GUIDE ST 6.

3 / 14 January 2013

RADIATION SAFETY IN NUCLEAR

MEDICINE
1 General 3
2 Definitions 3
3 Use of radiation and the safety licence 3
3.1 The responsible party shall be responsible for safety 3
3.2 The use of radiation requires a safety licence 4

4 Performance of procedures 4
4.1 Procedures shall be justified and optimised 4
4.2 Radiation protection of patients 4
4.3 Reference levels for nuclear medicine examinations and their use 5
4.3.1 How to determine the mean activity to be administered to patients? 5
4.3.2 Actions in the case that the mean activity differs from the reference level 5
4.3.3 Recording of results 6
4.4 Radiation protection shall be ensured for patients’ family members
and other individuals 6
4.4.1 Dose constraints 6
4.4.2 Radiation protection instructions shall be provided both orally and in writing 6

5 Written instructions shall be available for examinations

and treatments 7
6 Equipment shall comply with the set requirements 7
6.1 General requirements 7
6.2 Acceptability criteria during the use of equipment 7

7 Responsible parties shall be liable for quality assurance

for their operations 8
7.1 Quality assurance programme 8
7.2 Quality control of devices 8
7.2.1 Acceptance testing 8
7.2.2 Quality control during the use of equipment 8

This Guide is valid as of 1 March 2013 until further notice.It replaces Guide ST 6.3,
Use of radiation in nuclear medicine, issued on 18 March 2003.
Helsinki 2013 ISBN 978-952-478-778-9 (pdf)
ISSN 0789-4716 ISBN 978-952-478-779-6 (html)

STUK • SÄTEILYTURVAKESKUS Osoite/Address • Laippatie 4, 00880 Helsinki

STRÅLSÄKERHETSCENTRALEN Postiosoite / Postal address • PL / P.O.Box 14, FIN-00881 Helsinki, FINLAND
RADIATION AND NUCLEAR SAFETY AUTHORITY Puh./Tel. (09) 759 881, +358 9 759 881 • Fax (09) 759 88 500, +358 9 759 88 500 • www.stuk.fi
STU K GUIDE ST 6.3 / 14 January 2013

7.3 Quality assurance for radiopharmaceuticals 9

7.4 Records for quality assurance 9

8 Clinical audit and self-assessment 9

9 Grounds shall be given for the justification of radiation
exposure due to scientific research 10
10 Special protection during pregnancy and breastfeeding 10
10.1 Assessing the possibility of pregnancy 10
10.2 Protection of the foetus 10
10.3 Avoiding pregnancy after nuclear medicine examinations or
radionuclide therapies 10
10.4 Protection of the child during breastfeeding 11

11 How to record and report information on nuclear

medicine examinations and radionuclide therapies? 11
12 Abnormal events in the use of radiation 11
12.1 Anticipation of abnormal events 12
12.2 Dealing with abnormal events 12
12.3 Reporting abnormal events 12

Appendix Data to be recorded when determining the mean activity of

radiopharmaceuticals to be administered to patients?

Authorization
The Radiation Act stipulates that the party running a radiation practice is
responsible for the safety of the operations. The responsible party is obliged
to ensure that the level of safety specified in the ST Guides is attained and
maintained.
Under section 70, paragraph 2, of the Radiation Act (592/1991), STUK –
Radiation and Nuclear Safety Authority (Finland) issues general instructions,
known as Radiation Safety Guides (ST Guides), concerning the use of radiation
and operations involving radiation.

Translation. In the event of any differences in interpretation of this guide, the

Finnish and Swedish versions shall take precedence over this translation.
GUIDE ST 6.3 / 14 January 2013 S T U K

1 General instruction of workers are laid down in section 36 of

the Radiation Act. Also Guide ST 1.6 gives instructions
This ST Guide presents the essential radiation concerning the training and instruction of workers.
safety requirements for nuclear medicine. These The requirements for the training and qualifications
requirements shall also apply to procedures of health care professionals are prescribed in chapter
performed on healthy persons participating in 5 of the MSAH Decree. The requirements for the
scientific research and to procedures performed professional supplementary training for persons
on patients. These requirements shall also engaged in medical use of radiation are prescribed in
apply to the radiation exposure of persons section 27 of the MSAH Decree. Guide ST 1.7 prescribes
who voluntarily and otherwise than due to the requirements concerning the radiation protection
their occupations assist persons subjected to training of workers participating in procedures
procedures involving exposure to radiation. involving exposure to radiation in health care.

