1 / 17 March 2008
2 RISK ASSESSMENT 3 LABORATORY CLASSIFICATION 4 REQUIREMENTS FOR THE STRUCTURE AND EQUIPMENT OF RADIONUCLIDE LABORATORIES
4.1 General
4.1.1 Protection of the general public 4.1.2 Protection of workers
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4.3 Type B laboratory 4.4 Type A laboratory, facilities for production of radionuclides and large-scale use of unsealed sources 4.5 Handling facilities of radiopharmaceuticals and other premises of the nuclear medicine unit
4.5.1 General 4.5.2 Handling facilities of radiopharmaceuticals and patient rooms 4.5.3 PET-CT and SPET-CT
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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 ISSN 0789-4716 ISBN 978-952-478-419-1 (pdf) ISBN 978-952-478-420-7 (html)
STUK STEILYTURVAKESKUS
STRLSKERHETSCENTRALEN RADIATION AND NUCLEAR SAFETY AUTHORITY
Osoite/Address Laippatie 4, 00880 Helsinki Postiosoite / Postal address PL / P .O.Box 14, FIN-00881 Helsinki, FINLAND Puh./Tel. (09) 759 881, +358 9 759 881 Fax (09) 759 88 500, +358 9 759 88 500 www.stuk.fi
STUK
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9 ABNORMAL INCIDENTS
9.1 Preparation for abnormal incidents 9.2 Procedures in the event of an abnormal incident 9.3 Notication of abnormal incidents
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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.
This Guide includes the requirements relating to the implementation of Council Directive 96/29/Euratom; OJ No. L 159, 29.6.1996, p.1.
STUK access control, security arrangements and potential abnormal incidents, among other things. If the conditions change considerably, risks shall be reassessed.
1 General
In order to ensure the safe use of radioactive substances, it is important that attention is paid, already when planning a laboratory or other place of radiation use, to the radiation safety requirements arising from the nature of the work and the radionuclides used. The underlying principles of the planning are to ensure that it is safe to work in the laboratory, discharges of radioactive substances into the environment remain minimal also in abnormal conditions, and that the passage of radioactive substances from the laboratory into the hands of unauthorised persons is prevented. According to section 26 of the Radiation Act (592/1991), the safety requirements, affecting safety in the use of radioactive substances, that are to be taken into account in the planning of laboratories and other premises will be confirmed by the Radiation and Nuclear Safety Authority (STUK). This guide lays down the requirements for radionuclide laboratories and storage rooms of radioactive substances, in which radioactive substances are used or stored as unsealed sources.*) Some general instructions for working in radionuclide laboratories are also set out. In addition, this guide states the requirements for tracer tests carried out outside the laboratory. Guide ST 6.2 has been issued on the treatment of radioactive waste.
3 Laboratory classification
Radionuclide laboratories are classified as laboratories of type C, B and A. The laboratory type required for a specific operation is determined by the radionuclides used, the activity handled at any one time, and the nature of the work involved. In radionuclide laboratories, the controlled and supervised areas, as specified in Guide ST 1.6, shall also be defined and delineated. The radionuclide laboratory shall be equipped to comply with the requirements of laboratory type C, B or A, in accordance with the activity limits specified in Table I. If the activity handled at any one time is less than the exemption value given in Guide ST 1.5, no structural special requirements will be set for the laboratory.
Table I. Definition of the laboratory type on the basis of the radionuclides used and the activity handled at any one time.
Maximum activity handled at any one time 10-fold exemption value*) 104-fold exemption value*) Larger than 104-fold exemption value*)
2 Risk assessment
The party running a radiation practice (hereafter the responsible party) must identify the risks of the operations in advance. When planning such premises where radioactive substances are used and stored as unsealed sources, the planning shall be based on a risk assessment carried out by the responsible party to ensure the appropriateness of the facilities. The assessment shall take into account external radiation (also doses to the hands), internal radiation, contamination risk, stay time in the laboratory facilities,
The activity limits presented in Table I shall be applied when radioactive substances are handled using conventional chemical procedures. In case of uncomplicated handling, such as the dilution of stock solutions, the activities specified in Table I can be multiplied by ten. In case of especially hazardous work with a danger of splashing or vaporisation (e.g. animal experiments, complicated handling of liquids, handling of dry matter), a coefficient of 0.1 shall be used. For the storage of radioactive liquids a coefficient of 100
*) A
sealed source is a source, the structure of which prevents any dispersion of radioactive substances into the environment in normal use conditions. Other radiation sources are unsealed sources.
