GUIDE ST 6.3 / 18 MARCH 2003
USE OF RADIATION IN
NUCLEAR MEDICINE
1 GENERAL 3
2 DEFINITIONS 3
3 SAFETY LICENSE REQUIRED FOR NUCLEAR MEDICINE ACTIVITIES 3
4 OPTIMISATION OF TREATMENTS AND EXAMINATIONS
AND RADIATION PROTECTION OF THE PATIENT 3
5 USE OF REFERENCE LEVELS FOR NUCLEAR MEDICINE
EXAMINATIONS 4
5.1 How to determine the mean activities to be administered
to patients? 4
5.2 Approaches when the mean activities obtained differ
from the reference levels 4
5.3 Recording of results 4
6 WRITTEN INSTRUCTIONS TO BE AVAILABLE FOR
EXAMINATIONS AND TREATMENT 5
7 INSTRUCTIONS FOR QUALITY ASSURANCE 5
7.1 The quality system 5
7.2 Quality assurance programme 5
7.3 Quality requirements for equipment 6
7.4 Quality assurance of radiopharmaceuticals 6
7.5 Records for quality assurance 6
8 CLINICAL AUDITS 6
9 SCIENTIFIC RESEARCH 6
This Guide is valid as of 2 May 2003 until further notice.
ISSN 0789-4716
Helsinki 2005
ISBN 951-712- 952-1 (pdf)
ISBN 951-712- 953-X (html)
STUK " SÄTEILYTURVAKESKUS Osoite/Address " Laippatie 4, 00880 Helsinki
STRÅLSÄKERHETSCENTRALEN Postiosoite / Postal address " PL / P.O.Box 14, FIN-00881 Helsinki, FINLAND
Puh./Tel. [phone] " Fax [phone] " www.stuk.fi
RADIATION AND NUCLEAR SAFETY AUTHORITY
S T U K GUIDE ST 6.3 / 18 MARCH 2003
10 SPECIAL PROTECTION DURING PREGNANCY AND
BREAST-FEEDING 7
10.1 Nuclear medicine examination 7
10.2 Radionuclide therapy 7
10.3 Protection of the child during breast-feeding 8
11 RADIATION PROTECTION OF THE PATIENT S FAMILY MEMBERS,
AND MEMBERS OF THE PUBLIC AFTER NUCLEAR MEDICINE
EXAMINATION AND RADIONUCLIDE THERAPY 8
11.1 Dose constraints 8
11.2 Radiation protection instructions to be provided both orally
and in writing 8
12 HOW TO RECORD AND REPORT INFORMATION ON NUCLEAR
MEDICINE PROCEDURES? 9
13 ABNORMAL EVENTS IN THE USE OF RADIATION 9
13.1 Dealing with abnormal events 9
13.2 Abnormal events to be notified without delay 9
14 BIBLIOGRAPHY 10
APPENDIX A RECORDING OF DATA WHEN DETERMINING THE MEAN ACTIVITIES OF
RADIOPHARMACEUTICALS TO BE ADMINISTERED TO PATIENTS
APPENDIX B ACCEPTANCE CRITERIA FOR GAMMA CAMERAS AND ACTIVITY METERS
APPENDIX C RECOMMENDATIONS ON THE DURATION OF INTERRUPTION OR CESSATION
OF BREAST-FEEDING
APPENDIX D PATIENT LEAVING HOSPITAL AFTER RADIONUCLIDE THERAPY
Authorization
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.
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.
Translation. Original text in Finnish.
