MT
BASIC SAFETY STANDARDS FOR IONISING RADIATION REGULATIONS
Table of Provisions (150)
Statutory Text (150 Articles)
BASIC SAFETY STANDARDS FOR IONISING RADIATION
SUBSIDIARY LEGISLATION 585.01
BASIC SAFETY STANDARDS FOR IONISING
RADIATION REGULATIONS
6th February, 2018
LEGAL NOTICE 210 of 2018, as amended by Legal Notice 184 of 2020
and 139 of 2022 and Act XXXIII of 2024.
(1)
The title of these regulations is the Basic Safety
Standards for Ionising Radiation Regulations.
(2) These regulations implement Directive 2013/59/
Euratom, Basic Safety Standards for Protection Against the Dangers
Arising From Exposure to Ionising Radiation.
(Regulation 4)
Radiation and tissue weighting factors
A. Radiation weighting factors
Radiation type
W R
Photons
Electrons and muons
Protons and charged pions
Alpha particles, fission fragments, heavy ions
Neutrons, E n <1 MeV
Neutrons, 1 MeV ≤ E n ≤50 MeV
Neutrons, E n >50 MeV
Note: All values relate to the radiation incident on the body or, for internal
radiation sources, emitted from the incorporated radionuclide(s).
B. Tissue weighting factors
Tissue
W T
Bone-marrow (red)
0.12
Colon
0.12
Lung
0.12
Stomach
0.12
Breast
0.12
Remainder tissues (*)
0.12
Gonads
0.08
Bladder
0.04
Oesophagus
0.04
Liver
0.04
Thyroid
0.04
Bone surface
0.01
Brain
0.01
Salivary glands
0.01
0.01
(*) The W T for the remainder tissues (0.12) applies to the arithmetic mean dose of the 13
organs and tissues for each sex listed below. Remainder tissues: adrenals, extrathoracic
(ET) region, gall bladder, heart, kidneys, lymphatic nodes, muscle, oral mucosa, pancreas,
prostate (male), small intestine, spleen, thymus, uterus/cervix (female).
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
These regulations establish the basic safety
standards for the protection of the health of individuals subject to
occupational, medical and public exposures against the dangers
arising from ionising radiation.
(2) These regulations apply to any planned, existing or
emergency exposure situation which involves a risk from exposure to
ionising radiation which cannot be disregarded from a radiation
protection point of view or with regard to the environment in view of
long-term human health protection.
(3) These regulations also provide for the security of
radioactive material and define specific requirements ensuring that
each such source is kept under control.
(4)
These regulations in particular apply to
(a)
the manufacture, production, processing,
handling, disposal, use, storage, holding, transport, import to,
and export from Malta of radioactive material;
(b)
the manufacture and the operation of electrical
equipment emitting ionising radiation and containing
components operating at a potential difference of more than 5
kilovolt (kV);
(c)
human activities which involve the presence of
natural radiation sources that lead to a significant increase in
the exposure of workers or members of the public, in
particular
(i)
the operation of aircraft in relation to the
exposure of crews;
(ii) the processing of materials containing
naturally-occurring radionuclides;
(d)
the exposure of workers or members of the
public to indoor radon, the external exposure from building
materials and cases of lasting exposure resulting from the
after-effects of an emergency or a past human activity;
(e)
the preparedness for, the planning of response to
BASIC SAFETY STANDARDS FOR IONISING RADIATION
and the management of emergency exposure situations that are
deemed to warrant measures to protect the health of members of
the public or workers.
(5)
These regulations shall not apply to
(a)
exposure to the natural level of radiation, such as
radionuclides contained in the human body and cosmic radiation
prevailing at ground level;
(b)
exposure to cosmic radiation in flight by members
of the public or workers other than aircrew;
(c)
aboveground exposure to radionuclides present in
the undisturbed earth's crust.
(Regulation 4)
Activity Of high-activity sealed sources and Security Values
For radionuclides not listed in the table below, the relevant activity is identical to
the D-value defined in the IAEA publication Dangerous quantities of radioactive
material (D-values), (EPR-D-VALUES 2006).
Table 1
IAEA Code of Conduct on the safety and security of radioactive sources
Category 1
Category 2
Category 3
Security Level A
Security Level B
Security Level C
D x 1000 value
D x10 value
D Value
Values defining high-activity sealed
sources in this regulation
Radionuclide
Activity (TBq)
Activity (TBq)
Activity (TBq)
Am-241
6 x 10 1
6 x 10 -1
6 x 10 -2
Am-241/Be ( 1 )
6 x 10 1
6 x 10 -1
6 x 10 -2
Cf-252
2 x 10 1
2 x 10 -1
2 x 10 -2
Cm-244
5 x 10 1
5 x 10 -1
5 x 10 -2
Co-60
-1
3 x 10 -2
3 x 10
3 x 10
Cs-137
1 x 10 2
1 x 10 0
1 x 10 -1
1 x 10 1
1 x 10 0
Gd-153
1 x 103
8 x 10 1
8 x 10 -1
8 x 10 -2
Ir-192
Pm-147
4 x 10 4
4 x 10 2
4 x 10 1
Pu-238
6 x 10 1
6 x 10 -1
6 x 10 -2
Pu-239/Be
6 x 10 1
6 x 10 -1
6 x 10 -2
4 x 10 1
4 x 10 -1
4 x 10 -2
Ra-226
Se-75
2 x 10 2
2 x 10 0
2 x 10 -1
Sr-90 (Y-90)
1 x 103
1 x 10 1
1 x 10 0
Tm-170
2 x 10 4
2 x 10 2
2 x 10 1
Yb-169
3 x 10 -1
3 x 10
3x 10
Au-198
2 x 10 2
2x 10 0
2 x 10 -1
Cd-109
2 x 10 4
2 x 10 2
2 x 10 1
Co-57
7 x 10 2
7 x 10 0
7 x 10 -1
Fe-55
8 x 105
8 x 103
8 x 10 2
7 x 10 -1
Ge-68
7 x 10
7 x 10
Ni-63
6 x 10 4
6 x 10 2
6 x 10 1
Pd-103
9 x 10 4
9 x 10 2
9 x 10 1
Po-210
6 x 10 1
6 x 10 -1
6 x 10 -2
Ru-106
3 x 10 2
3 x 10 0
3 x 10 -1
Tl-204
2 x 10 4
2 x 10 2
2 x 10 1
( 1 ) The activity is that of the alpha-emitting radionuclide
BASIC SAFETY STANDARDS FOR IONISING RADIATION
The Commission shall have the power to enforce these
regulations.
Part II
Definitions
(Regulation 27)
JUSTIFICATION OF NEW CLASSES
OR
TYPES
OF
PRACTICES
INVOLVING CONSUMER PRODUCTS
(A) Any undertaking intending to manufacture or import into Malta
consumer products for which the intended use is likely to lead to a new class or type
of practice, shall provide the Commission with all relevant information, as to the
(i)
intended use of the product,
(ii)
technical characteristics of the product;
(iii) in the case of products containing radioactive substances, information as to
their means of fixation;
(iv) dose rates at relevant distances for the use of the product, including dose
rates at a distance of 10cm from any accessible surface;
(v)
expected doses to regular users of the product.
(B) The Commission shall examine that information and in particular
assess whether
(i)
the performance of the consumer product justifies its intended use;
(ii) the design is adequate in order to minimize exposures in normal use and the
likelihood and consequences of misuse or accidental exposures, or whether there should
be conditions imposed on the technical and physical characteristics of the product;
(iii) the product is adequately designed to meet the exemption criteria, and,
where applicable, is of an approved type and does not necessitate specific precautions for
disposal when no longer in use;
(iv) the product is appropriately labelled and suitable documentation is provided
to the consumer with instructions for proper use and disposal.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
In these regulations, unless the context otherwise
requires
"acceptance test" means is a test to check the compliance of
equipment, used in connection with medical exposure, with specified
tolerances;
"accident" shall mean any unintended event, including operating
errors, equipment failures and other mishaps, the consequences or
potential consequences of which are not negligible from the point of
view of radiation protection or safety;
"Act" means the Nuclear Safety and Radiation Protection Act;
"absorbed dose" (D) means the energy absorbed per unit mass
Where
is the mean energy imparted by ionizing radiation to the
matter in a volume element, dm is the mass of the matter in this
volume element.
In these regulations, absorbed dose denotes the dose averaged
over a tissue or an organ. The unit for absorbed dose is the gray (Gy)
where one gray is equal to one joule per kilogram;
"accelerator" means equipment or installation, in which
BASIC SAFETY STANDARDS FOR IONISING RADIATION
particles are accelerated, emitting ionizing radiation with an energy
higher than 1 mega-electron volt (MeV);
"accidental exposure" means an exposure of individuals, other
than emergency workers, as a result of an accident;
"activation" means a process through which a stable nuclide is
transformed into a radionuclide by irradiating with particles or high-
energy photons the material in which it is contained;
"activity" (A) is the activity of an amount of a radionuclide in a
particular energy state at a given time. It is the quotient of dN by dt,
where dN is the expectation value of the number of nuclear
transitions from that energy state in the time interval dt
The unit of activity is the Becquerel (Bq);
"apprentice" means a person receiving training or instruction
within an undertaking with a view to exercising a specific skill;
"applicant" means a legal person who applies to Secretariat
filing a application to the Secretariat for the purpose of obtaining the
authorisation for undertaking of specific activities;
"authorisation" means a permission granted in a document by
the Secretariat to carry out a practice or any other action within the
scope of these regulations. Authorisations can take the form of a
registration or a licence.
"becquerel" (Bq) is the special name of the unit of activity.
One becquerel is equivalent to one nuclear transition per second;
"building material" means any construction product for
incorporation in a permanent manner in a building or parts thereof
and the performance of which has an effect on the performance of the
building with regard to exposure of its occupants to ionising
radiation;
"carers and comforters" means individuals knowingly and
willingly incurring an exposure to ionising radiation by helping, other
than as part of their occupation, in the support and comfort of
individuals undergoing or having undergone medical exposure;
"clearance levels" means values, established by the
Commission, and expressed in terms of activity concentrations at or
below which materials arising from any practice subject to
notification or authorisation may be released from the requirements
of these regulations;
"clinical audit" means a systematic examination or review of
BASIC SAFETY STANDARDS FOR IONISING RADIATION
medical radiological procedures which seeks to improve the quality
and outcome of patient care through structured review, whereby
medical radiological practices, procedures and results are examined
against agreed standards for good medical radiological procedures,
with modification of practices, where appropriate, and the application
of new standards if necessary;
"clinical responsibility" means responsibility of a practitioner
for individual medical exposures, in particular, justification;
optimisation; clinical evaluation of the outcome; cooperation with
other specialists and staff, as appropriate, regarding practical aspects
of medical radiological procedures; obtaining information, if
appropriate, on previous examinations; providing existing medical
radiological information and/or records to other practitioners and/or
the referrer, as required; and giving information on the risk of ionising
radiation to patients and other individuals involved, as appropriate;
"Commission" means the Commission for the Protection from
Ionising and Non-Ionising Radiation, as established by article 10 of the
Act, which acts as the regulatory authority in the field of nuclear safety
and radiation protection and has the legal authority for the purpose of
these regulations;
"committed effective dose" (E(τ)) is the sum of the committed
organ or tissue equivalent doses HT(τ) resulting from an intake, each
multiplied by the appropriate tissue weighting factor w T . It is defined
by
In specifying E(τ), is given in the number of years over which
the integration is made. For the purpose of complying with dose limits
specified in these regulations, is a period of 50 years following intake
for adults and up to the age of 70 for infants and children. The unit for
committed effective dose is the sievert (Sv);
"committed equivalent dose" (HT(τ)) is the integral over time (t)
of the equivalent dose rate in tissue or organ T that will be received by
an individual as a result of an intake.
It is given by
for an intake at time t 0 where
T ( t ) is the relevant equivalent dose rate in organ or tissue T at
BASIC SAFETY STANDARDS FOR IONISING RADIATION
time t,
τ is the time over which the integration is performed.
In specifying HT(τ), is given in number of years over which
the integration is made. For the purpose of complying with dose
limits specified in these regulations, τ is a period of 50 years for
adults and up to the age of 70 for infants and children. The unit for
committed equivalent dose is the sievert (Sv);
"consumer product" means a device or manufactured item into
which one or more radionuclides have deliberately been incorporated
or produced by activation, or which generates ionising radiation, and
which can be sold or made available to members of the public
without special surveillance or regulatory control after sale;
"constancy test" means a test intended to monitor the
constancy of the functional performance of the equipment used in
connection with medical exposures;
"contamination" means the unintended or undesirable presence
of radioactive substances on surfaces or within solids, liquids or
gases or on the human body;
"controlled area" means an area subject to special rules for the
purpose of protection against ionising radiation or preventing the
spread of radioactive contamination and to which access is
controlled;
"diagnostic reference levels" means dose levels in medical
radiodiagnostic or interventional radiology practices, or, in the case
of radio-pharmaceuticals, levels of activity, for typical examinations
for groups of standard-sized patients or standard phantoms for
broadly defined types of equipment;
"disused source" means a sealed source which is no longer
used or intended to be used for the practice for which authorisation
was granted but continues to require safe management;
"dose constraint" means a constraint set as a prospective upper
bound of individual doses, used to define the range of options
considered in the process of optimisation for a given radiation source
in a planned exposure situation;
"dose limit" means the value of the effective dose (where
applicable, committed effective dose) or the equivalent dose in a
specified period which shall not be exceeded for an individual;
"dosimetry service" means a body or an individual competent
to calibrate, read or interpret individual monitoring devices, or to
measure radioactivity in the human body or in biological samples, or
to assess doses, whose capacity to act in this respect is recognised by
the Commission;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
"effective dose" (E) is the sum of the weighted equivalent doses
in all the tissues and organs of the body from internal and external
exposure. It is defined by the expression
Where
is the absorbed dose averaged over tissue or organ T, due to
radiation R,
is the radiation weighting factor and
is the tissue weighting factor for tissue or organ T
is the equivalent dose absorbed by tissue T
The values for
and
are specified in the First Schedule.
The unit for effective dose is the sievert (Sv);
"emergency" means a non-routine situation or event involving a
radiation source that necessitates prompt action to mitigate serious
adverse consequences for human health and safety, quality of life,
property or the environment, or a hazard that could give rise to such
serious adverse consequences;
"emergency exposure situation" means a situation of exposure
due to an emergency;
"emergency management system" means the elements listed in
Section A of the Tenth Schedule, as incorporated in the national
radiological emergency plan, for emergency preparedness and
response, and arrangements for decision making in the event of an
emergency exposure situation;
"emergency occupational exposure" means exposure received in
an emergency exposure situation by an emergency worker;
"emergency response plan" means those elements listed in
Section B of the Tenth Schedule to plan for adequate response in the
event of an emergency exposure situation on the basis of postulated
events and related scenarios;
"emergency worker" means any person having a defined role in
an emergency and who might be exposed to radiation while taking
action in response to the emergency;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
"environmental monitoring" means the measurement of
external dose rates due to radioactive substances in the environment
or of concentrations of radionuclides in environmental media;
"equivalent dose" (HT) is the absorbed dose, in tissue or organ
T weighted for the type and quality of radiation R. It is given by
where
is the absorbed dose averaged over tissue or organ T, due to
radiation R,
is the radiation weighting factor.
When the radiation field is composed of types and energies
with different values of
, the total equivalent dose,
, is given
by
The values for
are specified in Section A of the First The
unit for equivalent dose is the sievert (Sv);
"exemption level" means a value established the Commission
and expressed in terms of activity concentration or total activity at or
below which a radiation source is not subject to notification or
authorisation;
"existing exposure situation" means an exposure situation that
already exists when a decision on its control has to be taken and
which does not call or no longer calls for urgent measures to be
taken;
"exposed worker" means a person, either self-employed or
working under an employer, who is subject to exposure at work
carried out within a practice regulated by these regulations and who
is liable to receive doses exceeding any one of the dose limits for
public exposure;
"exposure" means the act of exposing or condition of being
exposed to ionising radiation emitted outside the body (external
exposure) or within the body (internal exposure);
"extremities" means the hands, forearms, feet and ankles;
"graded approach" means a structured method by which the
BASIC SAFETY STANDARDS FOR IONISING RADIATION
stringency of control to be applied to a product or process is
commensurate with the risk;
"health detriment" means reduction in length and quality of life
occurring in a population following exposure, including those arising
from tissue reactions, cancer and severe genetic disorder;
"health screening" means a procedure using medical
radiological installations for early diagnosis in population groups at
risk;
"high-activity sealed source" means a sealed source for which
the activity of the contained radionuclide is equal to or exceeds the
relevant activity value laid down in the fourth column of the table of
the Second Schedule;
"individual detriment" means clinically observable deleterious
effects in individuals or their descendants, the appearance of which is
either immediate or delayed and, in the latter case, implies a
probability rather than a certainty of appearance;
"inspection" means an investigation by the Secretariat to verify
regulatory compliance;
"intake" means the total activity of a radionuclide entering the
body from the external environment;
"interventional radiology" means the use of X-ray imaging
techniques to facilitate the introduction and guidance of devices in the
body for diagnostic or treatment purposes;
"ionising radiation" means energy transferred in the form of
particles or electromagnetic waves of a wavelength of 100 nanometres
or less (a frequency of 3 × 10 15 hertz or more) capable of producing
ions directly or indirectly;
"licence" means permission granted in a document by the
Secretariat to carry out a practice in accordance with specific
conditions laid down in that document;
"medical exposure" means exposure incurred by patients or
asymptomatic individuals as part of their own medical or dental
diagnosis or treatment, and intended to benefit their health, as well as
exposure incurred by carers and comforters and by volunteers in
medical or biomedical research;
"medical physics expert" means an individual having the
knowledge, training and experience to act or give advice on matters
relating to radiation physics applied to medical exposure, whose
competence in this respect is recognised by the Commission;
"medical radiographer" shall have the meaning ascribed by
radiographer under the Health Care Professions Act;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
"medical radiological" means pertaining to radiodiagnostic
and radiotherapeutic procedures, and interventional radiology or
other medical uses of ionising radiation for planning, guiding and
verification purposes;
"medical radiological installation" means a facility where
medical radiological procedures are performed;
"medical radiological procedure" means any procedure giving
rise to medical exposure;
"members of the public" means individuals who may be
subject to public exposure;
"Minister" means the minister responsible for the Nuclear
Safety and Radiation Protection Act;
"National Radioactivity Monitoring Programme" means the
system by which the environment is monitored for ionising radiation
and the presence of radioactivity in environmental media, in
accordance with regulation 95, in order to assess the levels of
radiation and radioactivity in the environment to which the Maltese
population is exposed;.
"natural radiation source" means a source of ionising radiation
of natural, terrestrial or cosmic origin;
"non-medical imaging exposure" means any deliberate
exposure of humans for imaging purposes where the primary
intention of the exposure is not to bring a health benefit to the
individual being exposed;
"normal exposure" means exposure expected to occur under
the normal operating conditions of a facility or activity (including
maintenance, inspection, decommissioning), including minor
incidents that can be kept under control, i.e. during normal operation
and anticipated operational occurrences;
"notification" means the requirement of submitting a document
to the Secretariat to notify the intention to carry out a practice within
the scope of these regulations;
"occupational exposure" means exposure of workers,
apprentices and students, incurred in the course of their work;
"occupational health service" means a health professional or
body competent to perform medical surveillance of exposed workers
and whose capacity to act in that respect is recognised by the
Commission;
"orphan source" means a radioactive source which is neither
exempted nor under regulatory control, e.g. because it has never been
under regulatory control or because it has been abandoned, lost,
BASIC SAFETY STANDARDS FOR IONISING RADIATION
misplaced, stolen or otherwise transferred without proper
authorisation;
"outside worker" means any exposed worker who is not
employed by the undertaking responsible for the supervised and
controlled areas, but performs activities in those areas, including,
apprentices and students;
"planned exposure situation" means an exposure situation that
arises from the planned operation of a radiation source or from a
human activity which alters exposure pathways, so as to cause the
exposure or potential exposure of people or the environment. Planned
exposure situations may include both normal exposures and potential
exposures;
"potential exposure" means exposure that is not expected with
certainty but may result from an event or sequence of events of a
probabilistic nature, including equipment failures and operating errors;
"practical aspects of medical radiological procedures" means the
physical conduct of a medical exposure and any supporting aspects,
including handling and use of medical radiological equipment, the
assessment of technical and physical parameters (including radiation
doses), calibration and maintenance of equipment, preparation and
administration of radio-pharmaceuticals, and image processing;
"practice" means a human activity that can increase the
exposure of individuals to radiation from a radiation source and is
managed as a planned exposure situation;
"practitioner" means a medical doctor, dentist or other health
professional who is entitled to take clinical responsibility and is
approved by an undertaking in accordance with regulation 67;
"processing" means chemical or physical operations on
radioactive material including the mining, conversion, enrichment of
fissile or fertile nuclear material and the reprocessing of spent fuel;
"protective measures" means measures, other than remedial
measures, for the purpose of avoiding or reducing doses that might
otherwise be received in an emergency exposure situation or an
existing exposure situation;
"public exposure" means exposure of individuals, excluding any
occupational or medical exposure;
"quality assurance" means all those planned and systematic
actions necessary to provide adequate assurance that a structure,
system, component or procedure will perform satisfactorily in
compliance with agreed standards. Quality control is a part of quality
assurance;
"quality control" means the set of operations (programming,
BASIC SAFETY STANDARDS FOR IONISING RADIATION
coordinating, implementing) intended to maintain or to improve
quality. It includes monitoring, evaluation and maintenance at
required levels of all characteristics of performance of equipment that
can be defined, measured, and controlled;
"radiation generator" means a device capable of generating
ionising radiation, such as X-rays, neutrons, electrons or other
charged particles;
"radiation protection" means protection of people from the
harmful effects of exposure to ionising radiation, and the means for
achieving of this protection;
"radiation protection expert" means an individual having the
knowledge, training and experience needed to give radiation
protection advice in order to ensure the effective protection of
individuals, and whose competence in this respect is recognised by
the Commission;
"radiation protection officer" means a individual designated by
an undertaking, who is technically competent in radiation protection
matters relevant for a given type of practice to supervise or perform
the implementation of the radiation protection arrangements given in
an undertaking’s radiation protection programme;
"radiation protection programme" means the systemic
arrangements that are aimed at providing adequate consideration of
radiation protection;
"radiation source" means an entity that may cause exposure,
such as by emitting ionising radiation or by releasing radioactive
material;
"radioactive material"
means
material
incorporating
radioactive substances;
"radioactive source" means a radiation source incorporating
radioactive material for the purpose of utilising its radioactivity;
"radioactive substance" means any substance that contains one
or more radionuclides the activity or activity concentration of which
cannot be disregarded from a radiation protection point of view;
"radioactive waste" means radioactive material in gaseous,
liquid or solid form for which no further use is foreseen or material
that the Commission requires to be regulated as radioactive waste;
"radiodiagnostic" means pertaining to in-vivo diagnostic
nuclear medicine, medical diagnostic radiology using ionising
radiation, and dental radiology;
"radiotherapeutic" means pertaining to radiotherapy, including
nuclear medicine for therapeutic purposes;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
"radon" means the radionuclide Rn-222 and its progeny, as
appropriate;
"exposure to radon" means exposure to radon progeny;
"reference level" means in an emergency exposure situation or
in an existing exposure situation, the level of effective dose or
equivalent dose or activity concentration above which it is judged
inappropriate to allow exposures to occur as a result of that exposure
situation, even though it is not a limit that may not be exceeded;
"referrer" means a medical doctor, dentist or other health
professional who is authorised, in accordance with the undertakings
procedures, to refer individuals for medical radiological procedures to
a practitioner;
"registration" means permission granted in a document by the
Secretariat, through a simplified procedure, to carry out a practice in
accordance with conditions laid by the Commission for this type or
class of practice;
"regulatory control" means any form of control or regulation
applied to human activities for the enforcement of radiation protection
requirements;
"remedial measures" means the removal of a radiation source or
the reduction of its magnitude (in terms of activity or amount) or the
interruption of exposure pathways or the reduction of their impact for
the purposes of avoiding or reducing doses that might otherwise be
received in an existing exposure situation;
"representative person" means an individual receiving a dose
that is representative of the more highly exposed individuals in the
population, excluding those individuals having extreme or rare habits;
"safety assessment" means an assessment of all aspects of a
practice that are relevant to radiation protection; for an authorised
facility, this includes siting, design and operation of the facility in
accordance with regulation 101;
"safety culture" means the assembly of characteristics and
attitudes in organizations and individuals, which establishes that as an
overriding priority, protection and safety issues receive the attention
warranted by their significance.
