety of the appliance or method meant for practice referred to in subsection 1.
The undertaking must ensure that STUK has an opinion at its disposal for the purposes of the justification assessment referred to in section 24 of the Radiation Act from:
1) an ethics committee referred to in the Medical Research Act if radiation is intentionally directed at a human being within the said Act’s scope of application;
2) the National Institute for Health and Welfare on the assessment of a health care method, in the case of a new type of medical exposure method involving exposure to a large part of the population, or which causes a high level of medical exposure.
The ethics committee hears experts on the medical use of radiation in a matter referred to in subsection 3, paragraph 1.
Section 8 Limitation of exposure in the optimization of radiation protection
The optimization of radiation protection referred to in section 6, subsection 1 of the Radiation Act with regard to occupational and public exposure shall be carried out in such a way that the magnitude of the dose to a person, the probability of the exposure and the number of exposed persons are kept as low as reasonably achievable taking into account current knowledge and technology as well as economic and societal factors.
Unnecessary medical exposure shall be avoided. In this respect, the following must be taken in consideration:
1) the selection of appliances;
2) the selection of parameters affecting the performance of the appliance;
3) the determination of the patient dose and the measurement of the activity of the radiopharmaceutical to be administered to the patient;
4) quality assurance.
Section 9 Optimization of the radiation protection of a research subject taking part in medical research
The radiation exposure of a research subject taking part in medical research as referred to in the Medical Research Act must be planned individually if the health of the research subject is expected to gain medical benefit from the examination, procedure or treatment. A dose constraint must be applied to an individual who is not expected to gain direct medical benefit from the radiation exposure caused by the research.
Section 10 Optimization of carer’s and comforter’s radiation protection
A carer and comforter must be instructed and protected in such a way that their radiation exposure remains as low as reasonably achievable.
Section 11 Release of a patient who emits radiation
In the event that medical exposure is attributable to a radiopharmaceutical or a sealed source implanted in the patient, the individual subject to the radiation exposure may not be released until the dose arised from the radioactive substance in the body to the carer or comforter or members of the public is expected to remain less than the dose constraint.
The physician responsible for the medical exposure is responsible for the patient’s release and for providing the patient or their representative with written instructions on how to prevent unnecessary exposure to individuals in contact with the patient.
Section 12 Calculation and determination grounds for radiation exposure
The calculation method used for the determination of radiation exposure must be suitable for the purpose and proven as reliable.
Radiation exposure must determined with the calculation and determination grounds provided in Annexes 1–3.
Chapter 3 Dose limits
Section 13 Dose limits for a radiation worker
The effective dose of a radiation worker may not be higher than 20 millisieverts a year.
The equivalent dose of the lens of the eye may not be higher than 100 millisieverts during a time period of five consecutive years. However, during a single year, the dose may not be higher than 50 millisieverts.
The equivalent dose of skin may not be higher than 500 millisieverts a year as an average dose on one square centimeter size of the most exposed skin area.
The equivalent dose of hands, arms, feet and ankles may not be higher than 500 millisieverts a year.
Section 14 Dose limits for members of the public and a comparable worker
The effective dose of members of the public attributable to radiation practices may not be higher than 1 millisievert a year.
The equivalent dose of the lens of the eye may not be higher than 15 millisieverts a year.
The equivalent dose of skin may not be higher than 50 millisieverts a year as an average dose on one square centimeter size of the most exposed skin area.
What is provided in subsections 1–3 also applies to a worker who is not a radiation worker, an emergency worker or an emergency helper.
Section 15 Dose limits for students and apprentices
When a student or apprentice participates in the use of radiation sources according to what is provided in section 99 of the Radiation Act, the effective dose caused may not be higher than 6 millisieverts a year.
The equivalent dose of the lens of the eye may not be higher than 15 millisieverts a year.
The equivalent dose of skin may not be higher than 150 millisieverts a year as an average dose on one square centimeter size of the most exposed skin area.
The equivalent dose of hands, arms, feet and ankles may not be higher than 150 millisieverts a year.
Any apprentices and students who have turned 18 and who have to use radiation sources in their work during their studies are subject to the dose limits of a radiation worker provided in section 13.
Other apprentices and students are subject to the dose limits of members of the public and a comparable worker provided in section 14.
Chapter 4 Obligations of the undertaking
Section 16 Categorization of radiation practices
The categorizations concerning radiation practices referred to in section 27 of the Radiation Act must be carried out separately for occupational exposure, public exposure and medical exposure. For the purpose of the categorization, the radiation exposure from normal operations and the potential exposure from radiation safety deviations must be considered.