GUIDE ST 6.3 / 18 MARCH 2003 S T U K
radiopharmaceutical
1 General
A radioactive medicinal product
The basic provisions governing the medical use
of radiation are set out in chapter 10 of the reference level
Radiation Act (521/1991, amendment 1142/1998). A predetermined activity level in nuclear
Section 41 of the Radiation Act is the authorising medicine examinations, that is not presumed to
provision for the Decree of the Ministry of Social be exceeded in a procedure performed according
Affairs and Health on the medical use of radiation to the standards of good practice upon a person
(no. 423 of 2000, hereinafter referred to as the of normal size
MSAH Decree). The Decree contains provisions
governing the grounds for procedures involving quality assurance programme
exposure to radiation and the instructions to be The document referred to in section 18 of the
followed when performing such procedures. MSAH Decree including written specifications of
This ST Guide presents the essential radiation quality assurance activities in the medical use of
safety requirements for nuclear medicine. These radiation.
requirements also apply to procedures performed
on healthy persons and patients participating
3 Safety license
in scientific research. The requirements also
apply to the radiation exposure of persons who
required for nuclear
voluntarily and otherwise than as part of their
occupation assist a person who is subject to
medicine activities
a procedure involving exposure to radiation.
Other instructions pertaining to radiation For nuclear medicine activities the party running
safety are listed below: a radiation practice (hereafter the responsible
" The training and qualification requirements party) shall have the safety license referred to in
for workers involved in nuclear medicine section 16 of the Radiation Act (592/1991). The
activity are prescribed in chapter 5 of the description of organisation required by section 18
MSAH Decree. of the Radiation Act must specify the assignment
" Requirements for radiation protection training of responsibilities with respect to radiation safety.
in health care are set out in Guide ST 1.7. The radiation user s organisation is governed by
" The radiation safety requirements for Guide ST 1.4.
laboratory and patient premises are set out in
Guide ST 6.1.
4 Optimisation
" Radiation safety requirements on the handling
of radioactive wastes and discharges into the
of treatments and
environment are set out in Guide ST 6.2.
" Requirements on the use of sealed sources in
examinations and radiation
radiotherapy are set out in Guide ST 2.1.
protection of the patient
Nuclear medicine examination must be performed
2 Definitions
in a manner that achieves the objective set for
The following terms used in this Guide shall the examination while minimising the exposure
have the following meanings: of the examinee to radiation.
The dose in radionuclide therapy must be
nuclear medicine planned individually for each patient so that
A medical speciality in which radioactive the radiation dose to target tissue or organ is
substances are used as unsealed sources in the sufficient to bring about the desired effect. At the
form of radiopharmaceuticals to diagnose and same time the dose to non-target tissues must be
treat illnesses and for scientific research. as low as reasonable achievable.
3
S T U K GUIDE ST 6.3 / 18 MARCH 2003
The referral must clearly state indication 5.1 How to determine the mean activities
of the examination or treatment and other to be administered to patients?
necessary information enabling the examination The quality assurance programme must include
or treatment to be performed in an optimal an evaluation of the activities administered
manner. to patients in various examinations and
The activity of a radiopharmaceutical must a comparison thereof to reference levels. The
be measured with an activity meter before it is mean activity is determined for a group of no
administered to the patient. The activity of the fewer than ten patients of normal size for each
radiopharmaceutical, the radionuclide, and the examination at intervals of at least three years.
chemical form of the radiopharmaceutical or If the activity administered to a patient
the abbreviation generally used for it must be depends on the weight of the patient, then
entered in the patient s medical record. patients will be selected so that their weights fall
Where alternative radiopharmaceuticals may in the range 60 80 kilograms. In the event that
be used, the radiopharmaceutical selected must, the same examination may be performed with
where possible, be the radiopharmaceutical that several equipments, the mean activity will be
minimises the radiation dose to the patient. determined for each equipment separately. If the
Available measures must be used to reduce examination practice or equipment changes in
the radiation dose to the patient in diagnostic a manner that affects the activity administered
and therapeutic nuclear medicine procedures. to a patient, then the mean activity will be
These measures include preventing radioactive determined again at the earliest opportunity.
substances from accumulating in organs that are The mean activity need not be determined for
not being examined and accelerating excretion of examinations performed fewer than 20 times
radioactive substances. a year.
Patients treated with unsealed radioactive
substances shall be accommodated in hospital in 5.2 Approaches when the mean activities
a manner that minimises the radiation exposure obtained differ from the reference levels
of workers, other patients and visitors. If the mean activity obtained exceeds the
reference level, then the reasons for the exceeding
must be investigated and steps must be taken
5 Use of reference
where necessary to optimise the examination.