Safety culture includes
(a)
individual and collective commitment to safety on
the part of the leadership, the management and personnel at all
levels;
(b)
accountability of organizations and of individuals
at all levels for safety;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(c)
measures to encourage a questioning and
learning attitude and to discourage complacency with regard to
safety;
"Secretariat" means the Secretariat of the Commission as
established by article 12 of the Act;
"security" means the prevention and detection of, and
response to, theft, sabotage, unauthorised access, illegal transfer or
other malicious acts involving nuclear or other radioactive material,
or their associated facilities;
"security culture" means characteristics and attitudes in
organisations and of individuals which establish that security issues
receive the attention warranted by their significance;
"sealed source" means a radioactive source in which the
radioactive material is permanently sealed in a capsule or
incorporated in a solid form with the objective of preventing, under
normal conditions of use, any dispersion of radioactive substances;
"sievert" (Sv) is the special name of the unit of equivalent or
effective dose. One sievert is equivalent to one joule per kilogram: 1
Sv =1 J kg -1 ;
"spacecraft" means a manned vehicle designed to operate at an
altitude of more than 100 km above sea level;
"storage" means the holding of radioactive material, including
spent fuel, a radioactive source or radioactive waste, in a facility with
the intention of retrieval;
"supervised area" means an area subject to supervision for the
purpose of protection against ionising radiation;
"source container" means an assembly of components intended
to guarantee the containment of a sealed source, where it is not an
integral part of the source but is meant for shielding the source during
its transport and handling;
"standard values and relationships" means values and
relationships recommended in chapters 4 and 5 of ICRP Publication
116 for the estimation of doses from external exposure and chapter 1
of ICRP Publication 119 for the estimation of doses from internal
exposure, including updates approved by the Commission. The
Commission may approve the use of specific methods in specified
cases relating to the physico-chemical properties of the radionuclide
or other features of the exposure situation or of the exposed
individual;
"thoron" means the radionuclide Rn-220 and its progeny, as
appropriate;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
"technical service provider" means service providers in safety,
providing either consultancy and maintenance services or calibration
and testing services;
"undertaking" means a natural or legal person who has legal
responsibility under national law for carrying out a practice, or for a
radiation source (including cases where the owner or holder of a
radiation source does not conduct related human activities);
"unintended exposure" means medical exposure that is
significantly different from the medical exposure intended for a given
purpose.
Part III
SYSTEM OF RADIATION PROTECTION
Amended by
L.N. 184 of 2020.
(Regulation 23)
LIST OF JUSTIFIABLE PRACTICES
INVOLVING IONIZING RADIATION
Pursuant to regulation 23 the following classes and types of practice resulting in
exposure to ionising radiation that are deemed justified.
This list may be updated by the Commission, the updated list will be made
publicly available by the Commission
1. Medical Exposures
(i)
Diagnosis
Use of ionising radiation in radiography, fluoroscopy, computed tomography, in-
vivo nuclear and in-vitro nuclear medicine.
(ii)
Therapy
Use of ionising radiation in interventional radiology, in-vivo nuclear medicines,
external beam radiotherapy, brachytherapy, radiography (for planning purposes)
fluoroscopy (for planning purposes), computed tomography.
(iii)
Health screening
Use of ionising radiation in radiography and nuclear medicine.
2. Non-medical imaging exposure of humans
(i)
Practices using medical radiological equipment
(a)
Radiological health assessment for employment purposes;
(b)
Radiological health assessment for immigration purposes;
(c)
Radiological health assessment for insurance purposes;
(d) Radiological evaluation of the physical development of children and
adolescents with a view to a career in sports, dancing, etc.;
(e)
Radiological age assessment;
(f)
Use of ionising radiation for the identification of concealed objects within
the human body.
(ii)
Practices not using medical radiological equipment
(a) Use of ionising radiation for detection of concealed humans as part of
cargo screening;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(b)
Practices involving the use of ionising radiation for legal or security
purposes.
(c) Use of ionising radiation for detection of concealed objects on or attached to
the human body.
3. Industrial
(i)
Production of radioactive products
Manufacture of radioisotopes using accelerators
(ii)
Non-destructive testing
Use of radioactive sources, substances and radiation generators for radiography
(iii)
Substance measurement and process control
Use of sealed sources and x-ray generators for thickness gauging, density gauging,
moisture Gauging, level gauging, flow measurement, borehole and well logging, control
of pipeline crawlers
(iv)
Detection and analysis
(a)
Use of sealed sources and x-ray generators for analysis
(b)
Use of beta sources for gas chromatography detectors
(v)
Elimination of static electricity
Use of radioactive sources to eliminate static electricity
(vi)
Illumination
(a) Use and repair of gaseous tritium light sources for illumination, in safety
signs and equipment, sighting and location markers, watches and instruments.
(b) Use of radioluminous paint (tritium and promethium -1 47) for the luminising
of timepieces and the repair of radioluminised timepieces.
(vii) Security screening
Use of x-rays, gamma rays to examine packages, baggage, containers or vehicles.
4. Other Practices
(i)
Equipment producing ionising radiation incidentally
Use of electron beam welders, electron microscopes, radar, thermionic valves,
cathode ray tubes, ion implantation machines and high voltage switchgear.
(ii)
Radioactive tracers
Use of radioactive tracers for medical or biological techniques.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(iii)
Medical and biomedical research
Use of ionising radiation in radiography, fluoroscopy, interventional
radiography, computed tomography, in-vivo nuclear medicine, invitro nuclear
medicine, teletherapy, brachytherapy and neutron analysis
(iv)
Diagnosis – veterinary
Use of ionising radiation in radiography
(v)
Transport of radioactive material
(vi)
Safety devices
(vi)
Import or export of equipment that can produce ionising radiation
Use of ionising radiation in smoke and fire detectors and other safety instruments
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
The regulatory control regime is based on the
principles of justification, optimisation and dose limitation as follows
(a)
Justification: Decisions introducing a practice
shall be justified in the sense that such decisions shall be taken
with the intent to ensure that the individual or societal benefit
resulting from the practice outweighs the health detriment that it
may cause. Decisions introducing or altering an exposure
pathway for existing and emergency exposure situations shall be
justified in the sense that they should do more good than harm.
(b)
Optimisation: Radiation protection of individuals
subject to public or occupational exposure shall be optimised
with the aim of keeping the magnitude of individual doses, the
likelihood of exposure and the number of individuals exposed as
low as reasonably achievable taking into account the current
state of technical knowledge and economic and societal factors.
The optimisation of the protection of individuals subject to
medical exposure shall apply to the magnitude of individual
doses and be consistent with the medical purpose of the
exposure, as described in regulation 66. This principle shall be
applied not only in terms of effective dose but also, where
appropriate, in terms of equivalent doses, as a precautionary
measure to allow for uncertainties as to health detriment below
the threshold for tissue reactions.
(c)
Dose limitation: In planned exposure situations,
the sum of doses to an individual shall not exceed the dose
limits laid down for occupational exposure or public exposure.
Dose limits shall not apply to medical exposures.
(2) The regulatory control regime shall make use of the
graded approach.
(3)
The prime responsibility for the safety and security of
BASIC SAFETY STANDARDS FOR IONISING RADIATION
ionising radiation sources rests with the undertaking
Provided that the prime responsibility for safety and
security rests with the licence holder. That responsibility cannot be
delegated and includes responsibility for the activities of contractors
and sub-contractors whose activities might affect safety and security.
(Regulation 33)
LIST OF INDUSTRIAL SECTORS INVOLVING NATURALLY-OCCURRING
RADIOACTIVE MATERIAL
Extraction of rare earths from monazite
Production of thorium compounds and manufacture of thorium-containing products
Processing of niobium/tantalum ore
Oil and gas production
Geothermal energy production
TiO 2 pigment production
Thermal phosphorus production
Zircon and zirconium industry
Production of phosphate fertilisers
Cement production, maintenance of clinker ovens
Coal-fired power plants, maintenance of boilers
Phosphoric acid production
Primary iron production
Tin/lead/copper smelting
Ground water filtration facilities
Mining of ores other than uranium ore
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Dose constraints for the purpose of prospective
optimisation of protection shall be
(1) (a)
for occupational exposure, the dose constraint
shall be established as an operational tool for optimisation by the
undertaking and shall be one third of any dose limits specified in
regulations 9,10 and 11. In the case of outside workers the dose
constraint shall be established in cooperation between the employer
of the outside worker and the undertaking;
(b)
for public exposure, the dose constraint shall be
0.25mSv per year for the individual dose that members of the
public receive from the planned operation of a specified
radiation source;
(c)
for medical exposure, dose constraints shall apply
only with regard to the protection of carers and comforters,
which shall be 1.5mSv per five years pursuant to regulation
66(6a) and volunteers participating in medical or biomedical
research pursuant to regulation 66(4c).
(2) In the event that any dose constraint is exceeded the
undertaking is to immediately inform the Commission and then
produce a report detailing the event and doses received.
(Regulation 35 and 39)
EXEMPTION AND CLEARANCE CRITERIA
1. Exemption
Practices may be exempted from notification either directly, on the basis of
compliance with exemption levels (activity values (in Bq) or activity concentration
values (in kBq kg -1 )) laid down in section 2, or on the basis of higher values that, for
specific applications, are established by the Commission, satisfying the general
exemption and clearance criteria set out in section 3. Practices subject to notification
may be exempted from authorisation by law or general administrative act, or through an
ad-hoc regulatory decision, on the basis of the information provided in conjunction
with the notification of the practice and in line with general exemption criteria set out in
section 3.
2. Exemption and clearance levels
(a) The total activity values (in Bq) for exemption apply to the total activity
involved in a practice and are laid down in column 3 of Table B for artificial
radionuclides and for some naturally-occurring radionuclides used in consumer
products. For other practices involving naturally-occurring radionuclides, such values
are, in general, not applicable
(b) The exempt activity concentration values (in kBq kg -1 ) for the materials
involved in the practice are laid down in Table A, Part 1, for artificial radionuclides,
and in Table A, Part 2, for naturally-occurring radionuclides. The values in Table A,
Part 1, are given for individual radionuclides, where applicable, including short-lived
radionuclides in equilibrium with the parent nuclide, as indicated. The values in Table
A, Part 2, apply to all radionuclides in the decay chain of U-238 or Th-232, but for
segments of the decay chain, which are not in equilibrium with the parent radionuclide,
higher values may be applied
(c) The concentration values in Table A, Part 1, or in Table A, Part 2, also
apply to the clearance of solid materials for reuse, recycling, conventional disposal or
incineration. Higher values may be defined for specific materials or specific pathways,
taking Community guidance into account, including, where appropriate, additional
requirements, in terms of surface activity or monitoring requirements
(d) For mixtures of artificial radionuclides, the weighted sum of nuclide-
specific activities or concentrations (for various radionuclides contained in the same
matrix) divided by the corresponding exemption value shall be less than unity. Where
appropriate, this condition can be verified on the basis of best estimates of the
composition of the radionuclide mix. The values in Table A, Part 2, apply individually
BASIC SAFETY STANDARDS FOR IONISING RADIATION
to each parent nuclide. Some elements in the decay chain, e.g. Po-210 or Pb-210, may
warrant the use of higher values taking Community guidance into account.
(e) The values in Table A, Part 2, may not be used to exempt the incorporation
into building materials of residues from industries processing naturally-occurring
radioactive material. For this purpose, compliance with the provisions of regulation 98
shall be verified. The values laid down in Table B, column 3, apply to the total inventory
of radioactive substances held by a person or undertaking as part of a specific practice at
any point in time. However, the Commission may apply these values to smaller entities
or packages, for instance to exempt the transport or storage of exempted consumer
products, if the general exemption criteria in section 3 are satisfied.
(3)
General exemption and clearance criteria
(a) The general criteria for the exemption of practices from notification or
authorisation or for the clearance of materials from authorised practices are as follows
(i)
the radiological risks to individuals caused by the practice are sufficiently
low, as to be of no regulatory concern; and
(ii)
the type of practice has been determined to be justified; and
(iii)
the practice is inherently safe
(b) Practices involving small amounts of radioactive substances or low activity
concentrations, comparable to the exemption values laid down in Table A or Table B are
deemed to fulfil criterion (iii).
(c) Practices involving amounts of radioactive substances or activity
concentrations below the exemption values laid down in Table A, Part 1, or Table B, are
deemed to comply with criterion (i) without further consideration. This is also the case
for the values in Table A, Part 2, with the exception of the recycling of residues in
building materials or the case of specific exposure pathways, for instance, drinking water
(d) In the case of moderate amounts of material, as specified by Commission
for specific types of practice, the activity concentration values laid down in Table B,
column 2, may be used instead of the values laid down in Table A, Part 1, for the purpose
of exemption from authorisation.
(e) For the purpose of exemption from notification or for the purpose of
clearance, where amounts of radioactive substances or activity concentrations do not
comply with the values laid down in Table A or Table B, an assessment shall be made in
the light of the general criteria (i) to (iii) above. For compliance with the general
criterion (i), it shall be demonstrated that workers should not be classified as exposed
workers, and the following criteria for the exposure of members of the public are met in
all feasible circumstances
-
For artificial radionuclides
The effective dose expected to be incurred by a member of the public due to the
exempted practice is of the order of 10 μSv or less in a year.
-
For naturally-occurring radionuclides
BASIC SAFETY STANDARDS FOR IONISING RADIATION
The dose increment, allowing for the prevailing background radiation from
natural radiation sources, liable to be incurred by an individual due to the exempted
practice is of the order of 1 mSv or less in a year. The assessment of doses to members
of the public shall take into account not only pathways of exposure through airborne or
liquid effluent, but also pathways resulting from the disposal or recycling of solid
residues. The Commission may specify dose criteria lower than 1 mSv per year for
specific types of practices or specific pathways of exposure.
For the purpose of exemption from authorisation, less restrictive dose criteria
may be applied.
TABLE A
Activity concentration values for exemption or clearance of materials
which can be applied by default to any amount and to any type of solid material
TABLE A
PART 1
Artificial radionuclides
Activity
Activity
Activity
concentration
concentration
concentration
Radionuclide
Radionuclide
Radionuclide
(kBq kg -1 )
(kBq kg -1 )
(kBq kg -1 )
H-3
Co-55
a
Sr-91 ( )
Be-7
Co-56
0.1
Sr-92
C-14
Co-57
Y-90
1 000
F-18
Co-58
Y-91
Na-22
0.1
Co-58m
10 000
Y-91m
Na-24
Co-60
0.1
Y-92
Si-31
1 000
Co-60m
1 000
Y-93
P-32
1 000
Co-61
Zr-93
P-33
1 000
Co-62m
Zr-95 ( a )
S-35
Ni-59
a
Zr-97 ( )
Cl-36
Ni-63
Nb-93m
Cl-38
Ni-65
Nb-94
0.1
K-42
Cu-64
Nb-95
K-43
Zn-65
0.1
Nb-97 ( a )
Ca-45
Zn-69
1 000
Nb-98
Ca-47
Zn-69m ( a )
Mo-90
Sc-46
0.1
Ga-72
Mo-93
Sc-47
Ge-71
10 000
a
Mo-99 ( )
Sc-48
As-73
1 000
Mo-101 ( a
)
V-48
As-74
Tc-96
Cr-51
As-76
Tc-96m
1 000
Mn-51
As-77
1 000
Tc-97
Mn-52
Se-75
Tc-97m
Mn-52m
Br-82
Tc-99
Mn-53
Rb-86
Tc-99m
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Activity
Activity
Activity
concentration
concentration
concentration
Radionuclide
Radionuclide
Radionuclide
(kBq kg -1 )
(kBq kg -1 )
(kBq kg -1 )
Mn-54
0.1
Sr-85
Ru-97
Mn-56
Sr-85m
Ru-103 ( a )
a )
Sr-87m
Ru-105 ( a )
Fe-52 (
0.1
Fe-55
1 000
Sr-89
1 000
Ru-106 ( a )
Fe-59
Sr-90 ( a )
Rh-103m
10 000
Rh-105
I-123
Pm-147
1 000
1 000
I-125
Pm-149
1 000
a )
Pd-103 (
I-126
Sm-151
1 000
Pd-109 ( a )
Ag-105
I-129
0.01
Sm-153
0.1
I-130
Eu-152
0 1
Ag-110m ( a )
Ag-111
I-131
Eu-152m
Cd-109 ( a )
I-132
Eu-154
0 1
a
I-133
Eu-155
Cd-115 ( )
Cd-115m ( a )
I-134
Gd-153
In-111
I-135
Gd-159
In-113m
Cs-129
Tb-160
In-114m ( a )
Cs-131
1 000
Dy-165
1 000
In-115m
Cs-132
Dy-166
Sn-113 ( a )
Cs-134
0,1
Ho-166
Sn-125
Cs-134m
1 000
Er-169
1 000
Sb-122
Cs-135
Er-171
Sb-124
Cs-136
Tm-170
Sb-125 ( a )
0.1
Cs-137 ( a )
0.1
Tm-171
1 000
Te-123m
Cs-138
Yb-175
Te-125m
1 000
Ba-131
Lu-177
Te-127
1 000
Ba-140
Hf-181
La-140
Ta-182
0 1
Te-127m ( a )
Te-129
Ce-139
W-181
Te-129m ( a
Ce-141
W-185
1 000
)
Te-131
Ce-143
W-187
Ce-144
Re-186
1 000
a
Te-131m ( )
a
Pr-142
Re-188
Te-132 ( )
Te-133
Pr-143
1 000
Os-185
Te-133m
Nd-147
Os-191
Te-134
Nd-149
Os-191m
1 000
Os-193
U-230
Cm-246
0.1
Ir-190
0.1
U-231 ( a )
Cm-247 ( a )
Ir-192
U-232 ( a )
0.1
Cm-248
0.1
Ir-194
U-233
Bk-249
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Activity
Activity
Activity
concentration
concentration
concentration
Radionuclide
Radionuclide
Radionuclide
(kBq kg -1 )
(kBq kg -1 )
(kBq kg -1 )
Pt-191
U-236
Cf-246
1 000
Pt-193m
1 000
U-237
Cf-248
Pt-197
1 000
U-239
Cf-249
0.1
Pt-197m
Cf-250
U-240 ( a )
Au-198
Cf-251
0.1
Np-237 ( a )
Au-199
Np-239
Cf-252
Hg-197
Np-240
Cf-253
Hg-197m
Pu-234
Cf-254
Hg-203
Pu-235
Es-253
Tl-200
Pu-236
Es-254 ( a )
0.1
Tl-201
Pu-237
Es-254m ( a )
Tl-202
Pu-238
0.1
Fm-254
10 000
Tl-204
Pu-239
0.1
Fm-255
Pb-203
Pu-240
0.1
Bi-206
Pu-241
Bi-207
0.1
Pu-242
0,1
Po-203
Pu-243
1 000
Po-205
Pu-244 ( a )
0.1
Po-207
Am-241
0.1
At-211
1 000
Am-242
1 000
Ra-225
0.1
Am-242 ( a )
Ra-227
Am-243 ( a )
0.1
Th-226
1 000
Cm-242
Th-229
0.1
Cm-243
Pa-230
Cm-244
Pa-233
Cm-245
0.1
( a ) Parent radionuclides, and their progeny whose dose contributions are taken into account
in the dose calculation (thus requiring only the exemption level of the parent radionuclide
to be considered), are listed in the following table.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Parent
Parent
Parent
Progeny
Progeny
Progeny
Radionuclide
Radionuclide
Radionuclide
Fe-52
Mn-52m
Pd-103
Rh-103m
Te132
I-132
Zn-69m
Zn-69
Pd-109
Ag-109m
Cs-137
Ba-137m
Sr-90
Y-90
Ag-110m
Ag-110
Ce-144
Pr-144, Pr-144m
Pr-144m
Sr-91
Y-91m
Cd-109
Ag-109m
U-232
Th-228, Ra-224,
Rn-220, Po-216,
Pb-212, Bi-212,
Tl-208
Zr-95
Nb-95
Cd-115
In-115m
U-240
Np-240m,
Np-240
Zr-97
Nb-97m,
Cd-115m
In-115m
Np237
Pa-233
Nb-97
Nb-97
Nb-97m
In-114m
In-114
Pu-244
