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In accordance with a decision of the Radiation and Nuclear Safety Authority, the following provisions are issued by virtue of the Radiation Act (859/2018):

Section 1 Scope of application

This regulation shall apply to the use of radiation requiring a safety licence.

Section 2 Definitions

For the purposes of this regulation:

1. open beam analyser shall refer to an X-ray analyser according to IEC 62495, with the radiation beam is directed outside the appliance;
2. accelerator shall refer to a radiation appliance in which ionizing radiation with energy higher than 1 mega electronvolt is generated by means of particle acceleration;
3. in-service acceptability criteria of the appliance shall refer to the minimum requirements set for the performance of the appliance, the acceptability limits;
4. radiometric measuring device means a measuring device consisting of a sealed source in a radiation shield, a radiation detector and measurement electronics;
5. X-ray appliance shall refer to a device which produces ionizing radiation electrically, which is not an accelerator;
6. closed beam analyser shall refer to an X-ray analyser according to IEC 62495, with the radiation beam is directed inside the device;
7. shielded fluoroscopic device shall refer to an X-ray device according to IEC 61010-2-091, where the X-ray tube and the radiation beam are protected by structural shields and the object to be examined or analysed is contained within the shield in a space accessible when the equipment is producing radiation.

Section 3 Activity values of high-activity sealed sources

Activity values of high-activity sealed sources are specified in Appendix 1.

Section 4 Radiation shielding of premises where radiation sources are used and stored

Premises where radiation sources are used and stored shall be planned and implemented in such a way that the exposure caused to employees and the public is as low as reasonably achievable, and that the dose caused does not exceed the dose constraint applicable to the facility and place where the radiation source is used and stored.

The type of use of the radiation source and the use of premises surrounding the place where the source is used and stored shall be considered in radiation shielding.

The adequacy of radiation shielding shall be re-evaluated if:

1. the radiation source is changed to another type or additional sources are added;
2. the type of use of the radiation source changes;
3. the use of premises surrounding the place where the source is used and stored changes in a way that might increase occupational or public exposure.

The adequacy of radiation shielding shall be ensured by means of radiation measurements or other reliable methods after the shielding has been constructed or changed.

Section 5 Activation

The design and implementation of places of use of neutron sources and accelerators must take into account possible activation of structures, systems and other materials regarding:

1. occupational and public exposure;
2. the nature, quantity and rendering harmless of radioactive waste arising from the decommissioning of the facility.

Section 6 Structural solutions contributing to the management of the radiation safety deviations

In facilities and places where radiation sources are used and stored, structural solutions shall be used which allow the organization of activities in such a way that:

1. potential exposure and its likelihood are as low as practicably achievable and the exposure does not exceed the constraint for potential exposure;
2. the radiation safety deviation can be managed;
3. after the radiation safety deviation:

1. sources can be be made safe for workers and the public;
2. radiation sources and the places of use can be brought into a safe situation allowing further use or treatment;
3. the places of use can be cleaned of any radioactive substances that have spread in them.

Priority must be given to exploiting inherent safety features and systems and equipment which, in the event of a failure, are placed in a safety-favorable condition.

Section 7 Safety and alarm systems

Safety and alarm systems appropriate to the safety of the practice shall be placed in the place where radiation is used, in the space outside it, the control room, the control panel and the control device, such as:

1. emergency buttons which end the generation of radiation when pressed;
2. safety switches which prevent the generation of radiation if the door or similar to the place of use is used or someone enters a specific area when the appliance is on;
3. acknowledging switches used to ensure that no one stays in the space where radiation is used before the radiation appliance is started;
4. alarm lights or some other method of detecting when the radiation appliance is in operation and when it is generating radiation.

In addition, the use of particle accelerators for isotope production and research shall have safety, warning and measurement systems for releases, dose rate and pressure in the place of use and in order to ensure the safe status of the target of the accelerator, transmission line and hot cell.

In the use of a radiation appliance which result to occupational exposure category 1 due to potential exposure, the place of use shall be equipped with a warning light or other method referred to section 1, subsection 4, which is independent of the control system of the radiation appliance.

When the safety system referred to in subsection 1 has prevented the generation of radiation, operation may only be continued from the control unit or operating unit.

Section 8 Other safety and functionality

One of the doors leading to the place where the radiation source is used or stored shall be such that it can always be opened from inside the room. It shall also be possible to open the door in case of malfunction.

When using radiation in healthcare, the control room must have a visual and speech connection to the patient in the treatment or examination room, as appropriate for the safety of the operation. Also, the doors leading to the treatment or examination room shall be visible from the control room if the doors are not locked.

When radiation is used in industry and research whereby the occupational exposure category is 1 or 2, the room where the appliance is used or the door to this room shall be visible from the control or operating unit of the radiation appliance.