If the activities administered to patients fall
levels for nuclear
substantially below the reference levels, then it
must be ensured that adequate information is
medicine examinations
being procured for the purpose of diagnosis.
Reference levels referred to in section 16 of
the MSAH Decree shall be introduced by 5.3 Recording of results
the responsible party to nuclear medicine The measurement results, determined mean
examinations. The use of reference levels is values and information on corrective measures
prescribed in section 17 of the MSAH Decree. The must be recorded and archived for at least five
Radiation and Nuclear Safety Authority (STUK) years. The measurement results must specify the
has issued reference levels for the most common information presented in Appendix A.
nuclear medicine examinations in decision no.
596/310/00 (8 December 2000), and these are
revised as necessary.
4
GUIDE ST 6.3 / 18 MARCH 2003 S T U K
are in working order and that their operating
6 Written instructions
instructions and procedures are appropriate. The
operating condition of radiological equipment
to be available for
must be checked:
examinations and treatment
" before the equipment is commissioned
Written instructions shall be available for " at specified intervals according to device-
nuclear medicine examinations and radionuclide specific instructions
therapies. For the most common examinations and " following repairs or servicing
therapeutic procedures, the written instructions " when there is cause to suspect a fault or
shall cover all stages of the examination or malfunction.
therapeutic procedures, including the preparation
and processing of radiopharmaceuticals and According to section 32 of the MSAH Decree,
handling of radioactive wastes. The written the quality assurance programme shall set
instructions shall also include instructions on out the principal tasks involved in supervising
radiation protection and safety regulations, the operating condition and performance
together with instructions for responding when characteristics of radiological equipment. The
incidents or accidents occur. instructions and responsibilities pertaining to
supervision of equipment must be specified for
each equipment. Documentation must also exist
7 Instructions for
in respect of each equipment as follows:
" inspections and measurements to be performed
quality assurance
and the purpose thereof
7.1 The quality system " methods of inspection and measurement
The best way to implement the requirements " apparatus and instruments to be used
imposed on responsible parties by radiation " intervals for performing inspections and
legislation is to use a quality system covering measurements
all operations. A quality system is a system of " acceptability criteria for inspections and
organisational structures, procedures, processes measurements (action levels)
and resources required in quality control. The " measures to be taken when the acceptability
quality system is described in quality documents criteria are exceeded.
arranged as an integrated collection that is
continually updated (a quality manual or The persons performing inspections and
equivalent). measurements (vocational group) must be
specified. The inspection and measurement
7.2 Quality assurance programme methods must be described in sufficient detail for
The responsible party shall ensure that quality the inspections and measurements to be repeated
assurance functions are planned and specified on the basis of the quality assurance programme
in a written quality assurance programme in in the manner intended by the person who
the manner prescribed in the MSAH Decree prepared the programme.
(especially section 18). According to section 18 of the Decree of the
The responsible party shall supervise the MSAH Decree, the quality assurance programme
apparatus used in nuclear activity in the manner shall include the principles for preventing errors
referred to in section 40 of the Radiation Act or damage from which radiation doses may arise
(592/1991, amendment 1142/1998), in order unintentionally.
to be sure that all devices and instruments
5
S T U K GUIDE ST 6.3 / 18 MARCH 2003
7.3 Quality requirements for equipment 7.4 Quality assurance of
Procedures involving exposure to radiation shall radiopharmaceuticals
be performed using equipment suited for the said The quality assurance operations and acceptability
purpose. criteria pertaining to radiopharmaceuticals must
The Medical Devices Act (1505/1994) also be set out in the quality documents.
governs equipment used in nuclear activity. The processing and manufacture of
Apparatus manufactured after 13 June 1998 radiopharmaceuticals must conform to Good
must bear the CE marking (Directive 93/42/EEC) Radiopharmaceutical Practice (GRP). This
referred to in the Act. The said CE marking is includes both radiation safety aspects and purity
a manufacturer s warranty that the apparatus requirements.
