Table of contents
- Section 1 Definitions
- Section 2 Ensuring justification assessment
- Section 3 Justification assessment in the absence of referral guidelines
- Section 4 Justification assessment concerning the medical exposure of a foetus or child
- Section 5 Practical measures in the optimization of radiation protection in medical exposure
- Section 6 Optimizing the radiation protection of a foetus or a child
- Section 7 Optimization in nuclear medicine
- Section 8 The optimization of radiation protection due to a nuclear medicine examination or nuclear medicine treatment
- Section 9 Optimizing radiotherapy
- Section 10 Reference level for a patient’s exposure
- Section 11 Entry into force
- Annexes 1-7
Radiation and Nuclear Safety Authority Regulation on Justification Assessment and Optimisation of Radiation Protection in Medical ExposureSTUK S/4/2019
In accordance with a decision of the Radiation and Nuclear Safety Authority, the following provisions are issued by virtue of section 10, subsection 3, section 109, subsection 2, and section 112, subsection 4 of the Radiation Act (859/2018):
Section 1 Definitions
The reference level for a patient’s exposure means, in this regulation, a predetermined value describing the radiation exposure of a patient arising from an examination or procedure and the value of the activity administered to a patient in a nuclear medicine examination, which is not expected to be exceeded in an examination or procedure performed according to good practice upon a patient of normal size.
Section 2 Ensuring justification assessment
To ensure the justification assessment, the undertaking must ascertain:
- the identity of the person subject to medical exposure;
- the adequacy of the information referred to in section 113, subsection 1, paragraph 1 of the Radiation Act in terms of ensuring the justification assessment of the examination, procedure, or treatment;
- the accuracy and subject of the examination, procedure, or treatment specified in the referral.
However, what is specified above in subsection 1, paragraph 1 does not apply to carers and comforters.
Section 3 Justification assessment in the absence of referral guidelines
In the absence of referral guidelines, the referring physician or dentist must carry out the justification assessment referred to in section 110 of the Radiation Act.
Section 4 Justification assessment concerning the medical exposure of a foetus or child
Before referring a person of childbearing age to an examination, procedure, or treatment resulting in medical exposure, the referring physician or dentist must investigate whether the person is pregnant. However, the investigation is not required prior to an X-ray examination or procedure resulting in medical exposure of the teeth, head and neck area, or the extremities, provided that the radiation is not directed near the abdomen or pelvis, and when medical exposure is justified as an urgent procedure necessary for saving the patient’s life.
In addition to what is provided in subsection 1, the possibility of pregnancy must be checked with an adequately sensitive and specific method in the case of:
- a nuclear medicine examination resulting in a high level of medical exposure for a foetus;
- an X-ray examination or procedure of the abdomen or pelvis area carried out with computed tomography or some other method which results in a high level of medical exposure.
The justification assessment concerning the examination, procedure, or treatment of a pregnant or breastfeeding person resulting in medical exposure to a foetus or breastfed child must particularly consider medical methods alternative to medical exposure or the possibility of postponing the examination, procedure, or treatment to a later date.
The justification assessment concerning an examination, procedure, or treatment causing medical exposure to a child must particularly consider alternative medical methods or the possibility of postponing the examination, procedure, or treatment to a later date.
Section 5 Practical measures in the optimization of radiation protection in medical exposure
Written instructions must be provided for the performance of the most common examinations, procedures, and treatments, including the phases of the examination, procedure, or treatment process to optimize radiation protection in medical exposure
The examination instructions concerning X-ray examinations and procedures must include the examination-specific typical projections and the patient shielding to be used in each examination. The patient shielding must be used if it can materially reduce the radiation exposure of the person or foetus subject to the examination, procedure, or treatment and provided that the shielding does not compromise the performance of the examination, procedure, or treatment.
The indication of the examination or procedure must be accounted for when optimizing radiation protection in the examination or procedure.
The radiation beam in an X-ray examination or procedure must be limited so that it is as small as possible, but nevertheless in such a way that nothing which is material in terms of the examination or procedure is left outside the imaging area.
The undertaking must ensure that the optimization has been carried out in terms of the most common imaging programs of each appliance used for patient imaging.
Section 6 Optimizing the radiation protection of a foetus or a child
The effective dose of a foetus may not exceed 1 mSv, unless this is particularly justified in terms of the overall care of the person examined. The radiation protection of a foetus must be optimized particularly in medical exposure as referred to in section 4, subsection 2.
The optimization of a child’s radiation protection must account for the child’s size and any other special characteristics of the examination. An examination, procedure, or treatment exposing a child to radiation must be planned individually and performed with an appliance that allows for achieving the lowest radiation exposure reasonably possible.
Patients must be urged to stop breastfeeding or to take a break from breastfeeding due to a nuclear medicine examination or nuclear medicine treatment so that the radiation exposure of the breastfed child is as low as possible and at the very least not higher than the dose limit for members of the public.
Section 7 Optimization in nuclear medicine
The activity of a radiopharmaceutical or a tracer must be measured with an activity meter prior to administering the pharmaceutical or tracer to the patient.
If the use of alternative radiopharmaceuticals in the examination is possible, a radiopharmaceutical which results, within reason, in the smallest radiation dose for the patient must be selected.
Section 8 The optimization of radiation protection due to a nuclear medicine examination or nuclear medicine treatment
Following a nuclear medicine examination or nuclear medicine treatment, patients must be urged to avoid pregnancy for a sufficient period of time which ensures that the radiation exposure of an unborn child does not exceed the dose limit for members of the public.
Section 9 Optimizing radiotherapy
In radiotherapy, the radiation must be directed at the target area with the precision required by the objective of the therapy.
In external radiotherapy, the uncertainty of the dose may not be greater than, on average,
- 5%, when using photon radiation greater than 1 MV;
- 10%, when using electron or X-radiation.
Medical exposure in radiotherapy must be planned patient-specifically and the magnitude and focus of the exposure must be verified. The dose received by tissues and organs other than those targeted must be as low as reasonably possible.
Section 10 Reference level for a patient’s exposure
The reference levels for a patient’s exposure are specified in Annex 1–7. The value of a reference level determined by the undertaking itself may not exceed that which is specified in the Annex.
The undertaking must compare the value describing the average radiation exposure of a patient and the activity administered to a patient to the reference level at least once every three years and whenever examination practices or imaging values are changed in such a way that the radiation dose or activity undergoes a material change. This is not applicable to the use of a dental X-ray equipment that images to an intraoral image detector.
The average value and activity describing the radiation exposure must be determined as the median of a sample of at least ten patients of a normal size, either by measurement or by calculated estimation, unless otherwise provided in the Annex.
During the years when the determination is not carried out, it must be ensured that the value describing the radiation exposure or activity has not changed.
If the determined average value describing the patient’s radiation exposure or activity exceeds the reference level, the reason for the high radiation exposure or activity must be investigated and, if necessary, measures must be taken to reduce patients’ radiation exposure.
Section 11 Entry into force
This regulation enters into force on 5 April 2019 and is valid until further notice
This regulation applies to any matters pending on the date of its entry into force.
In Helsinki on 4 April 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.