BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 1
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.
Arrangement of Regulations
Part I
GENERAL PROVISIONS
1 Citation and commencement
2 Subject Matter and Scope 3 Enforcement
Part II
DEFINITIONS
4 Definitions
Part III
SYSTEM Of RADIATION PROTECTION
5 General Principles
6 Optimisation - use of dose constraints7 Optimisation - use of Reference levels in existing and
emergency situations.
8 Dose limitation - age limit for exposed workers9 Dose limits for occupational exposure 
10 Dose limitation for pregna ncy and breastfeeding
11 Dose limitation for apprentices and students12 Dose limitation for public exposure13 Estimation of the effective and equivalent dose
Part IV
RADIATION PROTECTION E DUCATION, TRAINING AND 
INFORMATION
14 General training in radiation protection
15 Work specific training of exposed workers and information
provided to them
16 Information and training of workers potentially exposed to
orphan sources
17 Prior information and training for emergency18-22 Approval, Education, informa tion and training in the field  of
medical exposure
2 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
Part V
JUSTIFICATION AND REGULATORY CONTROL OF PRACTICES
(SECTION 1)
Justification and prohibition of practices
23-26 Justification
27 Practices involving consumer products28 Prohibited Practices29-31 Deliberate Exposures of hu mans for non-medical purposes
(SECTION 2)
REGULATORY CONTROL
32 Graded approach to regulatory control
33 Identification of practices i nvolving naturally-occurring
radioactive material
34 Notification35 Exemption from notification36 Registration versus licensing37 Licensing38 Authorisation39 Release from regulatory control
Part VI
OCCUPATIONAL EXPOSURES
40 Responsibilities
41 Operational protection of exposed workers42 Operational protection of apprentices and students43 Consultations with a ra diation protection expert
44 Arrangements in workplaces45 Classification of workplaces46 Controlled areas47 Supervised areas48 Radiological surveillance of the workplace49 Categorisation of exposed workers50 Individual monitoring51 Dose assessment in the c ase of accidental exposure
52 Recording and reporting of results53 Access to the results of individual monitoring54 Data on outside workers to be supplied55 Medical surveillanc e of exposed workers
56 Medical classification57 Prohibition to employ or classify unfit workers58 Medical records59 Special medical surveillance60 Appeals61 Protection of outside workers62 Specially authorised exposures
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 3
63 Emergency occupational exposure
64 Radon in workplaces
Part VII
MEDICAL EXPOSURES
65 Justification66 Optimisation67-69 Approval & Responsibilities70 Procedures71 Training and recognition72-80 Equipment81 Special practices82 Special protection during pr egnancy and breastfeeding
83 Accidental and unintended exposures84 Estimates of population doses
Part VIII
PUBLIC EXPOSURES 
(SECTION 1)
PROTECTION OF MEMBERS OF THE PUBLIC AND LONG-
TERM HEALTH PROTECTION  IN NORMAL CIRCUMSTANCE
85 Operational protection of members of the public
86 Estimation of doses to th e members of the public
87 Radioactive discharges88 Tasks for the undertaking
(SECTION 2)
EMERGENCY EXPOSURE SITUATIONS
89-92 Emergency response
93 Information to the members of the public likely to be
affected in the event of an emergency
94 Information to the members of the public actually affected in
the event of an emergency
(SECTION 3)
EXISTING EXPOSURE SITUATIONS
95 Environmental monitoring programme
96 Contaminated areas97 Indoor exposure to radon98 Gamma radiation from building materials
Part IX
RESPONSIBILITIES AND OTHER ELEMENTS OF 
REGULATORY CONTROL
(SECTION 1)
GENERAL RESPONSIBIL ITIES OF UNDERTAKINGS
99 Safety Culture
4 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
100 Radiation Protection Programmes
101 Safety Assessments
(SECTION 2)
GENERAL RESPONSIBILIT IES OF UNDERTAKINGS
102 Recognition of ser vices and experts
103 Occupational health services104 Dosimetry services105-106 Radiation protection expert107-109 Medical physics expert110-111 Radiation protection officer
(SECTION 3)
CONTROL OF RADIOACTIVE SOURCES
112 General requirements for unsealed sources
113 General requirements for sealed sources114 Requirements for control of high-activity sealed sources115 Record keeping by the undertaking116 Control of high-activity sealed sources identification and
marking
(SECTION 4)
ORPHAN SOURCES
117 Detection of orphan sources
118 Metal contamination119 Recovery, management, control and disposal of orphan
sources
120 Financial security for orphan sources
(SECTION 5)
SIGNIFICANT EVENTS
121 Notification and recordin g of significant events
122 National Emergency preparedness123 International cooperation
(SECTION 6)
EXISTING EXPOSURE SITUATIONS
124 Programmes on existing exposure situations
125 Establishment of strategies126 Implementation of strategies127 Radon action plan
(SECTION 7)
SYSTEM OF ENFORCEMENT
128 Inspections
129 Enforcement
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 5
FIRST SCHEDULE 
Radiation and tissue weighting factors
SECOND SCHEDULE 
Activity of high-activity sealed sources and security values
THIRD SCHEDULE
Justification of new classes o r types of practices involving
consumer products
FOURTH SCHEDULE 
List of justifiable practices  involving ionizing radiation
FIFTH SCHEDULE 
List of industrial sectors involving naturally-occurringradioactive material
SIXTH SCHEDULE 
Exemption and clearance criteria
SEVENTH SCHEDULE 
Definition and use of the activ ity concentration index for the
gamma radiation emitted by building materials
EIGHTH SCHEDULE 
List of information fo r licence applications
NINTH SCHEDULE 
Data system for individual radiological monitoring
 TENTH SCHEDULE 
Emergency management systems and emergency responseplans
 ELEVENTH SCHEDULE 
Information to members of the public about healthprotection measures to be applied and steps to be taken inthe event of an emergency
TWELVE SCHEDULE
Indicative list of types of build ing materials considered with
regard to their emi tted gamma radiation 
THIRTEENTH SCHEDULE
Standard record sheet for high-activity sealed sources
FOURTEENTH SCHEDULE
Security measures fo r high activity sources
FIFTEENTH SCHEDULE 
Indicative list of types of exi sting exposure situations 
6 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
SIXTEENTH SCHEDULE 
List of items to be considered in preparing the nationalaction-plan to address long-ter m risks from radon exposures 
SEVENTEENTH SCHEDULE
Qualification and experiences for persons involved in medicalexposures
EIGHTEENTH SCHEDULE 
Information to be supplied to the secretariat each time anacceptance test is performed
NINETEENTH SCHEDULE 
Exposure to ionising radiation to an extent much greater thanintended
TWENTIETH SCHEDULE 
Requirements for medi cal physics expert
TWENTY-FIRST SCHEDULE
Elements of national radioactivity monitoring programme
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 7
Part I
General Provisions
Citation. 1. (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 Dang ers
Arising From Exposure to Ionising Radiation. 
Subject matter and 
scope.2. (1) These regulations establish the basic safety
standards for the protection of the health of individuals subje ct 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 whic h involves a risk from exposur e to
ionising radiation which cannot be disregarded from a radiationprotection point of view or with regard to the environment in v iew 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 k ept 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 containingcomponents operating at a potential difference of more than 5kilovolt (kV);
(c) human activities which involve the presence of
natural radiation sources that l ead to a significant increase i n
the exposure of workers or members of the public, inparticular:
(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 buildingmaterials and cases of lasti ng exposure resulting from the
after-effects of an emergenc y or a past human activity; 
(e) the preparedness for, th e planning of response to
8 [S.L.585.01 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 ofthe 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 radiationprevailing 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.
Enforcement. 3. The Commission shall have the power to enforce these
regulations.
Part II
Definitions
Interpretation.
Amended by:
L.N. 184 of 2020.4. In these regulations, unless the context otherwise
requires:
"acceptance test" means is a test to check the compliance of
equipment, used in connection w ith medical exposure, with speci fied
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 poi nt of
view of radiation protection or safety; 
Cap. 585. "Act" means the Nuclear Safety  and Radiation Protection Act;
"absorbed dose" (D) m eans 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 thi s
volume element.
In these regulations, absorbed dose denotes the dose averaged
over a tissue or an organ. The unit for absorbed dose is the gr ay (Gy)
where one gray is equal to one joule per kilogram;
"accelerator" means equipment or installation, in which

BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 9
particles are accelerated, emittin g 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 t hrough which a stable nuclide is
transformed into a radionuclide by irradiating with particles o r high-
energy photons the material in which it is contained;
"activity" (A) is the activity of an amount of a radionuclide i n 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 nucleartransitions 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 skil l;
"applicant" means a legal person who applies to Secretariat
filing a application to the Secretariat for the purpose of obta ining 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 wit hin 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 secon d;
"building material" means any construction product for
incorporation in a permanent manner in a building or parts ther eof
and the performance of which has an effect on the performance o f the
building with regard to exposure of its occupants to ionisingradiation;
"carers and comforters" means individuals knowingly and
willingly incurring an exposure to ionising radiation by helpin g, other
than as part of their occupation, in the support and comfort ofindividuals undergoing or havi ng undergone medical exposure;
"clearance levels" means values, established by the
Commission, and expressed in terms of activity concentrations a t or
below which materials arising from any practice subject tonotification or authorisation may be released from the requirem ents
of these regulations;
"clinical audit" means a syste matic examination or review of

10 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
medical radiological procedures which seeks to improve the qual ity
and outcome of patient care through structured review, wherebymedical radiological practices, procedures and results are exam ined
against agreed standards for good  medical radiological procedur es,
with modification of practices, where appropriate, and the appl ication
of new standards if necessary;
"clinical responsibility" means responsibility of a practitione r
for individual medical exposures , in particular, justification;
optimisation; clinical evaluation of the outcome; cooperation w ith
other specialists and staff, as appropriate, regarding practica l aspects
of medical radiological procedures; obtaining information, ifappropriate, on previous examina tions; providing existing medic al
radiological information and/or records to other practitioners and/or
the referrer, as required; and gi ving information on the risk o f ionising
radiation to patients and other individuals involved, as approp riate;
"Commission" means the Commissi on 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 nuc lear safety
and radiation protection and has the legal authority for the pu rpose 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 followi ng intake
for adults and up to the age of 70 for infants and children. Th e 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 r eceived by
an individual as a r esult of an intake.
It is given by:
for an intake at time t0 where
T (t) is the relevant equivalent dos e rate in organ or tissue T at

BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 11
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 doselimits specified in these regulations, τ is a period of 50 year s for
adults and up to the age of 70 for infants and children. The un it for
committed equivalent dose is the sievert (Sv);
"consumer product" means a dev ice or manufactured item into
which one or more radionuclides have deliberately been incorpor ated
or produced by activation, or which generates ionising radiatio n, and
which can be sold or made available to members of the publicwithout special surveillance or r egulatory control after sale;
"constancy test" means a test intended to monitor the
constancy of the functional performance of the equipment used i n
connection with medical exposures;
"contamination" means the unintended or undesirable presence
of radioactive substances on su rfaces or within solids, liquids  o r
gases or on the human body; 
"controlled area" means an area subject to special rules for th e
purpose of protection against ionising radiation or preventing the
spread of radioactive contamin ation and to which access is
controlled; 
"diagnostic reference levels" m eans dose levels in medical
radiodiagnostic or interventional radiology practices, or, in t he case
of radio-pharmaceuticals, levels of activity, for typical exami nations
for groups of standard-sized patients or standard phantoms forbroadly 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 authoris ation
was granted but continues to  require safe management;
"dose constraint" means a constr aint set as a prospective upper
bound of individual doses, used to define the range of optionsconsidered in the process of op timisation 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 b ody or an individual competent
to calibrate, read or interpret individual monitoring devices, or to
measure radioactivity in the human body or in biological sample s, or
to assess doses, whose capacity to act in this respect is recog nised by
the Commission;
12 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
 "effective dose" (E) is the sum of the weighted equivalent dos es
in all the tissues and organs of the body from internal and ext ernal
exposure. It is defin ed by the expression:
Where
The values for and are specified in the First Schedule.
The unit for effective dos e is the sievert (Sv);
"emergency" means a non-routine situation or event involving a
radiation source that necessita tes prompt action to mitigate se rious
adverse consequences for human health and safety, quality of li fe,
property or the environment, or a hazard that could give rise t o 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 nationa l
radiological emergency plan, fo r emergency preparedness and
response, and arrangements for d ecision making in the event of an
emergency exposure situation;
"emergency occupational exposure" means exposure received in
an emergency exposure situati on by an emergency worker;
"emergency response plan" means those elements listed in
Section B of the Tenth Schedule to plan for adequate response i n the
event of an emergency exposure situation on the basis of postul ated
events and related scenarios;
"emergency worker" means any person having a defined role in
an emergency and who might be exposed to radiation while takingaction in response to the emergency;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

BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 13
"environmental monitoring" means the measurement of
external dose rates due to radioa ctive substances in the enviro nment
or of concentrations of radionuc lides in environmental media;
"equivalent dose" (HT) is the a bsorbed dose, in tissue or organ
T weighted for the type and quality  of radiation R. It is given  by:
where
When the radiation field is composed of types and energies
with different values of , the total equivalent dose, , is give n
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 activ ity at or
below which a radiation source is not subject to notification o r
authorisation;
"existing exposure situation" m eans an exposure situation that
already exists when a decision on its control has to be taken a nd
which does not call or no longer calls for urgent measures to b e
taken;
"exposed worker" means a person, either self-employed or
working under an employer, who is subject to exposure at workcarried out within a practice regulated by these regulations an d who
is liable to receive doses e xceeding any one of the dose limits  f o r
public exposure;
"exposure" means the act of exposing or condition of being
exposed to ionising radiation emitted outside the body (externa l
exposure) or within the body (internal exposure);
"extremities" means the hands , forearms, feet and ankles;
"graded approach" means a structured method by which the is the absorbed dose averaged  over tissue or organ T, due to
radiation R,
is the radiation weighting factor.