meets the equipment safety requirements The quality documents must contain a descrip-
imposed by European Community Directives. tion of the measures ensuring that the right
Criteria of acceptability denote the minimum patient receives the correct amount of the right
equipment performance requirements that are radiopharmaceutical. They must also include
applied as action levels or remedial levels when a description of the measures to be taken to
using the equipment. If the equipment does not alleviate the harmful effects of any dosage error
meet the criteria, then measures must ultimately that may occur.
be taken to repair the equipment and restore its
performance to the acceptable level. If necessary, 7.5 Records for quality assurance
the equipment must be decommissioned. Records must be kept of the inspections and
The equipment may not be used for patient measurements involved in quality assurance,
examinations before it has been repaired and specifying that the said inspections and
found to be fit for use once again. measurements have been made and by whom,
Criteria of acceptability are not limiting values the results thereof and the measures taken
for the optimal performance of the equipment. on account of those results. Records must also
When procuring new equipment, at acceptance be kept of any faults, malfunctions and other
tests and in the course of quality control of incidents occurring in use of the apparatus that
equipment at the time of use, responsible disrupt the said use or endanger safety.
parties may apply stricter requirements, which
may be based, for example, on the equipment
8 Clinical audits
specifications or performance tolerance values
proposed in equipment standards. The obligation of a responsible party to arrange
Appendix B sets out the acceptability criteria clinical audits is prescribed in section 39c of the
for gamma cameras intended for planar imaging Radiation Act (592/1991 amendment 1142/1998)
and SPECT, and activity meters. They are based and in chapter 4 of the MSAH Decree. According
on European Commission publication Radiation to the Decree, clinical audits shall be arranged so
Protection 91, Criteria for acceptability of that it complements self-assessment of activities
radiological (including radiotherapy) and nuclear in an expedient manner. The objective is for the
medicine installations. During use equipment activity to be audited in all essential respects at
must at least meet the criteria of acceptability intervals not exceeding five years.
set out in Appendix B. The results of audits and an account of
The responsible party must ensure that any corrective measures taken must be submitted on
equipment used in nuclear medicine activity has request to STUK.
been approved in an acceptance test before it is
taken into use. In the acceptance test gamma
9 Scientific research
cameras for planar imaging and SPECT and
activity meters must at least conform to the The requirements for scientific research are
acceptability criteria set out in Appendix B. prescribed in section 6 of the MSAH Decree.
6
GUIDE ST 6.3 / 18 MARCH 2003 S T U K
Implementation of research and the measures to " If volunteers participating in scientific
be followed therein are governed by the provisions research are exposed to radiation in their
of the Medical Research Act (488/1999). work, then the person performing the research
The European Commission publication shall ensure that the volunteers understand
Radiation Protection 99, Guidance on medical the significance of the additional risk caused
exposures in medical and biomedical research by the research. Category A radiation workers
sets out the risk classes into which research is should not normally be accepted as volunteers
divided on the basis of the radiation exposure for scientific research.
that it causes to persons involved in the research.
This risk classification may be applied when
10 Special protection
assessing the justification for scientific research.
The classification is derived from publication 62
during pregnancy and
of the International Commission on Radiological
Protection.
breast-feeding*)
Attention shall be paid to the following factors
when selecting persons for scientific research 10.1 Nuclear medicine examination
involving the exposure of subjects to radioactive There is no need to avoid pregnancy after most
substances: nuclear medicine examinations. Some nuclear
" Persons under 18 years of age shall not medicine examinations may, however, cause
participate in scientific research unless the a radiation dose to an unborn child exceeding
subject of the research is the particular 1 mSv. In such cases the patient is to be urged to
problems of this specific age group. avoid pregnancy for a certain period of time.