U-240, Np-
240m,
Np-240
Mo-99
Tc-99m
Sn-113
In-113m
Am-242m
Np-238
Mo-101
Tc-101
Sb-125
Te-125m
Am-243
Np-239
Ru-103
Rh-103m
Te-127m
Te-127
Cm-247
Pu-243
Ru-105
Rh-105m
Te-129m
Te-129
Es-254
Bk-250
Ru-106
Rh-106
Te-131m
Te-131
Es-254m
Fm-254
For radionuclides not listed in Table A, Part 1 the Commission shall assign
appropriate values for the quantities and concentrations of activity per unit mass
where the need arises. Values thus assigned shall be complementary to those in
Table A, Part 1
TABLE A PART 2
Naturally occurring radionuclides
Values for exemption or clearance for naturally occurring radionuclides in solid materials
in secular equilibrium with their progeny
Natural radionuclides from the U-238 series
1 kBq kg -1
Natural radionuclides from the Th-232 series
1 kBq kg -1
K-40
10 kBq kg -1
BASIC SAFETY STANDARDS FOR IONISING RADIATION
TABLE B
Total activity values for exemption (column 3) and exemption values for the activity
concentration in moderate amounts of any type of material (column 2)
Activity
Activity
Activity
Activity
concentration
concentration
Radionuclide
Radionuclide
(Bq)
(Bq)
-1
-1
(kBq kg )
(kBq kg )
H-3
1x10 6
1x10 9
Mn-56
1x10 1
1x10 5
Be-7
1x10 3
1x10 7
Fe-52
1x10 1
1x10 6
C-14
1x10 4
1x10 7
Fe-55
1x10 4
1x10 6
O-15
1x10 2
1x10 9
Fe-59
1x10 1
1x10 6
1x10 1
1x10 6
1x10 1
1x10 6
F-18
Co-55
Na-22
1x10 1
1x10 6
Co-56
1x10 1
1x10 5
Na-24
1x10 1
1x10 5
Co-57
1x10 2
1x10 6
Si-31
1x10 3
1x10 6
Co-58
1x10 1
1x10 6
P-32
1x10 3
1x10 5
Co-58m
1x10 4
1x10 7
P-33
Co-60
1x10 5
1x10 8
1x10 1
1x10 5
S-35
1x10 5
1x10 8
Co-60m
1x10 3
1x10 6
1x10 4
1x10 6
1x10 2
1x10 6
Cl-36
Co-61
Cl-38
1x10 1
1x10 5
Co-62m
1x10 1
1x10 5
Ar-37
Ni-59
1x10 6
1x10 8
1x10 4
1x10 8
Ar-41
1x10 2
1x10 9
Ni-63
1x10 5
1x10 8
K-40 ( 1 )
1x10 2
1x10 6
Ni-65
1x10 1
1x10 6
K-42
1x10 2
1x10 6
Cu-64
1x10 2
1x10 6
K-43
1x10 1
1x10 6
Zn-65
1x10 1
1x10 6
1x10 4
1x10 7
1x10 4
1x10 6
Ca-45
Zn-69
Ca-47
1x10 1
1x10 6
Zn-69m
1x10 2
1x10 6
Sc-46
1x10 1
1x10 6
Ga-72
1x10 1
1x10 5
Sc-47
1x10 2
1x10 6
Ge-71
1x10 4
1x10 8
Sc-48
1x10 1
1x10 5
As-73
1x10 3
1x10 7
V-48
1x10 1
1x10 5
As-74
1x10 1
1x10 6
1x10 3
1x10 7
1x10 2
1x10 5
Cr-51
As-76
Mn-51
1x10 1
1x10 5
As-77
1x10 3
1x10 6
Mn-52
1x10 1
1x10 5
Se-75
1x10 2
1x10 6
Mn-52m
1x10 1
1x10 5
Br-82
1x10 1
1x10 6
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Activity
Activity
Activity
Activity
concentration
concentration
Radionuclide
Radionuclide
(Bq)
(Bq)
-1
-1
(kBq kg )
(kBq kg )
Mn-53
Kr-74
1x10 2
1x10 9
1x10
1x10
Mn-54
1x10 1
1x10 6
Kr-76
1x10 2
1x10 9
Kr-77
1x10 2
1x10 9
Mo-93
1x10 3
1x10 8
Kr-79
1x10 3
1x10 5
Mo-99
1x10 2
1x10 6
Kr-81
1x10 4
1x10 7
Mo-101
1x10 1
1x10 6
1x10 5
1x10 12
1x10 1
1x10 6
Kr-83m
Tc-96
Kr-85
1x10 5
1x10 4
Tc-96m
1x10 3
1x10 7
Kr-85m
1x10 3
1x10 10
Tc-97
1x10 3
1x10 8
Kr-87
1x10 2
1x10 9
Tc-97m
1x10 3
1x10 7
Kr-88
Tc-99
1x10 2
1x10 9
1x10 4
1x10 7
Rb-86
1x10 2
1x10 5
Tc-99m
1x10 2
1x10 7
1x10 2
1x10 6
1x10 2
1x10 7
Sr-85
Ru-97
Sr-85m
1x10 2
1x10 7
Ru-103
1x10 2
1x10 6
Sr-87m
Ru-105
1x10 2
1x10 6
1x10 1
1x10 6
Sr-89
1x10 3
1x10 6
Ru-106( b )
1x10 2
1x10 5
Sr-90 ( b )
1x10 2
1x10 4
Rh-103m
1x10 4
1x10 8
Sr-91
1x10 1
1x10 5
Rh-105
1x10 2
1x10 7
Sr-92
1x10 1
1x10 6
Pd-103
1x10 3
1x10 8
1x10 3
1x10 5
1x10 3
1x10 6
Y-90
Pd-109
Y-91
1x10 3
1x10 6
Ag-105
1x10 2
1x10 6
Y-91m
1x10 2
1x10 6
Ag-108m
1x10 1
1x10 6
Y-92
1x10 2
1x10 5
Ag-110m
1x10 1
1x10 6
Y-93
1x10 2
1x10 5
Ag-111
1x10 3
1x10 6
Zr-93( b )
1x10 3
1x10 7
Cd-109
1x10 4
1x10 6
1x10 1
1x10 6
1x10 2
1x10 6
Zr-95
Cd-115
Zr-97( b )
1x10 1
1x10 5
Cd-115m
1x10 3
1x10 6
Nb-93m
1x10 4
1x10 7
In-111
1x10 2
1x10 6
Nb-94
1x10 1
1x10 6
In-113m
1x10 2
1x10 6
Nb-95
1x10 1
1x10 6
In-114m
1x10 2
1x10 6
Nb-97
In-115m
1x10 1
1x10 6
1x10 2
1x10 6
Nb-98
1x10 1
1x10 5
Sn-113
1x10 3
1x10 7
1x10 1
1x10 6
1x10 2
1x10 5
Mo-90
Sn-125
Sb-122
1x10 2
1x10 4
Cs-132
1x10 1
1x10 5
Sb-124
Cs-134m
1x10 1
1x10 6
1x10 3
1x10 5
Sb-125
1x10 2
1x10 6
Cs-134
1x10 1
1x10 4
Te-123m
1x10 2
1x10 7
Cs-135
1x10 4
1x10 7
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Activity
Activity
Activity
Activity
concentration
concentration
Radionuclide
Radionuclide
(Bq)
(Bq)
-1
-1
(kBq kg )
(kBq kg )
Te-125m
Cs-136
1x10 1
1x10 5
1x10
1x10
Te-127
1x10 3
1x10 6
Cs-137( b )
1x10 1
1x10 4
Te-127m
1x10 3
1x10 7
Cs-138
1x10 1
1x10 4
Te-129
1x10 2
1x10 6
Ba-131
1x10 2
1x10 6
Te-129m
1x10 3
1x10 6
Ba-140( b )
1x10 1
1x10 5
1x10 2
1x10 5
1x10 1
1x10 5
Te-131
La-140
Te-131m
1x10 1
1x10 6
Ce-139
1x10 2
1x10 6
Te-132
1x10 2
1x10 7
Ce-141
1x10 2
1x10 7
Te-133
1x10 1
1x10 5
Ce-143
1x10 2
1x10 6
Te-133m
1x10 1
1x10 5
Ce-144( b )
1x10 2
1x10 5
Te-134
1x10 1
1x10 6
Pr-142
1x10 2
1x10 5
1x10 2
1x10 7
1x10 4
1x10 6
I-123
Pr-143
I-125
1x10 3
1x10 6
Nd-147
1x10 2
1x10 6
I-126
Nd-149
1x10 2
1x10 6
1x10 2
1x10 6
I-129
1x10 2
1x10 5
Pm-147
1x10 4
1x10 7
I-130
1x10 1
1x10 6
Pm-149
1x10 3
1x10 6
I-131
1x10 2
1x10 6
Sm-151
1x10 4
1x10 8
I-132
1x10 1
1x10 5
Sm-153
1x10 2
1x10 6
1x10 1
1x10 6
1x10 1
1x10 6
I-133
Eu-152
I-134
1x10 1
1x10 5
Eu-152m
1x10 2
1x10 6
I-135
1x10 1
1x10 6
Eu-154
1x10 1
1x10 6
Xe-131m
1x10 4
1x10 4
Eu-155
1x10 2
1x10 7
Xe-133
1x10 3
1x10 4
Gd-153
1x10 2
1x10 7
Xe-135
1x10 3
1x10 10
Gd-159
1x10 3
1x10 6
1x10 2
1x10 5
1x10 1
1x10 6
Cs-129
Tb-160
Cs-131
1x10 3
1x10 6
Dy-165
1x10 3
1x10 6
Dy-166
1x10 3
1x10 6
Hg-203
1x10 2
1x10 5
Ho-166
1x10 3
1x10 5
Tl-200
1x10 1
1x10 6
Er-169
1x10 4
1x10 7
Tl-201
1x10 2
1x10 6
Er-171
Tl-202
1x10 2
1x10 6
1x10 2
1x10 6
Tm-170
1x10 3
1x10 6
Tl-204
1x10 4
1x10 4
1x10 4
1x10 8
1x10 2
1x10 6
Tm-171
Pb-203
Yb-175
1x10 3
1x10 7
Pb-210( b )
1x10 1
1x10 4
Lu-177
1x10 3
1x10 7
Pb-212( b )
1x10 1
1x10 5
Hf-181
1x10 1
1x10 6
Bi-206
1x10 1
1x10 5
Ta-182
1x10 1
1x10 4
Bi-207
1x10 1
1x10 6
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Activity
Activity
Activity
Activity
concentration
concentration
Radionuclide
Radionuclide
(Bq)
(Bq)
-1
-1
(kBq kg )
(kBq kg )
W-181
Bi-210
1x10 3
1x10 6
1x10
1x10
W-185
1x10 4
1x10 7
Bi-212( b )
1x10 1
1x10 5
W-187
1x10 2
1x10 6
Po-203
1x10 1
1x10 6
Re-186
1x10 3
1x10 6
Po-205
1x10 1
1x10 6
Re-188
1x10 2
1x10 5
Po-207
1x10 1
1x10 6
1x10 1
1x10 6
1x10 1
1x10 4
Os-185
Po-210
Os-191
1x10 2
1x10 7
At-211
1x10 3
1x10 7
Os-191m
1x10 3
1x10 7
Rn-220( b )
1x10 4
1x10 7
Os-193
1x10 2
1x10 6
Rn-222( b )
1x10 1
1x10 8
Ir-190
1x10 1
1x10 6
Ra-223( b )
1x10 2
1x10 5
Ir-192
1x10 1
1x10 4
Ra-224( b )
1x10 1
1x10 5
1x10 2
1x10 5
1x10 2
1x10 5
Ir-194
Ra-225
Pt-191
1x10 2
1x10 6
Ra-226( b )
1x10 1
1x10 4
Pt-193m
Ra-227
1x10 3
1x10 7
1x10 2
1x10 6
Pt-197
1x10 3
1x10 6
Ra-228( b )
1x10 1
1x10 5
Pt-197m
1x10 2
1x10 6
Ac-228
1x10 1
1x10 6
Au-198
1x10 2
1x10 6
Th-226( b )
1x10 3
1x10 7
Au-199
1x10 2
1x10 6
Th-227
1x10 1
1x10 4
1x10 2
1x10 7
Th-228( b )
1x10 0
1x10 4
Hg-197
Hg-197m
1x10 2
1x10 6
Th-229( b )
1x10 0
1x10 3
(b) http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/
?uri=OJ:L:2014:013:FULL&from=EN - ntr3-L_2014013EN.01004501-E0003
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
Without prejudice to reference levels set for
equivalent doses, that may be specified by the Commission, the
reference levels for any persons expressed in effective doses shall be
1mSv per year for existing exposure situations and 20mSv (acute or
annual) for emergency exposure situations.
Provided that optimization of protection shall give
priority to exposures above these reference levels and shall continue
to be implemented below the reference level.
Provided that in specific situations the Commission may
lower the reference levels taking into account optimisation and shall
give due consideration to
(a)
a reference level below 20mSv may be set in an
emergency exposure situation where appropriate protection
can be provided without causing a disproportionate detriment
from the corresponding countermeasures or an excessive cost;
(b)
a reference level below 1mSv per year may be
set, where appropriate, in an existing exposure situation for
BASIC SAFETY STANDARDS FOR IONISING RADIATION
specific source-related exposures or pathways of exposure
(2) For the transition from an emergency exposure situation
to an existing exposure situation, appropriate reference levels shall be
set, in particular upon the termination of long-term countermeasures.
(3) The reference levels set shall take account of the features
of prevailing situations as well as societal criteria, which may include
the following
(a)
for exposures below or equal to 1mSv per year,
general information on the level of exposure, without specific
consideration of individual exposures;
(b)
in the range up to or equal to 20mSv per year,
specific information to enable individuals to manage their own
exposure, if possible
(c)
in the range up to or equal to 100 mSv per year,
assessment of individual doses and specific information on
radiation risks and on available actions to reduce exposures.
(4) For existing exposure situations involving exposure to
radon, the reference levels shall be set in terms of radon activity
concentration in air of 300 Bqm -3 for members of the public and
workers.
(Regulation 98)
DEFINITION AND USE OF THE ACTIVITY CONCENTRATION INDEX FOR THE
GAMMA RADIATION EMITTED BY BUILDING MATERIALS
For the purposes of regulation 98(2),for identified types of building materials,
the activity concentrations of primordial radionuclides Ra-226, Th-232 (or its decay
product Ra-228) and K-40 shall be determined.
The activity concentration index I is given by the following formula
I = C Ra226 /300 Bq/kg + C Th232 /200 Bq/kg + C K40 /3000 Bq/kg
where C Ra226 , C Th232 and C K40 are the activity concentrations in Bq/kg of the
corresponding radionuclides in the building material.
The index relates to the gamma radiation dose, in excess of typical outdoor
exposure, in a building constructed from a specified building material. The index
applies to the building material, not to its constituents except when those constituents
are building materials themselves and are separately assessed as such. For application
of the index to such constituents, in particular residues from industries processing
naturally-occurring radioactive material recycled into building materials, an
appropriate partitioning factor needs to be applied. The activity concentration index
value of 1 can be used as a conservative screening tool for identifying materials that
may cause the reference level laid down in regulation 98(1) to be exceeded. The
calculation of dose needs to take into account other factors such as density, thickness of
the material as well as factors relating to the type of building and the intended use of the
material (bulk or superficial).
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1) Persons under 18 years of age may not be assigned to
any work which would result in them as being classed as an exposed
worker subject to regulation 11(2).
(2) No person under 16 years of age shall be allowed to be
subject to any form of occupational exposure.
(Regulation 38)
LIST OF INFORMATION FOR LICENCE APPLICATIONS
(a)
Responsibilities and organisational arrangements for protection and safety
(b)
Staff competences, including information and training
(c)
Design features of the facility and of radiation sources
(d)
Anticipated occupational and public exposures in normal operation
(e)
Safety assessment of the activities and the facility.
(f)
Emergency procedures.
(g) Maintenance, testing, inspection and servicing so as to ensure that the
radiation source and the facility continue to meet the design requirements, operational
limits and conditions of operation throughout their lifetime.
(h) Management of radioactive waste and arrangements for the disposal of such
waste, in accordance with applicable regulatory requirements
(i)
Management of disused sources.
(j)
Quality assurance programmes.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
The dose limits for occupational exposure apply to
the sum of annual occupational exposures of a worker from all
authorised practices, occupational exposure to radon in workplaces
requiring notification in accordance with regulation 64(3), and other
occupational exposure from existing exposure situations in accordance
with regulation 124(3). For emergency occupational exposure
regulation 63 shall apply.
(2) The limit on effective dose for occupational exposure
shall be 20mSv in any single year. In special circumstances or for
certain exposure situations where the Secretariat is satisfied that a dose
in excess of the annual limit is appropriate, the Secretariat may
authorise a higher effective dose of up to 50mSv in a single year,
provided that the average annual dose over any five (5) consecutive
years, including the years for which the limit has been exceeded, does
not exceed 20mSv.
(3) In addition to the limits on effective dose laid down in
sub-regulation (2), the following limits on equivalent dose shall apply
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(a)
the limit on the equivalent dose for the lens of
the eye shall be 20mSv in a single year or 100mSv in any five
consecutive years subject to a maximum dose of 50mSv in a
single year;
(b)
the limit on the equivalent dose for the skin shall
be 500mSv in a year, this limit shall apply to the dose averaged
over any area of 1 cm 2 , regardless of the area exposed;
(c)
the limit on the equivalent dose for the
extremities shall be 500mSv in a year.
(Regulation 52)
DATA SYSTEM FOR INDIVIDUAL RADIOLOGICAL MONITORING
(1)
Individual monitoring data to be kept by the undertaking/employer of
outside worker for exposed workers
(a)
Surname
(b)
First Name
(c)
Maltese ID number or other overseas unique personal ID
(d)
Sex
(e)
Date of Birth
(f)
Nationality
(g)
Categorisation of the worker in accordance with regulation 49
(h)
Particulars of any Medical surveillance required under the regulations
(i)
Results of individual monitoring of the exposed worker pursuant to regulations
50, 51, 61, 62, 63 and, if decided by the Commission pursuant to regulations
44(2), 64(3)
(j)
The starting date of individual monitoring and where available the end date
(k)
Data on the undertaking, including the name, address, Commission reference
number for undertaking.
(2)
Data to be sent in the form of an annual return to the Secretariat.
The Secretariat will specify the format in which the data is to be sent.
(a)
Name of the undertaking/employer of the outside worker
(b)
Report year
(c)
Dosimetry service provider and any local agents for dosimetry service provider
(d)
Surname
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(e)
First Name
(f)
Maltese ID number or other overseas unique personal ID
(g)
Categorisation of the worker in accordance with regulation 49
(h)
Results of individual monitoring of the exposed worker
(3)
Data on outside workers to be supplied to an undertaking.
(a)
Name of the employer of the outside worker
(b)
Name of the undertaking owning the controlled area
(c)
Start date of work in the undertaking’s controlled area
(d)
End date of work in the undertaking’s controlled area
(e)
Surname
(f)
First Name
(g)
Maltese ID number or other overseas unique personal ID
(h)
Nationality
(i)
Categorisation of the worker in accordance with regulation 49
(j)
Particulars of any Medical surveillance required under the regulations and if the
worker is classed fit, fit subject to conditions or unfit.
(k)
Any restrictions of working with ionizing radiation and if so specify them
(l)
Date of last periodic health review and the period of the validity of result
(m)
Results of individual monitoring of the exposed worker over the preceding 5 year
period.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
As soon as a pregnant worker informs the
undertaking or, in the case of an outside worker, the employer of the
outside worker, of the pregnancy, in accordance with regulation 3 of
Protection of Maternity at Work Places Regulations, the undertaking,
and the employer of the outside worker, shall ensure that the
employment conditions for the pregnant worker are such that the
protection of the unborn child is comparable with that provided for
members of the public and the equivalent dose to the unborn child is
as low as reasonably achievable and unlikely to exceed 1mSv during
at least the remainder of the pregnancy.
(2) As soon as workers inform the undertaking, or in case of
outside workers, the employer of the outside worker, that they are
breastfeeding an infant, they shall not be employed in work involving
a significant risk of intake of radionuclides or of bodily
contamination.
Amended by
L.N. 184 of 2020.
(Regulation 91 and 122)
EMERGENCY MANAGEMENT SYSTEMS
AND EMERGENCY RESPONSE PLANS
Elements to be included in an emergency management system
(1)
Assessment of potential emergency exposure situations and associated public
and emergency occupational exposures;
(2)
Clear allocation of the responsibilities of persons and organisations having a
role in preparedness and response arrangements;
(3)
Establishment of emergency response plans at appropriate levels and related to
a specific facility or human activity;
(4)
Reliable communications and efficient and effective arrangements for
cooperation and coordination at the installation and at appropriate national and
international levels;
(5)
Health protection of emergency workers;
(6)
Arrangements for the provision of prior information and training for emergency
workers and all other persons with duties or responsibilities in emergency
response, including regular exercises;
(7)
Arrangements for individual monitoring or assessment of individual doses of
emergency workers and the recording of doses;
(8)
Public information arrangements;
(9)
Involvement of stakeholders;
(10)
Transition from an emergency exposure situation to an existing exposure
situation including recovery and remediation.
Elements to be included in an emergency response plan
For emergency preparedness
(1)
Reference levels for public exposure, taking into account the criteria laid down
in regulation 7
(2)
Reference levels for emergency occupational exposure taking into account
regulation 63
(3)
Optimised protection strategies for members of the public who may be exposed,
for different postulated events and related scenarios;
(4)
Predefined generic criteria for particular protective measures;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(5)
Default triggers or operational criteria such as observables and indicators of on-
scene conditions;
(6)
Arrangements for prompt coordination between organisations having a role in
emergency preparedness and response and with all other Member States and with
third countries which may be involved or are likely to be affected;
(7)
Arrangements for the emergency response plan to be reviewed and revised to
take account of changes or lessons learned from exercises and events.
Arrangements shall be established in advance to revise these elements, as
appropriate during an emergency exposure situation, to accommodate the
prevailing conditions as these evolve throughout the response.
For emergency response
The response to an emergency exposure situation shall be undertaken through the
timely implementation of preparedness arrangements, including but not limited
to
(1)
Promptly implementing protective measures, if possible, before any exposure
occurs;
(2)
Assessing the effectiveness of strategies and implemented actions and adjusting
them as appropriate to the prevailing situation;
(3)
Comparing the doses against the applicable reference level, focusing on those
groups whose doses exceed the reference level;
(4)
Implementing further protection strategies, as necessary, based on prevailing
conditions and available information.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
The dose limits for apprentices aged 18 years or
over and students aged 18 years or over who, in the course of their
studies, are obliged to work with radiation sources, shall be the same
as the dose limits for occupational exposure laid down in regulation
9. (2) The limit on the effective dose for apprentices aged
between 16 and 18 years and for students aged between 16 and 18
years who, in the course of their studies, are obliged to work with
radiation sources, shall be 6mSv in a year.
(3) In addition to the limits on effective dose laid down in
sub-regulation (2), the following limits on equivalent dose shall
apply
(a)
the limit on the equivalent dose for the lens of
the eye shall be 15mSv in a year;
(b)
the limit on the equivalent dose for the skin shall
be 150mSv in a year, this limit shall apply to the dose averaged
over any area of 1cm 2 , regardless of the area exposed;
(c)
the limit on the equivalent dose for the
extremities shall be 150mSv in a year
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(4) The dose limits for apprentices and students who are not
subject to the provisions of sub-regulations 1, 2 and 3 shall be the same
as the dose limits for members of the public as specified in regulation
Amended by
L.N. 184 of 2020;
(Regulation 93 and 94)
L.N. 139 of 2021.