In addition, a categorization based on radiation sources shall be made for unsealed sources in laboratories, discharges of radioactive substances, sealed sources and waste to be disposed of in the form of mounding.
The category of the radiation exposure and radiation source may be 1, 2 or 3. Category 1 is equivalent to the highest and category 3 to the lowest radiation exposure, activity of the radiation source or amount of waste or activity concentration. If the practice in question does not include a radiation exposure or radiation source functioning as a basis for the categorization, the category of the radiation exposure or radiation source is E. The categorizations of radiation exposures and radiation sources are provided for in Annex 4.
Section 17 Use of a radiation safety expert
The undertaking must ensure that the radiation safety expert is:
1) closely involved in the radiation practice if the category of the occupational or public exposure referred to in section 16 is 1 or 2;
2) available for the radiation practice when the category of the occupational or public exposure is 3.
A radiation safety expert must also be used:
1) at the commencement of a new radiation practice;
2) when changing a radiation practice in such a way that the category of the occupational or public exposure may change;
3) in the event of a problem observed in the radiation protection of workers or members of the public;
4) in connection to the decommissioning of a radiation practice which involves the handling of radioactive substances when it pertains to a matter referred to in section 18, subsection 12 or 13.
By way of derogation from what is provided in subsection 1 and 2, a radiation safety expert must at least be used when advice is required in a matter referred to in section 18:
1) in dental x-ray imaging by using panoramic tomography x-ray equipment, cephalostats or dental x-ray equipment for imaging with an intraoral imaging receptor;
2) in veterinary x-ray examinations conducted with dental x-ray equipment;
3) the use of shielded x-ray equipment in industry;
4) in an aviation practice requiring a safety licence.
Section 18 Areas of radiation safety expert’s use
A radiation safety expert must be used as provided in section 17 at least in:
1) demonstrating the justification of a radiation practice;
2) assessing and limiting occupational and public exposure;
3) setting and using dose constraints for the optimization of radiation protection;
4) preparing for radiation safety deviations and drawing up the plans concerning them;
5) preparing a safety assessment concerning a radiation practice;
6) preparing a security arrangements plan;
7) preparing quality assurance programmes concerning radiation practices;
8) preparing workers’ radiation safety instructions;
9) determining the need for workers’ radiation protection training and supplementary training and the planning of training;
10) taking into service of radiation meters and radiation measuring instruments and ensuring the constancy of the measurements;
11) taking into service of radiation sources and facilities and places for their use and storage and the related radiation shielding and systems pertaining to safety;
12) arrangements concerning the management of radioactive waste;
13) decommissioning of radiation sources and facilities;
14) the categorization of radiation workers;
15) the categorization of working areas;
16) organizing radiological surveillance and individual monitoring;
17) the working arrangements of pregnant or breast-feeding workers;
18) arrangements concerning the discharges of radioactive substances;
19) organizing the monitoring of public exposure;
20) preparing a baseline environmental radioactivity study;
21) the investigation of the reasons for a radiation safety deviation and the radiation exposure caused as well as in the planning of measures required to prevent comparable events.
Section 19 Use of a medical physics expert
The undertaking must ensure that a medical physics expert is closely involved in radiotherapy practices, excluding standardised radionuclide therapy.
A medical physics expert must be used in any radionuclide therapy other than that referred to in subsection 1 as well as in interventional radiology, computerized tomography and other practices involving high medical exposures.
In practices other than those referred to in subsection 1 and 2, a medical physics expert must be used at the commencement of the practice and the expert must be available during the practice.
By way of derogation from what is provided in subsection 3, dental radiography in health care using panoramic tomography equipment, cephalostats or dental radiography equipment for imaging on an intraoral imaging receptor are subject to the use of a medical physics expert, provided that advice is required in some matter referred to in section 20.
Any imaging referred to in Chapter 14 of the Radiation Act with a health care appliance is subject to subsection 3 and 4.
Section 20 Areas of medical physics expert’s use
A medical physics expert must be used in taking care of the dosimetry of medical exposure, including the physical measurements needed for the determination of radiation exposure and to provide advice on radiation appliances.
A medical physics expert must furthermore be used in:
1) optimizing the radiation protection of an individual subject to medical exposure as well as of the foetus of a pregnant individual being examined, receiving treatment or subject to a procedure;
2) comparing a patient’s radiation exposure to reference levels;
3) preparing instructions concerning the performance of conventional radiological examinations, procedures and treatments;
4) selecting of measurement equipment;
5) the technical specification of radiation appliances;
6) the design of facilities;
7) planning and implementation of a quality assurance programme for radiation appliances;
8) the acceptance tests of appliances and in demonstrating the fulfilment of the appliances’ in-service acceptability requirements and other requirements concerning the appliances and their use;
9) preparing a safety assessment with respect to medical exposure;
10) investing unplanned medical exposure and planning measures required to prevent comparable events;
11) planning and organizing personnel’s radiation protection training.