Participation of children and young adults in
scientific research is generally not justified. If 10.2 Radionuclide therapy
possible, healthy volunteers should be over 50 When considering radionuclide therapy to
years of age. a pregnant woman, the dose to the foetus must
" The number of persons participating in the be estimated. If the treatment cannot be delayed
research shall be limited to the smallest until after confinement, then the dose to the
possible number required to procure the unborn child must be minimised.
desired information. The prior radiation A female patient is to be urged to avoid
exposure of the persons participating in the pregnancy for a certain period of time following
research must be investigated. radionuclide therapy. This ensures that the dose
" A dose constraint shall be imposed on healthy caused to the unborn child does not exceed 1 mSv
volunteers. The effective dose applied to if pregnancy begins at this time.
healthy volunteers shall not normally exceed Spermatozoa may also be damaged through
10 mSv per year. radionuclide therapy. For this reason, male
" When women of childbearing age participate patients are to be advised not to father children
in research the possibility of pregnancy shall for a period of four months following 32P, 89Sr and
131
be considered. Pregnant and breast-feeding I (activity up to 800 MBq) treatment. The four
women may participate in scientific research month period is recommended as it exceeds the
only when studying particular problems life span of spermatozoa.
pertaining to pregnancy and when no
alternative research methods are available.
*)
European Commission. Radiation protection 100. Guidance
for protection of unborn children and infants irradiated due
to parental medical exposure.
7
S T U K GUIDE ST 6.3 / 18 MARCH 2003
10.3 Protection of the child If it is possible that the dose constraints of
during breast-feeding family members and others will be exceeded,
Children should not be breast-fed after nuclear then the patient must remain in hospital until
medicine examination until the dose to the child the residual activity in the patient has fallen by
can be estimated to be smaller than 1 mSv. Before a sufficient amount.
131
the procedure is performed, breast-feeding women Before a patient is discharged following I
shall be advised of the anticipated interruption therapy it must be verified that the residual
in breast-feeding. The recommended lengths of activity in the patient does not exceed 800 MBq.
interruption in breast-feeding following various
nuclear medicine examinations are set out in 11.2 Radiation protection instructions to
Appendix C. Breast-feeding must generally be be provided both orally and in writing
stopped altogether after radionuclide therapy. Section 11 of the MSAH Decree provides that
before a patient is discharged, the patient and
any person attending thereto shall be furnished
11 Radiation protection
with proper protection instructions, which shall
also be provided in writing.
of the patient s family
Before the patient, administered radiopharma-
ceutical for the treatment, is discharged and
members, and members
any person attending thereto shall be furnished
of the public after nuclear
with instructions on how to act so as to
prevent unnecessary exposure to radiation of
medicine examination
persons coming into contact with the patient.
The instructions must be provided both orally
and radionuclide therapy
and in writing, and in a form that the patient
11.1 Dose constraints understands. The fact that instructions have
Section 10 of the MSAH Decree prescribes that been given must be entered in the patient s
dose constraints are to be used as necessary medical record. The instructions should include
to limit the radiation exposure of voluntary at least the following details:
assistants. STUK is authorised to issue guidance " the name and address of the patient
on the use of dose constraints. " the name, address and telephone number of
A patient to whom a radioactive substance the hospital
has been administered may be treated as an out- " a person to contact if problems arise
patient, or an in-patient may be discharged only " the radiopharmaceutical administered to the
after the radiation exposure caused to family patient and its activity
members and other persons by the residual " the date of administering
activity in the patient has become insignificant. " practical instructions for limiting the radiation
The following dose constraints will be applied exposure of persons coming into contact with
in such cases*): the patient
Family members of the patient " the length of time for which the instructions
Children (including unborn children) 1 mSv must be followed.
Adults (under 60 years of age) 3 mSv
Adults (60 years of age and older) 15 mSv The publication Radiation Protection 97,
Other persons (members of the public)**) 0.3 mSv Radiation Protection following Iodine-131 therapy
*)
European Commission publication. Radiation Protection
97. Radiation Protection following Iodine-131 therapy (ex-
posures due to out-patients or discharged in-patients).
**)
The exposure of other persons is subject to the dose limit
for the members of the public, which is 1 mSv per year. As
the dose may be caused by other radiation sources, the dose
constraint for exposure due to a single radiation source is
0.3 mSv.