Section 9 Radiation safety solutions as a whole

If the occupational exposure category is 1 or 2 due to potential exposure, the structural solutions of the places where radiation sources are used, and the safety systems referred to in section 7 shall be such that:

1. an individual technical failure, human error or acting in violation of the instructions does not cause the realization of the potential occupational or public exposure;
2. radiation sources can be made safe for the exposure in question even if an individual safety device is out of use or not operating.

Section 10 Marking of places of use

The marking warning of radiation hazard referred to in section 66, subsection 2, of the Radiation Act, shall be placed at the doors of places where radiation is used and stored if the door is at the border of the controlled or supervised area. The marking shall be done in accordance with standard SFS-EN ISO 361. The marking may also be a marking of the intended use of the room, if the related radiation hazard is shown clearly in the marking.

Places of use and storage of radiation sources in which the design of radiation shielding is based on the estimate that no one stays in the room permanently shall be marked with a sign prohibiting people from staying in such rooms. However, marking is not necessary if the purpose of the place or other considerations do not allow for continuous occupation.

Section 11 Specific requirements for contamination

When unsealed sources are used and in other activities involving the risk of contamination, solutions shall be implemented in the places where radiation sources are used and stored which allow the organization of activities in such a way that during normal operation and in case of a radiation safety deviation:

1. contamination can be removed from surfaces as easily as possible;
2. spreading of radioactive substances to indoor air in the place of use and to the other places of the building can be restricted effectively;
3. releases of radioactive substances to the environment can be restricted effectively;
4. transfer of contamination outside the place of use with the employees can be restricted effectively;
5. waste generated in the operations can be processed safely.

Section 12 Specific requirements for the patient room

A patient who is hospitalized as a result of exposure to radiation following isotope treatment must have a separate patient room with its own washroom and toilet. Entry to the patient room shall be marked with a sign warning of a radiation hazard.

Section 13 Specific requirements for the storge of a radiation source

Radiation sources containing radioactive substance must be stored separately from goods and materials not related to their use.

Section 14 Specific requirements for places surrounding the place for radiotherapy

If the places surrounding the place intended for radiotherapy include areas where the dose rate of radiation is higher than 20 µSv/h, working and staying in these areas shall be restricted.

Section 15 General requirements

The radiation source and the equipment related to its use shall be suitable for the intended use

An appliance generating radiation electrically shall not be used at operating values higher than necessary for its intended purpose.

The sealed source shall comply with the requirements of SFS-EN ISO 2919.

The marking of the sealed source referred to in section 66, subsection 2, shall be the word “Radioactive”, or, if this is not possible, the symbol for ionizing radiation in accordance with SFSEN ISO 361:2015.

Section 16 In-service acceptability criteria for a heath care radiation appliance

In addition to what is specified section 15, a heath care radiation appliance shall meet the inservice acceptability criteria specified in this section.

During use, the appliance shall meet the essential performance and safety characteristics declared by the manufacturer.

Information shall be available at the place of operation of the appliance, indicating the inservice acceptability criteria and their fulfilment.

Further provisions on the in-service acceptability criteria for health care and veterinary radiation appliances are given in Appendices 2 – 5.

Section 17 In-service acceptability criteria for a radiation appliance for industrial and research purposes

In addition to what is specified section 15, a radiation appliance for industrial and research purposes shall meet the in-service acceptability criteria specified in this section.

During use, the radiation appliance shall meet the radiation and safety characteristics declared by the manufacture and specified in the application for a safety license or in the notification.

Further provisions on the in-service acceptability criteria for a radiation appliance for industrial and research purposes are given in Appendices 6 – 8.

Section 18 Information about the radioactive substance

The shield or storage container or cover of a radiation source containing radioactive substance shall be marked with the radionuclide, activity and the activity’s determination date.

In case of unsealed sources, the total volume or activity concentration shall be marked.

Section 19 Identification of sealed source and information concerning the identification of the source

The serial number of sealed source or other identifier of the source shall be presented in the certificate of compliance referred to in section 73, subsection 1, of the Radiation Act.

A high-activity sealed source shall be identified by means of a serial number assigned by the manufacturer.

Section 20 Records of high-activity sealed sources

Information to be included in the records of high-activity sealed sources is set out in Appendix 9.

Section 21 Information provided with the radiation source

A sealed source shall be accompanied with the manufacturer’s written commitment referred to in section 76, subsection 1 of the Radiation Act, to receive the sealed source after the end of use, unless the source can be safely aged in the manner referred to in the same section as well as the results of the latest leak test.

A high-activity sealed source shall be accompanied with written documentation indicating that the sealed source is marked and identified in accordance with section 15, subsection 4, and section 19. The documentation shall also include pictures of the sealed source and its transport packaging as well as the structure of its shielding and the appliance in which it is used.