2 Definitions
The basic provisions concerning medical uses of
radiation are laid down in chapter 10 of the Radiation
Act (592/1991). The Decree of the Ministry of Social In this Guide,
Affairs and Health on the medical use of radiation quality control refers to the measurements,
(423/2000, hereinafter referred to as the MSAH Decree) tests, inspections and assessments used for
lays down the provisions concerning the grounds of determining and monitoring the operating
procedures which cause exposure to radiation. Guides conditions and performance capabilities of
ST 1.1 and ST 1.6 present general safety principles, appliances used in radiation practices
radiation safety measures, and general principles quality assurance refers to all the planned,
concerning security arrangements. systematic measures taken in order to ensure
Guide ST 6.1 presents the radiation safety that all methods, appliances and their use fulfil
requirements for laboratories and patient facilities as the specified quality requirements
well as general instructions on working with unsealed quality assurance programme refers
sources. Guide ST 1.10 gives instructions concerning to the document referred to in section 18 of
the radiation shielding of places of use of radiation the MSAH Decree, specifying in writing the
sources. Instructions concerning the handling and quality assurance activities in the medical use of
discharges of radioactive wastes into the environment radiation
are set forth in Guide ST 6.2. management system refers to the system
Guide ST 5.1 presents the radiation safety comprising the organizational structures,
requirements for sealed sources and devices containing procedures, processes and resources required
sealed sources as well as for the use and installation for managing and developing the operation. A
of them. Instructions on the use of sealed sources in management system can also be called a quality
radiotherapy are set forth in Guide ST 2.1. system.
Provisions concerning the classification of facilities

3 Use of radiation and

into controlled and supervised areas as well as the
protection of workers and their medical surveillance
are laid down in sections 32 and 33 of the Radiation
Act. Guide ST 1.6 gives instructions concerning the
the safety licence
classification of working areas and workers. Guide ST 3.1 The responsible party shall
7.1 gives more detailed instructions on the monitoring be responsible for safety
of radiation exposures of workers, and Guide ST The party running a radiation practice (hereafter
7.5 gives more detailed instructions on the medical the responsible party) shall be responsible
surveillance of occupationally exposed workers. for ensuring that all operations are arranged
Provisions are laid down in section 14 a of the so that their practices fulfil all requirements
Radiation Act concerning the responsible party’s and regulations under the Radiation Act and
duty to arrange training for individuals engaged in any statutes under it, and that the danger of
the use of radiation. Provisions on the training and events leading to any abnormal exposure to

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STUK GUIDE ST 6.3 / 14 January 2013

radiation is prevented with sufficient efficiency.

The responsible parties shall be liable for the
4 Performance of
implementation of such measures to improve procedures
radiation safety that can be considered
reasonable with respect to their nature and 4.1 Procedures shall be
extent. justified and optimized
In matters concerning the safety of operations, Responsible parties shall ensure that good
the responsible parties shall ascertain that they practices are applied in nuclear medicine
possess the expertise required with respect to the examinations and radionuclide therapies.
nature and extent of the operations. The referring physicians shall consider the
justification of the nuclear medicine examinations
The general obligations of a responsible party are laid and radionuclide therapies when writing the
down in chapter 4 of the Radiation Act. The training referrals. In addition, the nuclear medicine
and qualification requirements for operating personnel specialists in charge of these procedures shall
are laid down in the Radiation Act and in chapter 5 of ascertain the justification of each procedure. A
the MSAH Decree. referral shall clearly state the indication of the
examination or treatment and other necessary
3.2 The use of radiation information so that the procedure can be
requires a safety licence performed in an optimal manner.
Safety licences are granted by STUK upon Nuclear medicine examinations shall be
application. STUK shall grant the safety licence optimized to fulfil the purpose of the procedure
if the intended use of radiation fulfils the while minimising the radiation exposure to the
general provisions laid down in the law and if subject. This requires e.g. that
the application demonstrates in a sufficiently • all staff participating in the use of radiation
reliable manner that, for example: have been trained and fulfil the respective
• the purpose and the place of use of radiation, qualification requirements
the radiation sources, and the equipment • the appliances in use are suitable for the
related to the use of radiation intended examinations and in proper working
• radiation user’s organization, and order
• the arrangements for handling the radioactive • the examination procedures are optimized
waste possibly produced by the operations • the image quality is sufficient for reliable
are such that radiation can be used safely. diagnoses.