14 [S.L.585.01 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 lif e
occurring in a population following exposure, including those a rising
from tissue reactions, cancer and severe genetic disorder;
"health screening" means a procedure using medical
radiological installations for early diagnosis in population gr oups at
risk;
 "high-activity sealed source" means a sealed source for which
the activity of the contained radionuclide is equal to or excee ds the
relevant activity value laid down in the fourth column of the t able 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 aprobability rather than a c ertainty of appearance;
 "inspection" means an investiga tion by the Secretariat to veri fy
regulatory compliance;
 "intake" means the total activity of a radionuclide entering t he
body from the external environment;
 "interventional radiology" means the use of X-ray imaging
techniques to facilitate the intr oduction and guidance of devic es in the
body for diagnostic or treatment purposes;
 "ionising radiation" means energy transferred in the form of
particles or electromagnetic wav es of a wavelength of 100 nanom etres
or less (a frequency of 3 × 10
15hertz 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 specificconditions laid down in that document;
 "medical exposure" means exposure incurred by patients or
asymptomatic individuals as part of their own medical or dentaldiagnosis or treatment, and inte nded to benefit their health, a s well as
exposure incurred by carers and comforters and by volunteers inmedical or biomedical research;
"medical physics expert" means an individual having the
knowledge, training and experience to act or give advice on mat ters
relating to radiation physics applied to medical exposure, whos e
competence in this respect is recognised by the Commission;
Cap. 464. "medical radiographer" shall have the meaning ascribed by
radiographer under the Hea lth Care Professions Act;
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 15
 "medical radiological" means pertaining to radiodiagnostic
and radiotherapeutic procedures, and interventional radiology o r
other medical uses of ionising radiation for planning, guiding and
verification purposes;
"medical radiological installation" means a facility where
medical radiological proc edures 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;
Cap. 585. "Minister" means the ministe r  r e s p o n s i b l e  f o r  t h e  N u c l e a r
Safety and Radiation Protection Act;
"National Radioactivity Monitoring Programme" means the
system by which the environment is monitored for ionising radia tion
and the presence of radioactiv ity in environmental media, in
accordance with regulation 95, in order to assess the levels ofradiation and radioactivity in the environment to which the Mal tese
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 primaryintention of the exposure is not to bring a health benefit to t he
individual being exposed;
"normal exposure" means exposur e expected to occur under
the normal operating conditions of a facility or activity (incl uding
maintenance, inspection, decommissioning), including minorincidents that can be kept under control, i.e. during normal op eration
and anticipated opera tional occurrences;
"notification" means the requirement of submitting a document
to the Secretariat to notify the intention to carry out a pract ice within
the scope of these regulations;
"occupational exposure" means exposure of workers,
apprentices and students, incurre d in the course of their work;
"occupational health service" me ans a health professional or
body competent to perform medical surveillance of exposed worke rs
and whose capacity to act in tha t 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 neve r been
under regulatory control or because it has been abandoned, lost ,
16 [S.L.585.01 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 andcontrolled areas, but performs activities in those areas, inclu ding,
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 t he
exposure or potential exposure of people or the environment. Pl anned
exposure situations may include both normal exposures and poten tial
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 operatin g errors;
"practical aspects of medical ra diological procedures" means th e
physical conduct of a medical exposure and any supporting aspec ts,
including handling and use of medical radiological equipment, t he
assessment of technical and physical parameters (including radi ation
doses), calibration and maintenance of equipment, preparation a nd
administration of radio-pharmac euticals, and image processing;
"practice" means a human activity that can increase the
exposure of individuals to radia tion from a radiation source an d is
managed as a planned  exposure situation;
 "practitioner" means a medical doctor, dentist or other health
professional who is entitled to take clinical responsibility an d is
approved by an undertaking in acc ordance with regulation 67;
"processing" means chemica l or physical operations on
radioactive material including the mining, conversion, enrichme nt of
fissile or fertile nuclear materia l and the reprocessing of spe nt fuel;
"protective measures" means measures, other than remedial
measures, for the purpose of avoiding or reducing doses that mi ght
otherwise be received in an emergency exposure situation or anexisting 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 adequ ate assurance that a structur e,
system, component or procedure will perform satisfactorily incompliance 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 [S.L.585.01 17
coordinating, implementing) intended to maintain or to improve
quality. It includes monitoring, evaluation and maintenance atrequired levels of all characteri stics of performance of equipm ent that
can be defined, measured, and controlled;
"radiation generator" means a device capable of generating
ionising radiation, such as X-ra ys, neutrons, electrons or othe r
charged particles; 
 "radiation protection" means p rotection of people from the
harmful effects of exposure to ionising radiation, and the mean s for
achieving of this protection; 
"radiation protection expert" means an individual having the
knowledge, training and experience needed to give radiationprotection advice in order to ensure the effective protection o f
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 prote ction
matters relevant for a given type of practice to supervise or p erform
the implementation of the radiation protection arrangements giv en 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 radioact ive
material;
"radioactive material" means material incorporating
radioactive substances;
"radioactive source" means a radiation source incorporating
radioactive material for the purpose of utilising its radioacti vity;
"radioactive substance" means a ny substance that contains one
or more radionuclides the activity or activity concentration of  which
cannot be disregarded from a rad iation protection point of view ;
"radioactive waste" means rad ioactive material in gaseous,
liquid or solid form for which no further use is foreseen or ma terial
that the Commission requires to b e regulated as radioactive was te;
"radiodiagnostic" means pertaining to in-vivo diagnostic
nuclear medicine, medical diagnostic radiology using ionisingradiation, and dental radiology;
"radiotherapeutic" means pertaining to radiotherapy, including
nuclear medicine for therapeutic purposes;
18 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
"radon" means the radionuclide Rn-222 and its progeny, as
appropriate;
"exposure to radon" means ex posure 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 jud ged
inappropriate to allow exposures t o occur as a result of that e xposure
situation, even though it is not a limit that may not be exceed ed;
 "referrer" means a medical doctor, dentist or other health
professional who is authorised, in  accordance with the undertak ings
procedures, to refer individuals f or medical radiological proce dures to
a practitioner;
"registration" means permission granted in a document by the
Secretariat, through a simplified procedure, to carry out a pra ctice in
accordance with conditions laid by the Commission for this type  o r
class of practice;
"regulatory control" means any form of control or regulation
applied to human activities for the enforcement of radiation pr otection
requirements;
"remedial measures" means the re moval 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 imp act for
the purposes of avoiding or reducing doses that might otherwise  b e
received in an existi ng exposure situation;
"representative person" means an individual receiving a dose
that is representative of the more highly exposed individuals i n the
population, excluding those indivi duals having extreme or rare habits;
 "safety assessment" means an assessment of all aspects of a
practice that are relevant to radiation protection; for an auth orised
facility, this includes siting, design and operation of the fac ility in
accordance with regulation 101;
"safety culture" means the ass embly of characteristics and
attitudes in organizations and individuals, which establishes t hat as an
overriding priority, protection an d safety issues receive the a ttention
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 alllevels; 
(b) accountability of organizations and of individuals
at all levels for safety; 
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 19
(c) measures to encourage a questioning and
learning attitude and to discourage complacency with regard tosafety;
"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 tran sfer or
other malicious acts involving nuclear or other radioactive mat erial,
or their assoc iated facilities;
"security culture" means characteristics and attitudes in
organisations and of individuals which establish that security issues
receive the attention warra nted by their significance;
"sealed source" means a radi oactive source in which the
radioactive material is permanently sealed in a capsule orincorporated in a solid form with the objective of preventing, under
normal conditions of us e, any dispersion of radioactive substan ces;
"sievert" (Sv) is the special name of the unit of equivalent or
effective dose. One sievert is eq uivalent to one joule per kilo gram: 1
Sv =1 J kg
-1 ;
"spacecraft" means a manned vehi cle 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 fac ility 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 as sembly of components intended
to guarantee the containment of a  sealed source, where it is no t an
integral part of the source but is meant for shielding the sour ce during
its transport and handling;
"standard values and relati onships" means values and
relationships recommended in chapters 4 and 5 of ICRP Publicati on
116 for the estimation of doses from external exposure and chap ter 1
of ICRP Publication 119 for the estimation of doses from intern al
exposure, including updates approved by the Commission. TheCommission may approve the use of specific methods in specifiedcases relating to the physico-che mical properties of the radion uclide
or other features of the exposure situation or of the exposedindividual;
"thoron" means the radionuclide Rn-220 and its progeny, as
appropriate;
20 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
"technical service provider" means service providers in safety,
providing either consultancy and maintenance services or calibr ation
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 condu ct 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
General principles. 5. (1) The regulatory control regime is based on the
principles of justification, optimisation and dose limitation a s follows:
(a) Justification: Decisio ns introducing a practice
shall be justified in the sense that such decisions shall be ta ken
with the intent to ensure that t he individual or societal benef it
resulting from the practice outweighs the health detriment that  it
may cause. Decisions introducing or altering an exposurepathway for existing and emerge ncy 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 optimisedwith the aim of keeping the magnitude of individual doses, thelikelihood of exposure and the number of individuals exposed aslow as reasonably achievable taking into account the currentstate of technical knowledge and economic and societal factors.The optimisation of the protection of individuals subject tomedical exposure shall apply to the magnitude of individualdoses and be consistent with the medical purpose of theexposure, as described in regulation 66. This principle shall b e
applied not only in terms of effective dose but also, whereappropriate, in terms of equiva lent doses, as a precautionary
measure to allow for uncertaintie s 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 doselimits laid down for occupational exposure or public exposure.Dose limits shall not appl y 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 [S.L.585.01 21
ionising radiation sources rests with the undertaking:
 Provided that the prime responsibility for safety and
security rests with the licence holder. That responsibility can not be
delegated and includes respons ibility for the activities of con tractors
and sub-contractors whose activ ities might affect safety and se curity.
Optimisation - use 
of dose constraints.
Substituted by:L.N. 184 of 2020.6. Dose constraints for the purpose of prospective
optimisation of protection shall be:
(1) (a) for occupational expos ure, the dose constraint
shall be established as an operational tool for optimisation by  t h e
undertaking and shall be one third of any dose limits specified  i n
regulations 9,10 and 11. In the case of outside workers the dos e
constraint shall be established in cooperation between the empl oyer
of the outside worker and the undertaking;
(b) for public exposure, the dose constraint shall be
0.25mSv per year for the individu al dose that members of the
public receive from the planned operation of a specifiedradiation 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 regulation66(6a) and volunteers participating in medical or biomedicalresearch pursuant to regulation 66(4c).
(2) In the event that any dose constraint is exceeded the
undertaking is to immediately inform the Commission and thenproduce a report detailing th e event and doses received.
Optimisation - use 
of Reference levels in existing and 
emergency 
situations.Amended by:
L.N. 184 of 2020.7. (1) Without prejudice to reference levels set for
equivalent doses, that may be sp ecified by the Commission, the
reference levels for any persons  expressed in effective doses s hall 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 co ntinue
to be implemented belo w the reference level.
Provided that in specific s ituations 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 protectioncan be provided without causing a disproportionate detrimentfrom the corresponding countermea sures or an ex cessive cost;
(b) a reference level below 1mSv per year may be
set, where appropriate, in an existing exposure situation for
22 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
specific source-related exposu res 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 termin ation of long-term countermea sures.
 (3) The reference levels set shall take account of the feature s
of prevailing situations as well as societal criteria, which ma y include
the following:
(a) for exposures below or equal to 1mSv per year,
general information on the level of exposure, without specificconsideration of individual exposures;
(b) in the range up to or equal to 20mSv per year,
specific information to enable individuals to manage their ownexposure, if possible
(c) in the range up to or equal to 100 mSv per year ,
assessment of individual doses and specific information onradiation risks and on availabl e actions to reduce exposures.
(4) For existing exposure situ ations involving exposure to
radon, the reference levels shall be set in terms of radon acti vity
concentration in air of 300 Bqm
-3 for members of the public and
workers.
Dose limitation - 
age limit for 
exposed workers.
Substituted by:L.N. 184 of 2020.8. (1) Persons under 18 years of  age may not be assigned to
any work which would result in t hem as being classed as an expo sed
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. 
Dose limits for 
occupational 
exposure.9. (1)  The dose limits for occupational exposure apply
to the sum of annual occupational exposures of a worker from al l
authorised practices, occupationa l exposure to radon in workpla ces
requiring notification in accordance with regulation 64(3), and  othe r
occupational exposure from existing exposure  situations in acco rdance
with regulation 124(3). For emergency occupational exposureregulation 63 shall apply.
(2) The limit on the effective dose for occupational exposure
shall be 20mSv in any single year. However, in special circumst ances
or for certain exposure situations  a higher effective dose of u p to
50mSv may be authorised by the Secretariat in a single year, pr ovided
that the average annual dose over any five consecutive years, i ncluding
the years for which the limit has been exceeded, does not excee d
20mSv.
(3) In addition to the limits on effective dose laid down in
sub-regulation (2), the followi ng limits on equivalent dose sha ll apply:
(a) the limit on the equivalent dose for the lens of the
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 23
eye shall be 20mSv in a single year or 100mSv in any five
consecutive years subject to a maximum dose of 50mSv in asingle year;
(b) the limit on the equivalent  dose for the skin shall
be 500mSv in a year, this limit shall apply to the dose average d
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.
Dose limitation for 
pregnancy and 
breastfeeding.S.L. 424.11
Amended by:
L.N. 184 of 2020.10. (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 underta king,
and the employer of the outside worker, shall ensure that theemployment conditions for the pregnant worker are such that theprotection of the unborn child is comparable with that provided  for
members of the public and the equivalent dose to the unborn chi ld is
as low as reasonably achievable and unlikely to exceed 1mSv dur ing
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 inv olving
a significant risk of intake of radionuclides or of bodilycontamination.
Dose limitation for 
apprentices and 
students.11. (1) The dose limits for apprentices aged 18 years or
over and students aged 18 years or over who, in the course of t heir
studies, are obliged to work with radiation sources, shall be t he same
as the dose limits for occupationa l exposure laid down in regul ation
9.
(2) The limit on the effective dose for apprentices aged
between 16 and 18 years and for students aged between 16 and 18years who, in the course of their studies, are obliged to work with
radiation sources, sha ll 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 sha ll
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 average d
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
24 [S.L.585.01 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 b e the same
as the dose limits for members of the public as specified in re gulation
12 
Dose limitation for 
public exposure.12. (1) The effective dose limit for the public, applicable
to any one authorised practis e, shall be 0.25mSv per year.
 (2) The limit of the sum effective dose for a member of the
public resulting from all authoris ed practices is 1mSv in a yea r.
(3) In addition to the dose limit referred to in the sub-
regulation (1), the following limits  on the equivalent dose sha ll 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 ov er any
area of 1 cm2, regardless of the area exposed. 