The records referred to in section 25 of the events associated with the radiation appliance shall be supplied with the radiation appliance.

Section 22 Annual notifications of radiation sources

The annual notification on the manufacture, storage, trade, export and import of radiation sources referred to in section 71, subsection 2, of the Radiation Act, shall detail the information specified in Appendix 10. The notification shall be made even if no receipts or transfers have taken place and no radiation sources are possessed.

The notification on the use and possession of high-activity sealed sources referred to in section 71, subsection 3, of the Radiation Act, shall detail the information of the records of highactivity sealed sources referred to in section 20.

The notifications shall be submitted to the Radiation and Nuclear Safety Authority by the end of January of the year following the calendar year.

Section 23 Notification on transport requiring a safety licence

The notification referred to in section 72, subsection 3 of the Radiation Act, shall include the information specified in Appendix 10.

Section 24 Ensuring the operation of a radiation appliance

The safe operation of a radiation appliance shall be ensured following a substantial repair, maintenance or software update as well as always when there is reason to suspect that there are disturbances or changes in the operation of the appliance. Faults and deficiencies affecting radiation safety must be repaired before using the appliance.

Section 25 Documentation of events related to a radiation appliance

Records shall be kept of defects, malfunctions or other adverse events that have occurred during the use of the appliance as well as events affecting the use or safety of the appliance. The records shall be kept throughout the life cycle of the appliance.

Section 26 Acceptance inspection of a radiation appliance in health care and veterinary medicine

The quality assurance programme of the use of radiation in health care and veterinary medicine shall include an acceptance inspection in which compliance with the in-use acceptability requirements of the radiation appliance is ensured before its commissioning. The acceptance inspection shall also establish reference performance values which shall be used for monitoring of the appliance’s operational capacity and performance characteristics.

Section 27 Quality assurance measures in the use of radiation in health care and veterinary medicine

The quality assurance programme of the use of radiation in health care and veterinary medicine shall include measures to ensure:

1. before commissioning a medical radiation appliance, that adequate information on the risk assessment of the patients and the available clinical operation results of the appliance are available;
2. the targeting of the treatment dose to the specified target area in the designed magnitude as accurately as possible;
3. an imaging quality adequate for obtaining the examination result;
4. the accuracy of the assessment radiation exposure caused to the patient and the verification of activity administered to the patient.

The radiotherapy quality assurance programme shall include the risk assessment of exposure due to a radiation safety deviation or unplanned exposure based on the safety assessment referred to in section 26 of the Radiation Act.

The intervals of quality assurance measures in X-ray practices, nuclear medicine and veterinary medicine may not be longer than what is specified in Appendix 12.

Section 28 Commissioning and regular dose calibration of radiotherapy appliance

Before commissioning a radiotherapy appliance, the operator shall measure or verify the characteristics of the appliance that are needed for the input information of the radiotherapy treatment planning system used.

Quality assurance in radiotherapy must, before introducing new techniques for dose calculation and use of radiation, compare calculated and measured dose distributions using tests corresponding to a range of different treatment scenarios and, where appropriate, tests based on dose measurements of actual treatment plans. The radiotherapy appliance shall undergo regular dose calibrations.

Dose calibration shall be verified before the radiotherapy appliance is taken into use to treat patients in such a way that:

1. the verification is conducted by a person other than the one conducting the dose calibration;
2. the dosemeter and the equipment used with it during the measurement are others than those used in the dose calibration.

Furthermore, an independent verification of dose calibration shall be conducted before taking a radiotherapy beam with a different nominal energy or other characteristics into use to treat patients.

Section 29 Other quality assurance measures in radiotherapy

Quality assurance of radiotherapy shall include the verification of each individual treatment plan when taking a new method into use.

In addition, every whole-body treatment must include in vivo dose measurement if the treatment is not based on a sliced tomography. The targeting of treatment shall be individually verified.

Section 30 Leakage tests of sealed sources

The operator shall ensure that a sealed source requiring a safety licence is subjected to leakage testing in accordance with ISO 9978:

1. if the environmental conditions of the sealed source or other reasons may have impaired the tightness of the sealed source;
2. if it is possible that the sealed source has suffered damage as a result of an incident or handling;
3. if the place of use or storage of a radiometric measurement device or other fixed sealed source is changed and more than one year has passed since the last leakage test;
4. when a sealed source is removed from the shield or installed in a shield;
5. when more than 15 years or more than the recommended service life specified by the manufacturer has passed since the last demonstration of compliance, and at regular intervals after that, at least every three years, taking into account the design of the sealed source, the type of use and the environment and other factors affecting the tightness of the sealed source;
6. when a sealed source removed from use is handed over for transport.

