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Decree of the Ministry of Social Affairs and Health on ionizing radiation 22.11.2018/104422.11.2018

Translation from Finnish

Legally binding only in Finnish and Swedish

By decision of the Ministry of Social Affairs and Health, 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 Qualifications, radiation protection knowledge and work experience

Section 2 Knowledge and work experience of radiation safety expert

Provisions on the knowledge requirements and sufficient work experience required in terms of a radiation safety expert’s field of expertise are laid down in Annex 1.

Section 3 Knowledge and work experience of radiation safety officer

Provisions on the practice type-specific fields of expertise of a radiation safety officer are laid down in Annex 2.

Provisions on the knowledge requirements and sufficient work experience required in a radiation safety officer’s practice-type specific field of expertise are laid down in Annex 3.

Section 4 Certificate provided on the training of a radiation safety expert and radiation safety officer

The certificate provided to a person who has successfully completed the training of a radiation safety expert or radiation safety officer must indicate:

1) the organization which provides the certificate;

2) the name and date of birth of the person who has completed the training;

3) that the certificate concerns radiation protection training as referred to in section 37, subsection 1 or section 41, subsection 4 of the Radiation Act (859/2018);

4) the radiation safety expert’s field of expertise or the radiation safety officer’s practice type-specific field of expertise;

5) the content and scope of the provided radiation protection training in such a way that the certificate proves the fulfilment of the knowledge requirements referred to in section 2 and section 3, itemized in accordance with the knowledge requirements applicable to a radiation safety expert’s field of expertise or a radiation safety officer’s practice-type specific field of expertise as laid down in Annex 1 and Annex 3.

The certificate shall be signed by a person authorized to sign on behalf of the training organization or another person authorized by the training organization to sign the certificates in question.

If the radiation protection training of a radiation safety expert or radiation safety officer is included in their university degree, the completion of the training must be indicated in the diploma or a separate certificate must be provided on the completion of the training.

Section 5 Qualifications and competence of workers engaged in medical use of radiation

Workers engaged in the medical use of radiation must possess the knowledge, skills and competence in radiation physics, radiobiology and radiation protection required by their tasks.

The qualifications and radiation protection competence criteria of a worker engaged in the medical use of radiation are laid down in Annex 4.

Section 6 Practical prerequisites for carrying out of the tasks of experts and radiation safety officers

Radiation safety expert, medical physics expert and radiation safety officer must be fit for their jobs. The person must have a real possibility to carry out the tasks assigned to them by the undertaking.

A radiation safety officer’s place of work and other conditions must be organized in such a way that they are able to carry out their tasks as a radiation safety officer as required by the demands and extent of the use of radiation.

Chapter 3 Supplementary training

Section 7 Supplementary training maintaining professional skills

Supplementary radiation protection training ensures that workers engaged in radiation practices possess up-to-date knowledge on ionizing radiation and its impacts as well as on radiation protection and the provisions and instructions pertaining to radiation practices in line with their duties.

Section 8 Requirements concerning supplementary training

Workers engaged in radiation practices must be provided with supplementary radiation protection training in periods of at least five years. The supplementary training must focus on the special characteristics related to radiation safety in the task in question and on the latest knowledge and changes impacting radiation safety in the radiation practice in question.

Requirements applicable to supplementary training are laid down in Annex 5.

In addition to what is provided in subsection 1, a radiation safety expert or medical physics expert must be provided with a minimum of 20 hours of supplementary radiation protection training over a five-year period. In addition to what is provided in Annex 5, a radiation safety office must be provided with a minimum of ten hours of supplementary radiation protection training over a five-year period.

Chapter 4 Medical exposure

Section 9 Qualifications of a physician or dentist responsible for medical exposure

The qualification requirements of a physician or dentist responsible for medical exposure are:

1) in radiotherapy, a specialist in oncology or other specialist qualified for radiotherapy in their specialty;

2) in nuclear medicine, a specialist in clinical physiology and nuclear medicine or other specialist qualified in nuclear medicine;

3) in X-ray examinations and interventional radiology: a specialist in radiology; other specialist responsible for medical exposure arising from the use of X-ray equipment shall possess the knowledge of radiation protection necessary for the examinations, procedures or treatments performed in their specialty;

4) in dental X-ray examinations: a dentist or other physician with the necessary knowledge of radiation protection.

The qualification requirements specified above in subsection 1, paragraph 3 shall also apply to a physician performing an X-ray examination or procedure.

In examinations, procedures, or treatments other than those specified in subsection 1, the physician responsible for medical exposure must possess the necessary knowledge of radiation protection.

If the necessary knowledge on radiation protection has not been included in the medical studies of a physician referred to in subsection 1, paragraph 3, the knowledge can be acquired by completing the supplementary training referred to in section 8.

Section 10 Carrying out and reporting of self-assessment

In the medical use of radiation, self-assessment of practices shall be carried out at least once a year.

The content and reporting of the self-assessment is subject to what is provided in section 13 and section 14 on the matters to be accounted for and reported on when carrying out clinical audits.

Section 11 Performance of internal clinical audits

An internal clinical audit supplementing the self-assessments of practices must be carried out at least every four years in practices where the category of medical exposure is 1 or 2.

The audit must rely on up-to-date knowledge and experiences of good medical practices.

Section 12 Performance of external clinical audits

An external clinical audit, which supplements internal clinical audits and the self-assessments of practices, must be organized at least:

1) every six years in practices where the category of medical exposure is 1;

2) every eight years in practices where the category of medical exposure is 2.

External clinical audits shall be carried out by a group of qualified and experienced experts independent of the undertaking.