Section 21 Co-operation between experts
The undertaking must ensure that the radiation safety expert and the medical physics expert work in co-operation to optimize radiation protection in medical use of radiation.
Section 22 Human resources
To ensure safety in medical exposure:
1) an oncologist must be available for each fraction of radiotherapy and a specialist of clinical physiology and nuclear medicine must be available for radionuclide therapy;
2) two radiographers must be present during radiotherapy, or, if another radiographer is not available, a medical physicist with a protected title by the Health Care Professionals Act (559/1994) and who is competent to verify and interrupt a treatment may be present instead of one radiographer;
3) a medical physicist must be available for verifying each dose calculation and delivery of the radiotherapy, excluding standardised radionuclide therapies
4) a specialist of clinical physiology and nuclear medicine must be available for ensuring the justification assessment prior to every nuclear medicine examination and for the interpretation of images, and a physician trained in interpreting the images of hybrid imaging must be available for such interpretation;
5) the personnel required for compliance with the good manufacturing practice of medicines as referred to in section 14 of the Medicines Act (395/1987) must be available for the production of radiopharmaceuticals;
6) a health care professional, assigned to the task by a physician referred to in section 114, subsection 1 of the Radiation Act, must be available for the administration of radiopharmaceuticals to an individual to be examined or treated;
7) a radiographer, bioanalyst or a nurse trained for nuclear medicine imaging must be present during a nuclear medicine examination to ensure the progress of the examination.
In industrial radiography, the radiographer must have at least one assistant if the imaging is carried out in a place other than an imaging room intended for that purpose.
Chapter 5 Safety licence and security
Section 23 Information to be provided in the application for a safety licence
A safety licence application must include the information referred to in Annex 5.
Section 24 Inquiries and notifications concerning the import and export of a high-activity sealed source
Prior to granting a safety licence for the export of a high-activity sealed source belonging to category 1 or 2, STUK verifies with the appropriate regulatory authority of the State of destination that the said State has no obstacle for the export and that the consignee is entitled to receive the source.
The notifications referred to in section 72, subsection 3 of the Radiation Act must be made with regard to the import and export of high-activity sealed sources belonging in class 1 or 2 source for each consignment stated in more detail by STUK in the safety licence.
Section 25 Amending a safety licence
Material changes to the practice which require a prior amending of a safety licence include:
1) a change in the holder of the safety licence;
2) a change due to which the category of the radiation exposure or radiation source changes from category 2 or 3 to category 1, or from category 3 to category 2;
3) a change of the radiation safety officer or some other significant change in the management system;
4) a change due to which the security referred to in section 54 of the Radiation Act would have to be changed or the high-activity sealed source specified in the security changes;
5) the taking into service of a radiation source for a treatment purpose;
6) the taking into service of a radiation source other than a source referred to in point 4 or 5 if the source differs, in terms of its radiation or radiation safety properties, from what is already in use in the practice pursuant to the safety licence or if its in-service radiation safety requires changes to structural shieldings or arrangements related to the place of use;
7) the use of the radiation source for a purpose other than for which the licence was granted;
8) a change in the place where the practices are carried out;
9) a change in the practices in such a way that the amount or quality of the radioactive waste or the waste referred to in section 78, subsection 3 of the Radiation Act, or the arrangements concerning it, change from what was approved in the safety licence;
10) changing the practices in such a way that the discharges of radioactive substances or their quality change from what was approved in the safety licence.
Section 26 Notification of changes to a practice subject to a safety licence
Changes to a practice subject to a safety licence, which must be notified to STUK within two weeks of the change, are:
1) a change in the contact information of the holder of the safety licence;
2) a change due to which the category of the radiation exposure or radiation source changes from category 2 or 1 to category 3, or from category 1 to category 2;
3) the taking into service of a radiation source other than a source referred to in section 25, paragraphs 4–6;
4) a significant change to the quality assurance programme of radiotherapy;
5) removal of a radiation source from use;
6) partial or total cessation of a radiation practice.
If a radiation source whose possession requires a safety licence is removed from use by relinquishment to another undertaking, the notification concerning the removal from use must include a certificate provided by the consignee on taking possession of the radiation source.