A leakage test in accordance with ISO 9978 shall, however, be performed on high activity sealed sources at least once per year.

The leakage test does not need to be performed on a sealed source where the radioactive substance is in gaseous form and in the situations referred to in paragraphs 3, 4 and 6 of subsection 1, if the half-life of the radioactive material is is less than 150 days and no more than three years have elapsed since the last leakage test.

An operator who receives sealed sources for processing as radioactive waste shall perform the leakage test referred to in subsection 1 upon receipt of the sealed source.

If grounds exist to suspect that the tightness of the sealed source may have been compromised, the conformity of the source shall be redemonstrated before continuing its use.

Section 31 Quality assurance measures of radiation sources used in industry and research

The quality assurance measure applicable to use of radiation in industry and research are specified in Appendix 13.

Section 32 Ageing of radioactive substance

The following procedures shall be followed in the ageing of a radiation source containing radioactive substance by means of storage referred to in section 83, subsection 2, of the Radiation Act:

1. the objective, duration and target activity of ageing shall be determined in advance;
2. the objective of ageing shall be that:

1. the waste ceases to be considered as radioactive waste;
2. the waste can be reused, recycled, utilized or disposed of in accordance with section 84 of the Radiation Act; or
3. the waste can be released to the environment or to the sewer in accordance with section 127 of the Radiation Act; or
4. the ageing will result in some other pre-identified benefit for the safety, technical solutions or economy of rendering the waste harmless;

3. the maximum duration of storage shall be:

1. three years, when the objective of the ageing is in accordance with subsection 2, section a–c;

5. one year, when the objective of the ageing is in accordance with subsection 2, section d.

However, the duration of ageing may be longer than that referred to in section 1, subsection 1, if the safety assessment shows that ageing is the best option from the radiation safety point of view.

Section 33 Transferring a sealed source to another undertaking

When a sealed source removed from use is transferred to another licence-holder for use, the transferor shall ensure that:

1. the sealed source and its shielding as well as the information and documentation supplied with the source meet the applicable requirements;
2. the leakage tests referred to in section 30 have been conducted for the sealed source;
3. the sealed source has a transport packaging which meets the applicable legal requirements if the transfer requires transportation.

Section 34 Decommissioning of contaminated premises and activated structures and materials

Cleaning for which a safety licence is required in accordance with section 83, section 4, of the Radiation Act shall be planned in advance;

1. by identifying the type and level of contamination and activated structures and materials at the site;
2. by identifying the available cleaning methods and practices;
3. by assessing the volumes and types of waste generated in the cleaning and determining the possible waste management routes for the waste;
4. by identifying the possible methods of implementation, taking into account the results of studies referred to in subsections 1–3.

The cleaning method shall be selected in such a way that the best possible overall solution can be reached, considering the safety of cleaning as well as the hazards caused by handling, storage and management of the waste.

A cleaning plan shall be prepared, detailing in particular:

1. the desired end state and procedures used for the demonstration of its fulfilment after cleaning;
2. phases and schedule of measures;
3. work methods to be used;
4. arrangements for the radiation protection of workers and the members of the public, including arrangements for preventing the spread of contamination;
5. waste disposal arrangements;
6. arrangements for quality assurance and documentation of measures.

After the cleaning, the undertaking shall demonstrate that the desired end state has been reached.

Section 35 Entry into force

This regulation enters into force on 3 July 2019 and is valid until further notice.

This regulation applies to any matters pending on the date of its entry into force.

This regulation repeals the Radiation and Nuclear Safety Authority's Regulation on activity values for high-activity sealed sources (STUK S/1/2019).

In Helsinki on 2 July 2019

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.

APPENDICES:

1. Activity values of high-activity sealed sources;
2. In-service acceptability criteria for X-ray imaging and fluoroscopic appliances, computed tomography appliances and bone mineral density measurement appliances based on the attenuation of X-radiation used in health care;
3. In-service acceptability criteria for X-ray imaging and fluoroscopic appliance and the related auxiliary devices and equipment used in veterinary medicine;
4. In-service acceptability criteria for radiotherapy appliance and the related auxiliary devices and equipment;
5. In-service acceptability criteria for equipment used in nuclear medicine;
6. In-service acceptability criteria for radiometric measurement devices in industrial use;
7. In-service acceptability criteria for imaging equipment in industrial use;
8. In-service acceptablity criteria for X-ray appliances used in industry and research;
9. Information to be presented in the records for high-activity sealed sources;
10. Information to be presented in the notification on the receipt, transfer and possession of radiation sources;
11. Information to be presented in the notification on transport requiring a safety licence;
12. Intervals of quality assurance measures in radiography practices, nuclear medicine and veterinary medicine;
13. Quality assurance measures of radiation sources used in industry.

Appendices