Section 13 Matters to be accounted for in the performance of clinical audits

At least the following must be paid attention to in a clinical audit:

1) the practical implementation of the defined power and responsibilities;

2) the practice and information flow observed in justification assessments;

3) the practices of optimizing radiation protection, including:

a) instructions and practices pertaining to the performance of examinations, treatment, and procedures involving exposure to radiation as well as ensuring the implementation of the planned treatment;

b) the optimal and appropriate use equipment for examinations and treatment;

c) optimizing the dose arising from the medical exposure and the quality of the image;

d) the quality of the radiological report to be provided on the examinations;

4) the examination and treatment results achieved and their communication;

5) staff training;

6) quality assurance, the results of the self-assessment of the practices, and the use of the results.

Section 14 Report on clinical audit

The report to be prepared on the clinical audit shall present the course of the audit as well as the essential observations made in the audit, the assessments and conclusions drawn on their basis, and the recommendations of the party performing the audit for development measures.

The audit report is addressed to the undertaking.

Chapter 5 Existing exposure situations

Section 15 Limitation of chapter’s scope of application

The provisions of this chapter do not apply to situations pertaining to natural radiation which are provided for in chapter 6.

Section 16 Reference level of occupational exposure in protective actions

In an existing exposure situation, the reference level of occupational exposure in protective actions, as an effective dose, is one millisievert a year.

Section 17 Setting a reference level for public exposure

In an existing exposure situation, the reference level of public exposure, as an effective dose, may be at maximum 10 millisieverts a year. The reference level may be set to below the level of 1 millisievert a year if it concerns a particular area or object or a specific exposure pathway related to it. However, the reference level may not be set below the level of 0.1 millisieverts a year if the achievement of this would require unreasonably extensive or expensive measures.

When the radiation exposure decreases, the reference level for public exposure must be decreased, provided that further decrease of the radiation exposure is possible within reason.

Section 18 Use of reference levels

The effective dose caused by occupational or public exposure is compared against the reference level. The determination of the effective dose must account for all exposure pathways other than exposure caused by radon.

The protective actions should be carried out in such a way that the effective dose caused by the radiation exposure remains below the reference level. However, a dose greater than the reference level can be accepted if the achievement of a dose below the reference level requires actions which would result in unreasonable harm in relation to the benefit gained.

Chapter 6 Natural radiation

Section 19 Reference level for the radon concentration in a workplace and reference level for occupational exposure to radon

The reference level for the radon concentration in a workplace is 300 becquerels per cubic meter in a space where working time is 600 hours or more per year. The radon concentration is calculated as the annual average of radon concentration during working hours.

The reference level for occupational exposure to radon is 500,000 becquerel hours per cubic meter a year. Exposure is calculated as the sum of the exposures accumulated in all work spaces during a year.

The reference level for occupational exposure to radon is not applied if the worker works only in a space where the radon concentration is lower than the reference level for the radon concentration in the workplace’s indoor air.

Section 20 Reference levels for and measurement of the radon concentration in a dwelling or other occupied space

The reference level for the indoor air radon concentration in a dwelling or other occupied space is 300 becquerels per cubic meter.

The radon concentration in a dwelling is determined as the annual average radon concentration, which is either measured or estimated on the basis of a measurement during a continuous period of twelve months. The radon concentration of other occupied space is calculated as the annual average radon concentration during the space’s use.

The measurement of the radon concentration must be continuous and last for at least two months. The measuring must be conducted between the beginning of September and the end of May. Supplementary measurements may also be carried out in other occupied spaces for more accurate determination of the radon concentration.

Section 21 Reference level for the radon concentration in a new building

The reference level for the radon concentration in indoor air when designing and implementing new buildings is 200 becquerels per cubic meter.

The annual average radon concentration in a dwelling or other occupied space and the annual average radon concentration during working hours in a workplace is compared against the reference level specified in subsection 1.

Section 22 Reference level for exposure caused by cosmic radiation

The reference level for the exposure of aircraft crew caused by cosmic radiation is, as an effective dose, one millisievert a year.

Section 23 Reference level for occupational exposure caused by other natural radiation

The reference level for occupational exposure arising from natural radiation other than radon or cosmic radiation from radiation practices is one millisievert a year. The exposure is determined as an addition of the effective dose to the effective dose caused by natural background radiation.

Section 24 Reference levels for public exposure from construction products

The reference level for public exposure arising from construction products meant for housing construction is 1 millisievert a year, although in such a way that the radiation dose from the cesium-137 in the construction products is at maximum 0.1 millisieverts a year.

The reference level for public exposure arising from materials used in the construction of roads, streets, and yards as well as in soil filling and landscaping is 0.1 millisieverts a year.

The public exposure is determined as an addition to the effective dose arising from the gamma radiation originating from natural radioactive substances and artificial radioactive substances present in nature on a permanent basis to the effective dose arising from natural background radiation.

Section 25 Reference levels for the radon concentration of household water and the public exposure arising from radioactive substances in household water

The reference levels for the radon concentration of household water and the public exposure arising from radioactive substances in household water shall be subject to what is provided on the quality requirements for radioactivity in section 17 of the Health Protection Act (763/1994).

Section 26 Reference level for public exposure arising from other natural radiation

The reference level for public exposure arising from natural radiation other than radon or cosmic radiation from radiation practices is 0.1 millisieverts a year. The exposure is determined as an addition of the effective dose to the effective dose caused by natural background radiation.

Radiation exposure caused by radioactive substances in construction products is not subject to subsection 1.

Chapter 7 Entry into force

Section 27 Entry into force

This Decree enters into force on 15 December 2018.

Annexes 1-5: Decree of the Ministry of Social Affairs and Health on ionizing radiation

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.