The safety licence application shall have an Radiation doses in radionuclide therapy shall
organization description appended that specifies be planned individually for each patient so that
the responsibilities relating to the use of the radiation dose to the target tissue or organ is
radiation. sufficient to bring about the desired effect. At the
same time, the radiation exposure of non-target
The provisions concerning the general principles of tissues shall be as low as reasonably achievable.
radiation safety are laid down in section 2 of the
Radiation Act. The provisions concerning the safety Provisions concerning justification and optimization
licence and granting the safety licence are laid down are laid down in section 38 of the Radiation Act and
in section 16 of the Radiation Act, and the provisions chapter 2 of the MSAH Decree.
concerning organization description are laid down in
section 18 of the Radiation Act. More details are set 4.2 Radiation protection of patients
out in Guide ST 1.1. Guides ST 1.4 and ST 1.8 give Before performing a procedure, the respective
more precise requirements concerning radiation users’ unit shall ensure that the patient holds a proper
organizations. referral for the examination, that radiation

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GUIDE ST 6.3 / 14 January 2013 S T U K

protection and safety have been ascertained, and patients on the basis of activity administered in a
that the patient has been appropriately informed certain examination. They should not be applied
about the intended procedure. to examinations of individual patients.
Before a radiopharmaceutical is administered Responsible parties are required to
to a patient, its activity shall be measured with introduce reference levels to nuclear medicine
an activity meter. examinations. The reference levels for the most
If alternative radiopharmaceuticals are common examinations are issued by STUK, and
possible for an examination, the radio­ pharma­ they are revised as necessary.
ceutical selected shall, when possible, be the
radiopharmaceutical that minimizes the Dose limits are given in chapter 2 of the Radiation
radiation dose to the patient. If the activity Decree (1512/1991). The requirements concerning the
administered to the patient depends on the use of reference levels are laid down in sections 16 and
device used for the examination, then the device 17 of the MSAH Decree.
selected shall be the one that minimizes the
activity that is necessarily delivered to the 4.3.1 How to determine the mean activity
patient in the examination. to be administered to patients?
All available measures must be made use The mean activity of radiopharmaceuticals
of in order to reduce the radiation exposures administered to patients in nuclear medicine
of patients caused by nuclear medicine examinations shall be compared to the reference
examinations and radionuclide therapies. These levels. Quality assurance programmes shall
measures include e.g. preventing radioactive include instructions concerning the assessment
substances from accumulating in organs that of the activity administered to patients in
are not being examined and accelerating the different types of examinations. The mean
excretion of the radioactive substances. activity shall be determined for a group of no
The management system documentation must fewer than ten patients of normal size for each
describe the measures applied in ensuring that type of examination at intervals of at least
the right patient receives the right amount of three years. If the activity administered to a
the right radiopharmaceutical. These documents patient depends on the weight of the patient,
must also describe the measures to be taken to patients shall be selected so that their weights
reduce the patient’s radiation exposure in the fall in the range 60–80 kilograms. If the activity
case of a dosage error. administered to a patient depends on the device
used for the examination, the mean activity shall
4.3 Reference levels for nuclear be determined per device. If the examination
medicine examinations and their use practice or equipment changes in a manner that
The dose limits set forth in the Radiation Decree affects the activity administered to patients, then
do not apply to patients’ radiation exposures. the mean activity shall be determined again at
However, the principle of optimization requires the earliest opportunity.
that the radiation exposure of any subject of
an examination or a therapeutic procedure be 4.3.2 Actions in the case that the mean
limited to the amount that is necessary for the activity differs from the reference level
gaining of the intended outcome to the procedure. If the mean activity administered to patients
Reference levels form an optimization tool for in an examination clearly exceeds the reference
nuclear medicine examinations. Reference level, the reasons for this shall be investigated,
level refers to predetermined activity levels any potential deficiencies corrected, and, if
administered to patients in nuclear medicine necessary, the examination must be optimized.
examinations that are not presumed to be If the mean activity administered to patients
exceeded in procedures performed according to falls substantially below the reference level, it
the standards of good practice upon patients of must be ensured that the acquired information is
normal size. sufficient for diagnosis.
Reference levels are determined for groups of

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STUK GUIDE ST 6.3 / 14 January 2013

4.3.3 Recording of results activity. Patients should be able to use public

The mean activity values and all information transportation for journeys of no longer than two
concerning corrective measures must be recorded hours.
and kept for at least five years. In addition, Patients with incontinence should not be
the information itemized in Appendix must be released to their own home or to nursing home
recorded and kept. immediately after treatment.
When using beta-emitting radionuclides,
4.4 Radiation protection shall such as 32P, 89Sr and 90Y, no radiation protection
be ensured for patients’ family measures are necessary after the residual
members and other individuals activity in patients no longer exceeds 200 MBq.
Autopsies may be performed without
4.4.1 Dose constraints radiation protection measures after the residual
Patients who have had radioactive substances 131I activity in the patients no longer exceeds

administered to them may be treated as 600 MBq.