STUK can be used. The quantities of stored unsealed sources are, however, to be kept to minimum.
guide ST 6.1 / 17 MARCH 2008 as reasonably possible (section 23, Radiation Decree). Radiation protection regulations for the discharges of radioactive substances into the environment are issued in Guide ST 6.2. 4.1.2 Protection of workers To protect workers from unnecessary radiation exposure, the following principles, in addition to those presented in item 4.1.1, are to be taken into account in the planning of a radionuclide laboratory: the radionuclide laboratory shall be spacious enough to enable safe working a sufficient number of radiation shields and personal protection devices shall be available all surfaces shall be easy to clean. The classification of workers in radiation work is addressed in Guide ST 1.6, the monitoring of radiation exposure in Guide ST 7.1 and the arrangement of medical surveillance of occupationally exposed workers in Guide ST 7.5.
guide ST 6.1 / 17 MARCH 2008 such as dilute acids, alkalis and organic solvents. Joints and gaps shall be filled so as to obtain a smooth, easy-to-clean surface. The walls and the ceiling shall be made of materials that have a smooth surface and are easy to clean. The working areas must be equipped with only the minimum furniture needed, the coatings of which do not accumulate dust and are easy to clean. No office or similar facilities may be located in the laboratory facilities. 4.2.3 Ventilation It shall be possible to ventilate the laboratory sufficiently. The distance between the intake and exhaust openings of the ventilation system of the building shall be sufficient to prevent possibly contaminated exhaust air from flowing back into the intake opening. If due to the nature of the work, it is probable that radioactive substances will pass into the air, the laboratory shall be equipped with a sufficient number of fume cupboards or glove boxes. The flow rate of air at the working opening of the cupboard shall be at least 0.5 m/s when the height of the opening is 30 cm. Any faucets connected to the cupboard shall be operable from outside the cupboard. The exhaust blower shall be located so as to ensure negative pressure in the exhaust duct. The fume cupboards and glove boxes shall be equipped with a light indicating when the blower is in operation. The exhaust air must not be circulated but shall be led outside via a separate exhaust duct. The need to filter the exhaust air shall be considered case by case. It depends on the nature of the work, the radionuclides used and on their chemical and physical form. If it is necessary to filter the exhaust air, the filter shall be located as close to the fume cupboard or glove box as possible, in such a manner as to prevent the radioactive substances, accumulating in the filter, from constituting
STUK a radiation danger to the environment and to allow easy replacement of the filter. The exhaust duct shall be designed so that radioactive vapours do not condense in it. When necessary, the exhaust duct shall be furnished with a sign indicating a danger of radiation, in a manner that is clearly visible for the maintenance personnel. For maintenance, ventilation drawings shall indicate which ventilation flues come from radionuclide laboratories. More detailed regulations for discharges into the air are given in Guide ST 6.2. 4.2.4 Sewerage The following factors concerning sewerage shall be taken into account: If liquid radioactive wastes are discharged into the sewage system, there shall be a separate sink for this purpose, which shall be labelled with an ionising radiation symbol. The sewage pipes from the radionuclide laboratory should lead directly to the main sewage pipe. Inside the building, they should not be connected to any other sewage pipes than those coming from radionuclide laboratories. When necessary, the sewage pipes from radionuclide laboratories shall be furnished with a sign indicating a danger of radiation, in a manner which is clearly visible for the maintenance personnel. It is recommendable to prevent reflux. There shall be a washbasin for washing hands. The faucets of the basin shall be operable without having to touch them.
STUK The floor and the working benches shall be strong enough to bear the weight of a radiation shield assembled of lead bricks, for example. When locked, the windows must not be openable without a separate key. The laboratory shall be furnished with mechanical ventilation which maintains the air pressure in the handling area, during the use of radioactive substances, slightly lower than that in the surrounding area, in order to ensure that air flows towards those areas of the room which are most subjected to contamination.
guide ST 6.1 / 17 MARCH 2008 structural materials (a summary of the construction method) a description of the treatment and discharge of radioactive wastes a description of the radiation meters to be used for the protection of workers and the environment, and of their calibration a description of potential abnormal incidents and precautions as to them an evaluation of the exposure levels of workers and residents, caused by the incidents mentioned above. The requirements set for the type B laboratory also apply to the type A laboratory. In addition, STUK lays down safety requirements for each type A laboratory on a laboratory-specific basis, depending on the information presented in the plan. Final approval for the start-up of operations is granted in the safety license.