Estimation of the 
effective and 
equivalent dose.13. For the estimation of effective and equivalent doses, the
appropriate standard values and r elationships shall be used. Fo r
external radiation, the operati onal quantities defined in secti on 2.3 of
ICRP Publication 1 16 shall be used.
PART IV
RADIATION PROTECTION E DUCATION, TRAINING AND 
INFORMATION
General training in 
radiation 
protection.14.  (1)  The undertaking or, in case of outside workers,
the employer of the outside worke r shall ensure that individual s whose
tasks require specific competen ces in radiation protection shal l:
(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 notexceed 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 a pproved syllabi, as appropriate  to field
of practice, and delivered by appr oved organisations or individ uals.
The Commission shall:
(a) approve syllabi for radia tion protection training; 
(b) approve organisations or individuals to provide
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 25
training; and
(c) accept as appropriate equivalent alternative
radiation safety training where the individual has carried outprior training outside of Malta.
(3) Approved training organization or individual shall issue
certificates of evidence that the Commission approved training has
been performed. 
Courses in medical 
and dental schools.
Added by:
L.N. 184 of 2020.14A. The Commission shall encourage the introduction of a
course on radiation protection in the basic curriculum of medic al and
dental schools.
Exposed workers 
to provide information.
Added by:
L.N. 184 of 2020.14B. Exposed workers shall make available to the
undertaking or the employer of the outside worker information o n
their past and present work that is relevant for ensuring effec tive and
comprehensive protection and safe ty for themselves and others.
Work specific 
training of exposed 
workers and 
information provided to them.15. (1) Undertakings are required to inform exposed
workers on:
(a) the radiation health ris ks 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 workingconditions of both the practice in general and each type ofworkstation or work to which they may be assigned;
(d) the relevant parts of the emergency response
plans and procedures;
(e) the importance of com plying 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 th e
importance of announcing the inte ntion to breast-feed an infant  i n
view of the risks of exposure for a breast-fed infant after int ake of
radionuclides or bodily contamination.
(4) The undertaking or, in case of outside workers, the
26 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
employer of the outside worker, provides appropriate radiation
protection training and informa tion programmes for exposed work ers.
(5) In addition to the information and training in the field of
radiation protection as specified in sub-regulations 1, 2, 3 an d 4, the
undertaking responsible for high- activity sealed sources shall ensure
that such training includes spec ific requirements for the safe and
secure management and control of high-activity sealed sources w ith a
view to preparing the relevant workers adequately for any event s
affecting the radiation protection. The information and trainin g 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.
Information and 
training of workers potentially exposed 
to orphan sources.16. (1) The Secretariat shall keep the customs authorities
and metal recycling installati ons informed of the possibility t hat 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.
Prior information 
and training for emergency.
Amended by:
L.N. 184 of 2020.17. ( 1 )  E m e r g e n c y  w o r k e r s  w h o  a r e  i d e n t i f i e d  i n  a n
emergency response plan of an undertaking or the employer of anoutside worker and persons involved in the national radiologica l
emergency plan as established by article 31 of the Act, shall b e given
adequate information:
(a) that is regularly updated on the health risks their
intervention might involve and on the precautionary measures tobe 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 a nd the type of intervention. 
  ( 2 )  I n  t h e  e v e n t  t h a t  a n  e m e r g e n c y  o c c u r s ,  t h e  i n f o r m a t i o n
referred to in the regulation 17(1a) shall be supplemented by
S e c r e t a r i a t  t o  e m e r g e n c y  w o r k e r s  a n d  a n y  o t h e r  p e r s o n s  i n v o l v e d ,
having regard to the sp ecific circumstance.
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 27
Approval, 
Education, 
informa tion and 
training in the field of medical 
exposure.18. (1) Undertakings shall entitle individuals to act as
referrers, practitioners and individuals involved in the practi cal
aspects of medical radiological exposures by approving them andshall establish a procedure with in its radiation protection pro gramme
for persons to be approved pursuan t to the requirements of regu lation
19. 
 (2) Referrers, practitioners and the individuals involved in
the practical aspects of medical radiological procedures shall have
the qualification and experience s tated in the Seventeenth Sche dule 
Lists of 
individuals.19. (1) Undertakings shall maintain lists of individuals
that have been approved. These lists shall specify any limitati ons of
the approval of individuals.
 (2) Undertakings shall maintain the following records for
each of its employees involve d in medical exposures: 
(a) name of individual;
(b) approval area, including: practitioner; person
performing the practical aspects of medical equipment formedical purposes; person performing the practical aspects forother purposes;
(c) qualification certificates to demonstrate training
(both academic and practical);
S.L. 424.14.(d) examination results if applicable (including
vision examinations pursuant to regulation 10 of the MinimumHealth and Safety Requirements for Work with Display ScreenEquipment 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 app roved
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
28 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
gross individual negligence; or
(c) not carrying out approved work for six
consecutive months.
Training 
programmes. 20. Individuals undergoing relevant training programmes
may participate in practical asp e c t s  f o r  t h e  p r o c e d u r e s  m e n t i o n ed in
regulation 69 provided that they are constantly under directsupervision of a practitioner.
Education and 
training.21. The undertaking shall facilitate the continuing education
and training of its employees.
Resources.
Added by:
L.N. 184 of 2020.21A.  The Commission shall allocate  the necessary resources in
order that staff of its Secretariat to obtain, maintain and fur ther develop
expertise and skills required in discharging the Commission’sresponsibilities.
Clinical use of new 
techniques.22. In the case of the clinical use of new techniques the
undertaking shall provide trainin g on these techniques and the relevant
radiation protection requirements.
Part V
JUSTIFICATION AND REGULATORY CONTROL OF PRACTICES
(SECTION 1)
Justification and prohibition of practices
Justification. 23.  ( 1 )  I t  i s  p r o h i b i t e d  t o  p e r f o r m  a  c l a s s  o r  t y p e  o f
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 thi s
regulation being published is giv en in the Fourth Schedule. 
(2) The Commission shall update and keep available a list of
classes and types of p ractice resulting in exposure to ionising  radiation
that are deemed justified.
New class or types 
of practice.24. 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 sh all be added to the list referr ed to in the
regulation 23.
Review of existing 
classes or types of 
practices.25. The Commission shall consider a review of existing
classes or types of practices hel d on the list referred to in r egulation 23
with regard to their justification whenever there is new and im portant
evidence about their efficacy or potential consequences or new and
important information about other techniques and technologies, if no
longer justified they sha ll be removed from the list.
Medical exposure. 26. Practices involving medical exposure shall be a justified
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 29
practices pursuant to regulation 23 and each individual medical
exposure shall be justified as  specified in regulation 65.
Practices involving 
consumer products.27. (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 a ll
relevant information, including that listed in Section A of the  Third
Schedule, so as to allow the imp lementation of the justificatio n
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 auth orities
of other Member States of this receipt and, upon request, of it s
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 justif ied or
their use would not fulfil the criteria for exemption from noti fication
under regulation 35. 
Prohibited 
practices.28. (1) It is prohibited to deliberately add radioactive
substances in the production of foodstuffs, animal feeding stuf fs, and
cosmetics, and it is prohibited to import or export of such pro ducts.
S.L. 449.26. (2) Without prejudice to the Irradiation of Food
Regulations, practices involving the activation of material res ulting
in an increase in activity in a consumer product, which at the time of
placing on the market cannot be disregarded from a radiationprotection point of view, shall be deemed not to be justified.However, the Commission may evaluate specific types of practice s
within this class with reg ard 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 plac ing on
the market of the products or of their manufacture, in an incre ase in
activity, which cannot be disregarded from a radiation protecti on
point of view is prohibited, and so is the import or export of such
products or materials.
Deliberate 
exposures of humans for non-
medical purposes.29. (1) With regard to practices and applications
involving non-medical imaging ex posure the Commission shall:
(a) identify in the list referred to under regulation
23, practices and applications  involving non-medical imaging
30 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
exposure which are deemed to be justified; 
(b) review the general and particular justification of
practices involving non-medi cal imaging exposures;
(c) regularly review the circumstances warranting
non-medical imaging exposures, without individual justificationof each exposure.
(2) Each particular application of an accepted type of
practice, as stipulated by regulation 23, shall be justified by  t h e
undertaking and shall be subject  to licensing by the Secretaria t.
 (3) With regard to practices and applications involving non-
medical imaging exposure undertakings shall give special attent ion to
justification in advance of all individual non-medical imagingexposure procedures using medical radiological equipment, takin g into
account the specific objectives of the procedure and the charac teristics
of the individual involved.
Justified practices. 30. Justified practices involving non-medical imaging
exposure using medical radiologica l equipment may be exempted b y
the Commission from the requirement for dose constraints accord ing
to regulation 6(b) and from th e dose limits set out in regulati on 12. 
Practices involving 
non-medical 
imaging exposure.31. (1) For practices involving non-medical imaging
exposure that are justified:
(a) the practice is subject to licensing which may
impose specific requirements;
(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 duringpregnancy and the appropriate involvement of themedical 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 a re put in place;
(2) For procedures not using medical radiological equipment,
shall have dose constraints that shall be established by the Co mmission
and its value shall not exceed an effective dose of 0.25mSv per  year for
the individual exposed and ;
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 31
(3) Information is provided to and consent sought from the
individual to be exposed, allowing for cases where the lawenforcement authorities may pr oceed without consent of the
individual according to  Maltese legislation. 
(SECTION 2)
Regulatory Control
Graded approach 
to regulatory 
control.
Substituted by:
L.N. 184 of 2020.32. (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 pro cess shall use a graded approac h. 
Registers.
Added by:
L.N. 184 of 2020.32A.  The Secretariat shall be responsible for maintaining a
registers of:
(1) undertakings and employe rs 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 pl acing
on the market; and
(c) the type of source.
(4) Transfers of equipment and ra dioactive material that require s
notification under these regulations.
Identification of 
practices involving 
naturally-occurring radioactive 
material.33. The Commission shall identify classes or types of
practice involving naturally–occurring radioactive material andleading to exposure of workers o r members of the public which
cannot be disregarded from a radi ation protection point of view . Such
identification shall be carried out by appropriate means taking  into
account industrial sectors liste d in the Fifth Schedule.
34. (1) Notification is required for all justified practices,
including those identified according to regulation 33. The noti fication
shall be made at least 30 days p rior to the practice commencing . The
Secretariat shall specify the information to be provided inconjunction with the notification. Where an application for anauthorisation is submitted, no se parate notification is needed.  A n
authorisation may lead to the Se cretariat issuing the undertaki ng with
either a registration or license.
(2) Undertakings shall immediately notify the Secretariat if
32 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
there is any change in the information supplied in connection w ith 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 iden tified by the Commission where  there
is concern that a practice identified in accordance with regula tion 33
may lead to the presence of naturally-occurring radionuclides i n water
liable to affect the quality of dr inking water supplies or affe ct any
other exposure pathways, so as to be of concern from a radiatio n
protection point of view, the Commission may require that the p ractice
be subject to notification.
(6) Human activities involving radioactively contaminated
materials resulting from authorised releases or materials clear ed in
accordance with regulation 39 shall not be managed as a plannedexposure situation and, hence, a re not required to be notified.  
Exemption from 
notification.35. (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 s et
out in Table B, Activity Column (Bq), of the Sixth Schedule, orhigher values that, for specific applications, are approved by the
Commission and satisfy the general exemption and clearancecriteria set out in the Sixth Schedule ; or
(b) without prejudice to regulation 34(6) radioactive
materials where the activity concentrations do not exceed theexemption values set out in Table A, Activity ConcentrationColumn (kBq kg
-1), of the Sixth Schedule, or higher values that,
for specific applications, are approved by the Commission andsatisfy the general exemption and clearance criteria set out inthe Sixth Schedule; or
(c) apparatus containing a sealed source, provided
that:
(i) the apparatus is of a type approved by the
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
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 33
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 apparatusoperating at a potential difference not exceeding 30 kilovolt (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 s pecific types of practices
from the notification requirement subject to compliance with th e
general exemption criteria estab lished in paragraph 3 of the Si xth
Schedule, on the basis of an as sessment showing that exemption is
the best option.
Registration versus 
licensing.36. (1) Registration or licensing is required for the
following practices:
(a) the operation of radiation generators or
accelerators or radioactive so urces for medical exposures or
for non-medical imaging purposes;
(b) the operation of radiation generators or
accelerators, except electron microscopes, or radioactive
sources for purposes not c overed by paragraph (a).
(2) The Commission may require registration or licensing
for other types of practices.
(3) The regulatory decision to submit types of practices to
either registration or licensing shall use a graded approach an d shall
consider regulatory experience. 
Licensing. 37. Licensing is required for the following practices:
(a) the deliberate administration of radioactive
substances to persons and, in so far as the radiation protectio n
of human beings is concerned, animals for the purpose ofmedical or veterinary diagnos is, 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 orother products, including medicinal products, and the importof such products;
(d) any practice involving a high-activity sealed
34 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
source;
(e) the operation, decommissioning and closure of
any facility for the long term sto rage or disposal of radioacti ve
waste, including facilities managing radioactive waste for thispurpose; the operation, decommissioning and closure of anyfacility for the long term storage  or disposal of radioactive
waste, including facilities managing radioactive waste for thispurpose;
(f) practices discharging significant amounts of
radioactive material with airborne or liquid effluent into theenvironment. 
Authorisation. 38. (1) In order to apply for a registration or license,
applicants are to provide the Sec retariat such information as s hall 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 item s in the
indicative list in the Eighth Schedule.
(3) A licence shall include, as appropriate, specific condition s
and reference to requirements in these regulations so as to ens ure that
the elements of the licence are legally enforceable, and imposeappropriate restrictions on the operational limits and conditio ns of
operation. 
(4) Where applicable, the licence shall include conditions on
the discharge of radioactive effluent, in connection with therequirements of regulation 87 for the authorisation of the rele ase 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
be seeking a re newal of their license.
Release from 
regulatory control.39. (1) Disposal, recycling or reuse of radioactive
materials arising from any authorised practice is subject toauthorisation.
(2) Materials for disposal, recycling or reuse may be released
from regulatory control provided  that the activity concentratio ns:
(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 materialsoriginating 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 technica l
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 35
guidance provided by the European Union. 
