RULEBOOK
ON CONDITIONS FOR OBTAINING DECISION TO
PERFORM ACTIVITIES IN THE FIELD OF RADIATION
PROTECTION
("Off. Gazette of the Republic of Serbia", no. 61/2011)
Article 1
This Rulebook shall regulate:
1. closer conditions that shall be meet by a legal person that performs activities of the
radioactivity monitoring or particular examinations thereof.
2. closer conditions that shall be met by a legal person that perform activities relating to the
measurements of radionuclides content in drinking water, foodstuffs, feeding stuffs, medicines,
general use products, construction materials and other goods;
3. closer conditions that shall be met by a legal person that perform measurements for early
warning of emergency;
4. the content of a project of radiation safety and security measures for each radiation practice;
5. closer conditions that shall be met by a legal person that perform development of a project of
radiation safety and security measures;
6. closer conditions that shall be met by a legal person that performs measurements to assess
the levels of exposure to ionizing radiation of occupationally exposed persons, patients and
population;
7. closer conditions that shall be met by a legal person that performs additional training and
specialised education of occupationally exposed persons and persons responsible for
implementation of radiation protection measures;
8. closer conditions that shall be met by a legal person that perform measurements in order to
control the quality management system of ionising radiation protection measures;
9. closer conditions that shall be met by a legal person that perform decontamination of working
and living environment;
10. closer conditions that must be met by a legal person that conducts human decontamination;
11. methods, types and time intervals for performing measurements in order to control the
quality management system of ionising radiation protection measures;
12. closer conditions for performing activities of determination of radionuclides content in
foodstuffs, drinking water, feeding stuffs, artificial fertilizers, medicines, general use products,
construction materials, ores, metal products of primary form, mineral raw materials, secondary
raw materials and other goods.
Article 2
Certain terms used herein shall have the following meanings:
1. Quality assurance means all the planned and systematically performed activities needed to
ensure a high degree of reliability, and that a system, system units and procedure satisfy
prescribed requirements;
2. Quality control is a set of procedures intended to maintain and improve quality, and includes
testing, evaluation and maintenance of all verifiable and measurable characteristics of a system
or device at the prescribed level;
3. Acceptance testing are tests conducted on a new source of ionizing radiation, space, process
or service, prior to placing on the market or in use, as well as tests conducted on a source of
ionizing radiation, space, procedure or service on the new location, if moved from one place to
another;
4. Periodic testing are regularly repeated tests conducted on a source of ionizing radiation,
space, procedure or service, at certain time intervals.
Article 3
In order to perform one or more activities in the field of radiation protection, a legal person shall
submit to the Serbian Radiation Protection and Nuclear Safety Agency (hereinafter referred to
as – the Agency) completed request form no. 3, for each type of activity referred to in Article 1 of
this Rulebook.
The content of the form and Form no. 3 are attached as Appendix 1 to this Rulebook and form
an integral part thereof.
In addition to the requirement under paragraph 1 of this Article, a legal person shall submit a
proof of registration, proof of payment of the fee for issuance of a decision of authorization, and
any other relevant documentation required under this Rulebook.
The Agency issues a decision to the legal person referred to in paragraph 1 of this Article to
perform only activities in the field of radiation protection for which the conditions specified in this
Rulebook are fulfilled.
Article 4
In order to obtain decision to perform one or more activities in the field of radiation protection
under Article 1, a legal person shall submit to the Agency a description of its work activities,
description of radiation protection measures, proof of medical ability for work with ionizing
radiation and proof of possessing qualifications for implementation of radiation safety measures
for each person occupationally exposed or to be occupationally exposed to ionizing radiation.
RADIOACTIVITY MONITORING ACTIVITIES AND RELATED
EXAMINATIONS
Article 5
Particular examinations within the radioactivity monitoring include: measurement of ambient
gamma dose equivalent in air, gamma spectrometric examination, gross alpha and gross beta
activity examination, strontium – 90 examination, tritium examination and radon concentration
examination.