Section 27 Practices exempt from a safety licence
Under section 49, subsection 1, paragraph 9 of the Radiation Act, a safety licence is not required for:
1) the use, manufacture, trade, installation, possession, safekeeping, import, transfer or storage of an appliance which produces ionizing radiation electrically, provided that the appliance operates with a maximum voltage of 30 kilovolts and does not cause, within a ten centimeter distance of the appliance’s accessible surfaces, a greater dose rate than one microsievert per hour;
2) the use of fire alarms and fire detectors containing radioactive americium-241 isotope in the purpose they have been designed for or their resale and use or the possession, safekeeping, storage, installation, maintenance or repair related to their use and resale; new fire alarms may nevertheless contain a maximum of 40 kilobecquerels of the americium-241 isotope;
3) the use of an appliance which produces ionizing radiation electrically or a sealed source containing a maximum of 40 kilobecquerels of the americium-241, strontium-90 or caesium-137 isotope with radiation safety properties meant for educational use, as a teaching aid in schools, vocational schools and comparable institutions, provided that the educational institution has appointed a person in charge of radiation safety;
4) the use of lamps and igniters containing a maximum equal to the exemption value of a radioactive substance in the purpose they have been designed for or their resale and use or the possession, safekeeping, storage, installation, maintenance or repair related to their use and resale.
Section 28 Prerequisites for exemption from a safety licence
The practice is inherently safe as referred to in section 50, subsection 1, paragraph 3 of the Radiation Act if the workers do not need to be categorized as radiation workers and the effective dose of a member of the public is at most, excluding unlikely radiation safety deviations, of the magnitude of:
1) 10 microsieverts a year from artificial radioactive substances;
2) 1 millisieverts a year from nature’s radioactive materials.
The effective dose to a member of the public in unlikely radiation safety deviations in a practice referred to in subsection 1, paragraph 1 may not be greater than 1 millisieverts a year.
An assessment of a dose arising from natural radioactive materials accounts for the practice’s addition to the dose arising from the existing local background radiation.
Section 29 Furnishing security
The basic charge for a security in a practice referred to in section 54, subsection 1, paragraphs 1–3 of the Radiation Act is EUR 10,000. The surcharge is EUR 75 per payment unit.
The number of payment units is calculated by dividing the activity value of the high-activity sealed source in question, the activity value of the radioactive substance being held at any one time or the value of the nuclide-specific combined activity of sealed sources removed from use annually by the value of the activity of a high-activity sealed source provided under section 75, subsection 5 of the Radiation Act.
STUK may estimate and impose the surcharge to be smaller than what is provided in subsection 1 if the number of the payment units is greater than 2,000 and the security would be clearly excessive in proportion to the risks related to the practice. In such a case, however, the security may not be less than EUR 160,000.
A practice referred to in section 54, subsection 1, paragraph 4 of the Radiation Act is subject to the furnishing a security if the amount of the costs arising from rendering the radioactive waste harmless, the measures necessary in terms of radiation safety in the waste management of waste referred to in section 78, subsection 3 of the Radiation Act or any environmental cleaning measures is estimated to be greater than EUR 100,000.
Chapter 6 Waste and discharges
Section 30 Radioactive waste
Solid waste generated in radiation practices is not radioactive waste if the waste’s activity concentration is smaller than the clearance level referred to in section 85 of the Radiation Act.
A radiation source is not radioactive waste if its activity or activity concentration is smaller than the exemption level referred to in section 49 of the Radiation Act. If the source contains different radionuclides or if more than one source is handled at the same time, a radiation source or a radiation source batch in which the nuclide-specific activity or activity concentration divided by a corresponding exemption level of all nuclides combined is smaller than one is not radioactive waste.
Radioactive substances discharged to the environment or sewerage system pursuant to section 127 of the Radiation Act are not radioactive waste.
Section 31 Waste other than radioactive waste
Waste generated in a practice causing exposure to natural radiation and in the implementation of protective measures, the activity concentration of which is greater than the clearance level referred to in section 85 of the Radiation Act is considered waste as referred to in section 78, subsection 3 of the Radiation Act.
Section 32 Subsidiary duty of care
STUK ensures that the duties falling under the scope of obligations imposed on the State in section 80, subsections 1–3 of the Radiation Act are carried out.
Responsibility for waste transfers to the State once the waste has been relinquished to the possession of STUK.