outpatients when radiation exposures caused
to family members and other persons by the Provisions are laid down in section 10 of the MSAH
residual activity in these patients remain Decree concerning the use of dose constraints for
insignificant. The following dose constraints limiting the radiation exposure of voluntary
shall be applied: assistants. Instructions for the release of patients after
Family members of the patient I treatment are available in the EU Commission
131

Children (including unborn children) 1 mSv/treatment publication ”Radiation protection 97, Radiation
Adults (under 60 years of age) 3 mSv/treatment Protection following Iodine-131 therapy (exposures due
Adults (60 years of age and older) 15 mSv/treatment to out-patients or discharged in-patients)”.
Other persons (members of the public)*) 0.3 mSv/year
4.4.2 Radiation protection instructions shall
If it is possible that the dose constraints of be provided both orally and in writing
family members or any other individuals might If there is any reason to suspect that the dose
be exceeded, (e.g. because of a long journey, or constraints presented in item 4.4.1 may be
if there are small children at home) the patient exceeded, and before releasing patients who have
must remain in hospital until the residual had radionuclide therapies, the unit responsible
activity in this patient has fallen sufficiently. for the procedures shall provide these patients or
Patients who have received radionuclide their caretakers with instructions concerning the
therapy shall be accommodated in the hospital limiting of the radiation exposure of individuals
facilities in a manner that minimizes the who come into contact with these patients. These
radiation exposure of workers, other patients instructions shall take into account the individual
and visitors. The doors leading to patient rooms circumstances of the patients, such as their living
(isolation rooms) shall carry signs calling and working conditions. The instructions must be
attention to a radiation hazard. provided both orally and in writing, and in a form
After 131I treatment the patient may be that the patients understand. The importance of
released from hospital after receiving the following the instructions shall be emphasized
relevant radiation protection instructions when to the patients. The fact that instructions were
the residual 131I activity in patient no longer given shall be entered into the patients’ medical
exceeds 800 MBq. Appropriate measurements records. The instructions should include at least
shall be made in order to ascertain the residual the following information:
• the name and identity number of the patient
*) The exposure of other persons is subject to the dose • the name, address and telephone number of
limit for the members of the public, which is 1 mSv the hospital
per year. As doses may be caused also by other
radiation sources, the dose constraint for exposure
due to a single radiation source is 0.3 mSv.

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GUIDE ST 6.3 / 14 January 2013 S T U K

• the person to contact if problems arise 5 Written instructions

• the radiopharmaceutical administered to the
patient and its activity shall be available
• the date on which the pharmaceutical was
administered for examinations
• practical instructions for limiting the
radiation exposure of persons coming into
and treatments
contact with the patient Written instructions shall be available for
• the period during which the instructions must performing nuclear medicine examinations
be followed. and radionuclide therapies. These written
instructions shall cover all stages of examinations
Practical instructions for steps for limiting and therapeutic procedures for the most common
the radiation exposure of persons coming into examinations and therapies, and they shall
contact with the patients shall be issued also also include the preparation and processing
when patients are transferred between units at a of radiopharmaceuticals and dealing with
hospital or to other hospitals. radioactive wastes. The written instructions are
The period during which the instructions also required to issue the relevant instructions
must be followed depends on the residual activity and safety directions concerning the radiation
in the patient and on the dose rate that this protection of both workers and patients.
causes.
If a patient plans to travel abroad immediately The requirements concerning written instructions for
after radionuclide therapy, the patient must be the performance of procedures are laid down in section
given a certificate of treatment, preferably in 14 of the MSAH Decree.
English, because radiation measurements are
likely at national borders.
The activity of radiopharmaceuticals 6 Equipment shall comply
administered to patients in nuclear medicine
examinations is generally so small that no
with the set requirements
precautions or restrictions on the behaviour of 6.1 General requirements
the patient are necessary. After nuclear medicine The statutes on medical devices also apply to
examinations, no practical instructions are devices used in nuclear medicine. Procedures
usually necessary in order to limit the radiation involving exposure to radiation shall be
exposures of persons coming into contact with performed using equipment that is suited for
these patients. Exceptions to this are nuclear the intended purpose. All devices must have a
medicine examinations in which the patient is CE marking to indicate their compliance with
administered 30 MBq or more of 131I, and the regulations.
cases in which reasons exist to suspect that any
of the dose constraints referred to in item 4.4.1 General requirements and limitations concerning
might be exceeded. equipment and their uses are given in section 30 of the
MSAH Decree. Provisions concerning the CE marking
Section 11 of the MSAH Decree lays down the are laid down in section 9 of the Medical Devices Act
provisions concerning protection instructions to the (629/2010).
patient or a person attending to the patient. The
publication “Radiation protection 97, Radiation 6.2 Acceptability criteria during
Protection following Iodine-131 therapy (exposures due the use of equipment
to out-patients or discharged in-patients)” includes an Nuclear medicine equipment and the related
example of the instructions to be provided to a patient auxiliaries and devices shall comply with all
following 131I therapy. acceptability criteria during the use of equipment