INFORMATION TO MEMBERS OF THE PUBLIC ABOUT HEALTH
PROTECTION MEASURES TO BE APPLIED AND STEPS TO BE TAKEN IN THE
EVENT OF AN EMERGENCY
Prior information to the members of the public likely to be affected by an
emergency
(1)
Basic facts about radioactivity and its effects on human beings and on the
environment;
(2)
The various types of emergency covered and their consequences for the public
and the environment;
(3)
Emergency measures envisaged to alert, protect and assist the public in the
event of an emergency.
(4)
Appropriate information on action to be taken by the public in the event of an
emergency.
Information to be provided to the affected members of the public in the
event of an emergency
(1)
On the basis of the emergency response plan previously drawn up in the
Commission, the members of the public actually affected in the event of an emergency
shall rapidly and regularly receive
(a) information on the type of emergency which has occurred and, where
possible, its characteristics (e.g. its origin, extent and probable development);
(b)
advice on protection, which, depending on the type of emergency, may
(i)
cover the following: restrictions on the consumption of certain
foodstuffs and water likely to be contaminated, simple rules on
hygiene and decontamination, recommendations to stay indoors,
distribution and use of protective substances, evacuation
arrangements;
(ii)
be accompanied, where necessary, by special warnings for certain
groups of the members of the public;
(c)
announcements recommending cooperation with instructions or requests.
(2)
If the emergency is preceded by a pre-alarm phase, the members of the public
likely to be affected shall already receive information and advice during that
phase, such as
(a)
an invitation to the members of the public concerned to tune in to relevant
communication channels;
(b)
preparatory advice to establishments with particular collective responsibilities;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(c)
recommendations to occupational groups particularly affected.
(3)
This information and advice shall be supplemented, if time permits, by a
reminder of the basic facts about radioactivity and its effects on human beings
and on the environment.
(1)
The effective dose limit for the public, applicable
to any one authorised practise, shall be 0.25mSv per year.
(2) The limit of the effective dose for public exposure is
1mSv per annum.
(3) In addition to the dose limit referred to in the sub-
regulation (1), the following limits on the equivalent dose shall apply
(a) the limit on the equivalent dose for the lens of the eye
shall be 15mSv in a year;
(b) the limit on the equivalent dose for the skin shall be
50mSv in a year, this limit shall apply to the dose averaged over any
area of 1 cm 2 , regardless of the area exposed.
(Regulation 98)
INDICATIVE LIST OF TYPES OF BUILDING MATERIALS CONSIDERED WITH
REGARD TO THEIR EMITTED GAMMA RADIATION
1. Natural materials
(a)
Alum-shale.
-
Building materials or additives of natural igneous origin, such as
-
granitoides (such as granites, syenite and orthogneiss),
-
porphyries;
-
tuff;
-
pozzolana (pozzolanic ash);
-
lava.
2. Materials incorporating residues from industries processing naturally-occurring
radioactive material, such as
-
fly ash;
-
phosphogypsum;
-
phosphorus slag;
-
tin slag;
-
copper slag;
-
red mud (residue from aluminium production);
-
residues from steel production
BASIC SAFETY STANDARDS FOR IONISING RADIATION
For the estimation of effective and equivalent doses, the
appropriate standard values and relationships shall be used. For
external radiation, the operational quantities defined in section 2.3 of
ICRP Publication 116 shall be used.
PART IV
RADIATION PROTECTION EDUCATION, TRAINING AND
INFORMATION
(Regulation 115)
STANDARD RECORD SHEET FOR HIGH-ACTIVITY SEALED SOURCES (HASS)
(optional in italics)
1. HASS identification
2. Identification of the
3. Location of HASS if not the
number
licensed undertaking
same as in 2
Name
Name
Address
Address
Manufacturer device
number
Country
Country
Field of use
Manufacturer □ Supplier □
Fixed use □ Storage □ Mobile
User□
use□
4. Recording
5. Licence
6. Operational controls of
HASS
Date of start of recording
Number
Date
Date of transfer of records
Date of issue
Date
to historic file
Date of expiry
Date
7. HASS characteristics
8. Receipt of HASS
Date
Year of manufacture
Date of Receipt
Date
Radionuclide
Receipt from
Date
Activity at the date of
Name
Date
manufacturing
Activity reference date
Address
Date
Manufacturer/Supplier (*)
Date
Name
Country
Date
Address
Manufacturer □ Supplier □
Date
User□
9. Transfer of HASS
10. Further information
Country
Date of transfer
Loss □ Date of Loss
Physical and chemical
Name
Theft □ Date of theft
characteristics
Source type Identification
Address
Findings: Yes□ No □
Capsule identification
ISO classification
Country
Date
ANSI classification
Licence Number
Place
IAEA source category
Date of issue
Other information
Neutron source Yes□ No□
Date of expiry
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Neutron source target
Manufacturer □ Supplier □
Other undertaking □
Neutron flux
Facility for long term storage
or disposal □
(*)Where the manufacturer of the source is established outside the community the
name and address of the importer-supplier may be provide instead
(1)
The undertaking or, in case of outside workers,
the employer of the outside worker shall ensure that individuals whose
tasks require specific competences in radiation protection shall
(a)
have received appropriate radiation protection
training before commencing work;
(b)
that the radiation protection training is repeated,
at intervals to be determined by the Commission but shall not
exceed a period of 5 years; and
(c)
keep records of training performed, including the
training certificates.
(2) The Commission shall set a date by which all training
shall be done in accordance to approved syllabi, as appropriate to field
of practice, and delivered by approved organisations or individuals.
The Commission shall
(a)
approve syllabi for radiation protection training;
(b)
approve organisations or individuals to provide
BASIC SAFETY STANDARDS FOR IONISING RADIATION
training; and
(c)
accept as appropriate equivalent alternative
radiation safety training where the individual has carried out
prior training outside of Malta.
(3) Approved training organization or individual shall issue
certificates of evidence that the Commission approved training has
been performed.
The Commission shall encourage the introduction of a
course on radiation protection in the basic curriculum of medical and
dental schools.
Exposed workers shall make available to the
undertaking or the employer of the outside worker information on
their past and present work that is relevant for ensuring effective and
comprehensive protection and safety for themselves and others.
(Regulation 114)
SECURITY MEASURES FOR HIGH ACTIVITY SOURCES
Table1 Type of security measures required
Security Level
Security Level
Security Level
C Sources
B Sources
A Sources
Safe management and protect as an asset
Deter unauthorised access
Timely detection of unauthorised access
Timely detection of unauthorised acquisition
Delay acquisition until
response is possible
Administrative Measures
Holders should have the following administrative procedures in order to comply
with these regulations
•
access control procedures;
•
key control procedures;
•
adequate surveillance for activity levels 1 & 2;
•
records related to management of sources;
•
inventories;
•
reliability and trustworthiness of personnel;
•
information security for activity levels 1 & 2;
•
quality assurance measures; and
•
establishment of a safety and security cultures.
Technical Measures
Technical measures pose a physical barrier to a source, device or facility in order
to separate it from unauthorised personnel and to deter, or to prevent, inadvertent
or unauthorised access to, or removal of, a radioactive source.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Technical measures are generally hardware or security devices and include
•
fences;
•
walls;
•
cages;
•
transport packages;
•
locks and interlocks for doors;
•
locked shielded containers;
•
intrusion-resistant source holding devices;
•
access points with alarm.
Table 2 Summary of Security Measures
Specific Security Measures
Security Level
Security Level
Security Level
A Sources
B Sources
C Sources
General administrative measures
Daily accounting
Weekly accounting
Semi-annual accounting
Access control to source location allowing timely detection of
Access control to source
unauthorised access
location
Deterrence provided by
Two technical measures
Two measures (one technical)
One technical measure
separating the source from
separating the source from
separating the source from
unauthorised personnel
unauthorised personnel
unauthorised personnel
Specific emergency response plan
Generic emergency plan
Background check
Security plan
Information security
Upgrade security for increased threat
Timely Detection provided by
Remotely monitored
Local Alarm
intruder alarm
Timely response to an alarm
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1) Undertakings are required to inform exposed
workers on
(a)
the radiation health risks involved in their work;
(b)
the general radiation protection procedures and
precautions to be taken;
(c)
the radiation protection procedures and
precautions connected with the operational and working
conditions of both the practice in general and each type of
workstation or work to which they may be assigned;
(d)
the relevant parts of the emergency response
plans and procedures;
(e)
the importance of complying with the technical,
medical and administrative requirements.
In the case of outside workers, the employer of the outside
worker shall ensure that the information required in paragraphs (a),
(b), and (e) is provided.
(2) The undertaking or, in case of outside workers, the
employer of the outside worker, is to inform exposed workers on the
importance of making an early declaration of pregnancy in view of
the risks of exposure for the unborn child.
(3) The undertaking or, in case of outside workers, the
employer of the outside worker, to inform exposed workers on the
importance of announcing the intention to breast-feed an infant in
view of the risks of exposure for a breast-fed infant after intake of
radionuclides or bodily contamination.
(4)
The undertaking or, in case of outside workers, the
BASIC SAFETY STANDARDS FOR IONISING RADIATION
employer of the outside worker, provides appropriate radiation
protection training and information programmes for exposed workers.
(5) In addition to the information and training in the field of
radiation protection as specified in sub-regulations 1, 2, 3 and 4, the
undertaking responsible for high-activity sealed sources shall ensure
that such training includes specific requirements for the safe and
secure management and control of high-activity sealed sources with a
view to preparing the relevant workers adequately for any events
affecting the radiation protection. The information and training shall
place particular emphasis on the necessary safety requirements and
shall contain specific information on the possible consequences of the
loss of adequate control of high-activity sealed sources.
(Regulation 124)
INDICATIVE LIST OF TYPES OF EXISTING EXPOSURE SITUATIONS
Exposure due to contamination of areas by residual radioactive material from
(i)
past activities that were never subject to regulatory control or were not
regulated in accordance with the requirements laid down by these
regulations;
(ii)
an emergency, after the emergency exposure situation has been
declared ended, as provided for in the emergency management system;
(iii)
residues from past activities for which the undertaking is no longer
legally accountable;
(a)
Exposure to natural radiation sources, including
(i)
indoor exposure to radon and thoron, in workplaces, dwellings and
other buildings;
(ii)
indoor external exposure from building materials;
(b)
Exposure to commodities excluding food, animal feeding stuffs and drinking
water incorporating
(i)
radionuclides from contaminated areas specified in paragraph (a), or
(ii)
naturally-occurring radionuclides.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
SIXTEENTH SCHEDULE
(Regulation 64 and 127)
LIST OF ITEMS TO BE CONSIDERED IN PREPARING THE NATIONAL
ACTION PLAN TO ADDRESS LONG-TERM RISKS FROM RADON EXPOSURES
1. Strategy for conducting surveys of indoor radon concentrations or soil gas
concentrations for the purpose of estimating the distribution of indoor radon
concentrations, for the management of measurement data and for the
establishment of other relevant parameters (such as soil and rock types,
permeability and radium-226 content of rock or soil).
2. Approach, data and criteria used for the delineation of areas or for the definition
of other parameters that can be used as specific indicators of situations with
potentially high exposure to radon.
3. Identification of types of workplaces and buildings with public access, such as
schools, underground workplaces, and those in certain areas, where
measurements are required, on the basis of a safety assessment, considering for
instance occupancy hours.
4. The basis for the establishment of reference levels for dwellings and workplaces.
If applicable, the basis for the establishment of different reference levels for
different uses of buildings (dwellings, buildings with public access, workplaces)
as well as for existing and for new buildings.
5. Assignment of responsibilities (governmental and non-governmental),
coordination mechanisms and available resources for implementation of the
action plan.
6. Strategy for reducing radon exposure in dwellings and for giving priority to
addressing the situations identified under paragraph 2.
7. Strategies for facilitating post construction remedial action.
8. Strategy, including methods and tools, for preventing radon ingress in new
buildings, including identification of building materials with significant radon
exhalation.
9. Schedules for reviews of the action plan.
10. Strategy for communication to increase public awareness and inform local
decision makers, employers and employees of the risks of radon, including in
relation to smoking.
11. Guidance on methods and tools for measurements and remedial measures.
Criteria for the accreditation of measurement and remediation services shall also
be considered.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
12. Where appropriate, provision of financial support for radon surveys and for
remedial measures, in particular for private dwellings with very high radon
concentrations.
13. Long-term goals in terms of reducing lung cancer risk attributable to radon
exposure (for smokers and non-smokers).
14. Where appropriate, consideration of other related issues and corresponding
programmes such as programmes on energy saving and indoor air quality.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
SEVENTEENTH SCHEDULE
Amended by
L.N. 184 of 2020.
(Regulation 18 and 67)
SEVENTEENTH SCHEDULE
(Regulation 18 and 67)
QUALIFICATION AND EXPERIENCES FOR PERSONS
INVOLVED IN MEDICAL EXPOSURES
1. Referrers shall have the following qualification and experience as detailed
below
Practitioners shall have the following qualification and experience as detailed
below
Qualification
Registered medical doctors, or
dentists, or
Practitioners when additional exposures are clinically indicated
Experience
No initial experience needed
2. Practitioners qualification and experience
Practitioners shall have the following qualification and experience as detailed
below
Qualification
Medical doctors who are on the Specialist Registers held by the Medical
Council for
Radiology;
Radiotherapy;
Nuclear Medicine,
or
Medical doctors who are on the Specialist Register held by the Medical
Council for
Cardiology;
Gastroenterology;
Respiratory Medicine;
Rheumatology;
Orthopedic Surgery; and
General Surgery
Oral and maxillo-facial surgery while carrying out interventions,
or
Dental surgeons,
or
Medical radiographers registered with Council for Professions
complimentary to medicine
Experience
At least one month on the job experience under the supervision of an
approved practitioner, excluding dental surgeons.
No initial experience for dental work performed by dental surgeons.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
3. Categorization of medical exposures
As the practical aspects of different procedures for medical exposures carry
different levels of risk, both to the person performing the practical aspects and to
the patient, the Commission has categorised medical exposures as shown in the
below table using the graded approach. This categorisation is being done in
relation to persons performing the practical aspects only
Risk Level
Type of medical exposure
Radiotherapy
Brachytherapy
Nuclear Medicine (diagnostic and therapeutic)
Interventional Radiology Fluoroscopic Techniques
CT
Mammography
Medium
General Diagnostic Radiography
Dental Radiography
Low output Diagnostic Radiography (e.g. bone density)
4. Qualification and experience for persons performing the practical aspects
Persons performing the practical aspects shall have the following qualification and
experience as detailed below
(i)
Persons performing the practical aspects of radiation producing medical
equipment for medical purposes
High Risk
Qualification
Practitioners with the proviso that a registered medical
Procedures
radiographer is in attendance during any form of
intervention by medical doctors who are on the specialist
registers listed in the table in part 1 of this Schedule.
Other persons approved under regulation 69 as long as a
practitioner is available
Experience
First time registered medical radiographers shall have at
least three months on the job orientation under the
supervision of a registered medical radiographer
approved to work in the specific area.
Persons approved by under regulation 69 shall have three
months on the job training under the supervision of a
Practitioner
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Medium Risk
Qualification
Practitioners, or
Procedures
Dentists for dental medical exposures
Other persons approved under regulation 69
Experience
First time registered medical radiographers, Practitioners,
shall have at least one month on the job orientation under
the supervision of an approved individual in the specific
area.
No initial experience for dental work performed by dental
surgeons specific area.
Persons approved by under regulation 69 shall have two
months on the job training under the supervision of a
Practitioner
Low Risk
Qualification
Practitioners, or
Procedures
Other persons approved under regulation 69
Experience
No initial experience for practitioners
Persons approved by under regulation 69 shall have two
months on the job training under the supervision of a
Practitioner.
(ii)
Persons performing the practical aspects administering sealed or unsealed
radioactive sources for medical exposure purposes
Brachytherapy
Qualification
Registered on the specialist register for oncology and
radiotherapy or
Medical radiographer
Experience
One month or several procedures of on the job
orientation under the supervision of an approved
individual in the specific area.
Therapeutic and
Qualification
Registered on specialist register for nuclear medicine or
Diagnostic
registered medical doctor or registered medical
Nuclear
radiographer , registered medical physicist as directed by
Medicine
an individual registered on specialist register for nuclear
medicine
Experience
One month or several procedures on the job orientation
under the supervision of an approved individual in the
specific area.
(iii)
Persons performing the practical aspects of other aspects of medical exposures
Gamma Camera/
Qualification
Registered on specialist register for nuclear medicine or
Positron
medical radiographer
Emission
Experience
Three months on the job orientation under the
Tomography
supervision of registered individual on specialist register
for nuclear medicine or medical radiographer.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(iv)
Persons performing the practical aspects of radiation producing medical
equipment for non medical purposes
Quality Control
Qualification
Medical physicists registered with Council for the
Procedures
Professions Complementary to Medicine,
Registered Medical radiographers,
or
persons specifically trained to carry out the quality
control of the relevant equipment.
Experience
At least nine months on the job orientation under the
supervision of an approved QC individual or 300 hours of
training in quality control.
Installation and
Qualification
Persons specifically trained by the manufacturer in the
Maintenance
areas that are needed to carry out their duty or trained by
other engineers/technicians certified competent by the
manufacturer
Experience
One month on the job training under the supervision of an
experienced installer
BASIC SAFETY STANDARDS FOR IONISING RADIATION
EIGHTEENTH SCHEDULE
(Regulation 74)
INFORMATION TO BE SUPPLIED TO THE SECRETARAIT EACH TIME AN
ACCEPTANCE TEST IS PERFORMED
(a)
Full equipment details including
type of equipment
manufacturer
model
serial numbers
year of manufacture
year of Installation
for x-ray equipment: Max KV. Max mA
location of equipment
(b)
Particulars of the test
reason for performing test
person(s) performing test
date of test
name of standard followed
specified tolerances, manufactures specification and other reference docu-
ments if appropriate
details of test equipment used, including calibration dates
(c)
Previous tests
Details of any on-site/factory tests performed by manufacturer and results of
such tests
(d)
For each of the required parameters tested the report should include
test procedure followed
measured values
manufacturers specification for that parameter.
if no manufactures specification available, the reason why and the value the
measured value was compared to
statement if the equipment passes that parameter
BASIC SAFETY STANDARDS FOR IONISING RADIATION
NINETEENTH SCHEDULE
(Regulation 83(e))
EXPOSURE TO IONISING RADIATION TO AN EXTENT MUCH GREATER THAN
INTENDED
If such an incident has or believed to have occurred, the undertaking has to carry
out a preliminary investigation. Unless this investigation establishes that no such
incident occurred, the Secretariat has to be immediately notified and a detailed
investigation has to be carried out.
During the preliminary and, if applicable, during the detailed investigation, any
process in connection with the incident, (from the receipt of the patient to the final
reporting) shall be stopped from use until the investigation is carried out and any
corrective actions taken. For example, these processes may include all the steps
from patient receipt to the final reporting.
The table below shows the interpretation of the term "much greater than intended
Table 1
Medical exposure
Much
Greater
than
intended
multiplying factor applied to intended
dose
Interventional radiology, radiographic and fluoroscopic
1.5
procedures involving contrast agents, nuclear medicine
with intended dose >5mSv and computed tomography
examinations
Mammography, nuclear medicine with intended E≤5mSv
but >0.5mSv, all other radiographic examinations not
referred to elsewhere in this table.
Radiography of extremities, skull, dentition, shoulder,
chest, elbow, knee and nuclear medicine with intended E≤
0.5mSv
Beam therapy, brachytherapy
1.1 (whole course) or
1.2 (any fraction)
Unsealed radionuclide therapy
1.2 (any administration)
Procedural failures
Incident
Undertaking’s Duty
Incorrect diagnostic procedure
Preliminary investigation and inform
the Secretariat
Wrong patient exposed to a dose of radiation
Preliminary investigation and inform
the Secretariat
Reject exposures due to other parameters resulting in
Perform Reject Analyses and take
inadequate diagnostic information
corrective action. The reports,
analyses and corrective actions to be
documented and made available to
the Secretariat
Any preliminary investigation reports shall be kept by the undertaking for a period
of at least 2 years from the date it was made. If a detailed investigation is made,
the report shall be kept for a period of at least 30 years from the date it was made.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
TWENTIETH SCHEDULE
(Regulation 68(b))
REQUIREMENTS FORMEDICAL PHYSICS EXPERTS
Table 1
Undertaking’s requirements for obtaining advice from Medical Physics Experts
Practice
Level of Involvement of the
Contractual agreement
medical physics expert
between undertaking and
the medical physics
expert
External Beam Radiotherapy
Close involvement
Brachytherapy
To be present on site for at least
Documented agreement
Other
Radiotherapeutic
part of the working day and to be
between undertaking and
practices
(Excluding
available for consultation as
medical physics expert
standardized nuclear medicine
required for any individual
practices)
patient-specific issues
Standardised nuclear medicine
radiotherapeutic procedures
Diagnostic nuclear medicine
Shall be involved
procedures
Interventional Radiology
Monitor practices regularly and
Documented agreement
between undertaking and
Computed Tomography
be available for consultation as
medical physics expert
required and to respond for any
individual patient-specific issues
Other
high
dose
radiodiagnostic practices
Health Screening
Other medical radiological
practices not covered by above
Involved as appropriate
None required
points
BASIC SAFETY STANDARDS FOR IONISING RADIATION
TWENTY-FIRST SCHEDULE
(Regulation 95(1)(a)
ELEMENTS OF NATIONAL RADIOACTIVITY MONITORING PROGRAMME
Table 1
Sampling frequency
Ambient gamma dose rate
Continuous
Air particulates
Continuous
Coastal Waters
Quarterly
Soil
Annually
Water for human consumption
Monthly
Food
Monthly
Milk
Quarterly
(1)
The Secretariat shall keep the customs authorities
and metal recycling installations informed of the possibility that they
may be confronted with a source.
(2) The Commission shall promote that workers in the
customs authorities and in metal recycling installations are
(a)
advised and trained in the visual detection of
sources and their containers;
(b)
informed of basic facts about ionising radiation
and its effects;
(c)
informed of and trained in the actions to be taken
on site in the event of the detection or suspected detection of a
source.
(1)
Emergency workers who are identified in an
emergency response plan of an undertaking or the employer of an
outside worker and persons involved in the national radiological
emergency plan as established by article 31 of the Act, shall be given
adequate information
(a)
that is regularly updated on the health risks their
intervention might involve and on the precautionary measures to
be taken in such an event;
(b)
on appropriate radiation protection training;
(c)
on national radiological emergency plan as set out
in regulation 122
Provided that this information shall take into account the
range of potential emergencies and the type of intervention.