Article 6
For issuance of a decision for performing radioactivity monitoring, a legal person shall submit a
request to the Agency (completed form 3) and other relevant documents, such as:
1. proof of employment of an adequate number of persons who acquired higher education,
academic studies in mathematics and science, or in technical and technological sciences, with
three years of work experience in the field of measurement of radioactivity in the environmental
samples;
2. description of laboratory space for processing, measurements and storage of samples;
3. description of standard laboratory equipment for preparation of samples;
4. description of the specific measuring equipment that fulfils prescribed metrological conditions;
5. copy of the Certificate and of Appendix to the certificate of accreditation of testing laboratory,
issued by the Accreditation body of Serbia for the appropriate type of examination specified in
Article 5 of this Rulebook under SRPS ISO/IEC 17025 for which authorization is being
requested; or a copy of certificate of international accreditation body recognized by the national
accreditation body.
Article 7
Legal person that submits to Agency a request under Article 3 of this Rulebook for obtaining
decision to perform particular examination within the monitoring shall be obliged to submit other
relevant documents, such as:
1. documents under Article 6, items 2, 3, 4 and 5 of this Rulebook;
2. proof of employment of at least one person who holds a university diploma acquired during
academic studies in mathematics and science or in technical and technological sciences,
including three years of work experience in the field of radioactivity measurements in the
environmental samples.
ACTIVITIES OF MEASUREMENT OF RADIONUCLIDES
CONTENT IN DRINKING WATER, FOODSTUFFS,
FEEDINGSTUFFS, MEDICINES AND OTHER GOODS
Article 8
For obtaining a decision to perform activities referred to in Article 1 item 2 of this Rulebook, a
legal person shall submit to the Agency the documents in accordance with Article 7 of this
Rulebook.
Article 9
Upon obtaining a decision on approving implementation of radiation protection measures
specified in Article 1 item 1 or item 2 of this Rulebook, a legal person shall also be authorised
for performing determination of radionuclides content in goods for import, export and transit.
Legal person shall obtain a decision on approving of the activities for determination of the
radionuclide content in goods for import, export and transit, if submits to the Agency a full and
proper documentation in accordance with Article 7 of this Rulebook.
Article 10
More detailed conditions in terms of equipment for implementation of radiation protection
measures referred to in Articles 6, 7, 8 and 9 of this Rulebook shall be defined by the
instructions of the Agency and shall be updated regularly.
MEASUREMENT FOR EARLY WARNING OF EMERGENCY
Article 11
The Agency shall provide functioning of the network of detectors on the territory of Serbia in
order to provide a continuous measurement of the ambient gamma dose rate equivalent for
early warning of emergency.
CONTENT OF THE PROJECT OF RADIATION SAFETY AND
SECURITY MEASURES
Article 12
A legal person authorised for the development of a project on radiation safety and security
measures shall be obliged to adjust the content of each document according to its purpose:
setting up or use of source of the ionizing radiation.
Legal person authorized for the development of a project on radiation safety and security
measures shall be obliged to adjust the content of each document to the type of ionizing
radiation source and radiation practice for which the source is intended for use.
The general content of the project concerning radiation safety and security measures shall be
given within the instructions prepared by the Agency.
CONDITIONS TO BE MET BY A LEGAL PERSON THAT
DEVELOP PROJECT OF RADIATION SAFETY AND SECURITY
MEASURES
Article 13
A legal person intending to obtain a decision for development of a Project of radiation safety and
security measures, shall submit to the Agency a request under Article 3 of this Rulebook.
The request under paragraph 1 of this Article shall be accompanied by other relevant
documentation, such as:
1. proof of employment of an adequate person with higher education diploma acquired during
academic studies in mathematics and science or technical and technological sciences, with at
least three years of experience in development of radiation protection measures;
2. proof of possession of an adequate space for computer equipment and project
documentation.
3. description of methods for evaluation and procession of data and for calculation of a barrier
thickness;
4. list of performed projects concerning radiation protection measures specifying the name of a
person responsible for the project development and the names of associates on the project, as
well as the name of a legal person that owns a source of ionizing radiation for which the project
has been developed.
Article 14
A legal person that obtained from the Agency a decision on approving development of a project
of radiation safety and security measures shall be required to indicate on the project's front
page the purpose of project development: Project on radiation safety and security measures for
installation and trial operation or Project on radiation safety and security measures for use of
ionizing radiation sources.