(3) The clearance of materials containing naturally-
occurring radionuclides, where th ese result from authorised pra ctices
in which natural radionuclides are processed for their radioact ive,
fissile or fertile properties, the clearance levels comply with  the dose
criteria for clearance of materials out in paragraph 3 of SixthSchedule ,
(4) It shall not be permitted to deliberately dilute
radioactive materials for the purpose of them being released fr om
regulatory control. The mixing of  materials that takes place in  normal
operations where radioactivity is not a consideration is not su bject to
this prohibition. The Commission may authorise, in specificcircumstances, the mixing of radioactive and non-radioactivematerials for the purposes o f re-use or recycling. 
PART VI
OCCUPATIONAL EXPOSURES
Responsibilities. 40. ( 1 )  U n d e r t a k i n g s  a r e  r e s p o n s i b l e  f o r  a s s e s s i n g  a n d
implementing arrangements for the radiation protection of expos ed
workers.
(2) In the case of outside worke rs, 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 rad iation
protection programme of the undertaking , for the protection ofworkers in any exposure situation, to an undertaking, an employ er of
the outside worker or any other organisation, in particular for  t h e
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 specifie d 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 theiremployees under the responsibility of another employer orundertaking. 
36 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
Operational 
protection of 
exposed workers.41. (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 o f
the safety assessment re quired 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, wherenecessary, individual monitoring;
(e) medical surveillance;
(f) education and training. 
Operational 
protection of apprentices and 
students.42. (1) Exposure conditions and operational protection of
apprentices and students aged 18 years or over referred to regu lation
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 ca tegory
B. 
Consultations with 
a radiation 
protection expert.43. Undertakings shall seek advice from a radiation
protection expert within the radiation protection expert’s area s 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
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 protectio n;
(d) regular checking of the e ffectiveness 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.
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 37
Arrangements in 
workplaces.44. (1) Undertakings shall give careful consideration
and implement radiation protection arrangements as regards allworkplaces where workers are lia ble to receive an exposure grea ter
than an effective dose of 1mSv per year or an equivalent dose o f
15mSv per year for the lens of the eye or 50mSv per year for th e 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 liabl e to exceed an effective dose o f 6mSv
per year or a corresponding time-integrated radon exposure valu e of
300Bq/m
3, these shall be managed as a planned exposure situation
and the Commission shall determine which requirements set out i n
this Part VI are appropriate. Fo r workplaces specified in regul ation
64(3), and where the effective dos e to workers is less than or equal to
6mSv per year or the exposure less than the corresponding time-integrated radon exposure value f or the workers, the Commission
shall require that exposur es 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 a pply,
allowing for the specific features of this exposure situation. In the
case that an effective dose to the crew is liable to be above 1 mSv per
year, the undertaking is take a ppropriate measures, in particul ar:
(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 thedoses of highly exposed crew;
(c) to inform the workers concerned of the health
risks their work involves and their individual dose;
(d) to apply regulation 10(1) to pregnant air crew.
Classification of 
workplaces.45. (1) Undertakings shall ensure that workplaces are
designated as either controlled or  supervised, where appropriat e, on
the basis of an assessment of the expected annual doses and the
probability and magnitude of potential exposures.
(2) Undertakings shall designate as a controlled area any
area under his control which: 
(a) it is necessary for any person who enters or
works in the area to follow special procedures designed torestrict significant exposure to ionising radiation in that are a or
prevent or limit the probability and magnitude of radiationaccidents or their effects; or 
(b) any person working in the area is likely to
38 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
receive an effective dose greater than 6mSv a year or an
equivalent dose greater than three-tenths of any relevant doselimit referred to in th ese regulations.
(3) Undertakings shall designate as a supervised area any
area under his control, not being an area designated as a contr olled
area: 
(a) where it is necessary to keep the conditions of the
area under review to determine whether the area should bedesignated 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 dosegreater than one-tenth of any relevant dose limit referred to i n
these regulations.
(4) Undertakings shall keep under review the working
conditions in controlled and supervised areas.
Controlled areas. 46. (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 receivedappropriate instructions and shall be controlled in accordancewith written procedures provided by the undertaking. Whereverthere is a significant risk of the spread of radioactivecontamination, specific arrang ements shall be made, including
for the access and exit of individuals and goods and formonitoring contamination within the controlled area and, whereappropriate, in the adjacent area.
(b) Taking into account the nature and extent of
radiological risks in the controlled area, radiologicalsurveillance of the workplace sh all 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 display ed.
(d) Working instructions appropriate to the
radiological risk associated with  the sources and the operation s
involved shall be laid down.
(e) The worker shall receive specific training in
connection with the characteristics of the workplace and theactivities.
(f) The worker shall be provi ded with the appropriate
personal protective equipment.
(2) The undertaking is responsible for implementation of
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 39
these duties taking into account the advice provided by the rad iation
protection expert.
Supervised areas. 47. (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, radiologicalsurveillance of the workplace sha ll 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 bedisplayed;
(c) if appropriate, working instructions appropriate
to the radiological risk associated with the sources and theoperations involved shall be laid down.
(2) The undertaking is responsible for implementation of
these duties taking into account the advice provided by the rad iation
protection expert.
Radiological 
surveillance of the 
workplace.
Amended by:L.N. 184 of 2020.48. (1) Undertakings shall ensu re that the radiological
surveillance of the workplace r eferred to in paragraph (b) of
regulation 46(1) and paragraph (a) of regulation 47(1) comprise s,
where appropriate:
(a) the measurement of external dose rates,
indicating the nature and quality o f the radiation in question;
(b) the measurement of the activity concentration in
air and the surface density of contaminating radionuclides,indicating their natu re and their physical a nd chemical states.
 (2) Results of these measurements shall be recorded and
shall be used, if necessary, for estimating individual doses, a s
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 calibra tion
shall be traceable to an acc redited standards laboratory.
Categorisation of 
exposed workers.49. (1) For the purposes of monitoring and surveillance,
every undertaking shall designate exposed workers into one of t wo
categories:
(a) category A: those exposed workers who are
liable to receive an effective dose greater than 6mSv per yearor an equivalent dose greater than 15mSv per year for the lensof the eye or greater than 150mSv per year for skin and
40 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
extremities;
(b) category B: those exposed workers who are not
classified as category A workers.
(2) The undertaking or, in the c ase of outside workers, the
employer of the outside worker, shall decide on the categorisat ion of
individual workers prior to their taking up work that may give rise to
exposure, and to regularly review this categorisation on the ba sis of
working conditions and medical surveillance. The distinction sh all also
take into account pot ential exposures.
Individual 
monitoring.50. (1) Undertakings shall ensure that category A
workers are systematically monitored based on individualmeasurements performed by a dos imetry service. In cases where
category A workers are liable to  receive significant internal e xposure
or significant exposure of the lens of the eye or extremities, an
adequate system for mon itoring shall be set up.
(2) Undertakings shall ensure that monitoring for category B
workers is at least sufficient to demonstrate that such workers  a r e
correctly classified in category B. The Secretariat may require  t h e
undertaking to perform individua l monitoring and if necessary
individual measurements, by a dosimetry service, for category Bworkers.
(3) In cases where individual measurements are not possible
or inadequate, the individual monitoring shall be based on an e stimate
arrived at from individual measurements made on other exposedworkers, from the results of the surveillance of the workplace provided
for in regulation 48 or on the basis of calculation methods app roved by
the Secretariat.
Dose assessment in 
the case of 
accidental 
exposure.51. (1) In the case of accidental exposure, the
undertaking is required to asses s the relevant doses and their
distribution in the body.
 (2) In the case of accidental exposure, the undertaking is
required to obtain the results o f dose assessments as soon as p ractically
possible.
Recording and 
reporting of 
results.52. (1) Undertakings and the employer of any outside
workers shall record the data specified in paragraph 1 of the N inth
Schedule for the individual monitoring that is made for categor y A
workers and any individual monitoring that is performed on cate gory B
workers.
(2) For the purposes of sub-regulation (1), the following
information on exposed wor kers shall be retained:
(a) a record of the exposur es measured or estimated,
as the case may be, of individua l doses pursuant to regulations
50, 51, 61, 62, 63 and, if required by the Secretariat pursuant  to
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 41
regulations 44(2), 64(3); 
(b) in the case of exposures as referred to in
regulations 51, 62, 63, the repor ts relating to the circumstanc es
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 t heir working life involving expo sure to
ionising radiation and afterwards until they have or would haveattained 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 dos e record referred to in sub-re gulation
(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
f o l l o w i n g  y e a r  i n  t h e  f o r m a t  s p e c i f i e d  b y  t h e  S e c r e t a r i a t  a n d  s hall
consist of the data in Sectio n 2 of the Ninth Schedule.
(6) The Secretariat may seek to verify any of the data supplied .
Access to the 
results of 
individual 
monitoring.53. (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;
(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 forhuman health, as provided fo r in regulation 55(2).
(2) The undertaking, or in case of outside workers, the
employer of the outside worker, to grant workers, at their requ est,
access to the results of their individual monitoring, including  t h e
results of measurements which may have been used in estimatingthese results, or to the results of the assessment of their dos es 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 doseassessments to the individual and the Secretariat without delay .
42 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(4) It is the responsibility of the undertaking and the
employer of the outside worker that arrangements are in place f or the
appropriate exchange, among the undertaking, in the case of an outside
worker, the employer, the Secreta riat, occupational health serv ices,
radiation protection experts, or dosimetry services of all rele vant
information on the doses previous ly received by a worker in ord er to
perform the medical examination prior to employment or classifi cation
as a category A worker pursuant to regulation 55 and to control  the
further exposure of workers.
Data on outside 
workers to be 
supplied.54. (1) Before the start of any activity, the employer of the
outside worker shall supply the data given in paragraph 3 of th e Ninth
Schedule to the undertaking data on the employment of the outsi de
worker. 
(2) The following data shall be recorded or have been
recorded by the undertaking in the data system for individualradiological monitoring after the end of any activity for the o utside
worker:
(a) the period covered by the activity;
(b) an estimate of any effective dose received by the
outside worker (for the perio d 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 th e committed effective dose.
Medical 
surveillance of exposed workers.55. (1) Medical surveillance of exposed workers shall be
based on the principles that go vern occupational medicine gener ally.
(2) The medical surveillance of category A workers shall be
undertaken by an occupational health service. This medicalsurveillance shall allow for the state of health of workers und er
surveillance to be ascertained as regards their fitness for the  t a s k s
assigned to them. To this end, t he occupational health service shall
have access to any relevant information they require, including  t h e
environmental conditions i n the working premises.
(3) Medical surveilla nce shall include:
(a) a medical examination prior to employment or
classification as a category A worker to determine the worker'sfitness 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 beperformed as many times as an occupational health service
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 43
considers necessary, shall depe nd 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 sa feguard the health of the perso n
concerned.
Medical 
classification.56. 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.
Prohibition to 
employ or classify 
unfit workers.57. No worker may be employed or  classified for any period
in a specific post as a category A worker if medical surveillan ce
establishes that the worker is  unfit for that specific post.
Medical records. 58. (1) Medical records shall be opened for each
category A worker and kept up to d ate so long as the worker rem ains
a worker in that category. Thereafter, it shall be retained unt il 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 invol ving
exposure to ionising radiation.
(2) The medical record shall include information regarding
the nature of the employment, th e results of the medical examin ations
prior to employment or classification as a category A worker, t he
periodic reviews of health and the record of doses required byregulation 52.
Special medical 
surveillance.59. (1) In addition to the medical surveillance of
exposed workers provided for in regulation 55, provision is mad e for
any further action considered ne cessary by an occupational heal th
service for the health protection of exposed individuals, such as
further examinations, decontamin ation measures, urgent remedial
treatment or other actions identified by the occupational healt h
service.
(2) Special medical surveillance shall be performed in each
case where any of the dose limits l aid down in regulation 9 has  been
exceeded. 
(3) Subsequent exposure conditions shall be subject to the
agreement of the occupational health service.
Appeals. 60. Workers may appeal to the Commission against the
findings and decisions made pursu ant to regulations 56, 57 and 59.
44 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
Protection of 
outside workers.61. (1) The system for individual radiological monitoring
shall afford outside workers equivalent protection to that for exposed
workers employed on a permanen t basis by the undertaking.
(2) The undertaking is responsible, either directly or through
contractual agreements with the e mployer of outside workers, fo r the
operational aspects of the radiation protection of outside work ers that
are directly related to the na ture of their activities in the u ndertaking.
(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 relatio n 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 outs ide
worker has received specific instructions and training inconnection with the characteristics of the workplace and theconducted 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 tothe radiological risk associated with the sources and theoperations involved, as required in paragraph (c) of regulation47(1); 
(e) ensure that the outside worker has been issued
with the necessary personal protective equipment;
(f) ensure that the outside worker receives individual
exposure monitoring appropriate to the nature of the activities ,
and any operational dosimetric monitoring that may benecessary;
(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 theradiological data from individual exposure monitoring of eachcategory A outside worker within the meaning of the regulation54(2), are recorded.
(4) Employers of outside worke rs ensure, either directly or
through contractual agreements with the undertaking, that the r adiation
protection of their workers is in accordance with the relevant
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 45
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 refe rred to in paragraphs (a), (b )
and (e) of regulation 15(1), regulations 15(2), 15(3), 15(4) isprovided;
(c) guaranteeing that their workers are subject to
appropriate assessment of e xposure and, for category A
workers, medical surveillance, under the conditions laid downin regulations 48 and 50 to 59;
(d) ensuring that the radiological data from the
individual exposure monitoring of each of their category Aworkers is kept up to date in the data system for individualradiological monitoring referred to in paragraph (a) ofregulation 53.
Specially 
authorised exposures.
Amended by:
L.N. 184 of 2020.62. (1) The Secretariat may decide that in exceptional
circumstances evaluated case by case, excluding emergencies, wh ere
a specific operation so require s, authorise individual occupati onal
exposures of identified workers exceeding the dose limits set o ut in
regulation 9 provided that such exposures are limited in time,confined to certain working areas and within the maximum exposu re
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, breastfeedin g
workers, are exclude d from such exposures;
(c) the undertaking justifies such exposures in
advance and thoroughly discuss them with the workers, theirrepresentatives, an occupational health service and theradiation protection expert;
(d) information about the risks involved and the
precautions to be taken during the operation are provided tothe relevant wor kers in advance;
(e) the workers have consented;(f) all doses relating to such exposures are
separately recorded in the medical record referred to inregulation 58 and the individual record referred to inregulation 52.
46 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(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 the m,
without their agreement.