Section 33 National programme for the waste management of radioactive waste
The national programme for the management of radioactive waste referred to in section 87 of the Radiation Act must present at least the following:
. 1) the general objectives of the national waste management policy concerning the management of radioactive waste;
2) the most important intermediate goals and clear schedules for the achievement of these intermediate goals, considering the programme’s general objectives;
3) total quantities of radioactive waste and estimates of future quantities, including waste arising from decommissioning;
4) the location and quantities of the radioactive waste in accordance with the appropriate categorization;
5) waste management plans and technical solutions for the management of radioactive waste from its generation to its disposal or some other method for rendering it harmless;
6) the plans concerning the time subsequent to the closure of the final disposal facility and the period of time for which the monitoring of the disposal will continue as well as the means by which knowledge concerning the facility in question will be stored in the long term;
7) the research, development and demonstration measures needed for the implementation of the waste management solutions for radioactive waste;
8) responsibility for the programme’s implementation and indicators for monitoring the implementation responsibility which enable the monitoring of the progress towards the objectives and the implementation of the programme;
9) an estimate of the programme’s costs and information on what the estimate is based on;
10) information on the funding arrangement applied to implement the management of the radioactive waste;
11) information on the publicity of the programme and how transparency will be ensured;
12) Finland’s treaties on radioactive waste made with other States.
Chapter 7 Occupational exposure
Section 34 Classification of radiation workers
A radiation worker belongs to category A if the effective dose attributable to the radiation work can be higher than 6 millisieverts in a year and the equivalent dose of the lens of the eye higher than 15 millisieverts a year or the equivalent dose of the skin, hands, arms, feet or ankles higher than 150 millisieverts a year.
Other radiation workers belong to category B.
Section 35 Classification of working areas
The identification and differentiation of the controlled and supervised areas must account for the nature of the practice and the magnitude of the radiation risk attributable to the practice.
An area must be differentiated as a supervised area if the effective dose to a radiation worker working there can be higher than 1 millisievert a year or the equivalent dose of the lens of the eye higher than 15 millisieverts a year or the equivalent dose of the skin, hands, arms, feet or ankles higher than 50 millisieverts a year.
An area in which working requires special measures to protect against ionizing radiation due to the radiation or contamination risk must be differentiated as a controlled area.
Section 36 Requirements for controlled areas
If the area carries a risk of the spread of radioactive contamination, necessary arrangements must be carried out for individuals’ arrival to and departure from the area and the delivery and removal of goods to and from the area.
A controlled area must have markings indicating the area’s classification, the nature of the radiation sources and the related hazards.
The undertaking shall provide workers working in the controlled area with training on the specific characteristics of the workplace and the work tasks and provide the workers with the personal protective equipment necessary for radiation protection.
Section 37 Requirements for supervised areas
A supervised area must have markings indicating the area’s classification, the nature of the radiation sources and the related hazards, should it be necessary in terms of considering the hazard.
Special rules must be confirmed for the supervised area, should it be necessary in terms of considering the hazard.
Section 38 Recording the results of radiological surveillance
The undertaking shall record the following with regard to the results of radiological surveillance:
1) the time of surveillance or measurements;
2) the determined dose or the dose rates of external radiation, in which case the radiation types and energies or the radionuclide emitting the radiation must also be recorded;
3) the radioactive substance which caused the contamination, its surface activity as well as its physical state and chemical form;
4) the activity concentration of the radioactive substance in the air as well as its physical state or chemical form, should they be necessary for the calculation of doses;
5) the results of a worker’s contamination measurement;
6) the duration of workers’ exposure, should it be necessary for the calculation of the doses;
7) a note in the event that no external radiation, contamination or radioactive substance in the air is found;
8) record-keeping on the use of a dosemeter shared by several individuals which allows for assessing the radiation exposure of workers and deducing the need for individual monitoring.
Section 39 Outside worker working in a controlled area
The undertaking must carry out the measures necessary for the determing the individual dose of an outside worker belonging in category A working in a controlled area after each working period for the dose entry referred to in subsection 2. If the dose measured during a working period cannot be obtained from a dosemeter immediately after the working period, the dose in question must be determined through the radiological surveillance. If the combined dose of different working periods cannot be higher than six millisieverts a month, the worker’s dose does not need to be determined separately for a period shorter than the measuring period.
The undertaking must record the following on the results of the individual monitoring of an outside worker working in a controlled area after each working period:
1) the duration of the working period;
2) an estimate of the effective dose during the working period;
3) in the case of ununiformly distributed radiation exposure, an estimate of the equivalent doses of various parts of the body;
4) in the case of internal exposure, an estimate of the intake of radionuclides or the committed effective dose.
Section 40 Storing the results of radiological surveillance and individual monitoring
The results of radiological surveillance must be stored for a minimum period of five years and for as long as the storage is necessary to ensure that the practice complies with the principles of optimization and limitation and for the development of the practice’s safety and working methods.