8
GUIDE ST 6.3 / 18 MARCH 2003 S T U K
(exposures due to out-patients or discharged in- The responsible party shall submit to
patients) includes a model of the instructions to STUK information of the number of nuclear
be provided to a patient following 131I therapy. medicine examinations (including scientific
The length of time for which the instructions investigations) and therapeutic procedures,
must be followed will depend on the residual the radiopharmaceuticals used, and the mean
activity in the patient and on the dose rate activities used in various examinations and
that this causes. Appendix D presents therapeutic procedures in the manner separately
a recommendation on the duration of restrictions notified by STUK. At the same time an account
on the behaviour of the patient after 131I therapy. of the equipment used in nuclear medicine
If a patient plans to travel abroad immediately examinations and therapeutic procedures
after radionuclide therapy, then the patient must (imaging devices, activity meters and other
be given a certificate of treatment as a radiation apparatus) shall also be provided.
measurement may be made at the national
frontier.
13 Abnormal events in
The activity of a radiopharmaceutical ad-
ministered to a patient in nuclear medicine
the use of radiation
examination is generally so small that no health
precautions or restrictions on the behaviour of 13.1 Dealing with abnormal events
the patient are necessary. After nuclear medicine When an abnormal event occurs, available
examination no instructions on the behaviour of measures must be taken to reduce the radiation
the patient in order to limit radiation exposure dose to the patient, the radiation dose received
of persons coming into contact with the patient by the patient must be estimated, the reasons for
are generally necessary. Nuclear medicine the abnormal event must be investigated, and
131
examinations in which 30 MBq or more of I action must be taken to prevent such events from
is administered to the patient, or where there recurring.
is a reason to assume that the dose constraints
referred to in item 11.1 could be exceeded, form 13.2 Abnormal events to be
an exception to this. notified without delay
Reporting of abnormal events pertaining to the
use of radiation is prescribed in section 17 of
12 How to record and report
the Radiation Decree (1512/1991). STUK must
be immediately notified of any abnormal event
information on nuclear
or other unusual observation or information of
substantial significance for radiation safety.
medicine procedures?
The report of an abnormal event must
Recording of information on procedures is specify:
prescribed in section 43 of the MSAH Decree. " the name and contact details of the person
The procedure must be entered in the patient s submitting the report
medical record. If the procedure was performed " the time and place of the event
in a substantially different manner than usual, " a description of the event
then this must also be entered in the patient s " details of any persons placed in hazardous
medical record. situations and of the radiation doses that
The written instructions pertaining to these persons sustained
performance of the procedure shall be archived " immediate measures taken on account of the
so that the radiation dose to the patient can event
be assessed at a later date where necessary. It " initial evaluations of the reasons for the
shall be possible to ascertain at a later date from event.
the archived documents the practice that was
followed at the time of the procedure. The report must be submitted in writing
9
S T U K GUIDE ST 6.3 / 18 MARCH 2003
immediately when the event has come to light. 7 International Commission on Radiological
The initial report may also be submitted by Protection. Radiological Protection in Bio-
telephone, but must later be confirmed in medical Research and Addendum 1 to
writing. Publication 53  Radiation Dose to Patients
Reporting of hazardous situations to the from Radiopharmaceuticals. ICRP Publication
National Agency for Medicines is prescribed in 62. Oxford: Pergamon Press; 1993.
the Medical Devices Act (1505/1994). 8 International Commission on Radiological
Protection. Radiation Dose to Patients from
Radiopharmaceuticals, Addendum to ICRP 53,
14 Bibliography
also includes Addendum 1 to ICRP Publication
1 European Commission. Criteria for 72. ICRP Publication 80. Oxford: Pergamon
acceptability of radiological (including Press; 1998.
radiotherapy) and nuclear medicine 9 Documents of the NRPB. Guidelines on
installations. Radiation protection 91. Patient Dose to Promote the Optimisation of
Luxembourg: Office for official Publications of Protection for Diagnostic Medical Exposure.
the European Communities; 1997*). Report of an Advisory Group on Ionising
2 European Commission. Radiation Protection Radiation 1999; 10 (1).
following iodine-131 therapy (Exposures due 10 NEMA NU 1-2001. Performance Measurements
to out-patients and discharged in-patients). of Scintillation Cameras. NEMA National
Radiation protection 97. Luxembourg: Office Electrical Manufacturers Association; 2001.
for official Publications of the European 11 NEMA NU 2-2001. Performance Measure-
Communities; 1998. ments of Positron Emission Tomographs.