The sources of ionizing radiation which were the subject matter of the developed project shall
be specified on the project's front page under paragraph 1 of this Article, below the stated
purpose.
MEASUREMENTS FOR ASSESSING THE LEVEL OF EXPOSURE
TO IONIZING RADIATION OF OCCUPATIONALLY EXPOSED
PERSONS, PACIENTS AND POPULATION
Article 15
Measurements for assessment of the level of exposure to ionizing radiation of occupationally
exposed persons, patients and population shall be: measurements to estimate exposure to
external radiation; measurements to assess internal exposure due to intake of radionuclides into
the body; biodosimetrical measurements of individual exposure and measurements of
radioactivity in the whole body or individual organs.
Article 16
A legal person submitting a request for a decision to perform activities of assessment of the
level of ionizing radiation exposure shall specify the measurement under Article 15 of this
Rulebook for which a decision is being sought.
Article 17
A legal person shall submit to the Agency a request under Article 3 and Article 16 of this
Rulebook for obtaining a decision to perform measurements to assess the level of exposure to
ionizing radiation of occupationally exposed persons, patients and population, along with other
relevant documents, such as:
1. proof of employment of an adequate number of persons holding higher education diploma
acquired in academic studies in mathematics and science or technical and technological
sciences, with at least three years of experience in measurements for assessment of the level of
ionizing radiation exposure;
2. list of all persons who will carry out technical activities regarding radiation protection with the
evidence on their qualifications;
3. project of radiation safety and security measures for those activities where practitioners are
occupationally exposed to the ionizing radiation;
4. proof of fulfilment of the health conditions for persons occupationally exposed to ionizing
radiation;
5. description of laboratory space and technical equipment;
6. description of standard and specific laboratory equipment needed for the activities for which
authorizations are being sought;
7. copy of the Certificate and copy of Appendix to the certificate of accreditation in accordance
with SRPS ISO/IEC 17025, or a copy of the certificate of an international accreditation body
recognized by the national accreditation body.
Legal person performing biodosimetrical measurements of individual exposure might provide a
certificate of accreditation in accordance with SRPS ISO/IEC 15189 instead the certificate
SRPS ISO/IEC 17025.
Article 18
Measuring methods that require accreditation referred to in Article 17 item 7 are defined by the
instructions of the Agency.
ADDITIONAL TRAINING AND SPECIALISED EDUCATION OF
OCCUPATIONALLY EXPOSED PERSONS AND PERSONS
RESPONSIBLE FOR THE IMPLEMENTATION OF RADIATION
PROTECTION MEASURES
Article 19
The Agency issues the following decisions for conducting additional training and specialised
education of occupationally exposed persons and persons responsible for the implementation of
radiation protection measures:
1. authorization to conduct additional training for work with the sources of ionizing radiation;
2. authorization for carrying out specialised education of occupationally exposed persons for the
implementation of radiation protection measures;
3. authorization for specialised education of the persons responsible for the implementation of
radiation protection measures.
Additional training for work with the sources of ionizing radiation referred to in paragraph 1 item
1 of this Article also includes specialised education for carrying out implementation of safety
measures.
Article 20
Legal person intending to obtain a decision for conducting activities specified in Article 1 item 7
of this Rulebook, shall indicate in the request for decision issuance a type of training planned to
be implemented under Article 19 paragraph 1 of this Rulebook.
Article 21
A legal person may obtain decision to conduct additional training under Article 19 paragraph 1
item 1 of this Rulebook only if holds a license for radiation practice or nuclear activity, which are
planned to be the subjects of the training courses.
Article 22
For obtaining decision under article 1 item 7 of this Rulebook, a legal person shall be obliged to
submit to the Agency a request pursuant to Article 3 and Article 20 of this Rulebook, and other
relevant documents, such as:
1. list of persons who will conduct training along with a proof of their eligibility in
accordance with the Rulebook on establishing program for additional training and
specialised education of occupationally exposed persons and persons responsible for
the implementation of radiation protection measures, together with the evidence of their
qualifications and a list of completed projects in the field relevant to the training that will
be carried out;
2. if a legal person holds no license for radiation practice which is planned to be the subject
matter of the trainings under Article 19 item 2 and item 3 of this Rulebook, the legal
person shall submit to the Agency a contract made with another legal person which is a
license holder for a corresponding practice (contractor) on holding practical part of
training course with the contractor.