The results of a worker’s individual monitoring must be stored in terms of the worker’s entire time at work for as long as the worker is employed by the undertaking or the employer. Any information which is material in terms of determining the worker’s individual dose, such as the results of thyroid gland and skin contamination measurements, must likewise be stored.
Personal data protection is subject to what is provided separately.
Section 41 Protection during pregnancy and breastfeeding
The work of a pregnant worker must be organized in such a way that the foetus’s equivalent dose is as low as reasonably achievable and that it is no greater than one millisievert during pregnancy once the worker has informed the undertaking or, in the case of an external worker, the employer of their pregnancy.
A breastfeeding worker must not be assigned work which involves a risk of radionuclide intake or body contamination.
Section 42 Information to be stored in workers’ dose register
In addition to what is provided in section 20 of the Radiation Act, the following information is stored in the workers’ dose register:
1) the first name, last name, personal identity code, gender and nationality of the worker, emergency worker and emergency helpers as well as the start and end date of the individual monitoring;
2) of the undertaking and the employer of an outside worker, the name, address and individual identification of the undertaking and the employer as well as the name of the employer’s contact person;
3) information on the radiation practice and the nature of the exposure as well as the category of the radiation worker;
4) of the results of individual monitoring, the time of the measurement period as well as the result of the measurement or dose determination and, in terms of internal exposure, the information used for determining the dose;
5) of radiation safety deviations, the investigations pertaining to the exposure conditions and performed measures.
If a worker’s individual dose has been determined, the effective dose is stored as millisieverts, the equivalent doses of different parts of the body, in the case of ununiformly distributed radiation, as millisieverts and, in the case of an intake of radionuclides, the committed effective dose as millisieverts.
Section 43 Requirements applicable to monitoring document
STUK provides an outside worker, at the worker’s request, with a document (monitoring document) on his or her individual radiation exposure from the workers’ dose register for the purpose of radiation work to be carried out abroad. The monitoring document contains the following:
1) information on the worker’s effective dose as millisieverts over a period of five years, including the year in question;
2) in the case of ununiformly distributed radiation exposure, insofar as determinations have been made, information on the dose of exposed parts of the body, such as the equivalent dose of an eye, hands, arms, feet and ankles, as millisieverts and, in the case of an intake of a radioactive substance, the committed effective dose as millisieverts;
3) the document’s issuer and their address;
4) the date on which the document is issued.
STUK will not, without acceptable grounds, provide the worker with a new monitoring document before the previously issued document has been returned.
Chapter 8 Non-medical imaging exposure
Section 44 Provision of information and requesting consent
The information referred to in section 124, subsection 1 of the Radiation Act must be provided prior to a request for consent.
The provision of information and the request for consent is the responsibility of the referring medical practitioner or dentist, if the imaging is part of a health examination or assessment of the state of health conducted by the physician or dentist. The legal person or authority requiring imaging to be carried out with health care appliance is responsible for the provision of information and the request for consent. Practical arrangements for the provision of information and request for consent can be made between the legal person or authority requiring imaging and the undertaking responsible for the imaging.
Seeking imaging on the basis of a physician’s referral after the provision of information can be deemed a consent.
In the case of imaging carried out with appliance other than health care appliance, an individual’s participation in imaging after they have received the information referred to in section 124, subsection 1 of the Radiation Act can be considered consent.
Chapter 9 Emergency exposure situations
Section 45 Setting a reference level to members of the public
The reference level of exposure resulting from an emergency exposure situation to members of the public is, as an effective dose, at least 20 and at most 100 millisieverts a year.
During an emergency exposure situation, the reference level can be set lower than what is provided in subsection 1 for the duration of the situation in question, should this be justified in consideration of the severity and extent of the situation. The reference level may not be set lower than 20 millisieverts, should its achievement require unreasonably extensive or expensive measures.
During an emergency exposure situation, the reference level of members of the public must be reduced as soon as the situation allows.
Section 46 Reference levels for emergency workers and helpers
The reference level of exposure resulting from an emergency exposure situation for emergency workers and helpers is, as an effective dose, 100 millisieverts a year.
In a situation involving the saving of lives, the prevention of serious health effects caused by radiation or preventing an accident from growing worse, the reference level for emergency workers and helpers is 500 millisieverts as an effective dose a year.
Section 47 Use of reference levels in preparedness
Undertakings and authorities must, in their emergency response planning related to emergency exposure situations, prepare for carrying out such protective actions they are responsible for which allow for keeping the dose of members of the public lower than the reference level for the emergency exposure situation.
Undertakings and authorities must, in their emergency response planning, prepare for the radiation protection of the emergency workers and helpers they are responsible for which allows for keeping the doses lower than the reference level for the emergency exposure situation.