3 European Commission. Guidance on medical NEMA National Electrical Manufacturers
exposures in medical and biomedical research. Association; 2001.
Radiation protection 99. Luxembourg: Office 12 Hart GC, Smith AH ed. Quality Standards
for official Publications of the European in Nuclear medicine. Report 65. IPSM The
Communities; 1998. Institute of Physical Sciences in Medicine;
4 European Commission. Guidance for 1992.
protection of unborn children and infants 13 Radiopharmacy. Preparation and control of
irradiated due to parental medical exposure. radiopharmaceuticals in hospitals. Nordic
Radiation protection 100. Luxembourg: Office guidelines. NLN Publication no 26. Uppsala:
for official Publications of the European Nordiska Läkemedelsnämnden; 1989.
Communities; 1998. 14 Working Party of the Radiation Protection
5 European Commission. Guidance on diagnostic Committee of the British Institute of Radio-
reference levels (DRLs) for medical exposures. logy, including representatives of the Health
Radiation protection 109. Luxembourg: Office and Safety Executive, the Department of
for official Publications of the European Health, the Environment Agency and the
Communities; 1999. National Radiological Protection Board.
6 International Commission on Radiological Patients leaving hospital after administration
Protection. Protection of the Patient in of radioactive substances. The British Journal
Nuclear Medicine. ICRP Publication 52. of Radiology 1999; 72: 121 125.
Oxford: Pergamon Press; 1987.
*)
European Union radiation protection publications are
available on the Internet at www.europa.eu.int/comm/
environment/radprot or from the Academic Bookstore,
Keskuskatu 1, 00100 Helsinki, tel. [phone], www.
akateeminen.com
10
GUIDE ST 6.3 / 18 MARCH 2003 S T U K
APPENDIX A
RECORDING OF DATA WHEN DETERMINING THE MEAN ACTIVITIES OF
RADIOPHARMACEUTICALS TO BE ADMINISTERED TO PATIENTS
Examination Type of examination
Apparatus Gamma camera
" Manufacturer and type
" Number of gamma camera heads
" 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 (%)
Date
Radiopharmaceutical
" Radionuclide and chemical form
" Mean activity administered to the patients
" Average time between administering activity and beginning imaging
" Average imaging time
" Weight of patients (when this affects the activity administered)
" Other factors affecting the mean activity administered to the patient
For each patient
" Activity of the radiopharmaceutical administered to the patient
" Weight of the patient
" Time between administering activity and beginning imaging
" Imaging time
11
S T U K GUIDE ST 6.3 / 18 MARCH 2003
APPENDIX B
ACCEPTANCE CRITERIA FOR GAMMA CAMERAS AND ACTIVITY METERS*)
Gamma camera (high resolution collimator  99mTc)
Uniformity
Variation should be less than Ä… 10% within used field. Test to be performed both with and without the
collimator at a specified energy window (E Ä… 10%).
Sensitivity
Sensitivity (ability to detect the gamma rays emitted from a radioactive source in cps/MBq) should not
deviate by more than Ä… 20% from the baseline value.
Centre of rotation (SPECT)
The deviation in centre of rotation should be stable within limits of 0.5 pixels.
Multi-headed camera
Sensitivity
Sensitivity differences between any of the heads should be less than Ä… 10%.
Geometry
Pixel by pixel correspondence of opposed views should be within 0.5 pixels (when matrix size is
64 x 64).
Activity meter (dose calibrator)
Linearity
Linearity should be better than Ä… 5% over the range of activities used.
