3908 ST6 1e PDF
3908 ST6 1e PDF
3908 ST6 1e PDF
1 / 17 March 2008
This Guide is valid as of 1 June 2008 until further notice. It replaces Guide ST 6.1,
Radiation Safety Requirements for Radionuclide Laboratories, issued on 1 July
1999.
Helsinki 2008 ISBN 978-952-478-419-1 (pdf)
ISSN 0789-4716 ISBN 978-952-478-420-7 (html)
9 Abnormal incidents 10
9.1 Preparation for abnormal incidents 10
9.2 Procedures in the event of an abnormal incident 10
9.3 Notification of abnormal incidents 10
Authorization
Under section 70, paragraph 2, of the Radiation Act (592/91), STUK – Radiation and
Nuclear Safety Authority (Finland) issues general instructions, known as Radiation
Safety Guides (ST Guides), concerning the use of radiation and other 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.
2 Risk assessment
*) The amount of activity as given in Guide ST 1.5.
The party running a radiation practice (hereafter The activity limits presented in Table I shall be
the responsible party) must identify the risks of applied when radioactive substances are handled
the operations in advance. When planning such using conventional chemical procedures. In case
premises where radioactive substances are used of uncomplicated handling, such as the dilution
and stored as unsealed sources, the planning of stock solutions, the activities specified in Table
shall be based on a risk assessment carried I can be multiplied by ten. In case of especially
out by the responsible party to ensure the ap- hazardous work with a danger of splashing
propriateness of the facilities. The assessment or vaporisation (e.g. animal experiments,
shall take into account external radiation (also complicated handling of liquids, handling of dry
doses to the hands), internal radiation, contami- matter), a coefficient of 0.1 shall be used. For the
nation risk, stay time in the laboratory facilities, storage of radioactive liquids a coefficient of 100
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STUK guide ST 6.1 / 17 March 2008
can be used. The quantities of stored unsealed as reasonably possible (section 23, Radiation
sources are, however, to be kept to minimum. Decree). Radiation protection regulations for
the discharges of radioactive substances into
the environment are issued in Guide ST 6.2.
4 Requirements for the
structure and equipment of 4.1.2 Protection of workers
To protect workers from unnecessary radiation
radionuclide laboratories exposure, the following principles, in addition
to those presented in item 4.1.1, are to be taken
4.1 General into account in the planning of a radionuclide
In the planning of a radionuclide laboratory, the laboratory:
radiation protection of workers and members of • the radionuclide laboratory shall be spacious
the general public shall be taken into account. enough to enable safe working
• a sufficient number of radiation shields and
4.1.1 Protection of the general public personal protection devices shall be available
In the planning, the following factors shall be • all surfaces shall be easy to clean.
taken into account:
• The operations shall be planned and executed The classification of workers in radiation work
in such a manner that the annual effective is addressed in Guide ST 1.6, the monitoring
dose for other persons than those engaged of radiation exposure in Guide ST 7.1 and
in radiation work does not exceed 0.3 mSv. the arrangement of medical surveillance of
This dose constraint is set according to the occupationally exposed workers in Guide ST 7.5.
section 7 of the Radiation Act (1512/1991) to
fulfil the principle of optimisation of radiation 4.2 Type C laboratory
protection and to take into account the A type C laboratory is intended for the handling
exposure caused by various radiation sources. of low activities. The structures and the
• Moving of radioactive substances on site shall equipment in the laboratory are similar to those
be kept to minimum by locating those premises of a modern, well-planned chemistry laboratory.
between which radioactive substances need to The radionuclide laboratory shall be furnished
be moved close to each other. with a sign indicating a danger of radiation
• The premises in which radioactive substances (see Guide ST 1.3). The laboratory shall be
are handled must be sufficiently protected. It lockable. Ground-floor windows shall not provide
is especially important to pay attention to the unimpeded access to the radionuclide laboratory.
radiation shielding of such premises in which In addition, the requirements laid down in items
radionuclides emitting penetrating radiation 4.2.1-4.2.4 apply to the type C laboratory.
are stored.