(2) In the event that an emergency occurs, the information
referred to in the regulation 17(1a) shall be supplemented by
Secretariat to emergency workers and any other persons involved,
having regard to the specific circumstance.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
Undertakings shall entitle individuals to act as
referrers, practitioners and individuals involved in the practical
aspects of medical radiological exposures by approving them and
shall establish a procedure within its radiation protection programme
for persons to be approved pursuant to the requirements of regulation
(2) Referrers, practitioners and the individuals involved in
the practical aspects of medical radiological procedures shall have
the qualification and experience stated in the Seventeenth Schedule
19. (1)
Undertakings shall maintain lists of individuals
that have been approved. These lists shall specify any limitations of
the approval of individuals.
(2) Undertakings shall maintain the following records for
each of its employees involved in medical exposures
(a)
name of individual;
(b)
approval area, including: practitioner; person
performing the practical aspects of medical equipment for
medical purposes; person performing the practical aspects for
other purposes;
(c)
qualification certificates to demonstrate training
(both academic and practical);
(d)
examination results if applicable (including
vision examinations pursuant to regulation 10 of the Minimum
Health and Safety Requirements for Work with Display Screen
Equipment Regulations) and their expiry;
(e)
documentation of any continuing professional
development;
(f)
contract or signed statement of employment of
the individual to act in the approved capacity.
(3) An undertaking may approve an individual to work in
the same capacity on the basis that the individual has been approved
by another undertaking provided that
(a)
the individual has proof of prior approval; and
(b)
the individual was working in the same capacity
in the last six months; and
(4)
The approval of an undertaking shall be deemed revoked
when
(a)
employment is terminated; or
(b)
preliminary investigations for accidents indicate
BASIC SAFETY STANDARDS FOR IONISING RADIATION
gross individual negligence; or
(c)
not carrying
out
approved
work
for
six
consecutive months.
Individuals undergoing relevant training programmes
may participate in practical aspects for the procedures mentioned in
regulation 69 provided that they are constantly under direct
supervision of a practitioner.
The undertaking shall facilitate the continuing education
and training of its employees.
The Commission shall allocate the necessary resources in
order that staff of its Secretariat to obtain, maintain and further develop
expertise and skills required in discharging the Commission’s
responsibilities.
In the case of the clinical use of new techniques the
undertaking shall provide training on these techniques and the relevant
radiation protection requirements.
Part V
JUSTIFICATION AND REGULATORY CONTROL OF PRACTICES
(SECTION 1)
Justification and prohibition of practices
(1)
It is prohibited to perform a class or type of
practice that is not justified.
A list of classes and types of practice resulting in exposure to
ionising radiation that are deemed justified at the time of this
regulation being published is given in the Fourth Schedule.
(2) The Commission shall update and keep available a list of
classes and types of practice resulting in exposure to ionising radiation
that are deemed justified.
The Commission shall not allow a new class or types of
practice resulting in exposure to ionising radiation unless it deems it to
be justified. If justified it shall be added to the list referred to in the
regulation 23.
The Commission shall consider a review of existing
classes or types of practices held on the list referred to in regulation 23
with regard to their justification whenever there is new and important
evidence about their efficacy or potential consequences or new and
important information about other techniques and technologies, if no
longer justified they shall be removed from the list.
Practices involving medical exposure shall be a justified
BASIC SAFETY STANDARDS FOR IONISING RADIATION
practices pursuant to regulation 23 and each individual medical
exposure shall be justified as specified in regulation 65.
(1)
Undertakings intending to manufacture or
import a consumer product for which the intended use is likely to be a
new class or type of practice, to provide the Commission with all
relevant information, including that listed in Section A of the Third
Schedule, so as to allow the implementation of the justification
requirement in regulation 25.
(2) The Commission shall assess this information and
decide if the intended use of the consumer product is justified based
on Section B of the Third Schedule.
(3) Without prejudice to sub-regulation (1), The
Commission which has received information according to that sub-
regulation, informs the point of contact for the competent authorities
of other Member States of this receipt and, upon request, of its
decision and the basis for that decision.
(4) It is prohibited to sale or the making available to the
public of consumer products if their intended use is not justified or
their use would not fulfil the criteria for exemption from notification
under regulation 35.
(1)
It is prohibited to deliberately add radioactive
substances in the production of foodstuffs, animal feeding stuffs, and
cosmetics, and it is prohibited to import or export of such products.
(2) Without prejudice to the Irradiation of Food
Regulations, practices involving the activation of material resulting
in an increase in activity in a consumer product, which at the time of
placing on the market cannot be disregarded from a radiation
protection point of view, shall be deemed not to be justified.
However, the Commission may evaluate specific types of practices
within this class with regard to their justification.
(3) The deliberate addition of radioactive substances in the
manufacture of toys and personal ornaments is prohibited and so is
the import or export of such products.
(4) Practices involving the activation of materials used in
toys and personal ornaments, resulting, at the time of the placing on
the market of the products or of their manufacture, in an increase in
activity, which cannot be disregarded from a radiation protection
point of view is prohibited, and so is the import or export of such
products or materials.
(1)
With regard to practices and applications
involving non-medical imaging exposure the Commission shall
(a)
identify in the list referred to under regulation
23, practices and applications involving non-medical imaging
BASIC SAFETY STANDARDS FOR IONISING RADIATION
exposure which are deemed to be justified;
(b)
review the general and particular justification of
practices involving non-medical imaging exposures;
(c)
regularly review the circumstances warranting
non-medical imaging exposures, without individual justification
of each exposure.
(2) Each particular application of an accepted type of
practice, as stipulated by regulation 23, shall be justified by the
undertaking and shall be subject to licensing by the Secretariat.
(3) With regard to practices and applications involving non-
medical imaging exposure undertakings shall give special attention to
justification in advance of all individual non-medical imaging
exposure procedures using medical radiological equipment, taking into
account the specific objectives of the procedure and the characteristics
of the individual involved.
Justified practices involving non-medical imaging
exposure using medical radiological equipment may be exempted by
the Commission from the requirement for dose constraints according
to regulation 6(b) and from the dose limits set out in regulation 12.
(1)
For practices involving non-medical imaging
exposure that are justified
(a)
the practice is subject to licensing by the
Commission and shall impose specific requirements, including
criteria for individual implementation, that have been
established by the Commission, making reference to guidance
available from international bodies, in cooperation with Maltese
professional bodies of practitioners, other governmental
regulatory bodies and any other such persons or bodies that the
Commission sees fit as appropriate;
(b)
for
procedures
using
medical
radiological
equipment
(i)
relevant requirements identified for
medical exposure as set out in Part VII are applied,
including
those
for
equipment,
optimisation,
responsibilities, training and special protection during
pregnancy and the appropriate involvement of the
medical physics expert;
(ii) where appropriate, specific protocols,
consistent with the objective of the exposure and required
image quality, are put in place;
(iii) where practicable, specific diagnostic
reference levels are put in place;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(2) For procedures not using medical radiological
equipment, shall have dose constraints that shall be established by the
Commission and its value shall not exceed an effective dose of
0.005mSv per procedure with a limit of 0.1mSv per year for the
individual exposed to that procedure and;
(3) Information is provided to and consent sought from the
individual to be exposed, allowing for cases where the law
enforcement authorities may proceed without consent of the
individual according to Maltese legislation.
(SECTION 2)
Regulatory Control
(1) Notified practices which are not exempted from
authorisation shall be subject to regulatory control through
registration or licensing.
(2) Regulatory control through the notification, registration/
licensing and the inspection process shall use a graded approach.
The Secretariat shall be responsible for maintaining a
registers of
(1)
undertakings and employers of outside workers;
(2)
equipment
that
requires
notification
under
these
regulations;
(3)
radioactive material that requires notification under these
regulations, and in particular the following information
(a)
radionuclide involved;
(b)
the activity at the time of manufacture or, if this
activity is not known, the activity at the time of the first placing
on the market; and
(c)
the type of source.
(4) Transfers of equipment and radioactive material that requires
notification under these regulations.
The Commission shall identify classes or types of
practice involving naturally–occurring radioactive material and
leading to exposure of workers or members of the public which
cannot be disregarded from a radiation protection point of view. Such
identification shall be carried out by appropriate means taking into
account industrial sectors listed in the Fifth Schedule.
(1)
Notification is required for all justified practices,
including those identified according to regulation 33. The notification
shall be made at least thirty (30) days prior to a practice commencing.
Existing practices shall notify within thirty (30) days of the
publication of this regulation. The Secretariat shall specify the
BASIC SAFETY STANDARDS FOR IONISING RADIATION
information to be provided in conjunction with the notification. Where
an application for an authorisation is submitted, no separate
notification is needed. An authorisation may lead to the Secretariat
issuing the undertaking with either a registration or license.
(2) Undertakings shall immediately notify the Secretariat if
there is any change in the information supplied in connection with the
above sub-regulation.
(3) Practices may be exempted from notification, as specified
in regulation 35.
(4) Notification is required for workplaces specified in
regulation 64(3) and for existing exposure situations that are managed
as a planned exposure situation, as specified in regulation 124(3).
(5) Notwithstanding the exemption criteria laid down in
regulation 35, in situations identified by the Commission where there
is concern that a practice identified in accordance with regulation 33
may lead to the presence of naturally-occurring radionuclides in water
liable to affect the quality of drinking water supplies or affect any
other exposure pathways, so as to be of concern from a radiation
protection point of view, the Commission may require that the practice
be subject to notification.
(6) Human activities involving radioactively contaminated
materials resulting from authorised releases or materials cleared in
accordance with regulation 39 shall not be managed as a planned
exposure situation and, hence, are not required to be notified.
(1)
The following justified practices do not need to be
notified
(a)
radioactive materials where the quantities of the
activity involved do not exceed in total the exemption values set
out in Table B, Activity Column (Bq), of the Sixth Schedule, or
higher values that, for specific applications, are approved by the
Commission and satisfy the general exemption and clearance
criteria set out in the Sixth Schedule ; or
(b)
without prejudice to regulation 34(6) radioactive
materials where the activity concentrations do not exceed the
exemption values set out in Table A, Activity Concentration
Column (kBq kg -1 ), of the Sixth Schedule, or higher values that,
for specific applications, are approved by the Commission and
satisfy the general exemption and clearance criteria set out in
the Sixth Schedule; or
(c)
apparatus containing a sealed source, provided
that
(i)
the apparatus is of a type approved by the
BASIC SAFETY STANDARDS FOR IONISING RADIATION
Commission;
(ii) the apparatus does not cause, in normal
operating conditions, a dose rate exceeding 1 μSv h -1 at
a distance of 10cm from any accessible surface; and
(iii) conditions for recycling or disposal have
been specified by the Commission; or
(d)
any electrical apparatus provided that
(i)
it is a cathode ray tube intended for the
display of visual images, or other electrical apparatus
operating at a potential difference not exceeding 30 kilo
volt (kV), or it is of a type approved by the Commission;
and
(ii) it does not cause, in normal operating
conditions, a dose rate exceeding 1 μSv h -1 at a distance
of 10cm m from any accessible surface.
(2) The Commission may exempt specific types of practices
from the notification requirement subject to compliance with the
general exemption criteria established in paragraph 3 of the Sixth
Schedule, on the basis of an assessment showing that exemption is
the best option.
(1) The Commission shall require either registration or
licensing of the following practices
(a) the operation of radiation generators or accelerators or
radioactive sources for medical exposures or for non-
medical imaging exposure purposes; and
(b) the operation of radiation generators or accelerators,
except electron microscopes, or radioactive sources for
purposes not covered by sub-paragraph (a).
(2) The Commission may require registration or licensing of
other types of practices.
(3) Subject to regulation 37, the Commission shall, in
accordance with sub-regulations (1) and (2), determine which
practices are subject to registration or licensing. The Commission
shall base its decision to submit a type of practice to registration or
licensing, using a graded approach and based on regulatory
experience taking into account
(a) the magnitude of expected or potential doses resulting
from the practice;
(b) the impact that regulatory control may have in
reducing such doses or improving radiological safety;
(c) the complexity of the practice; and
(d) safety and security having regard to the circumstances
in which the relevant practice is proposed to be carried
BASIC SAFETY STANDARDS FOR IONISING RADIATION
out.
Licensing is required for the following practices
(a)
the deliberate administration of radioactive
substances to persons and, in so far as the radiation protection of
human beings is concerned, animals for the purpose of medical
or veterinary diagnosis, treatment or research;
(b)
the operation and decommissioning of any nuclear
facility;
(c)
the deliberate addition of radioactive substances
in the production or manufacture of consumer products or other
products, including medicinal products, and the import of such
products;
(d)
any practice involving a high-activity sealed
source;
(e)
the operation, decommissioning and closure of
any facility for the long term storage or disposal of radioactive
waste, including facilities managing radioactive waste for this
purpose; the operation, decommissioning and closure of any
facility for the long term storage or disposal of radioactive
waste, including facilities managing radioactive waste for this
purpose;
(f)
practices discharging significant amounts of
radioactive material with airborne or liquid effluent into the
environment.
(1)
In order to apply for a registration or license,
applicants are to provide the Secretariat such information as shall be
stipulated by the Secretariat.
(2) The information that the Secretariat will require to be
supplied by applicants to apply for a license will include items in the
indicative list in the Eighth Schedule.
(3) A licence shall include, as appropriate, specific conditions
and reference to requirements in these regulations so as to ensure that
the elements of the licence are legally enforceable, and impose
appropriate restrictions on the operational limits and conditions of
operation.
(4) Where applicable, the licence shall include conditions on
the discharge of radioactive effluent, in connection with the
requirements of regulation 87 for the authorisation of the release of
radioactive effluent into the environment.
(5) Licensees shall notify the Secretariat at least one month
prior to the expiry of their License to inform the Secretariat if they will
BASIC SAFETY STANDARDS FOR IONISING RADIATION
be seeking a renewal of their license.
(1)
Disposal, recycling or reuse of radioactive
materials arising from any authorised practice is subject to
authorisation.
(2) Materials for disposal, recycling or reuse may be
released from regulatory control provided that the activity
concentrations
(a)
for solid material do not exceed the clearance
levels (kBq kg -1 ) set out in Table A of the Sixth Schedule; or
(b)
comply with specific clearance levels and
associated requirements for specific materials or for materials
originating from specific types of practices; these specific
clearance levels shall be established by the Commission,
following the general exemption and clearance criteria set out
in paragraph 3 of Sixth Schedule, and taking into account
technical guidance provided by the European Union.
(3) The clearance of materials containing naturally-
occurring radionuclides, where these result from authorised practices
in which natural radionuclides are processed for their radioactive,
fissile or fertile properties, the clearance levels comply with the dose
criteria for clearance of materials out in paragraph 3 of Sixth
Schedule ,
(4) It shall not be permitted to deliberately dilute
radioactive materials for the purpose of them being released from
regulatory control. The mixing of materials that takes place in normal
operations where radioactivity is not a consideration is not subject to
this prohibition. The Commission may authorise, in specific
circumstances, the mixing of radioactive and non-radioactive
materials for the purposes of re-use or recycling.
PART VI
OCCUPATIONAL EXPOSURES
(1)
Undertakings are responsible for assessing and
implementing arrangements for the radiation protection of exposed
workers.
(2) In the case of outside workers, the responsibilities of the
undertaking and the employer of outside workers are stipulated in
regulation 61.
(3) Without prejudice to sub-regulations 1 and 2, there shall
be a clear allocation of responsibilities, specified within radiation
protection programme of the undertaking , for the protection of
workers in any exposure situation, to an undertaking, an employer of
the outside worker or any other organisation, in particular for the
BASIC SAFETY STANDARDS FOR IONISING RADIATION
protection of
(a)
emergency workers;
(b)
workers involved in the remediation
of
contaminated land, buildings and other constructions;
(c)
workers who are exposed to radon at work, in the
situation specified in regulation 64(3),
This shall also apply to the protection of self-employed
individuals and individuals who work on a voluntary basis.
(4) Employers of outside workers shall ensure that they have
access to information on the possible exposure of their employees
under the responsibility of another employer or undertaking.
(1)
Operational protection of exposed workers shall
be based on
(a)
prior evaluation to identify the nature and
magnitude of the radiological risk to exposed workers as part of
the safety assessment required by regulation 101;
(b)
optimisation of radiation protection in all working
conditions;
(c)
classification of exposed workers as either
category A worker or category B worker;
(d)
control measures and monitoring relating to the
different areas and working conditions, including, where
necessary, individual monitoring;
(e)
medical surveillance;
(f)
education and training.
(1)
Exposure conditions and operational protection of
apprentices and students aged 18 years or over referred to regulation
11(1) is equivalent to that of exposed workers of category A or B as
appropriate.
(2) Exposure conditions and operational protection of
apprentices and students aged between 16 and 18 years referred to in
regulation 11(2) is equivalent to that of exposed workers of category
B.
Undertakings shall seek advice from a radiation
protection expert within the radiation protection expert’s areas of
competence (as outlined in regulation 105), on the issues below that
are relevant to the practice
(a)
the examination and testing of protective devices
BASIC SAFETY STANDARDS FOR IONISING RADIATION
and measuring instruments;
(b)
prior critical review of plans for installations
from the point of view of radiation protection;
(c)
the acceptance into service of new or modified
radiation sources from the point of view of radiation
protection;
(d)
regular checking of
the
effectiveness
of
protective devices and techniques;
(e)
regular calibration of measuring instruments and
regular checking that they are serviceable and correctly used;
(f)
radiation
protection
programme
of
the
undertaking.
(1)
Undertakings shall give careful consideration
and implement radiation protection arrangements as regards all
workplaces where workers are liable to receive an exposure greater
than an effective dose of 1mSv per year or an equivalent dose of
15mSv per year for the lens of the eye or 50mSv per year for the skin
and extremities.
Such arrangements shall use the graded approach.
(2) For workplaces specified in regulation 64(3) and where
the exposure of workers is liable to exceed an effective dose of 6mSv
per year or a corresponding time-integrated radon exposure value to
be determined by the Commission based on international guidance,
these shall be managed as a planned exposure situation and the
Commission shall determine which requirements set out in this Part
VI are appropriate. For workplaces specified in regulation 64(3), and
where the effective dose to workers is less than or equal to 6mSv per
year, or the exposure less than the corresponding time integrated
radon exposure value for the workers, the Commission shall require
that exposures are kept under review.
(3) For an undertaking operating aircraft where the effective
dose to the crew from cosmic radiation is liable to exceed 6mSv per
year, the relevant requirements set out in this Part VI shall apply,
allowing for the specific features of this exposure situation. In the
case that an effective dose to the crew is liable to be above 1mSv per
year, the undertaking is take appropriate measures, in particular
(a)
to assess the exposure of the crew concerned;
(b)
to take into account the assessed exposure when
organising working schedules with a view to reducing the
doses of highly exposed crew;
(c)
to inform the workers concerned of the health
BASIC SAFETY STANDARDS FOR IONISING RADIATION
risks their work involves and their individual dose;
(d)
to apply regulation 10(1) to pregnant air crew.
(1) Undertakings shall ensure that workplaces are designated
as either controlled or supervised, where appropriate, on the basis of the
safety assessment, made pursuant to regulation 101, of the expected
annual doses and the probability and magnitude of potential exposures.
(2) Undertakings shall refer to the Commission guidance on the
classification of controlled and supervised areas with regard to
particular circumstances.
(3) Undertakings shall designate as a controlled area any area
under their control which
(a) it is necessary for any person who enters or works in the
area to follow special procedures designed to restrict
significant exposure to ionising radiation in that area or
prevent or limit the probability and magnitude of radiation
accidents or their effects; or
(b) any person working in the area is likely to receive an
effective dose greater than 6mSv a year or an equivalent
dose greater than three-tenths of any relevant dose limit
referred to in these regulations.
(4) Undertakings shall designate as a supervised area any area
under their control, not being an area designated as a controlled area
(a)
where it is necessary to keep the conditions of the area
under review to determine whether the area should
be designated as a controlled area; or
(b)
in which any person is likely to receive an effective dose
greater than 1mSv a year or an equivalent dose
greater than one-tenth of any relevant dose limit
referred to in these regulations.
(5) On the basis of the documentation supplied, including the
Safety Assessment, by the undertaking to the Commission, the
Secretariat shall confirm that the appropriate area classification has been
made.
(1) The minimum requirements for a controlled area are
the following
(a)
The controlled area shall be delineated and access
to it shall be restricted to individuals who have received
appropriate instructions and shall be controlled in accordance
with written procedures provided by the undertaking. Wherever
there is a significant risk of the spread of radioactive
contamination, specific arrangements shall be made, including
for the access and exit of individuals and goods and for
monitoring contamination within the controlled area and, where
appropriate, in the adjacent area.
(b)
Taking into account the nature and extent of
BASIC SAFETY STANDARDS FOR IONISING RADIATION
radiological risks in the controlled area, radiological
surveillance of the workplace shall be organised in accordance
with the provisions of regulation 48.
(c)
Signs indicating that the area is Controlled, the
nature of the sources and their inherent risks shall be
displayed.
(d)
Working instructions appropriate to the
radiological risk associated with the sources and the operations
involved shall be laid down.
(e)
The worker shall receive specific training in
connection with the characteristics of the workplace and the
activities.
(f)
The worker shall be provided with the
appropriate personal protective equipment.
(2) The undertaking is responsible for implementation of
these duties taking into account the advice provided by the radiation
protection expert.
(1)
The requirements for a supervised area are the
following
(a)
taking into account the nature and extent of
radiological risks in the supervised area, radiological
surveillance of the workplace shall be organised in accordance
with the provisions of regulation 48;
(b)
signs indicating that the area is Supervised, the
nature of the sources and their inherent risks shall be
displayed;
(c)
if appropriate, working instructions appropriate
to the radiological risk associated with the sources and the
operations involved shall be laid down.
(2) The undertaking is responsible for implementation of
these duties taking into account the advice provided by the radiation
protection expert.
(1)
Undertakings shall ensure that the radiological
surveillance of the workplace referred to in paragraph (b) of
regulation 46(1) and paragraph (a) of regulation 47(1) comprises,
where appropriate
(a)
the measurement of external dose rates,
indicating the nature and quality of the radiation in question;
(b)
the measurement of the activity concentration in
air and the surface density of contaminating radionuclides,
indicating their nature and their physical and chemical states.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(2) Results of these measurements shall be recorded and shall
be used, if necessary, for estimating individual doses, as provided for
regulation 50.
(3) The results of radiological surveillance of the workplace
shall be kept for a minimum of two years.