4.4 Type A laboratory, facilities for production of radionuclides and largescale use of unsealed sources
A type A laboratory is intended for the large-scale use of radioactive substances. The maximum activities of radioactive substances used in type A laboratories are specified in the safety license, taking into account the environmental conditions, the laboratorys security systems, the properties and activities of the radionuclides to be used, and other factors linked to radiation safety. If the operations are expected to cause releases into the environment (into the air, waters, soil), plans for a type A laboratory and other large-scale use of radioactive substances, such as radionuclide production, shall be submitted to STUK for inspection prior to the start of construction. In the plan, the following matters concerning the environment, and the use, structures and safety arrangements of the laboratory shall, at the very least, be presented for the appraisal of safety: a map of the region showing the location of the installation residential and working premises in the near environs of the installation utilisation of soil and waters in the environs of the installation (e.g. agricultural land, water supplies, wells) a description of the operations, the radionuclides used and their activities layout of the rooms in the laboratory (plan drawings) heating, plumbing and ventilation arrangements (especially the filtering of exhaust air)
4.5 Handling facilities of radiopharmaceuticals and other premises of the nuclear medicine unit
4.5.1 General Units, where radioactive substances are used as unsealed sources in diagnostic and/or therapeutic nuclear medicine procedures, typically include: handling facilities of radiopharmaceuticals a room for changing clothes (vestibule) a room for carrying out cell labelling a room for administering radiopharmaceuticals to patients a waiting room for patients for patients, a room for changing clothes and a toilet imaging facilities a storage room for radiation sources a storage room for radioactive waste possibly a room for measuring samples a patient room for those receiving radionuclide therapy. The patient room of patients who have received radionuclide therapy may need to be radiationshielded to protect other patients and workers. Radiation shielding of the imaging room may also be necessary in order to prevent radiation
guide ST 6.1 / 17 MARCH 2008 sources outside the room from disturbing the functioning of the imaging device. When dividing the premises into controlled and supervised areas, guidelines laid down in Guide ST 1.6 must be followed. The waiting rooms of patients and imaging rooms can normally be classified as supervised areas. The rooms of patients receiving radionuclide therapy are generally controlled areas. 4.5.2 Handling facilities of radiopharmaceuticals and patient rooms Operations involving handling facilities for radiopharmaceuticals and patient rooms shall be arranged according to the following requirements: In relation to handling facilities of radiopharmaceuticals, it shall be taken into account that the operations are regulated by both the Drug Act (395/1987) and by the Radiation Act (592/1991) as well as by the provisions issued by virtue of both of these Acts. STUK oversees compliance with the Radiation Act and with the provisions and regulations issued by virtue of it. The National Agency for Medicines is responsible for the regulatory control of, and instructions for, radiopharmaceuticals as well as medical devices and accessories (Medical Devices Act, 1505/1994). A laboratory used for the handling of radiopharmaceuticals must comply with the requirements set for a type B laboratory (see items 4.2 and 4.3 of this Guide). Regulations for the handling facilities of radiopharmaceuticals have been laid down by the regulation of National Agency for Medicines 7/2007. The storage and injection of ready-to-use radiopharmaceuticals is allowed also in other suitable premises. For administering therapeutic amounts of radiopharmaceuticals, there shall be a separate room with a floor coating as specified in item 4.2.2. There shall be a separate patient room for those patients receiving 131I therapy who are staying at the hospital. The patient room shall be equipped with its own toilet and washing
STUK facilities. The patient room shall be furnished with a sign indicating a danger of radiation. The surfaces of the room where radiopharma ceuticals are administered to patients and of the imaging room shall be easy to clean, and the rooms shall be suitable for handling unsealed sources. 4.5.3 PET-CT and SPET-CT The requirements for structural shielding for CT devices belonging to PET-CT or SPET-CT equipment are the same as for x-ray devices. The radiation safety requirements for x-ray facilities are issued in Guide ST 3.6.