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STUK GUIDE ST 6.3 / 14 January 2013

given in STUK’s decisions. Acceptability criteria cause unintended radiation exposure. Quality
refer to the minimum requirements for the assurance practices shall be assessed regularly
performance capacity of equipment. If the and, when appropriate, changed.
acceptability criteria are not met, then one of the
following measures must be taken: Provisions are laid down in section 40 of the
• Repairs must be implemented to restore the Radiation Act concerning the responsible party’s
performance capacity of the device to an duty to implement quality assurance measures. The
acceptable level. requirements concerning the drafting of the quality
• The use of the device must be restricted so assurance programme are laid down in section 18 of
that the characteristic exceeding the tolerance the MSAH Decree.
limit does not affect any examination or
treatment. 7.2 Quality control of devices
• The device must be decommissioned.
7.2.1 Acceptance testing
Acceptability criteria are not tolerance limits for The responsible party shall ensure that any
the optimal performance of the apparatus. When device about to be commissioned has an
procuring new equipment, at acceptance tests acceptance test conducted before the device is
and in the course of monitoring performance used for examining or treating patients. The
during the use of equipment, responsible parties purpose of the acceptance test is to verify that
should apply stricter requirements, which may be the device functions appropriately and safely
based, for example, on the device specifications after transportation, installation and connection
or the performance tolerance limit proposed in of all parts. All equipment shall comply with the
equipment standards. requirements imposed by legislation, with the key
performance values and safety characteristics
Requirements and criteria of acceptability are laid given by the manufacturers, and with the
down in section 30 of the MSAH Decree. acceptability criteria during the use of equipment
given in the respective STUK decisions (see item
6.2). During the acceptance test, it is expedient to
7 Responsible parties define the reference values for the performance

shall be liable for parameters needed for monitoring the operating

condition of the equipment.
quality assurance for Acceptance tests may be carried out
by a representative of the user organization
their operations (purchaser), a representative of the supplier, or
The best way to implement the requirements a third party. If acceptance tests are carried out
imposed on responsible parties by radiation by a party other than the user organization’s
legislation is to use a management system representative, the tests shall be appropriately
covering all operations. The management supervised and a person shall be assigned to take
system shall be documented, and the respective charge of supervision.
documents shall be arranged to form a unified,
continuously updated entity (the procedures Requirements for acceptance test are laid down in
manual, the quality manual or similar). section 32 of the MSAH Decree.

7.1 Quality assurance programme 7.2.2 Quality control during the use of equipment
Responsible parties shall be liable for quality In addition to acceptance testing, the operation
assurance for their operations. Quality assurance of all equipment shall be inspected according to
functions shall be specified in writing in a quality device- specific instructions
assurance programme. The quality assurance • at regular intervals
programme shall include the principles for the • following significant repairs or servicing
prevention of errors and mishaps which may

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GUIDE ST 6.3 / 14 January 2013 S T U K

• at any time when there is cause to suspect a quality assurance functions for radiopharma­
malfunction or a change in the operation of ceuticals shall be specified in the quality
the equipment. assurance programme.