(4) Monitoring equipment used for radiological surveillance
of the workplace shall be annually recalibrated and the calibration
shall be traceable to an accredited standards laboratory.
(1)
For the purposes of monitoring and surveillance,
every undertaking shall designate exposed workers into one of two
categories
(a)
category A: those exposed workers who are liable
to receive an effective dose greater than 6mSv per year or an
equivalent dose greater than 15mSv per year for the lens of the
eye or greater than 150mSv per year for skin and extremities;
(b)
category B: those exposed workers who are not
classified as category A workers.
(2) The undertaking or, in the case of outside workers, the
employer of the outside worker, shall decide on the categorisation of
individual workers prior to their taking up work that may give rise to
exposure, and to regularly review this categorisation on the basis of
working conditions and medical surveillance. The distinction shall also
take into account potential exposures.
(1)
Undertakings shall ensure that category A
workers are systematically monitored based on individual
measurements performed by a dosimetry service. In cases where
category A workers are liable to receive significant internal exposure
or significant exposure of the lens of the eye or extremities, an
adequate system for monitoring shall be set up.
(2) Undertakings shall ensure that monitoring for category B
workers is at least sufficient to demonstrate that such workers are
correctly classified in category B. The Secretariat may require the
undertaking to perform individual monitoring and if necessary
individual measurements, by a dosimetry service, for category B
workers.
(3) In cases where individual measurements are not possible
or inadequate, the individual monitoring shall be based on an estimate
arrived at from individual measurements made on other exposed
workers, from the results of the surveillance of the workplace provided
for in regulation 48 or on the basis of calculation methods approved by
the Secretariat.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
In the case of accidental exposure, the
undertaking is required to assess the relevant doses and their
distribution in the body.
(2) In the case of accidental exposure, the undertaking is
required to obtain the results of dose assessments as soon as
practically possible.
(1)
Undertakings and the employer of any outside
workers shall record the data specified in paragraph 1 of the Ninth
Schedule for the individual monitoring that is made for category A
workers and any individual monitoring that is performed on category
B workers.
(2) For the purposes of sub-regulation (1), the following
information on exposed workers shall be retained
(a)
a record of the exposures measured or estimated,
as the case may be, of individual doses pursuant to regulations
50, 51, 61, 62, 63 and, if required by the Secretariat pursuant
to regulations 44(2), 64(3);
(b)
in the case of exposures as referred to in
regulations 51, 62, 63, the reports relating to the circumstances
and the action taken;
(c)
the results of workplace monitoring used to
assess individual doses where necessary.
(3) The information referred to in sub-regulation (1) shall be
retained during the period of their working life involving exposure to
ionising radiation and afterwards until they have or would have
attained the age of 75 years, but in any case not less than 30 years
after termination of the work involving exposure.
(4) Exposures as referred to in regulations 51, 62, 63, and, if
decided by the Secretariat pursuant to regulations 44(2), 64(3) shall
be recorded separately in the dose record referred to in sub-regulation
(1).
(5) The dose record referred to in sub-regulation (1) shall be
submitted to the Secretariat by the thirtieth day of April for the
following year in the format specified by the Secretariat and shall
consist of the data in Section 2 of the Ninth Schedule.
(6) The Secretariat may seek to verify any of the data supplied
(1) The results of the individual monitoring set out in
regulations 50, 51, 62, 63 shall pursuant to regulations 44(2), 64(3)
be
(a)
submitted to the Secretariat, to the undertaking,
and to the employer of outside workers;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(b)
made available to the worker concerned in
accordance with sub-regulation (2);
(c)
submitted to an occupational health service in
order for it to interpret the implications of the results for human
health, as provided for in regulation 55(2).
(2) The undertaking, or in case of outside workers, the
employer of the outside worker, to grant workers, at their request,
access to the results of their individual monitoring, including the
results of measurements which may have been used in estimating these
results, or to the results of the assessment of their doses made as a
result of surveillance of the workplace.
(3) In the case of an accidental exposure, the undertaking
shall communicate the results of individual monitoring and dose
assessments to the individual and the Secretariat without delay.
(4) It is the responsibility of the undertaking and the
employer of the outside worker that arrangements are in place for the
appropriate exchange, among the undertaking, in the case of an outside
worker, the employer, the Secretariat, occupational health services,
radiation protection experts, or dosimetry services of all relevant
information on the doses previously received by a worker in order to
perform the medical examination prior to employment or classification
as a category A worker pursuant to regulation 55 and to control the
further exposure of workers.
(1) Before the start of any activity, the employer of the
outside worker shall supply the data given in paragraph 3 of the Ninth
Schedule to the undertaking data on the employment of the outside
worker.
(2) The following data shall be recorded or have been
recorded by the undertaking in the data system for individual
radiological monitoring after the end of any activity for the outside
worker
(a)
the period covered by the activity;
(b)
an estimate of any effective dose received by the
outside worker (for the period covered by the activity);
(c)
in the event of non-uniform exposure, an estimate
of the equivalent doses in the different parts of the body;
(d)
in the event of an intake of radionuclides, an
estimate of the intake or the committed effective dose.
(1) Medical surveillance of exposed workers shall be
based on the principles that govern occupational medicine generally.
(2)
The medical surveillance of category A workers shall be
BASIC SAFETY STANDARDS FOR IONISING RADIATION
undertaken by an occupational health service. This medical
surveillance shall allow for the state of health of workers under
surveillance to be ascertained as regards their fitness for the tasks
assigned to them. To this end, the occupational health service shall
have access to any relevant information they require, including the
environmental conditions in the working premises.
(3)
Medical surveillance shall include
(a)
a medical examination prior to employment or
classification as a category A worker to determine the worker's
fitness for a post as a category A worker for which the worker
is being considered;
(b)
periodic reviews of health at least once a year, in
order to determine whether the category A workers remain fit
to perform their duties. The nature of these reviews, which can
be performed as many times as an occupational health service
considers necessary, shall depend on the type of work and on
the individual worker's state of health.
(4) An occupational health service may indicate the need for
medical surveillance to continue after cessation of work for as long as
they consider it necessary to safeguard the health of the person
concerned.
Workers shall have one of the following medical
classifications with respect to fitness for work as a category A
worker
(a)
a fit;
(b)
fit, subject to certain conditions;
(c)
unfit.
No worker may be employed or classified for any period
in a specific post as a category A worker if medical surveillance
establishes that the worker is unfit for that specific post.
(1)
Medical records shall be opened for each
category A worker and kept up to date so long as the worker remains
a worker in that category. Thereafter, it shall be retained until the
individual has or would have attained the age of 75 years, but in any
case not less than 30 years after termination of the work involving
exposure to ionising radiation.
(2) The medical record shall include information regarding
the nature of the employment, the results of the medical examinations
prior to employment or classification as a category A worker, the
periodic reviews of health and the record of doses required by
regulation 52.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
In addition to the medical surveillance of exposed
workers provided for in regulation 55, provision is made for any
further action considered necessary by an occupational health service
for the health protection of exposed individuals, such as further
examinations, decontamination measures, urgent remedial treatment or
other actions identified by the occupational health service.
(2) Special medical surveillance shall be performed in each
case where any of the dose limits laid down in regulation 9 has been
exceeded.
(3) Subsequent exposure conditions shall be subject to the
agreement of the occupational health service.
Workers may appeal to the Commission against the
findings and decisions made pursuant to regulations 56, 57 and 59.
(1) The system for individual radiological monitoring
shall afford outside workers equivalent protection to that for exposed
workers employed on a permanent basis by the undertaking.
(2) The undertaking is responsible, either directly or through
contractual agreements with the employer of outside workers, for the
operational aspects of the radiation protection of outside workers that
are directly related to the nature of their activities in the undertaking.
(3)
In particular, as a minimum requirement, the undertaking
shall
(a)
for category A workers entering controlled areas,
check that the outside worker concerned has been passed as
medically fit for the activities to be assigned to the worker;
(b)
check whether the categorisation of the outside
worker is appropriate in relation to the doses liable to be
received within the undertaking;
(c)
for entry into controlled areas, ensure that, in
addition to the basic training in radiation protection the outside
worker has received specific instructions and training in
connection with the characteristics of the workplace and the
conducted activities, in accordance with paragraphs (c) and (d)
of regulation 15(1);
(d)
for entry into supervised areas, ensure that the
outside worker has received working instructions appropriate to
the radiological risk associated with the sources and the
operations involved, as required in paragraph (c) of regulation
47(1);
(e)
ensure that the outside worker has been issued
with the necessary personal protective equipment;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(f)
ensure that the outside worker receives
individual exposure monitoring appropriate to the nature of the
activities, and any operational dosimetric monitoring that may
be necessary;
(g)
ensure compliance with the system of protection
as defined in Part III;
(h)
for entry into controlled areas, ensure or take all
appropriate steps to ensure that after every activity the
radiological data from individual exposure monitoring of each
category A outside worker within the meaning of the
regulation 54(2), are recorded.
(4) Employers of outside workers ensure, either directly or
through contractual agreements with the undertaking, that the
radiation protection of their workers is in accordance with the
relevant provisions of these regulations, in particular by
(a)
ensuring compliance
with
the
system
of
protection as defined in Part III;
(b)
ensuring that the information and training in the
field of radiation protection referred to in paragraphs (a), (b)
and (e) of regulation 15(1), regulations 15(2), 15(3), 15(4) is
provided;
(c)
guaranteeing that their workers are subject to
appropriate assessment of exposure and, for category A
workers, medical surveillance, under the conditions laid down
in regulations 48 and 50 to 59;
(d)
ensuring that the radiological data from the
individual exposure monitoring of each of their category A
workers is kept up to date in the data system for individual
radiological monitoring referred to in paragraph (a) of
regulation 53.
(1) The Secretariat may decide that in exceptional
circumstances evaluated case by case, excluding emergencies, where
a specific operation so requires, authorise individual occupational
exposures of identified workers exceeding the dose limits set out in
regulation 9 provided that such exposures are limited in time,
confined to certain working areas and within the maximum exposure
levels defined for the particular case by the Secretariat. The following
conditions shall be taken into account
(a)
only category A workers as defined in regulation
49 may be subject to such exposures;
(b)
apprentices, students, pregnant workers, and, if
there is a risk of intake or bodily contamination, breastfeeding
workers, are excluded from such exposures;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(c)
the undertaking justifies such exposures in
advance and thoroughly discuss them with the workers, their
representatives, an occupational health service and the radiation
protection expert;
(d)
information about the risks involved and the
precautions to be taken during the operation are provided to the
relevant workers in advance;
(e)
the workers have consented;
(f)
all doses relating to such exposures are separately
recorded in the medical record referred to in regulation 58 and
the individual record referred to in regulation 52.
(2) The exceeding of dose limits as a result of specially
authorised exposures shall not necessarily constitute a reason for
excluding workers from their usual occupation or relocating them,
without their agreement.
(3) The Secretariat shall be informed if the exposure of
spacecraft crew is likely to exceed dose limits and shall ensure that it is
managed as a specially authorised exposure.
(1) Emergency occupational exposures shall remain,
whenever possible, below the values of the dose limits laid down in
regulation 9.
(2) For situations where the above condition is not feasible,
the following conditions shall apply
(a)
reference levels for emergency occupational
exposure shall be an effective dose of 50mSv;
(b)
in exceptional situations, in order to save life,
prevent severe radiation-induced health effects, or prevent the
development of catastrophic conditions, a reference level for an
effective dose from external radiation of emergency workers
shall be 500mSv.
(3) In areas within workplaces, where the radon
concentration (as an annual average), continues to exceed the national
reference level, despite the action taken in accordance with the
principle of optimisation as set out in Part III and taking into account
parameters contained in the national action plan as under point 2 of the
Sixteenth Schedule notification in accordance with regulations 34(4)
and 44(2) shall apply.
(4) In the event of an emergency occupational exposure,
radiological monitoring of emergency workers shall be performed.
Individual monitoring or assessment of the individual doses shall be
carried out as appropriate to the circumstances.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(5) In the event of an emergency occupational exposure,
medical surveillance of emergency workers shall be required, as
defined in regulation 59, to be carried out as appropriate to the
circumstances.
(1)
The national reference level for the annual
average activity concentration for indoor radon concentrations in air
is 300 Bqm -3 for workplaces.
(2)
Radon measurements shall be carried out
(a)
in workplaces within the areas identified by the
Commission in accordance with regulation 127(3), that are
located on the ground floor or basement level or any other
subterranean work places; as well as
(b)
in specific types of workplaces identified in the
national action plan taking into account paragraph 3 of the
Sixteenth Schedule.
(3) In areas within workplaces, where the radon
concentration (as an annual average), continues to exceed the
national reference level, despite the action taken in accordance with
the principle of optimisation as set out in Part III, notification in
accordance with regulations 34(4) and 44(2) shall apply.
Part VII
MEDICAL EXPOSURES
(1)
Medical exposure shall show a sufficient net
benefit, weighing the total potential diagnostic or therapeutic benefits
it produces, including the direct benefits to health of an individual
and the benefits to society, against the individual detriment that the
exposure might cause, taking into account the efficacy, benefits and
risks of available alternative techniques having the same objective
but involving no or less exposure to ionising radiation.
(2) Undertakings shall apply the justification principle
defined in sub-regulation (1) is applied and in particular that
(a)
It is ensured that both the referrer and the
practitioner shall make reference to referral guidelines.
(b)
Undertakings inform and supply supporting
justification documentation to the Commission in advance of
that undertaking adopting any new types of practices involving
medical exposure.
(c)
All individual medical exposures are to be
justified in advance by a practitioner taking into account the
specific objectives of the exposure and the characteristics of
the individual involved.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(d)
Specific individual exposures can be justified,
where appropriate, in special circumstances, to be evaluated by
a practitioner on a case-by-case basis and documented for
practices involving medical exposure that are not justified in
general.
(e)
The referrer and the practitioner, shall seek, to
obtain previous diagnostic information or medical records
relevant to the planned exposure and consider these data to
avoid unnecessary exposure. Repeat of medical exposure is not
justified if the diagnostic information is already available.
(f)
For the justification of any medical exposure for
medical or biomedical research undertakings shall obtain
clearance from the Commission. Prior to the Commission
issuing clearance for any medical exposure for medical or
biomedical research the undertakings shall provide confirmation
that they have obtained clearance from the ethics committee.
(g)
Undertakings shall obtain clearance from the
Commission before any type of health screening is performed.
The Commission shall seek advice from any appropriate
medical scientific societies and health regulatory bodies and
shall make reference to any available internationally accepted
justification norms for screening.
(h)
The exposure of carers and comforters shall show
a sufficient net benefit, taking into account the direct health
benefits to a patient, the possible benefits to the carer /
comforter and the detriment that the exposure might cause.
(i)
Medical radiological procedure for the early
detection of disease on an asymptomatic individual can only be
performed if it is
(i)
part of a health screening programme, or
(ii) requires specific documented justification
for that individual by the practitioner, in consultation with
the referrer, following guidelines from relevant medical
scientific societies and the Commission.
Special attention shall be given to the provision of information
to the individual subject to medical exposure, as required by paragraph
(e) of regulation 68.
(3)
Referrers shall as part of the justification process
(a) ensure and document that the medical exposure of the
patient is warranted based on the medical indications;
(b) make reference to referral criteria;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(c) refer the patient to a practitioner, providing adequate
clinical details;
(d) state on each individual referral the clinical question to
be answered;
(e) where practical, seek, to obtain previous diagnostic
information or medical records relevant to the planned
exposure and consider this data to avoid unnecessary
exposure; and
(f)
seek the outcome of the exposure and act on the result.
(1)
All doses due to medical exposure for
radiodiagnostic, interventional radiology, planning, guiding and
verification purposes are to be kept as low as reasonably achievable
consistent with obtaining the required medical information, taking
into account economic and societal factors.
(2) For all medical exposure of patients for radiotherapeutic
purposes, exposures of target volumes shall be individually planned
and their delivery appropriately verified taking into account that
doses to non-target volumes and tissues shall be as low as reasonably
achievable and consistent with the intended radiotherapeutic purpose
of the exposure.
(3) (a) The Commission shall establish and regularly review
national diagnostic reference levels for radio-diagnostic
examinations, having regard to the current European diagnostic
reference levels where available, and where appropriate, for
interventional radiology procedures, and the availability of
guidance for this purpose.
(b) An undertaking shall ensure that diagnostic reference
levels for their radio-diagnostic examinations, and
where appropriate for interventional radiology
procedures, are established, regularly reviewed and
used, having regard to the national diagnostic
reference levels where available..
(4) For each medical or biomedical research project
involving medical exposure
(a)
the
individuals
concerned
participate
voluntarily;
(b)
these individuals are informed about the risks of
exposure;
(c)
a dose constraint is established for individuals
for whom no direct medical benefit is expected from exposure;
(d)
in the case of patients who voluntarily accept to
undergo an experimental medical practice and who are
expected to receive a diagnostic or therapeutic benefit from
BASIC SAFETY STANDARDS FOR IONISING RADIATION
this practice, the dose levels concerned shall be considered on
an individual basis by the practitioner and/or referrer prior to the
exposure taking place.
(5) Undertakings shall ensure that the optimisation includes
the selection of equipment, the consistent production of adequate
diagnostic information or therapeutic outcomes, the practical aspects
of medical radiological procedures, quality assurance, and the
assessment and evaluation of patient doses or the verification of
administered activities, taking into account economic and societal
factors.
(6)
Undertakings shall ensure that
(a)
a dose constraints of not more than 1.5mSv per
five years is applied exposure of carers and comforters, where
appropriate;
(b)
appropriate guidance is established for the
exposure of carers and comforters.
(7) In the case of a patient undergoing treatment or diagnosis
with radionuclides, the undertaking, shall ensure that the patient or
their representative is provided with information on the risks of
ionising radiation and appropriate instructions with a view to
restricting doses to persons in contact with the patient as far as
reasonably achievable. For therapeutic procedures these shall be
written instructions.
These instructions shall be handed out before leaving the
hospital or clinic.
The undertaking shall entitle individuals to act in the
different aspects of medical exposures by approving these individuals.
The undertaking is responsible to approve any individual whose
work relates to medical exposure. In making such approvals the
undertaking shall ensure that the individual meets the requirements of
the Seventeenth Schedule.
Undertakings shall ensure that
(a)
medical exposures shall take place under the
clinical responsibility of a practitioner;
(b)
in medical radiological practices, a medical
physics expert shall be appropriately involved, the level of
involvement being commensurate with the radiological risk
posed and is given in the Table 1 of the Twentieth Schedule;
(c)
practitioners, medical physics experts and those
entitled to carry out practical aspects of medical radiological
procedures shall be involved in the optimization process;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(d)
referrers and practitioners shall liaise as required
with each another in the justification process of individual
medical exposures;
(e)
wherever practicable and prior to the exposure
taking place, the practitioner and the referrer, is to ensure that
the patient or their representative is provided with adequate
information relating to the benefits and risks associated with
the radiation dose from the medical exposure. Similar
information as well as relevant guidance shall be given to
carers and comforters, in accordance with paragraph (b) of
regulation 66(6).
Practical aspects of medical radiological procedures
may be delegated by the undertaking or the practitioner, as
appropriate, to one or more individuals entitled to act in this respect
in a recognised field of specialization authorised by the Commission
to act in this respect.
Undertaking’s radiation protection programmes shall
include that
(a)
written protocols for every type of standard
medical radiological procedure are established for each
equipment for relevant categories of patients;
(b)
information relating to patient exposure forms
part of the report of the medical radiological procedure;
(c)
referral guidelines for medical imaging, taking
into account the radiation doses, are available to the referrers;
(d)
clinical audits are carried out in accordance to
the national procedures established by the Commission;
(e)
appropriate reviews are undertaken whenever
diagnostic reference levels are consistently exceeded and that
appropriate corrective action is taken without undue delay;
(f)
procedures are in place for
(i)
the correct identification of individuals
to be exposed to ionising radiation;
(ii) making enquiries of females of
childbearing age to establish whether the individual is or
may be pregnant or breastfeeding;
(iii) approval of individuals to act as
referrers, practitioners, and persons performing the
practical aspects;
(iv)
quality assurance;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(v)
the assessment of patient dose and
administered activity;
(vi) medical
and
biomedical
research
programmes including the use of dose constraints;
(vii) giving of information and
written
instructions as referred to in regulation 66(7);
(viii) recording of doses for each medical
exposure including, where appropriate, factors relevant to
patient dose;
(ix) ensuring that the probability and
magnitude of accidental or unintended doses to patients
from radiological practices are reduced as far as
reasonably achievable;
(x)
responding and reporting of incidents and
accidents;
(xi)
record keeping;
(xii) arrangements for monitoring workers and
the workplace;
(xiii) education and training programme on the
nature of the hazards, protection and safety;
(xiv) methods for periodically reviewing and
auditing the performance of the radiation protection
programme;
(xv) any others as required to be able to
demonstrate compliance with these regulations.
(1)
The Commission shall set the training and
recognition requirements, as laid down in regulations 102 and 14, for
the practitioner, the medical physics expert and the individuals referred
to in regulation 69.
(2) Undertakings shall ensure that practitioners and medical
physics experts and the individuals referred to in regulation 69 meet
the requirements of the above sub-regulation (1).
(1) The responsibility to ensure that the equipment is fit for
clinical use resides with the undertaking.
(2) Prior to acquiring medical radiological equipment the
undertaking shall ensure that there is adequate information on the
radiological risks for patients, and on the clinical evaluation of the
its use..
Upon installation of the equipment the supplier/installer
has to perform tests to ensure that all the safety features and warning
BASIC SAFETY STANDARDS FOR IONISING RADIATION
devices of the equipment are functioning. During installation, the
manufacturer’s instructions for use must be followed. These tests
shall be performed whenever new, second hand; refurbished and
relocated equipment has been installed, as well as after major
maintenance has been performed. These test results have to be kept
by the undertaking.
(1)
Acceptance testing must be carried out in
accordance with international standards. The standard to be used
shall be accepted by the Commission.
(2) Acceptance tests need to be carried out on installation or
relocation of equipment.
Testing for performance, equivalent to an acceptance test or
parts thereof shall be carried out
(a)
after major adjustments of functional
parameters, repairs or maintenance have been performed;
(b)
after components or sub-assemblies have been
added, modified, replaced or removed;
(c)
after each time the undertaking has to remove
the equipment from clinical use due to a malfunction or
maintenance that could affect the patient dose;
(d)
if tests show that the equipment has or is
producing doses other than the acceptable levels.
(3) Acceptance test results should be compared to and meet
the manufacturer’s tolerances. In the absence of such, as in the case
of aged equipment then European Union criteria for acceptability
may be used.
(4) After the acceptance testing is carried out, the test
reports and any other relevant documentation has to be passed on the
Secretariat. The Information to be supplied to the Secretariat with
regard to acceptance tests that have been performed is given in the
Eighteenth Schedule
(5) The records for such testing shall be kept for the lifetime
of the equipment.