MEASUREMENTS FOR CONTROL OF QUALITY MANAGEMENT
SYSTEM FOR RADIATION PROTECTION MEASURES
Article 23
A legal person that perform measurements in order to control the quality management system
for radiation protection measures in medicine and dental medicine may obtain the decision for
the following examinations: X-ray imaging device, x-ray illumination device, X-ray
mammography imaging, X-ray device for computerised tomography, dental X-ray device,
accelerators in radiotherapy, sealed radioactive sources in radiotherapy and devices used in
nuclear medicine.
Article 24
Legal person under Article 23 of this Rulebook shall have proper equipment for the specific
types of examinations, as defined in the instructions of the Agency.
The measuring devices under paragraph 1 above shall be calibrated according to national or
international regulations.
Article 25
Legal person intending to obtain decision under Article 1 item 8 of this Rulebook, along with the
request submitted to the Agency pursuant to Article 3 of this Rulebook, shall specify the types of
examinations under Article 23 of this Rulebook, and shall submit other relevant documents,
such as:
1. proof of employment of an adequate number of persons holding higher education diploma
acquired in academic studies in mathematics and science or technical and technological
sciences, including three years of work experience in measurements to control quality of the
radiation protection measures implementation;
2. proof that the personal dosimetry control has been provided to the persons employed,
together with the health surveillance and special training regarding the radiation protection
measures implementation;
3. proof on possessing proper equipment for each type of measurement in accordance with
Article 24 of this Rulebook;
4. proof of the developed protocols for quality control in accordance with the regulations
governing this field;
5. a copy of the Certificate and of Appendix to the certificate of accreditation in accordance with
SRPS ISO/IEC 17025, or a copy of the certificate of international accreditation body recognized
by the national accreditation body.
DECONTAMINATION OF WORKING AND LIVING
ENVIRONMENT
Article 26
Legal person shall submit to the Agency a request under Article 3 of this Rulebook for obtaining
decision to perform decontamination of working and living environment, together with other
relevant documents, such as:
1. proof of employment of an adequate number of persons holding higher education diploma
acquired in academic studies in mathematics and science, technical and technological sciences,
including three years of work experience in decontamination of working and living environment;
2. list of all persons who will perform technical activities of the radiation protection, together with
the evidence of their qualifications;
3. proof of satisfying health conditions for the persons occupationally exposed to ionizing
radiation;
4. project of radiation safety and security measures for performing decontamination, in which, in
addition to the standard content of the document, shall describe the decontamination at the site
and decontamination performed in its own space, the space for temporary storage of radioactive
waste, personal protective equipment, specific portable measuring and other equipment and
decontamination agents;
5. proof of possessing a special vehicle for transportation of radioactive materials.
HUMAN DECONTAMINATION
Article 27
Legal person shall submit to the Agency a request for obtaining decision, under Article 2 of this
Rulebook, to perform decontamination of persons, together with other relevant documents, such
as:
1. proof of employment of persons holding higher education diploma acquired in academic
studies in mathematics and science or technical and technological sciences, including three
years of work experience in decontamination of working and living environment;
2. proof of employment of a medical doctor and medical technician trained to work with the open
sources of ionizing radiation class III;
3. description of the space for human decontamination and the space for temporary storage of
radioactive materials;
4. list of the specific measuring equipment in possession along with the proof of fulfilling
metrological requirements;
5. list of standardized means for human decontamination in possession
METHOD, TYPES, AND TIME INTERVALS OF MEASUREMENTS
TO CONTROL QUALITY MANAGEMENT SYSTEM
Article 28
The sources of ionizing radiation shall be controlled: 1. before placing on the market and before
use; 2. at least once a year; 3. after any intervention or reconstruction and prior to placing back
on the market or reuse, and 4. before starting to use at the new space if the source was moved
from one place to another.
The examinations referred to in 1, 3 and 4 are considered as acceptance testing, and testing
listed under 2 as periodic testing.
Article 29
If there is no accredited laboratory in the Republic of Serbia for a particular measuring method,
the Agency may, in exceptional cases, issue an authorisation to the legal person to apply the
method of radiation protection that is not accredited.