(3) The Secretariat shall be informed if the exposure of
spacecraft crew is likely to exceed dose limits and shall ensur e that it is
managed as a specially  authorised exposure.
Emergency 
occupational 
exposure.Amended by:
L.N. 184 of 2020.63. (1) Emergency occupational exposures shall remain,
whenever possible, below the values of the dose limits laid dow n 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 ef fective dose of 50mSv;
(b) in exceptional situations, in order to save life,
prevent severe radiation-induced health effects, or prevent thedevelopment of catastrophic conditions, a reference level for a n
effective dose from external radiation of emergency workersshall be 500mSv.
( 3 )  I n  a r e a s  w i t h i n  w o r k p l a c e s ,  w h e r e  t h e  r a d o n
concentration (as an annual average), continues to exceed the n ational
reference level, despite the ac tion taken in accordance with th e
principle of optimisation as set out in Part III and taking int o account
parameters contained in the natio nal 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 sha ll be
carried out as appropriat e to the circumstances.
(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 t he
circumstances.
Radon in 
workplaces.64. (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 s hall be carried out:
(a) in workplaces within the areas identified by the
Commission in accordance with regulation 127(3), that arelocated on the ground floor or b asement level or any other
subterranean work places; as well as
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 47
(b) in specific types of workplaces identified in the
national action plan taking into account paragraph 3 of theSixteenth Schedule.
(3) In areas within workplaces, where the radon
concentration (as an annual average), continues to exceed thenational reference level, despite  the action taken in accordanc e with
the principle of optimisation as set out in Part III, notificat ion in
accordance with regulations 34(4) and 44(2) shall apply.
Part VII
MEDICAL EXPOSURES
Justification.
Amended by:
L.N. 184 of 2020.65. (1) Medical exposure shall show a sufficient net
benefit, weighing the total pot ential diagnostic or therapeutic  benefits
it produces, including the direct benefits to health of an indi vidual
and the benefits to society, against the individual detriment t hat the
exposure might cause, taking into account the efficacy, benefit s and
risks of available alternative te chniques having the same objec tive
but involving no or less exposu re 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 referen ce to referral guidelines. 
(b) Undertakings inform and supply supporting
justification documentation to the Commission in advance ofthat undertaking adopting any new types of practices involvingmedical exposure. 
( c ) A l l  i n d i v i d u a l  m e d i c a l  e x p o s u r e s  a r e  t o  b e
justified in advance by a practitioner taking into account thespecific objectives of the expo sure and the characteristics of
the individual involved.
(d) Specific individual exposures can be justified,
where appropriate, in special c ircumstances, to be evaluated
by a practitioner on a case-by-case basis and documented forpractices involving medical exposure that are not justified ingeneral.
(e) The referrer and the practitioner, shall seek, to
obtain previous diagnostic inf ormation or medical records
relevant to the planned exposure and consider these data toavoid unnecessary e xposure. Repeat of medical exposure is
not justified if the diagnostic i nformation is already availabl e.
(f) For the justification of any medical exposure for
medical or biomedical research undertakings shall obtainclearance from the Commission. Prior to the Commission
48 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
issuing clearance for any medical exposure for medical or
biomedical research the undertaki ngs shall provide confirmation
that they have obtained clea rance 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 appropriatemedical scientific societies an d health regulatory bodies and
shall make reference to any ava ilable internationally accepted
justification norms for screening.
(h) The exposure of carers and comforters shall show
a sufficient net benefit, taking into account the direct healthbenefits to a patient, the possible benefits to the carer /comforter and the detriment tha t the exposure might cause.
(i) Medical radiological procedure for the early
detection of disease on an asymptomatic individual can only beperformed if it is: 
(i) part of a health screening programme, or (ii) requires specific documented justification
for that individual by the practitioner, in consultation withthe referrer, following guidelines from relevant medicalscientific societies and the Commission.
Special attention shall be given to the provision of informatio n
to the individual subject to med ical exposure, as required by p aragraph
(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 o n the medical indications;
(b) make reference to referral criteria;(c) refer the patient to a practitioner, providing adequate
clinical details;
(d) state on each individual refer ral the clinical question to
be answered; 
(e) where practical, seek, to obtain previous diagnostic
information or medical record s relevant to the planned
exposure and consider this data to avoid unnecessary
exposure; and 
(f) seek the outcome of the e xposure and act on the result.
Optimisation.
Amended by:L.N. 184 of 2020.66. (1) All doses due to medical exposure for
radiodiagnostic, interventional radiology, planning, guiding an d
verification purposes are to be k ept as low as reasonably achie vable
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 49
consistent with obtaining the re quired medical information, tak ing
into account economic a nd societal factors.
(2) For all medical exposure of  patients for radiotherapeutic
purposes, exposures of target volumes shall be individually pla nned
and their delivery appropriately verified taking into account t hat
doses to non-target volumes and ti ssues shall be as low as reas onably
achievable and consistent with the  intended radiotherapeutic pu rpose
of the exposure.
(3) The Commission shall estab lish and regular review their
use of diagnostic reference levels for radio-diagnostic examina tions,
having regard to the current European diagnostic reference leve ls
where available, and where appropriate, for interventional radi ology
procedures, and the availability o f guidance for this purpose.
(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 areexpected to receive a diagnostic or therapeutic benefit fromthis practice, the dose levels c oncerned shall be considered on
an individual basis by the practitioner and/or referrer prior t o
the exposure taking place.
(5) Undertakings shall ensure that the optimisation includes
the selection of equipment, the consistent production of adequa te
diagnostic information or therape utic outcomes, the practical a spects
of medical radiological procedures, quality assurance, and theassessment and evaluation of patient doses or the verification of
administered activities, taking into account economic and socie tal
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
50 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
diagnosis with radionuclides, the undertaking, shall ensure tha t 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 c ontact with the patient as far  a s
reasonably achievable. For thera peutic procedures these shall b e
written instructions.
These instructions shall be h anded out before leaving the
hospital or clinic.
Approval and 
responsibilities.67. The undertaking shall entitle individuals to act in the
different aspects of medical expos ures by approving these indiv iduals.
The undertaking is responsible to approve any individual whose
work relates to medical exposure. In making such approvals theundertaking shall ensure that the individual meets the requirem ents of
the Seventeenth Schedule. 
Undertakings. 68. 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 ofinvolvement being commensurate with the radiological riskposed 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 radiologicalprocedures shall be involved in the optimization process;
(d) referrers and practitioners  shall liaise as required
with each another in the justification process of individualmedical exposures;
(e) wherever practicable and prior to the exposure
taking place, the practitioner and the referrer, is to ensure t hat
the patient or their representative is provided with adequateinformation relating to the benef its and risks associated with the
radiation dose from the medical exposure. Similar informationas well as relevant guidance shall be given to carers andcomforters, in accordance with paragraph (b) of regulation66(6).
Practical aspects of 
medical radiological 
procedures.69. Practical aspects of medical radiological procedures may
be delegated by the undertaking or the practitioner, as appropr iate, to
one or more individuals entitled to act in this respect in a re cognised
field of specialization authorised by the Commission to act in this
respect.
Procedures. 70. Undertaking’s radiation protection programmes shall
include that:
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 51
(a) written protocols for every type of standard
medical radiological procedure are established for eachequipment for relevant categories of patients;
(b) information relating to patient exposure forms
part of the report of the med ical radiological procedure;
(c) referral guidelines for medical imaging, taking
into account the radiation doses, a re available to the referrer s;
( d ) c l i n i c a l  a u d i t s  a r e  c a r r i e d  o u t  i n  a c c o r d a n c e  t o
the national procedures est ablished 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 ormay be pregnant or breastfeeding;
(iii) approval of individuals to act as
referrers, practitioners, and persons performing thepractical aspects;
(iv) quality assurance; 
(v) the assessment of patient dose and
administered activity;
(vi) medical and biomedical research
programmes including the us e of dose constraints; 
(vii) giving of information and written
instructions as referred t o in regulation 66(7); 
(viii) recording of doses for each medical
exposure including, where appropriate, factors relevantto patient dose;
(ix) ensuring that the probability and
magnitude of accidental or unintended doses to patientsfrom radiological practices are reduced as far asreasonably achievable;
(x) responding and reporting of incidents
and accidents;
(xi) record keeping;
52 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(xii) arrangements for monitoring workers and
the workplace;
(xiii) education and training programme on the
nature of the hazards, protection and safety;
( x i v ) m e t h o d s  f o r  p e r i o d i c a l l y  r e v i e w i n g  a n d
auditing the performance of the radiation protectionprogramme;
(xv) any others as required to be able to
demonstrate compliance with these regulations.
Training and 
recognition.
Amended by:
L.N. 184 of 2020.71. (1) The Commission shall set the training and
recognition requirements, as laid down in regulations 102 and 1 4, for
the practitioner, the medical phy sics expert and the individual s referred
to in regulation 69. 
 (2) Undertakings shall ensure that practitioners and medical
physics experts and the individua ls referred to in regulation 6 9 meet
the requirements of the a bove sub-regulation (1).
Equipment. 
Substituted by:
L.N. 184 of 2020.72. (1) The responsibility to ensure that the equipment is fit for
clinical use resides w ith 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..
Installation of the 
equipment.73. Upon installation of the equipment the supplier/installer
has to perform tests to ensure that all the safety features and  warning
devices of the equipment are functioning. During installation, the
manufacturer’s instructions for u se must be followed. These tes ts shall
be performed whenever new, seco nd hand; refurbished and relocat ed
equipment has been installed, as well as after major maintenanc e has
been performed. These test results have to be kept by the under taking.
Acceptance 
testing.74. (1) Acceptance testing must be carried out in
accordance with international standards. The standard to be use d 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
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 53
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 th e case
of aged equipment then European Union criteria for acceptabilit y
may be used. 
(4) After the acceptance testing is carried out, the test
reports and any other relevant documentation has to be passed o n the
Secretariat. The Information to b e 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 beperformed, such as setti ng up exposure protocols.
Constancy testing. 75. (1) Constancy testing must be carried out in
accordance with international sta ndards. The standard to be use d
shall be accepte d by the Commission.
(2) Constancy tests are to be performed:
(a) immediately after an the initial acceptance test
has indicated that the functional performance of the equipmentis 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 e quipment is suspected.
(3) Constancy tests records of shall be kept for three years
from the last date of entry. 
Recalibrated 
equipment.
Substituted by:
L.N. 184 of 2020.76. The calibration of equipment used for dosimetry of
patients and acceptance or consta ncy testing shall be traceable  to an
accredited standards dosimetry la boratory and shall be routinel y re-
calibrated according to its instructions for use. In the absenc e of any
specified dosimeter re-calibrati on period, the equipment calibr ation
period must not exceed a period of two years.
Acceptable levels. 77. (1)  If tests show that the equipment has or is
producing doses other than the ac ceptable levels, or a malfunct ion
54 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
has occurred that could affect pa tient dose, it shall be remove d from
clinical use and shall be r eported to the Secretariat.
(2) Acceptable levels are deemed the tolerances specified in
the manufacturer’s specifications or the current European UnionCriteria which ever is the most stringent. 
Clearance for 
clinical use.78. (1) Clearance for the clinical use of the equipment is
required from the Secretariat for all instances specified in re gulation
74(2).
(2) Clearance will only be issued after the Secretariat reviews
the acceptance tests requi red by regulation 74(1). 
Compliance.
Amended by:L.N. 184 of 2020.79. (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 theequipment;
(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 u se
it must be kept under strict surveillance regarding radiationprotection;
(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
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 55
is necessary, including, if appr opriate, taking the equipment
out of service;
(m) reasonably steps to prevent failure of radiation
equipment where such failure could result in exposure ofpatients to ionising radiation greater than intended; 
(n) on becoming aware of defects in equipment
during use, the undertaking asse sses in consultation with the
supplier (or where relevant t he 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 equipmentfailure and subsequent repair, the undertaking should considerthe likelihood and consequences o f 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 rema in
responsible for that equipment and if the equipment is sold, le ased or
given to another approved undertaking, than the Secretariat sha ll be
notified prior to this happening.
Specific 
requirements.80. Specific requirements for certain equipment:
(a) the use of fluoroscopy equipment without a
device to automatically control the dose rate, or without animage intensifier or equivalent device, is prohibited.
(b) equipment used for external beam radiotherapy
with a nominal beam energy exceeding 1 MeV has a device toverify key treatment parameters. Equipment installed prior to 6February 2018 may be exemp ted from this requirement.
(c) any equipment used for interventional radiology
has a device or a feature informing the practitioner and thosecarrying out practical aspects of the medical procedures ofquantity of radiation produced by the equipment during theprocedure. Equipment installed prior to 6 February 2018 maybe exempted from this requirement.
(d) any equipment used for interventional radiology
and computed tomography and any new equipment used forplanning, guiding and verifica tion 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 theinformation required under 3(d) to the record of theexamination. Equipment installed prior to 6 February 2018
56 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
may be exempted from this requirement.
(f) without prejudice to paragraphs (c), (d) and (e),
new medical radiodiagnostic equipment producing ionisingradiation has a device, or an equivalent means, informing thepractitioner of relevant paramete rs for assessing the patient
dose. Where appropriate, the equi pment shall have the capacity
to transfer this information to  the record of the examination.
Special practices. 81. (1) Appropriate medical radiological equipment,
practical techniques and ancillary equipment shall be used in m edical
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 admini stered
activity for these practices.
(3) Practitioners and those individuals referred to in
regulation 69 who perform the ex posures referred to in sub-regu lation
(1) shall obtain appropriate training on these medical radiolog ical
practices as required by regulation 18.
Special protection 
during pregnancy 
and breastfeeding.82. (1) The referrer and the practitioner, shall inquire, as
whether the individual subject to  medical exposure is pregnant or
breastfeeding, unless it can be r uled out for obvious reasons o r is not
relevant for the radiological procedure.
(2) If pregnancy cannot be ruled out and depending on the
medical radiological procedure, i n particular if abdominal and pelvic
regions are involved, special attention shall be given to thejustification, particularly the urgency, and to the optimisatio n, 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, spec ial
attention shall be given to the justification, particularly the  u r g e n c y ,
and to the optimisation, taking into account both the individua l 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 regula tion applies, through measures s uch as
public notices in a ppropriate places.