(6) In order to set up the optimal clinical operation of the
equipment, certain commissioning tests may be required to be
performed, such as setting up exposure protocols.
(1)
Constancy testing must be carried out in
accordance with international standards. The standard to be used
shall be accepted by the Commission.
(2)
Constancy tests are to be performed
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(a)
immediately after an the initial acceptance test has
indicated that the functional performance of the equipment is
satisfactory;
(b)
as often as the standard stipulates but shall not
exceed two years;
(c)
immediately after corrective maintenance that
could effect the radiation output of the equipment or;
(d)
when malfunction of equipment is suspected.
(3) Constancy tests records of shall be kept for three years
from the last date of entry.
The calibration of equipment used for dosimetry of
patients and acceptance or constancy testing shall be traceable to an
accredited standards dosimetry laboratory and shall be routinely re-
calibrated according to its instructions for use. In the absence of any
specified dosimeter re-calibration period, the equipment calibration
period must not exceed a period of two years.
(1)
If tests show that the equipment has or is
producing doses other than the acceptable levels, or a malfunction has
occurred that could affect patient dose, it shall be removed from
clinical use and shall be reported to the Secretariat.
(2) Acceptable levels are deemed the tolerances specified in
the manufacturer’s specifications or the current European Union
Criteria which ever is the most stringent.
(1)
Clearance for the clinical use of the equipment is
required from the Secretariat for all instances specified in regulation
74(2).
(2) Clearance will only be issued after the Secretariat reviews
the acceptance tests required by regulation 74(1).
(1)
The undertaking shall ensure that
(a)
all new equipment has an EC Declaration of
conformity;
(b)
all new equipment has, where practicable, a
device showing the quantity of the radiation produced by the
equipment;
(c)
an up to date inventory of radiological equipment
for each radiological installation is available;
(d)
When radiological equipment is not being used it
must be left in a safe and secure condition and when it is in use
it must be kept under strict surveillance regarding radiation
BASIC SAFETY STANDARDS FOR IONISING RADIATION
protection;
(e)
when in use the equipment must be adequately
supervised to ensure an adequate level of radiation protection;
(f)
appropriate routine maintenance is performed (in
line with manufactures recommendations);
(g)
appropriate quality assurance programmes are in
place, including a schedule for testing the equipment;
(h)
appropriate quality assurance programmes for
assessing patient dose or administered activity;
(i)
suitable measures are taken to
improve
inadequate or defective features of the equipment;
(j)
that there are suitable measures for putting
equipment into clinical use and removal from clinical use;
(k)
there is clear allocation of responsibilities for
who can declare that the equipment is fit/unfit for clinical use;
(l)
adopt specific criteria of acceptability for
equipment in order to indicate when appropriate remedial
action is necessary, including, if appropriate, taking the
equipment out of service;
(m)
reasonably steps to prevent failure of radiation
equipment where such failure could result in exposure of
patients to ionising radiation greater than intended;
(n)
on becoming aware of defects in equipment
during use, the undertaking assesses in consultation with the
supplier (or where relevant the service agent or original
manufacturer) and the medical physics expert, if appropriate,
whether any further action is necessary;
(o)
shall have a contingency plan for responding to
equipment failures or malfunction. Following equipment
failure and subsequent repair, the undertaking should consider
the likelihood and consequences of recurrence before returning
the equipment to clinical use.
(2) If the equipment is going to be taken out of clinical use,
with no intention of scrapping, then the undertaking shall remain
responsible for that equipment and if the equipment is sold, leased or
given to another approved undertaking, than the Secretariat shall be
notified prior to this happening.
Specific requirements for certain equipment
(a)
the use of fluoroscopy equipment without a
device to automatically control the dose rate, or without an
BASIC SAFETY STANDARDS FOR IONISING RADIATION
image intensifier or equivalent device, is prohibited.
(b)
equipment used for external beam radiotherapy
with a nominal beam energy exceeding 1 MeV has a device to
verify key treatment parameters. Equipment installed prior to 6
February 2018 may be exempted from this requirement.
(c)
any equipment used for interventional radiology
has a device or a feature informing the practitioner and those
carrying out practical aspects of the medical procedures of
quantity of radiation produced by the equipment during the
procedure. Equipment installed prior to 6 February 2018 may be
exempted from this requirement.
(d)
any equipment used for interventional radiology
and computed tomography and any new equipment used for
planning, guiding and verification purposes has a device or a
feature informing the practitioner, at the end of the procedure, of
relevant parameters for assessing the patient dose.
(e)
equipment used for interventional radiology and
computed tomography has the capacity to transfer the
information required under 3(d) to the record of the
examination. Equipment installed prior to 6 February 2018 may
be exempted from this requirement.
(f)
without prejudice to paragraphs (c), (d) and (e),
new medical radiodiagnostic equipment producing ionising
radiation has a device, or an equivalent means, informing the
practitioner of relevant parameters for assessing the patient
dose. Where appropriate, the equipment shall have the capacity
to transfer this information to the record of the examination.
(1)
Appropriate medical radiological equipment,
practical techniques and ancillary equipment shall be used in medical
exposure
(a)
of children;
(b)
as part of a health screening programme;
(c)
involving high doses to the patient, which may be
the case in interventional radiology, nuclear medicine,
computed tomography or radiotherapy.
(2) Special attention shall be given to quality assurance
programmes and the assessment of dose or verification of administered
activity for these practices.
(3) Practitioners and those individuals referred to in
regulation 69 who perform the exposures referred to in sub-regulation
(1) shall obtain appropriate training on these medical radiological
practices as required by regulation 18.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(1)
The referrer and the practitioner, shall inquire, as
whether the individual subject to medical exposure is pregnant or
breastfeeding, unless it can be ruled out for obvious reasons or is not
relevant for the radiological procedure.
(2) If pregnancy cannot be ruled out and depending on the
medical radiological procedure, in particular if abdominal and pelvic
regions are involved, special attention shall be given to the
justification, particularly the urgency, and to the optimisation, taking
into account both the expectant individual and the unborn child.
(3) In the case of a breastfeeding individual, in nuclear
medicine, depending on the medical radiological procedure, special
attention shall be given to the justification, particularly the urgency,
and to the optimisation, taking into account both the individual and
the child.
(4) Without prejudice to sub-regulations 1, 2 and 3,
undertakings shall take measures to increase the awareness of
individuals to whom this regulation applies, through measures such
as public notices in appropriate places.
Undertakings shall ensure that
(a)
all reasonable measures are taken to minimise
the probability and magnitude of accidental or unintended
exposures of individuals subject to medical exposure;
(b)
for radiotherapeutic practices the quality
assurance programme includes a study of the risk of accidental
or unintended exposures;
(c)
for all medical exposures that appropriate system
for the record keeping and analysis of events involving or
potentially involving accidental or unintended medical
exposures, commensurate with the radiological risk posed by
the practice;
(d)
arrangements are made to inform the referrer and
the practitioner, and the patient, or their representative, about
clinically significant unintended or accidental exposures and
the results of the analysis;
(e)
declares within two days to the Secretariat the
occurrence of medical exposures much greater than intended
and other significant events as defined in the Nineteenth
schedule;
(f)
the results of the investigation and the corrective
measures to avoid such events are reported to the Secretariat
within one week;
(g)
mechanisms are in place for the timely
BASIC SAFETY STANDARDS FOR IONISING RADIATION
dissemination of information, relevant to radiation protection in
medical exposure, regarding lessons learned from significant
events.
Undertakings shall ensure that the distribution of
individual dose estimates from medical exposure for radiodiagnostic
and interventional radiology purposes is determined, taking into
consideration the age and gender of the exposed and that this
information is made available to the Secretariat.
PART VIII
PUBLIC EXPOSURES
(SECTION 1)
PROTECTION OF MEMBERS OF THE PUBLIC AND LONG-
TERM HEALTH PROTECTION IN NORMAL CIRCUMSTANCES
(1) Undertakings shall take such measures as are necessary
to ensure the operational protection of members of the public in
normal circumstances having regard to the relevant provisions of
these regulations.
(2) For the purposes of these regulations, "operational
protection of members of the public" means, in normal
circumstances, all arrangements and surveys for detecting and
eliminating the factors which, in the course of any operation, may
result in actual or potential exposure to members of the public
exceeding the relevant dose constraint such that the exposure from
any one practice is not liable to exceed 0.25mSv in a year.
(3) For relevant activities, the Commission shall before
granting a registration or a licence in respect of a practice or
amending any condition attached to a registration or specified in a
licence, o r acce ptance into se rvice of a f acility, require the
undertaking to submit to it for examination and approval
(a) the proposed siting of the workplaces from a radiation
protection point of view, taking into account relevant
demographic, meteorological, geological, hydrological
and ecological conditions;
(b) a statement of planned arrangements to ensure adequate
protection against any exposure or radioactive
contamination liable to extend beyond the perimeter of
the workplaces or radioactive contamination liable to
extend to the ground beneath the facility;
(c) pursuant to regulation 87, plans for the discharge of
radioactive effluents;
(d) the results of a screening assessment of the doses liable
to be received by the population as a result of any
practice carried out by it; and
(e) a statement of planned measures to control the access of
members of the public to the facility.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(4) The Commission shall, pursuant to regulation 87, where
appropriate, establish limits and conditions on the quantities of
radionuclides discharged to air or water during a specified period,
which shall take into account
(a) the results of the optimisation of radiation protection;
(b) good practice in the operation of similar facilities; and
(c) where appropriate, results of generic screening
assessment based on internationally recognised
scientific guidance, where such an assessment has
been required by the Commission..
(1)
Undertakings shall estimate doses to members of
the public (which excludes occupational and medical doses) from
their practices.
(2) Undertakings shall provide the following information
with regard to public doses
(a)
An estimate of public doses prior to the
commencement of the practice.
(b)
Initial measurements of the relevant parameters
to confirm their estimate given, above once the practice is
functioning.
(c)
Results of routine re-assessments
and
measurements of the relevant parameters are performed.
(3)
The Secretariat shall in particular
(a)
decide on a reasonable extent of surveys to be
conducted and information to be taken into account in order to
identify the representative person, taking into account the
effective pathways for transmission of the radioactive
substances;
(b)
decide on a reasonable frequency of monitoring
of the relevant parameters as determined in paragraph (a);
(c)
ensure that the estimates of doses to the
representative person include
(i)
assessment of the doses due to external
radiation, indicating, where appropriate, the type of the
radiation in question;
(ii) assessment
of
the
intake
of
radionuclides, indicating the nature of the radionuclides
and, where necessary, their physical and chemical states,
and determination of the activity concentrations of these
radionuclides in food and drinking water or other
relevant environmental media;
(iii)
assessment
of
the
doses
that
the
BASIC SAFETY STANDARDS FOR IONISING RADIATION
representative person, as identified in paragraph (a), is
liable to receive;
(d)
require records relating to measurements of
external exposure and contamination, estimates of intakes of
radionuclides, and the results of the assessment of the doses
received by the representative person to be kept and be made
available on request to all stakeholders.
(1)
Pursuant to regulation 37(f), undertakings who
wish to discharge radioactive effluents shall apply to the Secretariat for
a discharge license.
(2) Undertakings shall provide to the Secretariat an estimate
of doses to individuals from the proposed discharges using generic
screening assessment based on internationally recognised scientific
guidance as part of their application for a discharge license.
(3) The Secretariat shall examine and approve plans for the
discharge of radioactive effluents and issue a discharge license.
(4) The Secretariat shall where appropriate establish
authorised limits as part of the discharge license and conditions for
discharging radioactive effluents which shall
(a)
take into account the results of the optimisation of
radiation protection;
(b)
reflect good practice in the operation of similar
facilities.
(5)
The Secretariat shall require the undertaking
responsible for practices where a discharge authorisation is
granted to monitor appropriately or where appropriate evaluate
the radioactive airborne or liquid discharges into the
environment in normal operation and to report the results
annually to the Secretariat.
Undertaking shall carry out the following tasks
(a)
achieve and maintain an optimal level of
protection of members of the public;
(b)
accept into service adequate equipment and
procedures for measuring and assessing exposure of members of
the public and radioactive contamination of the environment;
(c)
check the effectiveness and maintenance of
equipment as referred to in paragraph (b) and ensure the annual
recalibration of measuring instruments;
(d)
seek advice from a radiation protection expert in
the performance of the tasks referred to in paragraphs (a), (b)
BASIC SAFETY STANDARDS FOR IONISING RADIATION
and (c).
(SECTION 2)
EMERGENCY EXPOSURE SITUATIONS
(1)
The Commission shall develop and maintain the
national radiological emergency plan referred to in Article 31 of the
Act in consultation with the Civil Protection Department.
(2) The national radiological protection plan shall be
developed following a national radiological hazard assessment that
shall be performed by the Commission.
(3)
The national radiological protection plan shall be tested
at appropriate intervals.
(1)
Undertakings are to notify either the Secretariat
or the Civil Protection Department immediately of any emergency in
relation to the practices for which it is responsible and to take all
appropriate action to reduce the consequences.
(2) Undertakings shall make an initial provisional
assessment of the circumstances and consequences of the emergency
and assist with protective measures.
(3) Undertakings shall ensure that provision is made for
protective measures with regard to
(a)
the radiation source, to reduce or stop the
radiation, including the release of radionuclides;
(b)
the environment, to reduce the exposure to
individuals resulting from radioactive substances through
relevant pathways;
(c)
individuals, to reduce their exposure.
(1)
In the event of an emergency on or outside
Maltese territory, the Commission shall
(a)
work with the civil protection authorities to
organise the appropriate protective measures, taking account of
the real characteristics of the emergency and in accordance with
the optimised protection strategy as part of the national
radiological emergency plan referred to in regulation 89,
whereby the elements to be included in an emergency response
plan are indicated in Section B of the Tenth Schedule;
(b)
coordinate the recovery of any radioactive
material;
(c)
advice on the termination of nuclear or
radiological emergency and the transition to normal activities;
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(d)
assess and record the consequences of the
emergency and of the effectiveness of the protective measures.
(2) Undertakings shall have appropriate emergency
preparedness and response procedures in place as indicated in the
Tenth Schedule.
If the situation so requires, ensure that provision is made
to organise the medical treatment of those affected by the Ministry of
Health with the Secretariat providing any required advice.
(1)
Secretariat shall ensure that the members of the
public likely to be affected in the event of an emergency are given
information about the health protection measures applicable to them
and about the action they should take in the event of such an
emergency.
(2) The information supplied shall include at least the
elements set out in Section A of the Eleventh Schedule.
(3) The information shall be communicated to the members
of the public referred to in sub-regulation (1) without any request
being made.
(4) The Commission shall ensure that the information is
updated and distributed at regular intervals and whenever significant
changes take place. This information shall be permanently available to
the public.
(1)
The Secretariat and Civil Protection Department
shall ensure that, when an emergency occurs, the members of the
public actually affected are informed without delay about the facts of
the emergency, the steps to be taken and, as appropriate, the health
protection measures applicable to these members of the public.
(2) The information provided shall cover those paragraphs
listed in Section B of the Eleventh Schedule which are relevant to the
type of emergency.
(SECTION 3)
EXISTING EXPOSURE SITUATION
(1)
The Commission shall ensure that the National
Radioactivity Monitoring Programme is maintained.
(a)
In connection with the National Radioactivity
Monitoring Programme
(b)
The Commission shall ensure that the appropriate
government entities have an environmental monitoring
programme for ionizing radiation and radioactivity, as part of
the National Radioactivity Monitoring Programme, and in doing
BASIC SAFETY STANDARDS FOR IONISING RADIATION
so take into consideration any recommendations from the
European Commission. The minimum elements of the national
monitoring programme are given in the Table 1 of the Twenty
First Schedule.
(c)
Entities performing the monitoring for the
National Radioactivity Monitoring Programme shall enter into
a formal arrangement with the Commission for the provision
of the result data.
(d)
The entity performing the monitoring and the
Commission shall review the results.
(e)
The Commission shall collate the results and
send them to European Commission as required.
(f)
The Commission shall Produce an annual report
of the results which may be made public.
(2) The Secretariat shall require undertakings to perform
environmental monitoring as appropriate in connection with their
practices.
(1) The Commission shall ensure that optimised
protection strategies for managing contaminated areas shall
include, where applicable, the following
(a)
objectives, including long-term goals pursued by
the strategy and corresponding reference levels, in accordance
with regulation 7;
(b)
delineation of the affected areas
and
identification of the affected members of the public;
(c)
consideration of the need for and extent of
protective measures to be applied to the affected areas and
members of the public;
(d)
consideration of the need to prevent or control
access to the affected areas, or to impose restrictions on living
conditions in these areas;
(e)
assessment of the exposure of different groups in
the population and assessment of the means available to
individuals for controlling their own exposure.
(2) For areas with long-lasting residual contamination the
Commission shall consult entities that have responsibilities for land
use planning, land ownership, environmental protection and public
health and shall advise the government on allowing habitation and
the resumption of social and economic activities, to ensure that
arrangements are in place, as necessary, for the ongoing control of
exposure with the aim of establishing living conditions that can be
considered as normal, including
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(a) establishment of appropriate reference levels;
(b) establishment of an infrastructure to support continuing
self-help protective measures in the affected areas, such
as information provision, advice and monitoring;
(c) if appropriate, remedial measures;
(d) if appropriate, delineated areas.
(1)
The reference level for the annual average activity
concentration in air shall is 300 Bq m -3 .
(2) Under the national action plan referred to in regulation
127, The Commission shall promote action to identify dwellings, with
radon concentrations (as an annual average) exceeding the reference
level and encourage, where appropriate by technical or other means,
radon concentration-reducing measures in these dwellings.
(3) The Commission shall ensure that national information is
made available on indoor radon exposure and the associated health
risks, on the importance of performing radon measurements and on the
technical means available for reducing radon concentrations.
(1)
The reference level applying to indoor external
exposure to gamma radiation emitted by building materials, in addition
to outdoor external exposure, shall be 1mSv per year.
(2)
For building materials which are identified by the
Commission as being of concern from a radiation protection point of
view, taking into account the indicative list of materials set out in the
Twelfth Schedule with regard to their emitted gamma radiation, the
Commission shall consult with the entity responsible for placing
materials on the market in order that, before such materials are placed
on the market
(a)
the activity concentrations of the radionuclides
specified in the Seventh Schedule are determined, and that,
(b)
information to the Commission on the results of
measurements and the corresponding activity concentration
index, as well as other relevant factors, as defined in the Seventh
Schedule are provided if requested.
(3) For types of building materials identified in accordance
with sub-regulation (2) which are liable to give doses exceeding the
reference level, the Commission consults the entity responsible for
building and construction on appropriate measures, which may include
specific requirements in relevant building codes or restrictions on the
envisaged use of such materials.
(3) For types of building materials identified in accordance
with sub-regulation (2) which are liable to give doses exceeding the
reference level, The Commission shall decide on appropriate
measures, which may include specific requirements in relevant
BASIC SAFETY STANDARDS FOR IONISING RADIATION
building codes or restrictions on the envisaged use of such materials.
Part IX
RESPONSIBILITIES AND OTHER ELEMENTS OF
REGULATORY CONTROL
(SECTION 1)
GENERAL RESPONSIBILITIES OF UNDERTAKINGS
Undertakings shall promote a safety culture within its
organisation.
(1)
Undertakings
shall
establish
a
radiation
protection programme.
The radiation protection programme may form part of the
undertakings wider quality assurance programme.
(2)
The radiation protection programme shall be
(a)
commensurate to the
complexity
and
radiological safety and security risks;
(b)
take into account the prior safety assessment
pursuant to regulation 101;
(c)
take into account all the relevant provisions of
these regulations;
(d)
documented;
(e)
subject to periodic review by the undertaking;
(f)
made available as appropriate to employees of
the undertaking and
(g)
made available at the request of the Secretariat.
(3) The radiation protection programme shall indicate the
assignment of responsibilities of safety within the undertaking. The
undertaking shall be able to demonstrate leadership in radiation
safety matters at the highest levels in an organization.
(4) Undertakings shall record any report received from a
worker that identifies any radiological safety concerns or and shall
take appropriate action
(1) It is the responsibility of the undertaking to ensure that
a p p r o p r i a t e s a f e t y a s s e s s m e nt / s a r e p e r f o r m e d . T h e s a f e t y
assessment shall
(a) identify ways in which potential exposures or
accidental and unintended medical exposures could
BASIC SAFETY STANDARDS FOR IONISING RADIATION
occur;
(b) estimate, to the extent practicable, the probabilities and
magnitude of potential exposures;
(c) assess the quality and extent of protection and safety
provisions, including engineering features, as well as
administrative procedures;
(d) define the
operational
limits
and
conditions
of
operation.
(2) Before an undertaking commences a new practice or work
activity in which no safety assessment has been made, a suitable and
sufficient assessment shall be made.
(3) When carrying out safety assessments undertakings, shall
give adequate consideration to
(a)
That prior to performing the assessment the
undertaking shall have the necessary expertise and data
available.
(b)
The manner in which all practices that can effect
workers and any other persons that give rise to radiation risks.
(c)
That the primary purpose of the safety assessment
is to
(i)
Determine whether there is an adequate
level of radiation safety has or will be achieved.
(ii) Determine that the safety objectives
established by the designer have been achieved.
(iii) Determine that the safety objectives of the
undertakings have been achieved.
(iv) Determine that the operation is in
compliance with the obligations on the undertaking as
laid down in these regulations
(d)
The assessment of the site characteristics.
(e)
The identification and assessment of risks.
(f)
The specification and assessment of safety
functions.
(g)
The determination of whether adequate safety
measures are in place.
(h)
The determination of the adequacy of engineering
aspects.
(i)
The assessment of how human interactions can
BASIC SAFETY STANDARDS FOR IONISING RADIATION
effect safety.
(j)
The assessment of safety over the lifetime of a
facility or activity.
(k)
If defense in depth is used, the assessment shall
determine whether adequate provisions have been made at
each of the levels of protection.
(l)
If the facility or practise has different
operational states, then the performance of the facility or
activity needs to be assessed in the safety analysis, including,
if necessary, the post-operational phase.
(m)
Any calculation methods used in the safety
analysis shall undergo verification and validation.
(4)
Once the assessment is carried out
(a)
The results and findings of the safety assessment
shall be documented.
(b)
The undertaking shall consider the need to carry
out an independent verification of the safety assessment before
it is used by the operating organization or submitted to the
Secretariat.
(c)
The results of the safety assessment shall be
used to specify the programme for maintenance, surveillance
and inspection; to specify the procedures to be put in place for
all operational activities significant to safety, and for
responding to anticipated operational occurrences and
accidents; to specify the necessary competences for the staff
involved in the facility or activity; and to make decisions in an
integrated, risk informed approach.