Section 48 Use of reference levels in emergency exposure situations
In an emergency exposure situation, the aim must be to carry out the protective actions in such a way that the dose attributable to the radiation exposure remains lower than the reference level for the emergency exposure situation, taking into account all exposure pathways.
However, doses higher than the reference level are acceptable if the situation is, due to its extent or severity, such that maintaining the dose lower than the reference level cannot be ensured with protective measures or if it would require actions that would cause unreasonably extensive detriments in relation to the benefits to be gained.
Chapter 10 Existing exposure situations
Section 49 National action plan for identifying existing exposure situations
The national action plan referred to in section 142 of the Radiation Act must account for any of the following, with the potential to cause radiation exposure:
1) discontinued practices which have not been subject to regulatory control or which have not been regulated in the same way as similar practices at the time the plan is drawn up;
2) emergency exposure situations from which there has been a transition to an existing exposure situation;
3) practices in which the undertaking responsible for the practice cannot be identified;
4) naturally occurring radioactive substances in situations other than those provided for in Chapter 18 of the Radiation Act;
5) radioactive substances which have ended up in products meant for consumers from the situations referred to in paragraphs 1–4, excluding foodstuffs, feed, household water and construction products.
The national action plan must detail the procedures and parties responsible for identifying the situations referred to in subsection 1.
Section 50 Plan on measures in an existing exposure situation
The plan referred to in section 139, subsection 3 of the Radiation Act must detail:
1) the plan’s objectives;
2) the areas and groups of people affected by the existing exposure situation;
3) the applicable reference values referred to in section 140 of the Radiation Act;
4) the selected protective actions whose implementation method, extent and duration has been optimized;
5) measures for the provision of advice on radiation exposure management to individuals and regionally;
6) measures for the provision of instructions and information to exposed members of the public on the possible detriments to health and the means available for the reduction and monitoring of their own exposure;
7) the parties responsible for the measures and the procedures for mutual coordination.
If the exposure situation involves naturally occurring radioactive substances which are not controlled as part of the practice subject to a safety licence, the plan must also detail measures for the provision of instructions and information on appropriate monitoring methods for activity concentrations and radiation exposure and protective actions.
Section 51 Plan’s execution and review
The parties responsible for the execution of the plan referred to above, in section 50, must, in terms of their own areas of responsibility:
1) regularly evaluate the protective measures available for the achievement of the objectives and assess the effectiveness of planned and executed measures;
2) assess the radiation dose distribution of workers and members of the public resulting from the plan’s execution in co-operation with STUK;
3) consider possible additional measures for the optimization of protection and for the reduction of any radiation exposures higher than reference levels.
The National Supervisory Authority for Welfare and Health monitors the execution referred to in subsection 1 and revises the plan if necessary.
Chapter 11 Natural radiation
Section 52 Practices related to soil, rock and other materials subject to an investigation concerning radiation exposure
Practices referred to in section 151 of the Radiation Act, in which the radiation exposure arising from natural radiation may be higher than the reference level, include at least:
1) the production of rare earths;
2) the production of thorium compounds and the manufacture of products containing thorium;
3) the processing of niobium-tantalum ore;
4) the production and refining of oil and gas;
5) the production of geothermal energy;
6) the production of titanium dioxide pigment;
7) thermal phosphorus production;
8) the zircon and zirconium industry;
9) the production of phosphate fertilizers;
10) the production of cement and the maintenance of the clinker ovens used therein;
11) the use of peat and coal-fires power plants and the maintenance, repair and removal from use of the boilers in these plants;
12) the production of phosphoric acid;
13) the reduction smelting of metallic ores and concentrates;
14) the production of household water in ground water processing facilities;
15) the mining of ores other than uranium ore.
Section 53 Construction products subject to an investigation of radiation exposure
Construction products referred to in section 153 of the Radiation Act, in which the radiation exposure arising from natural radiation may be higher than the reference level, include at least:
1) building frame structures made of mineral-based raw materials;
2) construction products whose primary raw material consists of crushed rocks, gravel or sand which contains granite or other granitoids, such as granodiorite, tonalite or gneiss;
3) construction products whose raw material consists of intermediate or by-products or waste generated by industries which exploit ash or mineral-based natural raw materials.
Section 54 National action plan for preventing risks arising from radon
The national action plan referred to in section 159 of the Radiation Act addresses risks arising from exposure in dwellings, other occupied spaces and workplaces attributable to radon released from soil and bedrock, construction products and household water.
Further provisions on the more detailed content of the action plan are provided in Annex 6.
The action plan is updated every five years.