• Unauthorised access to radionuclide 4.2.1 Fire safety
laboratories and storages of radioactive With regard to the fire safety and the fire-
substances must be prevented. technical requirements of the structural elements,
• The management of radioactive waste shall be the laboratory must fulfil the requirements set
arranged so that it does not cause a radiation out for premises in special use, as specified in
hazard (see Guide ST 6.2). The National Building Code of Finland, Section
• If the nature of the operations results in E1 “Fire Safety of Buildings” and E2 “Fire Safety
unavoidable minor discharges of radioactive of Production and Warehouse Buildings”.
substances into the air, sewage system or
otherwise into the environment, special care 4.2.2 Surface materials and furniture
shall be taken to ensure that the quantities of • The floor and the surfaces of working benches
substances thus discharged remain below the shall be made of materials impermeable to
activity limits specified by STUK and as small moisture and resistant to ordinary chemicals,
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guide ST 6.1 / 17 March 2008 STUK
such as dilute acids, alkalis and organic a radiation danger to the environment and to
solvents. allow easy replacement of the filter.
• Joints and gaps shall be filled so as to obtain a • The exhaust duct shall be designed so that
smooth, easy-to-clean surface. radioactive vapours do not condense in it.
• The walls and the ceiling shall be made of • When necessary, the exhaust duct shall be
materials that have a smooth surface and are furnished with a sign indicating a danger of
easy to clean. radiation, in a manner that is clearly visible
• The working areas must be equipped with for the maintenance personnel.
only the minimum furniture needed, the • For maintenance, ventilation drawings shall
coatings of which do not accumulate dust and indicate which ventilation flues come from
are easy to clean. radionuclide laboratories.
• No office or similar facilities may be located in • More detailed regulations for discharges into
the laboratory facilities. the air are given in Guide ST 6.2.
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STUK guide ST 6.1 / 17 March 2008
• The floor and the working benches shall be • structural materials (a summary of the
strong enough to bear the weight of a radiation construction method)
shield assembled of lead bricks, for example. • a description of the treatment and discharge
• When locked, the windows must not be of radioactive wastes
openable without a separate key. • a description of the radiation meters to be
• The laboratory shall be furnished with used for the protection of workers and the
mechanical ventilation which maintains the environment, and of their calibration
air pressure in the handling area, during • a description of potential abnormal incidents
the use of radioactive substances, slightly and precautions as to them
lower than that in the surrounding area, in • an evaluation of the exposure levels of
order to ensure that air flows towards those workers and residents, caused by the incidents
areas of the room which are most subjected to mentioned above.
contamination.
The requirements set for the type B laboratory
4.4 Type A laboratory, facilities for also apply to the type A laboratory. In addition,
production of radionuclides and large- STUK lays down safety requirements for each
scale use of unsealed sources type A laboratory on a laboratory-specific basis,
A type A laboratory is intended for the large-scale depending on the information presented in the
use of radioactive substances. The maximum plan. Final approval for the start-up of operations
activities of radioactive substances used in type is granted in the safety license.
A laboratories are specified in the safety license,
taking into account the environmental conditions, 4.5 Handling facilities of
the laboratory’s security systems, the properties radiopharmaceuticals and other
and activities of the radionuclides to be used, premises of the nuclear medicine unit
and other factors linked to radiation safety. If the
operations are expected to cause releases into 4.5.1 General
the environment (into the air, waters, soil), plans Units, where radioactive substances are used as
for a type A laboratory and other large-scale use unsealed sources in diagnostic and/or therapeutic
of radioactive substances, such as radionuclide nuclear medicine procedures, typically include:
production, shall be submitted to STUK for • handling facilities of radiopharmaceuticals
inspection prior to the start of construction. In • a room for changing clothes (vestibule)
the plan, the following matters concerning the • a room for carrying out cell labelling
environment, and the use, structures and safety • a room for administering radiopharmaceuticals
arrangements of the laboratory shall, at the very to patients
least, be presented for the appraisal of safety: • a waiting room for patients
• a map of the region showing the location of • for patients, a room for changing clothes and a
the installation toilet
• residential and working premises in the near • imaging facilities
environs of the installation • a storage room for radiation sources
• utilisation of soil and waters in the environs of • a storage room for radioactive waste
the installation (e.g. agricultural land, water • possibly a room for measuring samples
supplies, wells) • a patient room for those receiving radionuclide
• a description of the operations, the therapy.
radionuclides used and their activities
• layout of the rooms in the laboratory (plan The patient room of patients who have received
drawings) radionuclide therapy may need to be radiation-
• heating, plumbing and ventilation shielded to protect other patients and workers.
arrangements (especially the filtering of Radiation shielding of the imaging room may
exhaust air) also be necessary in order to prevent radiation
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guide ST 6.1 / 17 March 2008 STUK
sources outside the room from disturbing the facilities. The patient room shall be furnished
functioning of the imaging device. with a sign indicating a danger of radiation.