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 57
Accidental and 
unintended 
exposures.83. Undertakings shall ensure that 
(a) all reasonable measures are taken to minimise
the probability and magnitude of accidental or unintendedexposures of individuals subj ect 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 orpotentially involving accidental or unintended medicalexposures, commensurate with the radiological risk posed bythe practice;
(d) arrangements are made to inform the referrer and
the practitioner, and the patient, or their representative, abo ut
clinically significant uninte nded or accidental exposures and
the results of the analysis;
( e ) d e c l a r e s  w i t h i n  t w o  d a y s  t o  t h e  S e c r e t a r i a t  t h e
occurrence of medical exposures much greater than intendedand other significant events as defined in the Nineteenthschedule;
(f) the results of the inves tigation and the corrective
measures to avoid such events are reported to the Secretariatwithin one week;
(g) mechanisms are in place for the timely
dissemination of information, relevant to radiation protectionin medical exposure, regar ding lessons learned from
significant events.
Estimates of 
population doses.84. Undertakings shall ensure that the distribution of
individual dose estimates from medical exposure for radiodiagno stic
and interventional radiology purposes is determined, taking int o
consideration the age and gender of the exposed and that thisinformation is made availa ble to the Secretariat.
PART VIII
PUBLIC EXPOSURES
(SECTION 1) 
PROTECTION OF MEMBERS OF THE PUBLIC AND LONG-
TERM HEALTH PROTECTION IN NORMAL CIRCUMSTANCES
Operational 
protection of members of the 
public.85. (1) Licensees shall ensure that the operational
protection of members of the public in normal circumstances fro m
their practice and shall include , for relevant facilities, the following:
58 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(a) at the design stage, the design of the proposed
siting of the facility from a radiation protection point of vie w,
taking into account relevant demographic, meteorological,geological, hydrological and ecological conditions;
(b) adequate protection being provided against any
exposure or radioactive contamination liable to extend beyondthe perimeter of the facility or radioactive contamination liab le
to extend to the ground beneath the facility;
(c) measures to control the access of members of the
public to the facility.
(2) Practices subject to registration shall ensure the protectio n
of members of the public i n normal circumstances. 
Estimation of 
doses to the 
members of the 
public.86. (1) Undertakings shall estimate doses to members of
the public (which excludes occupa tional 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 isfunctioning.
(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 toidentify the representative person, taking into account theeffective pathways for transmission of the radioactivesubstances;
(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 theradiation in question;
(ii) assessment of the intake of radionuclides,
indicating the nature of the radionuclides and, where
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 59
necessary, their physical a nd chemical states, and
determination of the activ ity concentrations of these
radionuclides in food and drinking water or otherrelevant environmental media;
(iii) assessment of the doses that the
representative person, as identified in paragraph (a), isliable to receive;
(d) require records rela ting to measurements of
external exposure and contamination, estimates of intakes ofradionuclides, and the results of the assessment of the doses
received by the representative pe rson to be kept and be made
available on request to all stakeholders.
Radioactive 
discharges.87. (1) Pursuant to regulation 37(f), undertakings who
wish to discharge radioactive effluents shall apply to the Secr etariat
for a discharge license.
(2) Undertakings shall provide to the Secretariat an estimate
of doses to individuals from th e proposed discharges using gene ric
screening assessment based on internationally recognised scient ific
guidance as part of their applic ation for a discharge license.
(3) The Secretariat shall examine and approve plans for the
discharge of radioactive effluent s and issue a discharge licens e.
(4) The Secretariat shall where appropriate establish
authorised limits as part of the discharge license and conditio ns 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 evaluatethe radioactive airborne or liquid discharges into theenvironment in normal operation and to report the resultsannually to the Secretariat.
Tasks for the 
undertaking.88. 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 theenvironment;
60 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(c) check the effectiveness and maintenance of
equipment as referred to in paragraph (b) and ensure the annualrecalibration of mea suring instruments;
(d) seek advice from a radiation protection expert in
the performance of the tasks refe rred to in paragraphs (a), (b)
and (c).
(SECTION 2) 
EMERGENCY EXPOSURE SITUATIONS
Emergency 
response.
Amended by:
L.N. 184 of 2020.89. (1) The Commission shall develop and maintain the
national radiological emergency pl an referred to in Article 31 of the
Act in consultation with the Civil Prot ection Department.
(2) The national radiological protection plan shall be
developed following a national ra diological hazard assessment t hat
shall be performed by the Commission. 
(3)  The national radiological protection plan shall be tested
at appropriate intervals.
Notification. 90. (1) Undertakings are to notify either the Secretariat or
the Civil Protection Department immediately of any emergency inrelation to the practices for whi ch it is responsible and to ta ke all
appropriate action to re duce the consequences.
(2) Undertakings shall make an initial provisional assessment
of the circumstances and conseque nces of the emergency and assi st
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 re lease of radionuclides;
(b) the environment, to reduce the exposure to
individuals resulting from radioactive substances throughrelevant pathways;
(c) individuals, to reduce their exposure.
Emergencies on or 
outside Maltese territory.
Substituted by:
L.N. 184 of 2020.91.(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 protec tive measures, taking account of
the real characteristics of the emergency and in accordance wit h
the optimised protection strategy as part of the nationalradiological emergency plan referred to in regulation 89,whereby the elements to be included in an emergency response
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 61
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;
(d) assess and record the consequences of the
emergency and of the effectivenes s of the protective measures.
(2) Undertakings shall have appropriate emergency
preparedness and response procedur es in place as indicated in t he
Tenth Schedule.
Medical treatment. 92. If the situation so requires, ensure that provision is made
to organise the medical treatment of those affected by the Mini stry of
Health with the Secretariat p roviding any required advice.
Information to the 
members of the 
public likely to be 
affected in the event of an 
emergency.93. (1) Secretariat shall ensure that the members of the
public likely to be affected in the event of an emergency are g iven
information about the health pro tection measures applicable to them
and about the action they should take in the event of such anemergency.
(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 req uest
being made.
(4) The Commission shall ensure that the information is
updated and distributed at regular intervals and whenever signi ficant
changes take place. This informa tion shall be permanently avail able
to the public.
Information to the 
members of the public actually 
affected in the 
event of an emergency.94. (1) The Secretariat and Civil Protection Department
s h a l l  e n s u r e  t h a t ,  w h e n  a n  e m e r g e n c y  o c c u r s ,  t h e  m e m b e r s  o f  t h epublic actually affected are informed without delay about the f acts of
the emergency, the steps to be taken and, as appropriate, the h ealth
protection measures applicable t o these members of the public.
(2) The information provided shall cover those paragraphs
listed in Section B of the Eleve nth Schedule which are relevant  to the
type of emergency.
(SECTION 3) 
EXISTING EXPOSURE SITUATION
Environmental 
monitoring 
programme.95. (1) The Commission shall ensure that the National
Radioactivity Monitoring Programme is maintained. 
62 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(a) In connection with the National Radioactivity
Monitoring Programme:
(b) The Commission shall ensure that the appropriate
government entities have an environmental monitoringprogramme for ionizing radiation and radioactivity, as part of
the National Radioactivity Monitoring Programme, and in doingso take into consideration any recommendations from theEuropean Commission. The minimum elements of the nationalmonitoring programme are given in the Table 1 of the TwentyFirst Schedule.
(c) Entities performing the monitoring for the
National Radioactivity Monitoring Programme shall enter into aformal arrangement with the Commission for the provision ofthe 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 thei r
practices.
Contaminated 
areas.96. (1) The Commission shall ensure that optimised
protection strategies for managing contaminated areas shall inc lude,
where applicable, the following:
(a) objectives, including long-term goals pursued by
the strategy and corresponding reference levels, in accordancewith regulation 7;
(b) delineation of the affecte d 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 andmembers of the public;
(d) consideration of the need to prevent or control
access to the affected areas, or to impose restrictions on livi ng
conditions in these areas;
(e) assessment of the exposure of different groups in
the population and assessment of the means available toindividuals for controlling their own exposure.
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 63
(2) For areas with long-lasting residual contamination in
which the Commission has advised the government to allowhabitation and the resumption of social and economic activities , the
government, following the advice of the Commission, shall ensur e, in
consultation with stakeholders, that arrangements are in place,  a s
necessary, for the ongoing control of exposure with the aim ofestablishing living conditions that can be considered as normal ,
including:
(a) establishment of appropriate reference levels;(b) establishment of an infrastructure to support
continuing self-help protective me asures in the affected areas,
such as information provision, advice and monitoring;
(c) if appropriate, re mediation measures;
(d) if appropriate, delineated areas.
Indoor exposure to 
radon.97. (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 a n annual average) exceeding the
reference level and encourage, where appropriate by technical o r
other means, radon concentrati on-reducing measures in these
dwellings.
(3) The Commission shall ensure that national information
is made available on indoor radon exposure and the associated h ealth
risks, on the importance of performing radon measurements and o n
the technical means available fo r reducing radon concentrations .
Gamma radiation 
from building 
materials.98. (1) The reference level applying to indoor external
exposure to gamma radiation emitted by building materials, inaddition to outdoor external expos ure, shall be 1 mSv per year.
(2) For building materials which are identified by the
Commission as being of concern from a radiation protection poin t of
view, taking into account the indicative list of materials set out in the
Twelve Schedule with regard to their emitted gamma radiation, i t
shall be ensured that, before su ch materials are placed on the market:
(a) the activity concentrations of the radionuclides
specified in the Seventh Sche dule are determined, and that,
(b) information to the Commission on the results of
measurements and the corresponding activity concentrationindex, as well as other relevant factors, as defined in theSeventh Schedule are provided if requested.
(3) For types of building materials identified in accordance
64 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
with sub-regulation (2) which are liable to give doses exceedin g the
reference level, The Commission  shall decide on appropriate
measures, which may include specific requirements in relevantbuilding codes or restrictions on the envisaged use of such mat erials.
Part IX
RESPONSIBILITIES AND OTHER ELEMENTS OF REGULATORY 
CONTROL
(SECTION 1) 
GENERAL RESPONSIBILIT IES OF UNDERTAKINGS
Safety culture. 99. Undertakings shall promote a safety culture within its
organisation.
Radiation 
Protection 
Programmes.
Amended by:L.N. 184 of 2020.100. (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 appropr iate 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 radiatio n 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
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 65
Safety 
Assessments.
Amended by:
L.N. 184 of 2020.101. (1) It is the responsibility of the undertaking to ensure that
appropriate safety assessmen t/s are performed. The safety
assessment shall:
(a) identify ways in which potential exposures or
accidental and unintended medical exposures could
occur; 
(b) estimate, to the extent p racticable, the probabilities
and magnitude of potential exposures; 
(c) assess the quality and extent of protection and safety
provisions, including engin eering 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, asuitable and sufficient a ssessment shall be made.
 (3) When carrying out safet y assessments undertakings,
shall give adequate consideration to:
(a) That prior to perfor ming the assessment the
undertaking shall have the n ecessary expertise and data
available.
(b) The manner in which all practices that can effect
workers and any other persons that give ris e 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 desi gner 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 aslaid down in these regulations
(d) The assessment of the site characteristics.
(e) The identification a nd assessment of risks.
(f) The specification a nd assessment of safety
functions.
(g) The determination of whether adequate safety
measures are in place.
66 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(h) The determination of the adequacy of engineering
aspects. 
(i) The assessment of how human interactions can
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 pro visions 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
b e  a s s e s s e d  i n  t h e  s a f e t y  a n a l y sis, including, i f necessary, th e
post-operational phase. 
(m) Any calculation methods used in the safety
analysis shall undergo ve rification and validation.
 (4) Once the assessment is carried out:
(a) The results and finding s of the safety assessment
shall be documented.
(b) The undertaking shall consider the need to carry
out an independent verification of the safety assessment beforeit is used by the operating organization or submitted to theSecretariat.
(c) The results of the safety  assessment shall be used
to specify the programme for maintenance, surveillance andinspection; to specify the proce dures to be put in place for al l
operational activities significant to safety, and for respondin g to
anticipated operational occurren ces and accidents; to specify t he
necessary competences for the staff involved in the facility oractivity; and to make decisions in an integrated, risk informedapproach.
(d) The safety assessment shall be periodically
reviewed and updated.
 (5) Where the assessment ma de for the purposes of this
regulation shows that a radiation risk to workers or other pers ons 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
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 67
(c) provide workers with the appropriate
information, instruction and training, and with the equipmentnecessary to restrict their ex posure to ionising radiation.
(SECTION 2) 
INSTITUTIONAL INFRASTRUCTURE
Recognition of 
services and experts.102. (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 certifi cates
shall be time limited and may specify limitations.
(4) The Commission shall endeavour to ensure that the
necessary arrangements are in pl a c e  t o  e n s u r e  t h e  c o n t i n u i t y  o f
expertise of these s ervices and experts.
Occupational 
health services.103. The Commission shall ensure that occupational health
services perform medical surveillance of exposed workers, inaccordance with Part VI, with reg ard to their exposure to ionis ing
radiation and their fitness for the tasks assigned to them invo lving
work with ionising radiation.
Dosimetry 
services.104. Dosimetry services shall dete rmine internal or external
doses to exposed workers subject to individual monitoring, in o rder
to record the dose in cooperation with the undertaking and in t he case
of outside workers, the employer of the outside worker, and whe re
relevant the occupational health service.
Radiation 
protection expert.
Amended by:L.N. 184 of 2020.105. (1) A radiation protection expert is to give competent
advice to the undertaking on matters relating to compliance wit h
applicable legal requirements, in respect of occupational and p ublic
exposure.
68 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(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
programme;
(b) development of safety culture; 
(c) optimisation and establishment of appropriate
dose constraints;
(d) plans for new installatio ns and the acceptance into
service of new or modified radiation sources in relation to anyengineering controls, design features, safety features andwarning devices relevant to radiation protection;
(e) categorisation of contro lled 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 radioa ctive waste management;
(l) arrangements for prevention of accidents and
incidents;
(m) preparedness and respon se in emergency exposure
situations;
(n) training and retraining programmes for exposed
workers;
(o) investigation and analysis of accidents and
incidents and appropria te remedial actions;
(p) employment conditions for pregnant and
breastfeeding workers;
(q) preparation of appropriate documentation
required under the radiation prot ection programme such as prior
safety assessments and  written procedures.
(3) The radiation protection e xpert shall, where appropriate,
liaise with the medical physics expert.
(4) The radiation protection expert may be assigned by the
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 69
undertaking the performance of the tasks of radiation protectio n of
workers and members of the public.