STUK Solutions which may develop excessive pressure shall be stored in such a way that there is no danger of radiation even if the container or package is broken. If radioactive substances may be released into the air, it shall be possible to ventilate the storage sufficiently. The storage room of radioactive substances shall be lockable. In the radionuclide laboratory, radioactive substances shall be stored in a locked cupboard or a locked refrigerator. Ground-floor windows shall not provide unimpeded access to the storage facility of radioactive substances.
guide ST 6.1 / 17 MARCH 2008 nor contamination protectors which are used in addition to the standard protective clothing when working in contaminated areas. Also in such cases, contamination shall, however, be kept as low as reasonably possible. When determining surface activity, the amount of both fixed and non-fixed contamination is to be taken into account. The surface activity is determined as the average activity over an area of not more than 100 cm2. The smear method is set out in standard SFS 4575.
6 Surface contamination
Good working practices, regular cleaning and contamination measurements are important for keeping the contamination at a low level on the premises. Cleaning of radioactive substances on the premises may also be necessary when operations are closed down and the radionuclide laboratory is put to other use. If the activity levels on various surfaces in the radionuclide laboratory and in other places of radiation use exceed the limits specified in Table II, measures are to be taken to remove or isolate the contamination. If the working site, tools or clothing cannot be decontaminated sufficiently, their use shall be restricted and the passage of radioactive substances into the body and their dispersal into the environment shall be prevented by other measures. The surface activity limits do not apply to the inner surfaces of fume cupboards and other similar handling areas, such as glove boxes,
Table II. Surface activity limits.
Working areas and tools Workers *) *) Controlled area Supervised Clothing Skin and other area (Bq/cm2) (Bq/cm2) (Bq/cm2) (Bq/cm2) Alpha emitters 4 0,4 0,4 0,2 Beta and gamma emitters 40 4 4 2 *) The definitions of and requirements for controlled and supervised areas are set out in Guide ST 1.6.
Radioactive substance
guide ST 6.1 / 17 MARCH 2008 radiation meters shall be available in the laboratory. Workers handling radioactive substances must wear adequate protective clothing. Such protective clothing must not be worn outside the laboratory. It is not permitted to eat, drink, smoke or make up in a radionuclide laboratory. Neither is pipetting by mouth permitted. Work involving the handling of volatile or dusty radioactive substances shall be carried out in a fume cupboard or glove box. If the work carries a specific risk of contamination, working alone in the radionuclide laboratory should be avoided. During work stages with a risk of contamination, working surfaces shall be covered with a material preventing the spread of the contamination. When handling radiation sources, radiation shielding (syringe shields, lead shields or equivalent) shall be used whenever possible. Radiation sources shall be labelled so that they are easily identifiable. The labelling shall at least include: the radionuclide, its activity, date the activity was measured and the person who measured it. For unsealed sources, the total volume or activity concentration shall also be indicated (activity per unit of volume, for example). Tools and equipment needed for preventing the spread of radioactive substances and removing contamination shall be available at all times. The dose rate of external radiation and the amount of contamination in the radionuclide laboratory shall be monitored at appropriate intervals. Contamination measurements shall be carried out after finishing work and always when considerable contamination of working benches or other surfaces, the air of the laboratory, working clothes or tools is suspected. The results of the measurements shall be documented. A record shall be kept of incoming shipments containing a radioactive substance and of stored radioactive substances. A record shall also be kept of radioactive wastes and discharges.
STUK In addition to what is stated above, any laboratory-specific special regulations and instructions shall be followed.
STUK There must be written instructions for the tracer tests, including instructions for radiation protection and the event of abnormal incidents. After finishing the tracer test, measurements shall be carried out to ensure that the area is not contaminated. In addition to requirements stated above, STUK may set out further requirements for a single tracer test. Other requirements shall be considered case by case.
guide ST 6.1 / 17 MARCH 2008 written instructions to workers engaged in duties involving radiation sources on how to act in the event of abnormal incidents. Further details of action to be taken in the event of abnormal incidents and of reporting of such incidents to STUK are set out in Guide ST1.6.