Reproducibility
Reproducibility should be better than Ä… 5%.
Accuracy
Accuracy should be better than Ä… 10% when measuring activities exceeding 3.7 MBq**).
Definitions of terms:
base line value; parameter reference value
Value obtained for this parameter in the initial constancy test performed immediately after the status
test, or where described in a corresponding special standard, the mean value of values obtained in a
series of initial constancy tests, immediately after a status test.
*)
European Commission. Radiation protection 91.Criteria for acceptability of radiological (including radiotherapy) and nu-
clear medicine installations.
**)
The activity meter accuracy requirement differs from the recommendation issued in the Radiation Protection 91 publica-
tion.
12
GUIDE ST 6.3 / 18 MARCH 2003 S T U K
APPENDIX B
Status tests
Tests carried out to establish the functional status of equipment at given time.
Accuracy
Correspondence between the observed value of a quantity and the true value. The percentage of
difference between measured value (m) and true value (t) is calculated as follows: 100 x (m-t)/t.
Reproducibility
Variation in observed values usually for a set of measurements made at different times. Measurements
are often performed after a certain period of time. Cf. precision.
Precision
Variation in observed values usually for a set of measurements made at about the same time.
13
S T U K GUIDE ST 6.3 / 18 MARCH 2003
APPENDIX C
RECOMMENDATIONS ON THE DURATION OF INTERRUPTION
OR CESSATION OF BREAST-FEEDING*)
Length of interruption of breast-feeding following nuclear medicine examination or radionuclide
therapy, so that the radiation dose to the child does not exceed 1 mSv.
I No interruption usually needed
51
Cr EDTA
99m
Tc DMSA
99m
Tc DTPA
99m
Tc diphosphonates
99m
Tc glucoheptonate
99m
Tc gluconate
99m
Tc HMPAO
99m
Tc MIBI
99m
Tc tetrophosmin
99m
Tc sulphur colloid
II No interruption needed unless activity applied is higher than stated
99m
Tc MAG3 (100 MBq)
111
I labelled leukocytes (20 MBq)
201
Tl chloride (80 MBq)
III Length of interruption
99m
Tc MAA (100 MBq) 12 hours
99m
Tc pertechnetate (80 MBq) 24 hours
99m
Tc pertechnetate (800 MBq) 48 hours
IV Length of interruption determined on the basis of activity
concentration measured in breast milk and biological half-life
99m
Tc labelled erythrocytes
99m
Tc aerosol (Technegas)
99m
Tc MAG3 (> 100 MBq)
99m
Tc microspheres
99m
Tc pyrophosphate
123
I iodide
123
I MIBG
123
I hippurate
V Breast-feeding must usually be ceased following radionuclide therapy
*)
These instructions are based on the publication Radiation Protection 100. Guidance for protection of unborn children and
infants irradiated due to parental medical exposures.
14
GUIDE ST 6.3 / 18 MARCH 2003 S T U K
APPENDIX D
PATIENT LEAVING HOSPITAL AFTER RADIONUCLIDE THERAPY
Duration of patient behaviour restrictions after 131I therapy.
Residual 131I activity in patient
30 400 (MBq) 400 600 (MBq) 600 800 (MBq)
Restriction to be observed after 131I therapy
Avoidance of close contact with small chil- 9 days 12 days 14 days
dren and pregnant women.
Avoidance of sustained (over 3 hours) close 21 days 25 days 27 days
contact with small children and pregnant
women.
Avoidance of sleeping in the same bed with - 4 days 8 days
an adult.
The patient may be discharged on receipt of radiation protection instructions after the residual 131I
activity in the patient no longer exceeds 800 MBq. Patient may use public transport for journeys of
about one hour.
Autopsy may be performed without radiation protection measures after the residual 131I activity in
the patient no longer exceeds 600 MBq.
When using beta emitting radionuclides, such as 32P, 89Sr and 90Y, no radiation protection measures
are necessary after the residual activity in the patient no longer exceeds 200 MBq.
15