(d)
The safety assessment shall be periodically
reviewed and updated.
(5) Where the assessment made for the purposes of this
regulation shows that a radiation risk to workers or other persons
exists from an identifiable radiation accident, the undertaking shall
take all reasonably practicable steps to-
(a)
prevent any such accident;
(b)
limit the consequences of any such accident
which does occur; and
(c)
provide workers with the appropriate
information, instruction and training, and with the equipment
necessary to restrict their exposure to ionising radiation.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(SECTION 2)
INSTITUTIONAL INFRASTRUCTURE
(1)
The Commission has the responsibility to
recognize
(a)
occupational health services;
(b)
dosimetry services;
(c)
radiation protection experts;
(d)
medical physics experts;
(e)
training organizations or individuals referred to in
regulation 14;
(f)
technical service providers.
(2) Commission shall make available the criteria required for
recognition for services or experts given in sub-regulation (1).
(3) Commission shall issue approval certificates for the
entities referred to in sub-regulation (1) and approval certificates shall
be time limited and may specify limitations.
(4) The Commission shall endeavour to ensure that the
necessary arrangements are in place to ensure the continuity of
expertise of these services and experts.
The Commission shall ensure that occupational health
services perform medical surveillance of exposed workers, in
accordance with Part VI, with regard to their exposure to ionising
radiation and their fitness for the tasks assigned to them involving
work with ionising radiation.
Dosimetry services shall determine internal or external
doses to exposed workers subject to individual monitoring, in order to
record the dose in cooperation with the undertaking and in the case of
outside workers, the employer of the outside worker, and where
relevant the occupational health service.
(1) A radiation protection expert is to give competent
advice to the undertaking on matters relating to compliance with
applicable legal requirements, in respect of occupational and public
exposure.
(2) The advice of the radiation protection expert shall cover,
where relevant, but not be limited to, the following
(a)
requirements
of
a
radiation
protection
BASIC SAFETY STANDARDS FOR IONISING RADIATION
programme;
(b)
development of safety culture;
(c)
optimisation and establishment of appropriate
dose constraints;
(d)
plans for new installations and the acceptance
into service of new or modified radiation sources in relation to
any engineering controls, design features, safety features and
warning devices relevant to radiation protection;
(e)
categorisation of controlled and supervised areas
(f)
classification of workers;
(g)
workplace
and
individual
monitoring
programmes and related personal dosimetry;
(h)
appropriate
radiation
monitoring
instrumentation;
(i)
quality assurance;
(j)
environmental monitoring programme;
(k)
arrangements
for
radioactive
waste
management;
(l)
arrangements for prevention of accidents and
incidents;
(m)
preparedness
and
response
in
emergency
exposure situations;
(n)
training and retraining programmes for exposed
workers;
(o)
investigation and analysis of accidents and
incidents and appropriate remedial actions;
(p)
employment
conditions
for
pregnant
and
breastfeeding workers;
(q)
preparation of appropriate documentation
required under the radiation protection programme such as
prior safety assessments and written procedures.
(3) The radiation protection expert shall, where appropriate,
liaise with the medical physics expert.
(4) The radiation protection expert may be assigned by the
undertaking the performance of the tasks of radiation protection of
workers and members of the public.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(5) Where a radiation protection expert is consulted pursuant
to the requirements of these regulations the undertaking shall appoint
that radiation protection expert in writing and shall include in that
appointment the scope of the advice which the radiation protection
expert is required to give.
(1) Radiation protection experts need to be recognized by
the Commission and will need to meet the following generic criteria
(a)
have a degree in radiation protection, physics,
engineering, mathematics, radiography or a suitable
combination of other qualifications and experience; and
(b)
sufficient work experience directly concerned
with radiation protection practice; and
(c)
undertake continued professional development.
(2) The Commission shall issue detailed requirements for
different applications based on the generic criteria given in the above.
(3) Radiation protection experts shall need re-certification by
the Commission.
(1)
Medical physics experts are to act or give
specialist advice, as appropriate, on matters relating to radiation
physics for implementing the requirements set out in Part VII and in
paragraph (b) of regulation 31(1).
(2) Depending on the medical radiological practice, the
medical physics expert shall take responsibility for dosimetry,
including physical measurements for evaluation of the dose delivered
to the patient and other individuals subject to medical exposure, give
advice on medical radiological equipment, and contribute in particular
to the following
(a)
radiation protection programme;
(b)
development of safety culture;
(c)
optimisation of the radiation protection of patients
and other individuals subject to medical exposure, including the
application and use of diagnostic reference levels;
(d)
the definition and performance of quality
assurance programmes of the medical radiological equipment;
(e)
testing of medical radiological equipment;
(f)
the preparation of technical specifications for
medical radiological equipment and installation design;
(g)
the surveillance of the medical radiological
BASIC SAFETY STANDARDS FOR IONISING RADIATION
installations;
(h)
the analysis of events involving, or potentially
involving, accidental or unintended medical exposures;
(i)
the selection of equipment required to perform
radiation protection measurements;
(j)
the training of practitioners and other staff in
relevant aspects of radiation protection.
(3) The medical physics expert shall, where appropriate,
liaise with the radiation protection expert.
The Commission shall issue approval certificates for
medical physics experts for a validity period of not greater than a
period of five years in a specialty (radiotherapy, nuclear medicine,
diagnostic and interventional radiology)
(1) Medical physics experts shall meet the following
criteria for initial certification by the Commission
(a) be registered by the Council for the Professions
complimentary to Medicine in Malta as a medical
physicist; and
(b) two (2) years documented full time work experience,
within the preceding twenty-eight (28) months, in
specialty (radiotherapy, nuclear medicine, diagnostic
and interventional radiology) with documented
Continuous Professional Development..
(2) Medical physics experts shall meet the following criteria
for re-certification by the Commission
(a)
48 months full time work experience in their
specialty during the valid approval period, but not necessary
48 consecutive months.
(b)
Documented CPD since the last certificate
issued.
(1)
All undertakings and employers of outside
workers shall designate a radiation protection officer.
(2) Undertakings and employers of outside workers shall
provide the radiation protection officers with the means necessary for
them to carry out their tasks.
(3) The radiation protection officer shall report directly to
the undertaking/and employers of outside workers.
(4) The undertaking is to ensure that the radiation protection
officer has sufficient training.
(1)
Radiation protection officers are to assist the
BASIC SAFETY STANDARDS FOR IONISING RADIATION
undertaking in the execution of its radiation protection programme.
(2) The undertaking shall specify the specific roles of the
radiation protection officer. The radiation protection officer may be
assigned to perform aspects of the radiation protection programme or
may have a supervisory role of some or all aspects of the programme.
(3) The task of the radiation protection officer may be carried
out by a radiation protection unit established within an undertaking or
by a radiation protection expert.
(SECTION 3)
CONTROL OF RADIOACTIVE SOURCES
(1)
The Secretariat shall specify in a license the
arrangements for use of unsealed sources. The Secretariat shall specify
in a separate discharge license conditions with regard to storage,
disposal and discharge to the environment of unsealed sources.
(2) The undertaking shall, as appropriate and to the extent
possible, keep records of unsealed sources under its responsibility,
including location, transfer, disposal and discharge to the environment.
The Secretariat shall require undertakings to notify it of discharges
from its facility on an annual or more frequent basis, as specified in
their appropriate license.
(3) Undertakings holding an unsealed radioactive source to
notify the Secretariat promptly of any loss, theft, significant spill, or
unauthorised use or release.
(1)
The Secretariat shall specify in a license the
arrangements for keeping control of sealed sources with regard to their
location, use, storage and, when no longer required, their recycling or
disposal.
(2) Undertakings shall keep records of all sealed sources
under its responsibility, including location, transfer and disposal.
(3) Undertakings shall give the Secretariat 30 days notice of
the intent to transfer any sealed source and shall not perform any
transfer until clearance is given by the Secretariat.
(4) Undertakings shall notify the Secretariat promptly of any
loss, significant leakage, theft or unauthorised use of a sealed source.
(1)
Undertakings shall obtain a prior license from the
Secretariat for any practice involving a high activity source, including
taking possession of a source.
(2)
The Commission shall require that adequate provision, by
way of a financial security or any other equivalent means appropriate to
the source in question, having been made for the safe management of
BASIC SAFETY STANDARDS FOR IONISING RADIATION
sources when they become disused sources, including the case where
the holder becomes insolvent or goes out of business
(3)
The radiation protection progamme shall address the
following issues, which are in addition to the general licensing
requirements set out in Part V, shall be provided to the Commission
when applying for a license
(a)
the safe and secure management of sources;
(b)
disused sources, including agreements regarding
the transfer, if appropriate, of disused sources to a supplier,
another licensee;
(c)
assignment
of
responsibilities
within
the
undertaking;
(d)
provision of minimum
staff
competencies,
including information and training;
(e)
obtaining the minimum source, source container
and additional equipment performance criteria;
(f)
emergency procedures and communication links;
(g)
work procedures to be followed;
(h)
maintenance
of
equipment,
sources
and
containers;
(i)
adequate management of disused sources,
including agreements regarding the transfer, if appropriate, of
disused sources to a supplier, another authorised holder or a
recognised installation;
(j)
developed a security plan or assessment including
measures to detect and delay the unauthorised access to, or the
theft, loss or unauthorised use or removal of radioactive sources
during all stages of management. The degree of security
required, shall be dependent on the security level as laid out in
the three columns of Table 1 of the Second Schedule. Security
measures for the different security levels are given in Table 1 in
the Fourteenth Schedule. The security plan or assessment shall
be periodically reviewed and records of such reviews kept;
(k)
minimum performance criteria and maintenance
requirements for equipment and systems used to ensure the
safety and security of radioactive sources;
(l)
measures to determine, as appropriate, the
trustworthiness of individuals involved in the management of
radioactive sources; and
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(m) the confidentiality of information relating to the
security of sources;
(n)
any other specific requirement that the Commission
may require.
(4)
Each undertaking in possession of high activity sealed
sources shall
(a)
ensure that suitable tests, such as leak tests based
on international standards, are undertaken every 14 months in
order to check and maintain the integrity of each source;
(b)
carry out verification that each source and, where
relevant, the equipment containing the source, is still present and
in apparently good condition at its place of use or of storage.
Verification frequency shall be as listed in Table 1 in the
Fourteenth Schedule;
(c)
ensure that each fixed and mobile source is subject
to adequate documented measures, such as written protocols and
procedures, aimed at preventing unauthorised access to or loss or
theft of the source or its damage by fire;
(d)
promptly notify the Secretariat of any loss, leakage,
theft or unauthorised use of a source, arrange for a check on the
integrity of each source after any event, including fire, that may
have damaged the source and, if appropriate, inform the Board
thereof and of the measures taken;
(e)
return each disused source to the supplier or place it
in a facility for long term storage or disposal or transfer it to
another authorised undertaking unless otherwise agreed by the
Commission, without undue delay after termination of the use;
(f)
ascertain that, before a transfer is made, the
recipient holds appropriate license;
(g)
promptly notify the Secretariat of any incident or
accident resulting in unintentional exposure of a worker or a
member of the public.
(5)
Each undertaking in possession of high activity sealed
sources shall in connection for training and information ensure
(a)
includes specific requirements for the safety and
security of the management of sources;
(b)
contain specific information on possible
consequences of the loss of adequate control of sources;
(c) repeated at regular intervals and documented, with a view
to preparing the relevant workers adequately for such events, be
BASIC SAFETY STANDARDS FOR IONISING RADIATION
addressed to exposed workers.
(6) The Commission shall review the radiation protection
programme at the authorisation stage and may impose specific
conditions involving the use of high activity sources in any licence
that may be issued.
(1)
The undertaking shall keep records for high-
activity sealed sources which shall include the information set out in
the Thirteenth Schedule.
(2) The undertaking shall provide the Secretariat with an
electronic or written copy of all relevant parts of the records referred
to in sub-regulation (1)
(a)
without undue delay, at the time of the
establishment of such records, which should be as soon as
possible after the source is acquired,
(b)
by the 31st of January of every year,
(c)
if the situation indicated on the information
sheet has changed,
(d)
without undue delay on the closure of the
records for a specific source when the holder no longer holds
this source; in this case the name of the holder or recognised
installation to which the source is transferred shall be
included,
(e)
without undue delay on the closure of such
records when the holder no longer holds any sources, and
(3) The undertaking’s records shall be available for
inspection by the Secretariat.
(1)
The manufacturer or supplier shall ensure that
(a)
Each high-activity sealed source is identified by
a unique number. This number shall be engraved or stamped
on the source, where practicable.
The number shall also be engraved or stamped on the
source container. If this is not feasible, or in the case of
reusable transport containers, the source container shall, at
least, bear information on the nature of the source.
(b)
The source container and, where practicable, the
source are marked and labelled with an appropriate sign to
warn people of the radiation hazard.
(2) The manufacturer shall provide a photograph of each
manufactured source design type and a photograph of the typical
source container.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(3) The undertaking shall ensure that each high-activity
sealed source is accompanied by written information indicating that
the source is identified and marked in compliance with sub-regulation
(1) and that the markings and labels referred to in sub-regulation (1)
remain legible. The information shall include photographs of the
source, source container, transport packaging, device and equipment as
appropriate.
(SECTION 4)
ORPHAN SOURCES
(1)
The Commission shall ensure that arrangements
are made for
(a)
raising general awareness of the possible
occurrence of orphan sources and associated hazards; and
(b)
issuing guidance for persons who suspect or have
knowledge of the presence of an orphan source and on the
actions to be taken.
(2) The Commission shall encourage the establishment of
systems aimed at detecting orphan sources at metal recycling
installations, waste handling installations and at ports of entry to Malta
(3) The Secretariat shall provide specialised technical advice
and assistance promptly to persons who suspect the presence of an
orphan source and who are not normally involved in operations subject
to radiation protection requirements.
(1)
The
Commission
shall
encourage
the
establishment of systems to detect the presence of radioactive
contamination in metal products at Maltese ports.
(2) Scrap recycling installations and operators of monitoring
equipment at ports shall promptly inform the Secretariat if they suspect
or have knowledge of any contaminated material or radioactive source
at their facility. Any contaminated material or radioactive source shall
not be used, placed on the market, transported or disposed of without
the involvement of the Secretariat.
(1)
The national radiological emergency plan, as set
out in regulation 122 shall include provisions for the assignment of
responsibilities, to control and recover orphan sources and to deal with
emergencies due to orphan sources.
(2) The Secretariat shall investigate as appropriate any past
facilities that may have used sources that are not on the national
inventory of sources. Any orphan sources discovered shall be brought
under regulatory control.
The Commission shall obtain the costs of recovering,
BASIC SAFETY STANDARDS FOR IONISING RADIATION
managing, controlling and disposing of the sources from the
government which may result from implementation of regulation
118. (SECTION 5)
SIGNIFICANT EVENTS
Undertaking shall
(a)
implement, as appropriate, a recording and
analysis system of significant events involving or potentially
involving accidental or unintended exposures;
(b)
promptly notify the Secretariat of the occurrence
of any significant event resulting or liable to result in the
exposure of an individual beyond the operational limits or
conditions of operation specified in authorising requirements
with regard to occupational or public exposure or as defined
by the Commission for medical exposure, including the results
of the investigation and the corrective measures to avoid such
events.
(1)
The Commission, shall, working closely with
Civil Protection, develop emergency management systems. These
systems shall be integrated in the national radiological emergency
plan. The national radiological emergency plan shall include the
elements listed in the Tenth Schedule.
(2) The national radiological emergency plan shall take into
account the risks identified in the national radiological hazard
assessment performed by the Commission.
(3)
The national radiological emergency plan shall
(a)
have the objective of avoiding tissue reactions
leading to severe deterministic effects in any individual from
the affected population and reducing the risk of stochastic
effects, taking account of the general principles of radiation
protection and the reference levels referred to in Part III;
(b)
include provision for the transition from an
emergency exposure situation to an existing exposure
situation;
(c)
be tested, reviewed and, as appropriate, revised
at regular intervals, taking into account lessons learned from
past emergency exposure situations and taking into account the
results of the participation in emergency exercises at national
and international level;
(d)
where appropriate, incorporate relevant elements
of the emergency management system referred to in regulation
BASIC SAFETY STANDARDS FOR IONISING RADIATION
122(1), 122(2);
(e)
The national radiological emergency plan shall
provide for the establishment of specific emergency response
plans to address specific issues.
(1)
The Commission shall cooperate with other
Member States and with third countries in addressing possible
emergencies on its territory which may affect other Member States or
third countries, in order to facilitate the organisation of radiological
protection in those Member States or third countries.
(2) The Commission shall, in the event of an emergency
occurring on its territory or likely to have radiological consequences
on its territory, promptly establish contact with all other Member
States and with third countries which may be involved or are likely to
be affected with a view to sharing the assessment of the exposure
situation and coordinating protective measures and public information
by using, as appropriate, bilateral or international information
exchange and coordination systems. These coordination activities shall
not prevent or delay any necessary actions to be taken on a national
level.
(3) The Commission shall promptly share information and
cooperate with other relevant Member States, relevant third countries
and relevant international organisations regarding the loss, theft or
discovery of high-activity sealed sources, other radioactive sources
and radioactive material of concern and regarding related follow-up or
investigations, without prejudice to relevant confidentiality
requirements and relevant national legislation.
(4) The Commission, where appropriate, cooperate with other
Member States and with third countries in the transition from an
emergency exposure situation to an existing exposure situation.
(5) The Secretariat, where appropriate, shall provide
information to other Member States and with third countries of
undeclared radioactive material detected at Maltese ports.
(SECTION 6)
EXISTING EXPOSURE SITUATIONS
(1)
The Commission shall ensure that measures are
taken, upon indication or evidence of exposures that cannot be
disregarded from a radiation protection point of view, to identify and
evaluate existing exposure situations taking into account the types of
existing exposure situations listed in the Fifteenth Schedule, and to
determine the corresponding occupational and public exposures.
(2) The Commission may decide, having regard to the
general principle of justification, that an existing exposure situation
warrants no consideration of protective or remedial measures.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(3) Existing exposure situations which are of concern from
a radiation protection point of view and for which legal responsibility
can be assigned shall be subject to the relevant requirements for
planned exposure situations and accordingly such exposure situations
shall be required to be notified as specified in regulation 34(4).
(1) The Commission strategy to ensure the appropriate
management of existing exposure situations commensurate with the
risks and with the effectiveness of protective measures shall
consider
(a)
delineation of the affected areas and identification
of the affected members of the public;
(b)
consideration of the need for and extent of
protective measures to be applied to the affected areas and
members of the public;
(c)
consideration of the need to prevent or control
access to the affected areas, or to impose restrictions on living
conditions in these areas;
(d)
assessment of the exposure of different groups in
the population and assessment of the means available to
individuals for controlling their own exposure;
(e)
controls
on
commodities
incorporating
radionuclides from the contaminated area;
(f)
consideration of the need to ensure that the form,
scale and duration of all protective measures in the strategy are
optimised; and
(g)
provision for cooperation, where appropriate, with
entities responsibilities for land use planning, land ownership,
environmental protection and public health.
(1)
Following consultations with entities responsible
for land use planning, land ownership, environmental protection and
public health, the Commission shall advise these entities and the
government on the implementation of strategies for the management
of existing exposure situations, and ensure appropriate coordination
between the entities involved in the implementation of remedial and
protective measures. Stakeholders shall be involved as appropriate in
decisions regarding the development and implementation of
strategies for managing exposure situations.
(2) The form, scale and duration of all protective measures
considered for implementation of a strategy shall be optimised.
(3) The distribution of doses that has resulted from the
implementation of a strategy shall be assessed. Further efforts shall
be considered with the aim of optimising protection and reducing any
exposures that are still above the reference level.
BASIC SAFETY STANDARDS FOR IONISING RADIATION
(4) In the implementation of a strategy the Commission shall
regularly
(a)
evaluate the available remedial and protective
measures for achieving the objectives and the efficiency of
planned and implemented measures;
(b)
provide information to exposed populations on the
potential health risks and on the available means for reducing
their exposure;
(c)
provide guidance for
the
management
of
exposures at individual or local level;
(d)
with regard to activities that involve naturally
occurring radioactive material and are not managed as planned
exposure situations, provide information on appropriate means
for monitoring concentrations and exposures and for taking
protective measures.
(1)
In application of regulation 124(1) the
Commission shall establish a national action plan addressing long-term
risks from radon exposures in dwellings, buildings with public access
and workplaces for any source of radon ingress, whether from soil,
building materials or water. The action plan shall take into account the
issues set out in the Sixteenth Schedule and be updated on a regular
basis.
(2) The Commission shall make recommendations to the
entity responsible for building and construction on any appropriate
measures that may need to be included in the national building codes
to reduce radon ingress into new buildings.
(3) Commission shall identify areas where the radon
concentration (as an annual average) in a significant number of
buildings is expected to exceed the relevant national reference level.
(SECTION 7)
SYSTEM OF ENFORCEMENT
(1)
The Secretariat shall establish a system or systems
of inspection to enforce the provisions adopted pursuant to these
regulations and to initiate surveillance and corrective action where
necessary.
(2) The Secretariat shall establish an inspection programme
taking into account the potential magnitude and nature of the hazard
associated with practices, a general assessment of radiation protection
issues in the practices, and the state of compliance with the provisions
adopted pursuant to these regulations.
(3)
The Secretariat shall ensure that the findings from each
BASIC SAFETY STANDARDS FOR IONISING RADIATION
inspection are recorded and communicated to the undertaking
concerned. If the findings are related to an outside worker or workers,
where appropriate, the findings shall also be communicated to the
employer of the outside worker.
(4) The Secretariat shall ensure that outlines of the
inspection programmes and the main findings from their
implementation are available to the public.
(5) The Secretariat shall ensure that mechanisms are in
place for the timely dissemination to relevant parties, including
manufacturers and suppliers of radiation sources and, where
appropriate, international organisations, of protection and safety
information concerning significant lessons learned from inspections
and from reported incidents and accidents and related findings.
Pursuant to the Act, the Secretariat has the power to
require any individual or legal person to take action to remedy
deficiencies and prevent their recurrence or to withdraw, where
appropriate, authorisation when the results of a regulatory inspection
or another regulatory assessment indicate that the exposure situation
is not in compliance with the provisions adopted pursuant to these
regulations.
Part X
REPEAL
The following regulations are hereby repealed
(a) Radiological Emergency (Information to the Public)
Regulations;
(b) regulations 17 to 59 of Nuclear Safety and Radiation
Protection Regulations;
(c) Control and Security of High-Activity Radioactive and
Orphan Sources Regulations; and
(d) Medical Exposure (Ionising Radiation) Regulations.
BASIC SAFETY STANDARDS FOR IONISING RADIATION