The quality control programme for a device Section 9.2 of regulation 6/2012 ”Sairaala-apteekin
shall set out the principal tasks involved in ja lääkekeskuksen toiminta” (“Operation of hospital
monitoring the operating condition and dispensaries and central dispensaries”) by the Finnish
performance characteristics of the equipment. Medicines Agency (Fimea) sets forth statutes concerning
The instructions and responsibilities pertaining radiopharmaceuticals.
to the monitoring of equipment shall be specified
per appliance. A quality control programme for a 7.4 Records for quality assurance
device shall specify Records must be kept of all inspections and
• the inspections and measurements to be measurements performed for the purpose of
performed as well as their purposes quality assurance, detailing which inspections
• the inspection and measurement methods and measurements have been made, by whom,
• the devices and instruments to be used in the results thereof, and the measures taken on
inspections and measurements account of those results.
• the intervals at which inspections and Records must also be kept of any equipment
measurements must be performed faults, malfunctions and other incidents that
• the approval criteria (action levels) for occur during the use of the equipment and that
inspection and measurement results disrupt its normal use or endanger safety. All
• the measures to be taken when the approval essential documents shall be kept through the
criteria are exceeded. service-life of the equipment.
In addition, if any abnormal events are
If inspection and measurement results exceed observed that are significant for radiation safety,
the set action levels, the measures given in the the measures should be taken that are presented
quality control programme must be performed. in chapter 12.
The responsible party may set the action levels.
However, action levels set to require repair shall
not be higher than the acceptance criteria set by 8 Clinical audit and
STUK.
The persons performing inspections and
self-assessment
measurements and the persons in charge of them The objective is for operations to be audited
(professional groups) must be specified. in all essential respects at least once per five
Instructions concerning the inspection and years. Clinical audits must be arranged so that
measurement methods must be issued in writing they complement the self-assessment of activities
in sufficient detail so that all inspections and in an expedient manner. An expedient audit
measurements can be repeated on the basis of respects the recommendations by the Finnish
these instructions as intended by the person who Advisory Committee for Clinical Audit, set by the
prepared the instructions. National Institute for Health and Welfare (THL)
(www.clinicalaudit.net).
Requirement for quality assurance programme is laid
down in section 32 of the MSAH Decree. The obligation of the responsible party to arrange
clinical auditing for the medical use of radiation is
7.3 Quality assurance for laid down in section 39 c of the Radiation Act and
radiopharmaceuticals in chapter 4 of the MSAH Decree. The duty of the
The handling and preparation of radio­ responsible party to set up self-assessment procedures
pharmaceuticals shall conform to good for the medical use of radiation is prescribed in section
radiopharmaceutical practice. This includes both 19 of the MSAH Decree.
radiation safety and purity requirements. The

9
STUK GUIDE ST 6.3 / 14 January 2013

9 Grounds shall be given and the radiation protection of the foetus shall
be implemented as prescribed in chapter 7 of the
for the justification of MSAH Decree.
Before radionuclide therapy or any exami­
radiation exposure due nation that might expose a foetus to an excessive

to scientific research dose, the possibility of pregnancy shall be ruled

out through a sensitive, specific pregnancy test.
The research plan for a scientific investigation
shall assess the radiation exposure to which Assessing the possibility of pregnancy is prescribed in
the participants of the investigation may be section 34 of the MSAH Decree.
subjected, and it shall also explain the grounds
that justify the exposure. 10.2 Protection of the foetus
The publication “Radiation protection 99” by If it is seen that performing a procedure involving
the EU Commission presents a risk categorization exposure to radiation on a pregnant woman
for scientific research projects on the basis of is absolutely necessary, the optimising of the
the radiation doses to the participants. This procedure shall receive particular attention. The
risk categorization, based on ICRP publication starting point is that the dose to the foetus should
No. 62, can be applied to the assessment of the not exceed 1 mSv. If the procedure is performed,
justification of scientific research that involves the exposure of the foetus to radiation shall be
radiation exposure. kept as low as possible. The estimated radiation
Special care shall be taken when subjects dose to the foetus and all data concerning the
are selected for scientific research in which procedure that are significant in view of radiation
participants are administered radioactive exposure shall be entered in the patient’s records.
substances. The principles presented in
“Radiation protection 99” shall be followed in the The protection of the foetus is prescribed in section 35 of
selection of subjects. the MSAH Decree.
Dose constraints shall be presented for
healthy volunteers. Effective doses to healthy 10.3 Avoiding pregnancy after
volunteers should not normally exceed 10 mSv nuclear medicine examinations
per year. or radionuclide therapies
There is no need to avoid pregnancy after most
The requirements for scientific research involving nuclear medicine examinations. Some nuclear
exposure to radiation are laid down in section 6 of the medicine examinations may, however, cause
MSAH Decree. Provisions concerning medical research radiation doses exceeding 1 mSv to an unborn
are laid down in the Medical Research Act (488/1999). child. In such cases the patients should be urged
The EU Commission publication “Radiation protection to avoid pregnancy for a certain period of time.
99, Guidance on medical exposures in medical and Female patients shall be urged to avoid
biomedical research” provides instructions concerning pregnancy after radionuclide therapy. This
the risk categorization and selection of subjects ensures that the dose to the unborn child does
applicable to scientific research. not exceed 1 mSv. The duration of the period in
which pregnancy should be avoided depends on
the applied radionuclide therapy. Spermatozoa
10 Special protection may also be damaged through radionuclide

during pregnancy therapy; for this reason, male patients shall

be advised not to father children for a certain
and breastfeeding period after radionuclide therapy. When thyroid
cancer is treated with 131I, both female and male
10.1 Assessing the possibility of pregnancy patients shall be instructed to use effective birth
If the patient is a woman of childbearing age, control and to avoid pregnancy for at least six
the possibility of pregnancy shall be ascertained months after the therapy.