9 Abnormal incidents
9.1 Preparation for abnormal incidents
The responsible party must identify the possible hazardous abnormal incidents associated with the use of radiation sources in advance. The responsible party must plan and implement operations in a manner that minimises the likelihood of abnormal incidents. Steps must nevertheless be taken to prepare for potential abnormal incidents by such means as issuing
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STUK 9. DIN 25425-1. Radionuklidlaboratorien - Teil 1: Regeln fr die Auslegung. Berlin: Deutsches Institut fr Normung. 10. DIN 25425-2. Radionuklidlaboratorien Teil 2: Betriebliche Strahlenschutzanweisungen. Berlin: Deutsches Institut fr Normung. 11. Madsen MT et al. AAPM Task Group 108: PET and PET/CT Shielding Requirements. Med. Phys. 2006; 33 (1): 4-15. 12. The National Building Code of Finland. E1 Fire Safety of Buildings. Regulations and guidelines 2002. Ministry of the Environment. Housing and Building Department. Available at www.ymparisto.fi 13. The National Building Code of Finland. E2 Fire Safety of Production and Warehouse Buildings. Guidelines 2005. Ministry of the Environment, Housing and Building Department. Available at www.ymparisto.fi 14. SFS 4575. Measurement of radioactive surface contamination. Smear method. Helsinki: Finnish Standards Association SFS. (in Finnish) 15. ISO 7503-1:1988, Evaluation of surface contamination Part 1. Beta- emitters (maximum beta energy greater than 0.15 MeV) and alpha-emitters. Geneva: International Organization for Standardization. 16. ISO 7503-2 :1988, Evaluation of surface contamination Part 2: tritium surface contamination. Geneva: International Organization for Standardization. 17. Lkelaitoksen mrys 7/2007. Sairaalaapteekin ja lkekeskusten toiminta. (Regulation of National Agency for Medicines 7/2007. The operation of hospital pharmacy and drug center). (4.12.2007). (in Finnish)
Bibliography
1. International Atomic Energy Agency. Safe Handling of Radionuclides. IAEA Safety Series No. 1. Vienna: IAEA; 1973. 2. International Atomic Energy Agency. Applying Radiation Safety Standards in Nuclear Medicine. IAEA Safety Reports Series No. 40. Vienna: IAEA; 2005. 3. International Atomic Energy Agency. Nuclear Medicine Resources Manual. Vienna: IAEA; 2006. 4. EU Commission Recommendation 1999/829/ Euratom of 6 December 1999 on the application of the Article 37 of the Euratom Treaty. Official Journal L 324, 16.12.1999, p. 00230043. 5. International Commission on Radiological Protection. 1990 recommendations of the International Commission on radiological Protection. ICRP Publication 60. Oxford: Pergamon Press; 1991. 6. International Commission on Radiological Protection. Protection of the Patient in Nuclear Medicine. ICRP Publication 52. Oxford: Pergamon Press; 1987. 7. International Commission on Radiological Protection. Radiological Protection of the Worker in Medicine and Dentistry. ICRP Publication 57. Oxford: Pergamon Press; 1990. 8. Medical and Dental Guidance Notes, 2002. A good practice guide on all aspects of ionising radiation protection in the clinical environment; Prepared by the Institute of Physics and Engineering in Medicine (IPEM) with the support of NRPB, HSE, Health Departments, Environment Agencies. York; IPEM: 2002.
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STUK
Radiation Therapy
ST 2.1 Quality Assurance in Radiotherapy, 22 May 2003 ST 2.2 Radiation Safety of Radiotherapy Equipment and Treatment Rooms, 2 February 2001.
Diagnostic Radiology
ST 3.1 Use and Regulatory Control of Dental X-ray Installations, 27 May 1999 ST 3.2 Mammography Equipment and Their Use, 13 August 2001 ST 3.3 X-ray Examinations in Health Care, 20 March 2006 ST 3.6 Radiation Safety in X-ray Facilities, 24 September 2001. ST 3.7 Breast Cancer Screening Based on Mammography, 28 March 2001
Non-Ionizing Radiation
ST 9.1 Radiation Safety Requirements and Regulatory Control of Tanning Appliances 1 December 2003 (in Finnish) ST 9.2 Radiation Safety of Pulsed Radars, 2 September 2003 (in Finnish) ST 9.3 Radiation Safety during Work on Masts at FM and TV Stations, 2 September 2003 (in Finnish) ST 9.4 Radiation Safety of High Power Display Lasers, 28 February 2007 (in Finnish)
Natural Radiation
ST 12.1 Radiation Safety in Practices Causing Exposure to Natural Radiation, 6 April 2000 ST 12.2 The Radioactivity of Building Materials and Ash, 8 October 2003 ST 12.3 Radioactivity of Household Water, 9 August 1993 ST 12.4 Radiation safety in aviation, 20 June 2005
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