When dividing the premises into controlled • The surfaces of the room where radiopharma
and supervised areas, guidelines laid down in ceuticals are administered to patients and
Guide ST 1.6 must be followed. The waiting rooms of the imaging room shall be easy to clean,
of patients and imaging rooms can normally and the rooms shall be suitable for handling
be classified as supervised areas. The rooms unsealed sources.
of patients receiving radionuclide therapy are
generally controlled areas. 4.5.3 PET-CT and SPET-CT
The requirements for structural shielding for
4.5.2 Handling facilities of CT devices belonging to PET-CT or SPET-CT
radiopharmaceuticals and patient rooms equipment are the same as for x-ray devices. The
Operations involving handling facilities for radiation safety requirements for x-ray facilities
radiopharmaceuticals and patient rooms are issued in Guide ST 3.6.
shall be arranged according to the following
requirements:
• In relation to handling facilities of 5 Storage of radioactive
radiopharmaceuticals, it shall be taken into
account that the operations are regulated
substances
by both the Drug Act (395/1987) and by the Radioactive substances shall be stored in such
Radiation Act (592/1991) as well as by the a manner as to prevent them from constituting
provisions issued by virtue of both of these a radiation hazard to the environment or
Acts. passing into the hands of unauthorised persons.
• STUK oversees compliance with the If significant quantities of radioactive waste
Radiation Act and with the provisions are generated, a separate storage facility for
and regulations issued by virtue of it. The radioactive waste might be needed. The following
National Agency for Medicines is responsible requirements apply to the storage of radioactive
for the regulatory control of, and instructions substances and radioactive waste:
for, radiopharmaceuticals as well as medical • As regards the fire safety of the storage facility
devices and accessories (Medical Devices Act, of radioactive substances, the requirements
1505/1994). specified in item 4.2.1 shall be taken into
• A laboratory used for the handling of account.
radiopharmaceuticals must comply with the • With regard to the surface materials and
requirements set for a type B laboratory (see furniture, the requirements specified in item
items 4.2 and 4.3 of this Guide). 4.2.2 shall be taken into account.
• Regulations for the handling facilities of • The radiation shielding of the storage facility
radiopharmaceuticals have been laid down shall be sufficient to ensure that the annual
by the regulation of National Agency for radiation dose accruing from stored radioactive
Medicines 7/2007. substances does not exceed 0.3 mSv for people
• The storage and injection of ready-to-use other than those engaged in radiation work.
radiopharmaceuticals is allowed also in other The dose rate outside the storage room should
suitable premises. not be more than 2.5 µSv/h.
• For administering therapeutic amounts of • The storage room must not be used for any
radiopharmaceuticals, there shall be a other purpose.
separate room with a floor coating as specified • The storage room shall be furnished with a
in item 4.2.2. sign indicating a danger of radiation.
• There shall be a separate patient room for • The storage room shall be organised so that
those patients receiving 131I therapy who are each radiation source can be taken into and
staying at the hospital. The patient room shall out of the room without causing any danger.
be equipped with its own toilet and washing
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STUK guide ST 6.1 / 17 March 2008
• Solutions which may develop excessive nor contamination protectors which are used in
pressure shall be stored in such a way that addition to the standard protective clothing when
there is no danger of radiation even if the working in contaminated areas. Also in such
container or package is broken. cases, contamination shall, however, be kept as
• If radioactive substances may be released into low as reasonably possible.
the air, it shall be possible to ventilate the When determining surface activity, the
storage sufficiently. amount of both fixed and non-fixed contamination
• The storage room of radioactive substances is to be taken into account. The surface activity is
shall be lockable. determined as the average activity over an area
• In the radionuclide laboratory, radioactive of not more than 100 cm2. The smear method is
substances shall be stored in a locked cupboard set out in standard SFS 4575.
or a locked refrigerator.
• Ground-floor windows shall not provide
unimpeded access to the storage facility of 7 Working with
radioactive substances.
unsealed sources
When using unsealed sources, attention shall be
6 Surface contamination paid not only to the exposure caused by external
Good working practices, regular cleaning and radiation but also to the exposure caused by
contamination measurements are important for internal radiation, which may be caused by
keeping the contamination at a low level on contaminated breathing air, working benches
the premises. Cleaning of radioactive substances or other surfaces. The passage of radioactive
on the premises may also be necessary when substances out of the laboratory or into the hands
operations are closed down and the radionuclide of unauthorised persons shall be prevented.
laboratory is put to other use. Below is a list of general working instruc
If the activity levels on various surfaces in tions:
the radionuclide laboratory and in other places • Unauthorised people are not to be admitted to
of radiation use exceed the limits specified in the radionuclide laboratory.