Chapter 12 Approval of dosimetry service and other radiation measurements
Section 55 Applying for the approval of a dosimetry service
The application for the approval of a dosimetry service must detail:
1) the name and contact person of the dosimetry service and the contact information of its place of business;
2) information on the dosimetry service’s organization, operations, the personnel’s adequate competence and on the quality standard complied with in the operations;
3) technical information on the dose measurement system, including the methods of measurement and quality assurance;
4) calibration certificates, test reports and an estimate on the measurement uncertainty, the measurements’ traceability to a metrological standard and a list of the standards used to demonstrate the reliability of the measurements;
5) an accreditation decision and the records of the accreditation service’s periodic evaluations;
6) grounds for the lack of accreditation if there is none, and a description on a quality system pursuant to standard SFS-EN ISO/IEC 17025.
An extract from the relevant register in terms of the information referred to in subsection 1, paragraph 1 must be appended to the application.
A dose measurement system includes individual dosemeters, reader devices and peripheral devices as well as the programs and procedural instructions to be used in the determination of doses.
Section 56 Applying for the approval of other radiation measurements
The application concerning approval referred to in section 64 of the Radiation Act must detail the following:
1) the information necessary to identify the applicant and a contact person;
2) the method of measurement, the intended purpose of use, reliability and suitability for the purpose of the meter or measuring equipment, the types and energy ranges of radiation to be measured and the measurement quantities and ranges;
3) technical information on the meter or the measuring equipment;
4) documents pertaining to calibrations, tests and measurement uncertainty.
The measuring equipment includes the measuring instruments and other equipment used to obtain the measurement result.
Chapter 13 Inspection programme of STUK
Section 57 Inspection programme of STUK
The content of the inspection programme referred to in section 182 of the Radiation Act must be such that the supervision pursuant to it achieves, taking into account the risks arising from the practice, sufficient assurance of the safety of the radiation practice and of compliance with the provisions of the Radiation Act and the conditions provided in safety licences.
Section 58 Content of inspection programme
The inspection programme includes announced and unannounced, regular and case discretionary inspections.
The inspection programme may also include inspections based on regulatory control questionnaires and information and data received from the undertaking which do not include a visit to the place in which the practice is carried out.
The programme specifies target intervals for regular inspections, the grounds for conducting different types of inspections and the main content of the inspections. The programme accounts for the categorizations of radiation practices referred to in section 27 of the Radiation Act and for experiences accumulated from observations made in previous inspections.
Chapter 14 Advisory Committee on Radiation Safety
Section 59 Duties
The role of the Advisory Committee on Radiation Safety is to:
1) issue statements on matters concerning radiation practices, existing exposure situations and emergency exposure situations as well as on other matters of importance for radiation safety;
2) issue statements on the provisions and regulations on radiation safety prepared by STUK and other authorities;
3) to monitor the development of radiation safety and research in this field;
4) to promote domestic co-operation in the field of radiation safety and monitor international co-operation;
5) to present initiatives to the competent authorities on necessary measures concerning radiation safety.
Section 60 Term and composition
The Government appoints the chairperson, deputy chairperson and a maximum of seven other members of the Advisory Committee on Radiation Safety for three years at a time. Each member has a personal deputy member. The individuals appointed as members of the committee must represent a high level of expertise in the field of radiation safety.
Section 61 Experts and divisions
The Advisory Committee on Radiation Safety may invite permanent experts for its term. The committee’s permanent expert is the Director General of STUK.
The committee may establish divisions for the purpose of preparing matters, to which the committee may also invite permanent experts who do not belong to the committee. A division may also hear experts. The chairperson of a division must be a member of the committee.
Section 62 Committee meetings and quorum
The Advisory Committee on Radiation Safety convenes at the invitation of the chairperson or, should the chairperson be prevented, at the invitation of the deputy chairperson and when at least two members have requested it in writing for the purpose of discussing the matter they have specified.
The committee has quorum when at least half of the members and either the chairperson or the deputy chairperson are present.
Section 63 Secretariat
The Advisory Committee on Radiation Safety can have one part-time executive secretary and one other part-time secretary, whom STUK will appoint to their tasks after hearing the committee.
Section 64 Reporting
The Advisory Committee on Radiation Safety prepares a report on its activities to the Ministry of Social Affairs and Health at the end of its term.
Chapter 15 Entry into force
Section 65 Entry into force
This Decree enters into force on 15th November 2018.
Council Directive 2013/59/Euratom (32013L0059); OJEU L 13, 17.1.2014, p. 1, Reported to the Commission in accordance with Article 33 of the Treaty establishing the European Atomic Energy Community.