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GUIDE ST 6.3 / 14 January 2013 S T U K

Instructions on special protection during pregnancy Patient data shall include the following items
and breastfeeding are available in the EU Commission concerning radiopharmaceuticals administered
publication “Radiation protection 100. Guidance for during examinations and treatments
protection of unborn children and infants irradiated • activity
due to parental medical exposure.” • radionuclide
• chemical form or the abbreviation generally
10.4 Protection of the child used for it.
during breastfeeding
When nuclear medicine examinations or Any CT examinations performed in connection
radionuclide therapies are considered, attention with nuclear medicine examinations shall be
shall be paid to radiation protection during recorded in the patient data in a manner that
breastfeeding. Before prescribing an examination enables the determination of patients’ radiation
or treatment, it must be ascertained whether a exposures even retrospectively.
woman is breastfeeding. Before any procedure All written instructions on the performance of
is performed, breastfeeding women shall be procedures shall be archived so that the radiation
advised of interruption that will be necessary doses to patients can be assessed afterwards if
in breastfeeding or, even, of the cessation of necessary. It shall also be possible to ascertain on
breastfeeding. Children should not be breastfed the basis of the archived documents afterwards
after nuclear medicine examinations until the which practice was followed at the time of a
dose to them can be estimated to be below 1 mSv. particular procedure. Examination instructions
The recommended lengths of interruption shall be kept for 20 years.
in breastfeeding following various nuclear Upon request and in the manner specified by
medicine examinations are set out in ICRP STUK on a case-by-case basis, the responsible
publication 106, in European Commission party shall submit to STUK information
publication “Radiation protection 100” and in the concerning nuclear medicine examinations and
specifications of radiopharmaceuticals. If it is radionuclide therapies for national appraisals of
not possible otherwise ascertain, that the dose to radiation exposure and its development.
the child remains below 1 mSv, the length of the
interruption shall be determined on the bases of The recording of information concerning procedures
activity concentration measured in breast milk and the obligation of STUK to collect and publish
and biological half life. national appraisals is prescribed in section 43 of the
Breastfeeding must be ceased altogether after MSAH Decree.
radionuclide therapy.

Protection during breastfeeding is prescribed in section 12 Abnormal events in

36 of the MSAH Decree.
the use of radiation
An abnormal event in the use of radiation refers
11 How to record and report to an event that differs from the normal activities

information on nuclear and results in a substantial safety hazard in

a place where radiation is used or near such
medicine examinations and a place. An abnormal event may also consist
of an exceptional observation or information
radionuclide therapies? concerning an issue that is of substantial
All procedures must be entered into the patients’ significance for the radiation safety of workers,
medical records. If a procedure was performed in the environment or patients.
a substantially different manner than usual, this
must also be entered into that patient’s medical Examples of abnormal events are presented in Guide
records. ST 1.6.

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STUK GUIDE ST 6.3 / 14 January 2013

12.1 Anticipation of abnormal events Supervisory Authority for Welfare and Health
The responsible party should identify in advance (Valvira).
the possible abnormal events relating to the use
of radiation. The responsible party shall plan and Provisions are laid down in section 17 of the Radiation
implement all operations so that the likelihood Decree concerning the responsible party’s duty to report
of any abnormal event is minimized. Abnormal abnormal events to STUK. The reporting of abnormal
events shall be anticipated by, for example, events is treated in chapter 7 in Guide ST 1.6. Guide
providing the workers with written instructions ST 5.1 provides instructions concerning the reporting
for the case that any such should occur. of abnormal events relating to sealed sources. Reporting
of hazardous situations to Valvira (www.valvira.fi) is
The anticipation of abnormal events is treated in more prescribed in the Medical Devices Act (629/2010).
detail in chapter 7 in Guide ST 1.6.