Table II, measures are to be taken to remove • The radionuclide laboratory must be kept
or isolate the contamination. If the working clean.
site, tools or clothing cannot be decontaminated • Tools and instruments which have been used
sufficiently, their use shall be restricted and the for handling radioactive substances shall be
passage of radioactive substances into the body cleaned after use and kept separate from
and their dispersal into the environment shall be other tools and instruments.
prevented by other measures. • A sufficient number (to be decided depending
The surface activity limits do not apply to on the nature of the operations) of radiation
the inner surfaces of fume cupboards and other shields, personal protection devices and
similar handling areas, such as glove boxes,
1.6.
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guide ST 6.1 / 17 March 2008 STUK
radiation meters shall be available in the In addition to what is stated above, any
laboratory. laboratory-specific special regulations and
• Workers handling radioactive substances instructions shall be followed.
must wear adequate protective clothing. Such
protective clothing must not be worn outside
the laboratory. 8 Tracer tests outside
• It is not permitted to eat, drink, smoke or
make up in a radionuclide laboratory. Neither
the laboratory
is pipetting by mouth permitted. Radioactive substances are used as unsealed
• Work involving the handling of volatile or sources in tracer tests also outside the laboratory.
dusty radioactive substances shall be carried Radioactive substances can, for example, assist
out in a fume cupboard or glove box. with the measurement of flow rates and lag
• If the work carries a specific risk of times of industrial and sewage processes, or
contamination, working alone in the of the mixing of substances in such processes.
radionuclide laboratory should be avoided. The radionuclides used for measurements
• During work stages with a risk of are normally short-lived gamma emitters, the
contamination, working surfaces shall be movement of which can be traced from the
covered with a material preventing the spread outside of pipes, or by taking samples.
of the contamination. Tracer tests using radioactive substances are
• When handling radiation sources, radiation prohibited in those water systems, the water of
shielding (syringe shields, lead shields or which is used as drinking water.
equivalent) shall be used whenever possible.
• Radiation sources shall be labelled so that 8.1 Radiation safety requirements
they are easily identifiable. The labelling shall The following radiation safety requirements
at least include: the radionuclide, its activity, apply to tracer tests:
date the activity was measured and the person • The requirements stated in Guide ST 6.2
who measured it. For unsealed sources, the for discharges of radioactive wastes into the
total volume or activity concentration shall environment also apply to tracer tests carried
also be indicated (activity per unit of volume, out outside the laboratory. When necessary,
for example). the fulfilment of these requirements shall be
• Tools and equipment needed for preventing demonstrated by calculations (evaluation of
the spread of radioactive substances and the radiation exposure caused by the tracer
removing contamination shall be available at tests to the member of the critical group) or by
all times. monitoring the discharges.
• The dose rate of external radiation and the • A person who independently carries out
amount of contamination in the radionuclide tracer tests outside the laboratory must be
laboratory shall be monitored at appropriate a radiation safety officer qualified to use
intervals. Contamination measurements unsealed sources in the industry, research and
shall be carried out after finishing work and education (see Guide ST 1.8).
always when considerable contamination of • When shipping radioactive substances,
working benches or other surfaces, the air the transport regulations of radioactive
of the laboratory, working clothes or tools is substances must be followed.
suspected. The results of the measurements • When tracer tests are carried out outside
shall be documented. the laboratory, the controlled area shall be
• A record shall be kept of incoming shipments separated by barricade tape or a clearly visible
containing a radioactive substance and of equivalent warning line, and furnished with a
stored radioactive substances. sign indicating a danger of radiation.
• A record shall also be kept of radioactive • Access of unauthorised persons into the
wastes and discharges. controlled area must be prevented.
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STUK guide ST 6.1 / 17 March 2008
• There must be written instructions for written instructions to workers engaged in duties
the tracer tests, including instructions for involving radiation sources on how to act in the
radiation protection and the event of abnormal event of abnormal incidents.
incidents. Further details of action to be taken in the
• After finishing the tracer test, measurements event of abnormal incidents and of reporting
shall be carried out to ensure that the area is of such incidents to STUK are set out in Guide
not contaminated. ST 1.6.
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guide ST 6.1 / 17 March 2008 STUK
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STUK guide ST 6.1 / 17 March 2008
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