(5) Where a radiation protection expert is consulted
pursuant to the requirements of t hese regulations the undertaki ng
shall appoint that radiation protection expert in writing and s hall
include in that appointment the scope of the advice which theradiation protection expert is required to give.
Radiation 
Protection Experts.106. (1) Radiation protection experts need to be recognized
by the Commission and will need to meet the following genericcriteria: 
(a) have a degree in radiography, medicine, or other
physical science or a suitable combination of otherqualifications and experience; and
(b) sufficient work experience directly concerned
with radiation protection practice; and
(c) undertake continued pr ofessional development.
(2) The Commission shall issue detailed requirements for
different applications based on the generic criteria given in t he above.
 (3) Radiation protection experts shall need re-certification
by the Commission.
Medical physics 
experts.107. (1) Medical physics experts are to act or give
specialist advice, as appropriate , on matters relating to radia tion
physics for implementing the requirements set out in Part VII a nd 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 deli vered
to the patient and other individuals subject to medical exposur e, give
advice on medical radiological equipment, and contribute inparticular 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 referencelevels;
(d) the definition and performance of quality
assurance programmes of the medical radiological equipment;
(e) testing of medical radiological equipment;
70 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(f) the preparation of technical specifications for
medical radiological equipmen t and installation design;
(g) the surveillance of the medical radiological
installations;
(h) the analysis of events involving, or potentially
involving, accidental or uni ntended 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.
Approval 
certificates.108. The Commission shall issue approval certificates for
medical physics experts for a validity period of not greater th an a
period of five years in a special ty (radiotherapy, nuclear medi cine,
diagnostic and interventional radiology)
 Meetings. 109. ( 1) Medical physics experts shall meet the following
criteria for initial certific ation by the Commission:
(a) be registered by the Council for the Professions
complimentary to Medicine in Malta as a medical physicist; and
(b) have attained European Qualifications Framework
(EQF) Level 7 (ex: Master with 90-120 European CreditTransfer and Accumulation System (ECTS)); and
(c) two years structured accre dited clinical training in
Medical Physics in specialty (radiotherapy, nuclear medicine,diagnostic and interven tional radiology); and
(d) two years documented full time work experience,
within the preceding 28 months, in specialty (radiotherapy,nuclear medicine, diagnostic and interventional radiology) with
documented CPD.
 (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 4 8
consecutive months.
(b) Documented CPD since the last certificate issued.
Radiation 
protection officer.110. (1) All undertakings and employers of outside
workers shall designate a ra diation protection officer. 
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 71
 (2) Undertakings and employers of outside workers shall
provide the radiation protection officers with the means necess ary 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.
Assistance. 111. (1) Radiation protection officers are to assist the
undertaking in the execution of its radiation protection progra mme. 
(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 program me or
may have a supervisory role of some or all aspects of the progr amme.
(3) The task of the radiation protection officer may be
carried out by a radiation protection unit established within a n
undertaking or by a radia tion protection expert.
(SECTION 3) 
CONTROL OF RADIOACTIVE SOURCES
General 
requirements for 
unsealed sources.112. (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 unsealedsources.
(2) The undertaking shall, as appropriate and to the extent
possible, keep records of unseale d sources under its responsibi lity,
including location, transfer, disposal and discharge to theenvironment. The Secretariat shall require undertakings to noti fy it of
discharges from its facility on an annual or more frequent basi s, 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.
General 
requirements for 
sealed sources.113. (1) The Secretariat shall specify in a license the
arrangements for keeping contro l of sealed sources with regard to
their location, use, storage and, when no longer required, thei r
recycling or disposal.
(2) Undertakings shall keep records of all sealed sources
under its responsibility, including location, transfer and disp osal.
(3) Undertakings shall give the  Secretariat 30 days notice of
the intent to transfer any sealed source and shall not perform any
72 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
transfer until clearance is  given by the Secretariat.
(4) Undertakings shall notify the Secretariat promptly of any
loss, significant leakage, theft o r unauthorised use of a seale d source.
Requirements for 
control of high-
activity sealed sources.
Substituted by:
L.N. 184 of 2020.114. (1) Undertakings shall obtain a prior license from the
Secretariat for any practice involving a high activity source, including
taking possessi on of a source. 
(2) The Commission shall require that adequate provision, by
way of a financial security or a ny other equivalent means appro priate to
the source in question, having been made for the safe managemen t of
sources when they become disused  sources, including the case wh ere
the holder becomes insolven t or goes out of business
(3) Undertakings are required, that in addition to the general
licensing requirements set out in Part V , shall have provided f or, within
its radiation protection programme for: 
(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 equipmen t performance criteria;
(f) emergency procedures a nd 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 disusedsources to a supplier, another authorised holder or a recognise d
installation;
(j) developed a security plan or assessment including
measures to detect and delay the unauthorised access to, or thetheft, loss or unauthorised use or removal of radioactive sourc es
during all stages of management. The degree of securityrequired, shall be dependent on the security level as laid out in
the three columns of Table 1 of the Second Schedule. Securitymeasures for the different security levels are given in Table 1  in
the Fourteenth Schedule. The sec urity plan or assessment shall
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 73
be periodically reviewed and re cords of such reviews kept; 
(k) minimum performance criteria and maintenance
requirements for equipment and systems used to ensure thesafety and security of radioactive sources;
(l) measures to determine, as appropriate, the
trustworthiness of individuals involved in the management ofradioactive sources; and
(m) the confidentiality of information relating to the
security of sources.
(4) Each undertaking in possession of high activity sealed
sources shall:
(a) ensure that suitable test s, such as leak tests based
on international standards, are undertaken every 14 months inorder 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 presentand in apparently good condition at its place of use or ofstorage. Verification frequency shall be as listed in Table 1 i n
the Fourteenth Schedule;
(c) ensure that each fixed and mobile source is
subject to adequate documented measures, such as writtenprotocols and procedures, aimed at preventing unauthorisedaccess to or loss or theft of t he source or its damage by fire;
(d) promptly notify the Secretariat of any loss,
leakage, theft or unauthorised u se of a source, arrange for a
check on the integrity of each source after any event, includin g
fire, that may have damaged the source and, if appropriate,inform the Board thereof a nd 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 theCommission, without undue delay a fter terminatio n 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 amember of the public.
(5) Each undertaking in possession of high activity sealed
sources shall in conne ction for training and information ensure :
(a) includes specific requirements for the safety and
74 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
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, b e
addressed to exposed workers.
Record keeping by 
the undertaking.115. (1) The undertaking shall keep records for high-
activity sealed sources which sha ll 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 aspossible 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 thissource; in this case the name of the holder or recognisedinstallation to which the source is transferred shall be includ ed,
(e) without undue delay on the closure of such
records when the holder no l onger holds any sources, and
(3) The undertaking’s records shall be available for
inspection by the Secretariat.
Control of high-
activity sealed 
sources identification and 
marking.116. (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 onthe 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 re usable
transport containers, the source container shall, at least, bea r
information on the nature of the source.
(b) The source container an d, where practicable, the
source are marked and labelled w ith an appropriate sign to warn
people of the radiation hazard.
(2) The manufacturer shall provide a photograph of each
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 75
manufactured source design type and a photograph of the typical
source container.
(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-regu lation
(1) and that the markings and labels referred to in sub-regulat ion (1)
remain legible. The information shall include photographs of th e
source, source container, transpor t packaging, device and equip ment
as appropriate.
(SECTION 4) 
ORPHAN SOURCES
Detection of 
orphan sources.117. (1) The Commission shall en sure 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 onthe actions to be taken.
(2) The Commission shall encourage the establishment of
systems aimed at detecting orphan sources at metal recyclinginstallations, waste handling in stallations and at ports of ent ry to
Malta
(3) The Secretariat shall provide specialised technical
advice and assistance promptly to persons who suspect the prese nce
of an orphan source and who are not normally involved in operat ions
subject to radiation protection requirements. 
Metal 
contamination.118. (1) The Commission shall encourage the
establishment of systems to dete c t  t h e  p r e s e n c e  o f  r a d i o a c t i v e
contamination in metal products at Maltese ports.
(2) Scrap recycling installations and operators of
monitoring equipment at ports shall promptly inform the Secreta riat
if they suspect or have knowledge of any contaminated material or
radioactive source at their facility. Any contaminated material  o r
radioactive source shall not be  used, placed on the market,
transported or disposed of without the involvement of the Secre tariat.
Recovery, 
management, 
control and disposal of orphan 
sources.119. (1) The national radiological emergency plan, as set
out in regulation 122 shall include provisions for the assignme nt of
responsibilities, to control and recover orphan sources and to deal
with emergencies due  to orphan sources. 
(2) The Secretariat shall inves tigate as appropriate any past
facilities that may have used sources that are not on the natio nal
76 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
inventory of sources. Any orphan sources discovered shall be br ought
under regulatory control.
Financial security 
for orphan sources.120. The Commission shall obtain the costs of recovering,
managing, controlling and disposing of the sources from thegovernment which may result from implementation of regulation 1 18.
(SECTION 5) 
SIGNIFICANT EVENTS
Notification and 
recording of 
significant events.121. Undertaking shall:
(a) implement, as appropr iate, a recording and
analysis system of significant events involving or potentiallyinvolving accidental or unintended exposures;
(b) promptly notify the Secretariat of the occurrence
of any significant event resulting or liable to result in theexposure of an individual beyond the operational limits orconditions of operation specified in authorising requirementswith regard to occupational or public exposure or as defined bythe Commission for medical exposure, including the results ofthe investigation and the corrective measures to avoid suchevents.
National 
Emergency 
preparedness.Amended by:
L.N. 184 of 2020.122. (1) The Commission, shall, working closely with
Civil Protection, develop emergency management systems. Thesesystems shall be integrated in the national radiological emerge ncy
plan. The national radiological emergency plan shall include th e
elements listed in the Tenth Schedule.
(2) The national radiological emergency plan shall take into
account the risks identified in the national radiological hazar d
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 fromthe affected population and reducing the risk of stochasticeffects, taking account of the general principles of radiationprotection and the reference le vels 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 a ccount lessons learned from pas t
emergency exposure situations and taking into account theresults of the participation in e mergency exercises at national
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 77
and international level;
(d) where appropriate, incorporate relevant elements
of the emergency management system referred to in regulation122(1), 122(2);
(e) The national radiological emergency plan shall
provide for the establishment of specific emergency responseplans to address sp ecific issues. 
International 
cooperation.123. (1) The Commission shall cooperate with other
Member States and with third countries in addressing possibleemergencies on its territory which may affect other Member Stat es or
third countries, in order to facilitate the organisation of rad iological
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 conse quences
on its territory, promptly establish contact with all other Mem ber
States and with third countries which may be involved or are li kely to
be affected with a view to sharing the assessment of the exposu re
situation and coordinating protective measures and publicinformation by using, as approp riate, bilateral or internationa l
information exchange and coordination systems. These coordinati on
activities shall not prevent or de lay any necessary actions to be taken
on a national level.
(3) The Commission shall promptly share information and
cooperate with other relevant Memb er States, relevant third cou ntries
and relevant international organisations regarding the loss, th eft or
discovery of high-activity sealed sources, other radioactive so urces
and radioactive material of con cern and regarding related follo w-up
or investigations, without prejudice to relevant confidentialit y
requirements and relevant  national legislation.
(4) The Commission, where appropriate, cooperate with
other Member States and with t hird 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 ofundeclared radioactive material  detected at Maltese ports.
(SECTION 6) 
EXISTING EXPOSURE SITUATIONS
Programmes on 
existing exposure 
situations.124. (1) The Commission shall ensure that measures are
taken, upon indication or evidence of exposures that cannot bedisregarded from a radiation protection point of view, to ident ify and
evaluate existing exposure situations taking into account the t ypes of
existing exposure situations listed in the Fifteenth Schedule, and to
determine the corresponding occ upational and public exposures.
78 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(2) The Commission may decide, having regard to the
general principle of justificatio n, that an existing exposure s ituation
warrants no consideration of pro tective or remedial measures.
(3) Existing exposure situations  which are of concern from a
radiation protection point of view and for which legal responsi bility
can be assigned shall be subject t o the relevant requirements f or
planned exposure situations and ac cordingly such exposure situa tions
shall be required to be notified as specified in regulation 34( 4).
Establishment of 
strategies.125. (1) The Commission sh all arrange for the
establishment of strategies to e nsure the appropriate managemen t of
existing exposure situations comme nsurate with the risks and wi th the
effectiveness of pro tective measures.
(2) Each strategy shall contain
(a) the objectives pursued;(b) appropriate reference levels, taking into account
the reference levels lai d down in regulation 7.
Implementation of 
strategies.126. (1) The Commission shall advice the |Minister on the
assignment of responsibilities for the implementation of strate gies for
the management of existing exposure situations, and ensureappropriate coordination between relevant parties involved in t he
implementation of remedial and pr otective measures. Stakeholder s
shall be involved as appropriate in decisions regarding thedevelopment and implementation of strategies for managing expos ure
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 sha ll be assessed. Further efforts  shall be
considered with the aim of optimising protection and reducing a ny
exposures that are still a bove the reference level.
(4) In the implementation of a strategy the Commission shall
regularly:
(a) evaluate the available remedial and protective
measures for achieving the obje ctives 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 reducingtheir exposure;
(c) provide guidance for the management of
exposures at individual or local level;
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 79
(d) with regard to activities that involve naturally
occurring radioactive material and are not managed as plannedexposure situations, provide inf ormation on appropriate means
for monitoring concentrations and exposures and for takingprotective measures.
Radon action plan. 127. (1) In application of regulation 124(1) the
Commission shall establish a national action plan addressing lo ng-
term risks from radon exposures in dwellings, buildings with pu blic
access and workplaces for any s ource of radon ingress, whether from
soil, building materials or water. The action plan shall take i nto
account the issues set out in the Sixteenth Schedule and be upd ated
on a regular basis.
(2) The Commission shall recommend to the Minister on
appropriate measures to prevent radon ingress into new building s.
These measures may include specific requirements in nationalbuilding codes.
(3) Commission shall identify areas where the radon
concentration (as an annual average) in a significant number ofbuildings is expected to exceed t he relevant national reference  level.
(SECTION 7) 
SYSTEM OF ENFORCEMENT
Inspections. 128. (1) The Secretariat shall establish a system or
systems of inspection to enforce the provisions adopted pursuan t to
these regulations and to initiate surveillance and corrective a ction
where necessary.