12.2 Dealing with abnormal events Bibliography

When an abnormal event is noticed or suspected, 1. European Commission. Criteria for
steps taken shall be in accordance with the acceptability of radiological (including radio­
instructions provided for the workplace. The therapy) and nuclear medicine installations.
radiation doses due to the abnormal event shall Radiation protection 91. Luxemburg: Office
be assessed. Abnormal events shall be studied by for Official Publications of the European
the radiation safety officer and the staff together Communities; 1997.
so that these events would be learned from and 2. European Commission. Radiation protection
similar events could be avoided in the future. following iodine-131 therapy (exposures due
to out-patients and discharged in-patients).
More detailed instructions concerning dealing with Radiation protection 97. Luxemburg: Office
abnormal events are presented in Guide ST 1.6. for Official Publications of the European
Communities; 1998.
12.3 Reporting abnormal events 3. European Commission. Guidance on medical
All events which result in a substantial safety exposures in medical and biomedical research.
hazard in a place where radiation is used or in Radiation protection 99. Luxemburg: Office
its environs shall be reported to STUK without for Official Publications of the European
delay. The initial report may be submitted Communities; 1998.
by telephone, but it must later be confirmed 4. European Commission. Guidance for
in writing. The personnel shall have clear protection of unborn children and infants
instructions for reporting abnormal events. irradiated due to parental medical exposure.
A report of an abnormal event must specify Radiation protection 100. Luxemburg: Office
• the responsible party (holder of the safety for Official Publications of the European
licence) and the radiation safety officer Communities; 1998.
• the name and contact information of the 5. European Commission. Guidance on
person giving the report diagnostic reference levels (DRLs) for
• the time and place of the event medical exposures. Radiation protection 109.
• a description of the event Luxemburg: Office for Official Publications of
• information about the endangered persons the European Communities; 1999.
and the radiation exposures to which they 6. International Commission on Radiological
may have been subjected Protection. The 2007 recommendations of the
• immediate measures taken after the event International Commission on Radiological
• first estimates of the reasons for the event. protection. ICRP Publication 103. Annals of
the ICRP 2007; 37 (2–4).
All hazardous situations in the use of medical
devices shall also be reported to the National

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GUIDE ST 6.3 / 14 January 2013 S T U K

7. International Commission on Radiological 14. NEMA NU 3-2004 Performance measure­

Protection. Radiological protection in ments and quality control guidelines for
medicine. ICRP Publication 105. Annals of the non-imaging intraoperative gamma probes.
ICRP 2007; 37 (6). NEMA National Electrical Manufacturers’
8. International Commission on Radiological Association; 2004.
Protection. Radiation dose to patients from 15. International Atomic Energy Agency. Quality
radiopharmaceuticals – Addendum 3 to ICRP assurance for PET and PET/CT systems.
Publication 53. ICRP Publication 106. Annals IAEA Human Health Series No. 1. Vienna:
of the ICRP 2008; 38 (1–2). IAEA; 2009.
9. International Commission on Radiological 16. International Atomic Energy Agency. Quality
Protection. Radiation dose to patients from assurance for SPECT systems. IAEA Human
radiopharmaceuticals (Addendum to ICRP Health Series No. 6. Vienna: IAEA; 2009.
Publication 53). ICRP Publication 80. Annals 17. International Atomic Energy Agency. Release
of the ICRP 1998; 28 (3). of patients after radionuclide therapy with
10. International Commission on Radiological contributions from the ICRP. IAEA Safety
Protection. Radiological protection in Report Series No. 63. Vienna: IAEA; 2009.
biomedical research. ICRP Publication 62. 18. The Finnish Medicines Agency Fimea.
Annals of the ICRP 1992; 22 (3). Regulation 6/2012. Sairaala-apteekin
11. International Commission on Radiological ja lääkekeskuksen toiminta (Operation
Protection. Release of patients after therapy of hospital dispensaries and central
with unsealed radionuclides. ICRP Publication dispensaries). Helsinki: The Finnish
94. Annals of the ICRP 2004; 34 (2). Medicines Agency (Fimea); 2012.
12. NEMA NU 1-2007. Performance measure­ 19. Quality control guidance for nuclear medicine
ments of gamma cameras. NEMA National equipment. Advice from STUK 1/2010.
Electrical Manufacturers’ Association; 2007. Helsinki: STUK – Radiation and Nuclear
13. NEMA NU 2-2007. Performance measure­ Safety Authority, Finland; 2010.
ments of positron emission tomographs.
NEMA National Electrical Manufacturers’
Association; 2007.

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STUK GUIDE ST 6.3 / 14 January 2013

Appendix

Data to be recorded when determining the mean activity of

radiopharmaceuticals to be administered to patients

Research Type of research

Equipment Imaging device

• Manufacturer and type
• Collimator type
• Imaging type (planar, SPECT, etc.)
• Sensitivity (cps/MBq)

Uptake measurements
• Manufacturer and type of detector
• Sensitivity (cps/MBq)

Activity meter
• Manufacturer and type
• Accuracy (%)

Radiopharmaceutical
• Radionuclide and chemical form

Patient data
• Date of examination
• Activity of radiopharmaceutical administered to the patient (MBq)
• Weight of the patient
• Time span between administering the activity and beginning imaging
• Imaging time
• Other factors affecting the activity administered to the patient

14