In that case, the Agency shall check the professional qualifications of the persons involved,
technical equipment, accuracy and traceability of the measuring equipment to ensure the
accuracy and reliability of results.
CLOSE CONDITIONS FOR DETERMINATION OF THE
RADIONUCLIDES CONTENT IN FOODSTUFF, DRINKING
WATER, FEEDING STUFFS, ARTIFICIAL FERTILIZERS,
MEDICINES, GENERAL USE PRODUCTS, CONSTRUCTION
MATERIALS, ORES, METAL PRODUCTS OF PRIMARY FORM,
MINERAL RAW MATERIALS, SECONDARY RAW MATERIALS
AND OTHER GOODS
Article 30
In order to perform activities relating to the determination of the radionuclide content in foodstuff,
drinking water, feeding stuffs, artificial fertilizers, medicines, general use products, construction
materials, ores, metal products of primary form, mineral raw materials, secondary raw materials
and other goods, the legal person shall submit to the Agency a request to perform the
abovementioned activities and shall furnish the request with the following:
1. proof of employment of an adequate number of persons holding higher education diploma
acquired in academic studies in mathematics and science or technical and technological
sciences, including three years of experience in the measurement of radioactivity in
environmental samples;
2. description of laboratory space for processing, measuring and storage of samples;
3. description of standard laboratory equipment for samples preparation;
4. description of the specific measuring equipment that meets the metrological requirements;
5. a copy of the Certificate and of Appendix to the certificate of accreditation of testing
laboratory, issued by the Accreditation Body of Serbia for the corresponding type of testing
specified in Article 5 of this Rulebook in accordance with SRPS ISO/IEC 17025, for which
authorization is being requested; or a copy of the certificate of international accreditation body
recognized by the national accreditation body.
Article 31
The Agency shall revoke from authorised legal person a decision to perform activities relating to
the radiation protection, if:
1. legal person submits a request for revocation of the decision;
2. legal person ceases to fulfil any of the prescribed conditions upon which a decision was
issued;
3. legal person fails to notify the Agency of an accident observed while performing radiation
protection activities;
4. found that a legal person does not perform radiation protection activities in accordance with
law, and if the legal person fails to eliminate the deficiencies and irregularities in its work
activities within a specified period;
5. legal person does not carry out the prescribed measurements, or conceals data or provides
false information important for taking radiation protection measures .
Article 32
This Rulebook shall enter into force on the eighth day following its publication in the "Official
Gazette of the Republic of Serbia".
Appendix 1
INFORMATION CONTAINED IN THE REQUEST FOR
OBTAINING AUTHORIZATION TO PERFORM ACTIVITIES IN
THE FIELD OF RADIATION PROTECTION
The request for authorization to perform activities in the field of radiation protection includes the
following information:
1. Data on the legal person or entrepreneur: name of the legal person or entrepreneur, official
identification number, tax identification number, city, ZIP code, street and number, telephone,
fax, e-mail, person responsible for radiation protection; contact person; activities in the field of
radiation protection for which authorization is being sought. (Complete a separate request for
each particular activity under Article 1 of this Rulebook on conditions for obtaining decision to
perform activities in the field of radiation protection. List the types of activities in the area for
which authorization is being requested.)
2. Authentication of legal person or entrepreneur shall contain the following information: place,
date, appendix, place for the stamp of legal person or entrepreneur, name and signature of
authorized person.
Form no.3
REQUEST FOR AUTHORIZATION FOR ACTIVITIES OF RADIATION
PROTECTION MEASURES IMPLEMENTATION
I. Details of legal person or entrepreneur
Name of legal person or entrepreneur
official identification number:
TIN:
Address:
City:
ZIP code:
Phone:
Fax:
E-mail:
Person responsible for the radiation protection:
Contact person:
Activities in the field of radiation protection for which authorization is being sought:
(Complete a separate request for each particular activity under Article 1 of this Rulebook on
conditions for obtaining decision to perform activities in the field of radiation protection. List the
types of activities in the field for which authorization is being requested.)
II. Authentication of legal person or entrepreneur
Place
Date:
Appendix:
For legal person or
entrepreneur:
PLACE FOR STAMP
Name, surname and
signature of responsible
person