(2) The Secretariat shall establish an inspection programme
taking into account the potential magnitude and nature of the h azard
associated with practices, a general assessment of radiationprotection 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
inspection are recorded and communicated to the undertakingconcerned. If the findings are related to an outside worker or workers,
where appropriate, the findings shall also be communicated to t he
employer of the outside worker.
(4) The Secretariat shall ensure that outlines of the
inspection programmes and the main findings from theirimplementation are available to the public.
(5) The Secretariat shall ensure that mechanisms are in
place for the timely dissemination to relevant parties, includi ng
manufacturers and suppliers of radiation sources and, whereappropriate, international organisations, of protection and saf ety
information concerning significan t lessons learned from inspect ions
80 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
and from reported inci dents and accidents and related findings.
.Enforcement. 129. Pursuant to the Act, the Secretariat has the power to
require any individual or legal person to take action to remedydeficiencies and prevent their recurrence or to withdraw, whereappropriate, authorisation when the results of a regulatory ins pection
or another regulatory assessment indicate th at the exposure sit uation is
not in compliance with the provisions adopted pursuant to theseregulations.
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 81
FIRST SCHEDULE 
(Regulation 4) 
Radiation and tissue weighting factors
A. Radiation weighting factors
Note: All values relate to the radiation incident on the body o r ,  f o r  i n t e r n a l
radiation sources, emitted from the incorporated radionuclide(s ).
B. Tissue weighting factors
(*) The WT for the remainder tissues (0. 12) applies to the arithmetic mea n dose of the 13
organs and tissues for each sex l isted below. Remainder tissues : adrenals, extrathoracic
(ET) region, gall bladder, heart , kidneys, lymphatic nodes, mus cle, oral mucosa, pancreas,
prostate (male), small intestine , spleen, thymus , uterus/cervix  (female).Radiation type WR
Photons 1
Electrons and muons 1
Protons and charged pions 2
Alpha particles, fission fragments, heavy ions 20
Neutrons, En<1 MeV
 
Neutrons, 1 MeV ≤ En≤50 MeV
Neutrons, En>50 MeV
Tissue WT
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
Skin 0.01

82 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
SECOND SCHEDULE 
(Regulation 4) 
Activity Of high-activity sealed  sources and Security Values
For radionuclides not listed in the table below, the relevant a ctivity is identical to
the D-value defined in the IAEA publication Dangerous quantitie s of radioactive
material (D-values), (EPR-D-V ALUES 2006).
Table 1
(1) The activity is that of th e alpha-emitting radionuclideIAEA Code of Conduct on the safe ty 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 hi gh-activity sealed 
sources in this regulation
Radionuclide Activity (TBq) Acti vity (TBq) Ac tivity (TBq)
Am-241 6 x 101 6 x 10-16 x 10-2
Am-241/Be (1)6  x  1 016 x 10-16 x 10-2
Cf-252 2 x 1012 x 10-12 x 10-2
Cm-244 5 x 1015 x 10-15 x 10-2
Co-60 3 x 1013 x 10-13 x 10-2
Cs-137 1 x 1021 x 1001 x 10-1
Gd-153 1 x 103 1 x 1011 x 100
Ir-192 8 x 1018 x 10-18 x 10-2
Pm-147 4 x 1044 x 1024 x 101
Pu-238 6 x 1016 x 10-16 x 10-2
Pu-239/Be 6 x 1016 x 10-16 x 10-2
Ra-226 4 x 1014 x 10-14 x 10-2
Se-75 2 x 1022 x 1002 x 10-1
Sr-90 (Y-90) 1 x 103 1 x 1011 x 100
Tm-170 2 x 1042 x 1022 x 101
Yb-169 3 x 1023x 1003 x 10-1
Au-198 2 x 1022x 1002 x 10-1
Cd-109 2 x 1042 x 1022 x 101
Co-57 7 x 1027 x 1007 x 10-1
Fe-55 8 x 105 8 x 103 8 x 102
Ge-68 7 x 1027 x 1007 x 10-1
Ni-63 6 x 1046 x 1026 x 101
Pd-103 9 x 1049 x 1029 x 101
Po-210 6 x 1016 x 10-16 x 10-2
Ru-106 3 x 1023 x 1003 x 10-1
Tl-204 2 x 1042 x 1022 x 101
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 83
THIRD SCHEDULE
(Regulation 27) 
JUSTIFICATION OF NEW CLASSES OR TYPES OF PRACTICES
INVOLVING CONSUMER PRODUCTS
(A) Any undertaking intending to manufacture or import into Malt a
consumer products for which the i ntended use is likely to lead to a new class or
type of practice, shall provide the Commission with all relevan t information, as to
the:
(i) intended use of the product,
(ii) technical characteristics of the product;(iii) in the case of products conta ining 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 regul ar users of the product.
(B) The Commission shall examine that information and in particu lar
assess whether:
(i) the performance of the consumer product justifies its intend ed use;
(ii) the design is adequate in order to minimize exposures in no rmal use and
the likelihood and consequences o f misuse or accidental exposur es, or whether there
should be conditions imposed on the technical and physical char acteristics of the
product;
(iii) the product is adequately designed to meet the exemption c riteria, and,
where applicable, is of an approved type and does not necessita te specific precautions
for disposal when no longer in use;
(iv) the product is appropriately labelled and suitable document ation is
provided to the consumer with ins tructions for proper use and d isposal.
84 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
LIST OF JUSTIFIABLE PRACTICES 
INVOLVING IONIZING RADIATION
Pursuant to regulation 23 the following classes and types of pr actice resulting in
exposure to ionising radiati on that are deemed justified.
This list may be updated by the Commission, the updated list wi ll 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, brac hytherapy, radiography (for pla nning purposes)
fluoroscopy (for planning purposes), computed tomography.
(iii) Health screening:
Use of ionising radiation in rad iography and nuclear medicine.
2. Non-medical imagin g exposure of humans
(i) Practices using medical radiological equipment:
(a) Radiological health assessment for employment purposes;
(b) Radiological health asses sment for immigration purposes;
(c) Radiological health asses sment for insurance purposes;
(d) Radiological evaluation of the physical development of child ren and
adolescents with a view to a c areer in sports, dancing, etc.;
(e) Radiological age assessment;(f) Use of ionising radiation for the identification of conceale d objects within
the human body.
(ii) Practices not using medi cal radiological equipment:
(a) Use of ionising radiation for detection of concealed humans as part of cargo
screening;Amended by:
L.N. 184 of 2020.FOURTH SCHEDULE 
(Regulation 23)
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 85
(b) Practices involving the use of ionising radiation for legal or security
purposes.
(c) Use of ionising radiation for detection of concealed object s on or attached
to the human body.
3. Industrial
(i) Production of radioactive products:
Manufacture of radioisot opes using a ccelerators
(ii) Non-destructive testing 
Use of radioactive sources, substances and radiation generators  for radiography
(iii) Substance measuremen t and process control:
Use of sealed sources and x-ray ge nerators for thickness gaugin g, density
gauging, moisture Gauging, level gauging, flow measurement, bor ehole 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 illumina tion, in safety
signs and equipment, sighting a nd location markers, watches and  instruments.
(b) Use of radioluminous paint (tritium and promethium
-147) for the
luminising of timepieces and the repair of radioluminised timep ieces.
(vii) Security screeningUse of x-rays, gamma rays to exa mine packages, baggage, contain ers or
vehicles.
4. Other Practices
(i) Equipment producing ionising radiation incidentallyUse of electron beam welders, electron microscopes, radar, ther mionic valves,
cathode ray tubes, ion implantati on machines and high voltage s witchgear.
(ii) Radioactive tracers
Use of radioactive tracers for me dical or biological techniques .
86 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(iii) Medical and biomedical research
Use of ionising radiation in radiography, fluoroscopy, interven tional radiography,
computed tomography, in-vivo nuc lear 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 ra diation
Use of ionising radiation in smo ke and fire detectors and other  safety instruments
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 87
FIFTH SCHEDULE 
(Regulation 33) 
LIST OF INDUSTRIAL SECTORS I NVOLVING NATURALLY-OCCURRING 
RADIOACTIVE MATERIAL
- Extraction of rare earths from monazite
- Production of thorium compounds and manufacture of thorium-con taining
products
- Processing of niobium/tantalum ore
- Oil and gas production
- Geothermal energy production-T i O
2pigment 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
88 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
SIXTH SCHEDULE 
(Regulation 35 and 39) 
EXEMPTION AND CLEARANCE CRITERIA
1. Exemption
Practices may be exempted from notification either directly, on  t h e  b a s i s  o f
compliance with exemption levels (activity values (in Bq) or ac tivity concentration
values (in kBq kg-1)) laid down in section 2, or on the basis of higher values tha t, for
specific applications, are established by the Commission, satis fying the general
exemption and clearance criteria set out in section 3. Practice s subject to notification
may be exempted from authorisation by law or general administra tive act, or through an
ad-hoc regulatory decision, on the basis of the information pro vided in conjunction with
the notification of the practice and in line with general exemp tion 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 us ed 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 natura lly-occurring radionuclides. The values in Table A, Part 1,
are given for individual radionuc lides, where applicable, inclu ding short-lived
radionuclides in equilibrium with the parent nuclide, as indica ted. 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 paren t 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, conve ntional disposal or
incineration. Higher values may be defined for specific materia ls or specific pathways,
taking Community guidance into account, including, where approp riate, additional
requirements, in terms of surfa ce activity or monitoring requir ements
(d) For mixtures of artificial radionuclides, the weighted sum o f nuclide-
specific activities or concentra tions (for various radionuclide s contained in the same
matrix) divided by the corresponding exemption value shall be l ess than unity. Where
appropriate, this condition can be verified on the basis of bes t estimates of the
composition of the radionuclide mix. The values in Table A, Par t 2, apply individually to
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 89
each parent nuclide. Some elemen ts in the decay chain, e.g. Po- 210 or Pb-210, may
warrant the use of higher value s 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 pro visions of regulation 98
shall be verified. The values la id down in Table B, column 3, a pply to the total
inventory of radioactive substances held by a person or underta king as part of a specific
practice at any point in time. However, the Commission may appl y these values to
smaller entities or packages, for instance to exempt the transp ort or storage of exempted
consumer products, if the genera l exemption criteria in section  3 are satisfied.
(3) General exemption and clearance criteria
(a) The general criteria for the exemption of practices from not ification or
authorisation or for the clearan ce 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 be en determined to be justified; a nd
(iii) the practice is inherently safe
(b) Practices involving small amounts of radioactive substances or low
activity concentrations, comparable to the exemption values lai d down in Table A or
Table B are deemed to fulfil criterion (iii).
(c) Practices involving amounts of  radioactive substances or act ivity
concentrations below the exemption values laid down in Table A,  Part 1, or Table B, are
deemed to comply with criterion (i ) without further considerati on. This is also the case
for the values in Table A, Part 2, with the exception of the re cycling of residues in
building materials or the case of specific exposure pathways, f or instance, drinking
water
(d) In the case of moderate amounts of material, as specified by  Commission
for specific types of practice, the activity concentration valu es laid down in Table B,
column 2, may be used instead of the values laid down in Table A ,  P a r t  1 ,  f o r  t h e
purpose of exemption from authorisation.
(e) For the purpose of exemption from notification or for the pu rpose of
clearance, where amounts of rad ioactive substances or activity concentrations do not
comply with the values laid down in Table A or Table B, an asse ssment shall be made in
the light of the general criteria (i) to (iii) above. For compl iance 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 p ublic due to the
exempted practice is of the orde r of 10 μSv or less in a year.
90 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
- For naturally-occurring radionuclides:
The dose increment, allowing for the prevailing background radi ation from natural
radiation sources, liable to be incurred by an individual due t o the exempted practice is of
the order of 1 mSv or less in a y ear. The assessment of doses to  members of the public
shall take into account not onl y pathways of exposure through a irborne or liquid effluent,
but also pathways resulting from the disposal or recycling of s olid residues. The
Commission may specify dose criteria lower than 1 mSv per year f or specific types of
practices or specific pa thways of exposure.
For the purpose of exemption from authorisation, less restricti ve dose criteria may
be applied.
TABLE A
Activity concentration values for  exemption or clearance of mat erials 
which can be applied by default to  any amount and to any type o f solid material
TABLE A 
PART 1
 Artificial radionuclides
RadionuclideActivity 
concentration
(kBq kg-1)RadionuclideActivity 
concentration
(kBq kg-1)RadionuclideActivity 
concentration
(kBq kg-1)
H-3 100 Co-55 10 Sr-91  (a) 10
Be-7 10 Co-56 0.1 Sr-92 10
C-14 1 Co-57 1 Y-90 1 000F-18 10 Co-58 1 Y-91 100Na-22 0.1 Co-58m 10 000 Y-91m 100Na-24 1 Co-60 0.1 Y-92 100
Si-31 1 000 Co-60m 1 000 Y-93 100
P-32 1 000 Co-61 100 Zr-93 10P-33 1 000 Co-62m 10 Zr-95  (
a) 1
S-35 100 Ni-59 100 Zr-97  (a) 10
Cl-36 1 Ni-63 100 Nb-93m 10
Cl-38 10 Ni-65 10 Nb-94 0.1
K-42 100 Cu-64 100 Nb-95 1K-43 10 Zn-65 0.1 Nb-97  (
a) 10
Ca-45 100 Zn-69 1 000 Nb-98 10
Ca-47 10 Zn-69m  (a) 10 Mo-90 10
Sc-46 0.1 Ga-72 10 Mo-93 10
Sc-47 100 Ge-71 10 000 Mo-99  (a) 10
Sc-48 1 As-73 1 000 Mo-101  (a) 10
V-48 1 As-74 10 Tc-96 1
Cr-51 100 As-76 10 Tc-96m 1 000
Mn-51 10 As-77 1 000 Tc-97 10
Mn-52 1 Se-75 1 Tc-97m 100
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 91
Mn-52m 10 Br-82 1 Tc-99 1
Mn-53 100 Rb-86 100 Tc-99m 100Mn-54 0.1 Sr-85 1 Ru-97 10Mn-56 10 Sr-85m 100 Ru-103  (
a) 1
Fe-52  (a) 10 Sr-87m 100 Ru-105  (a) 10
Fe-55 1 000 Sr-89 1 000 Ru-106  (a) 0.1
Fe-59 1 Sr-90  (a) 1 Rh-103m 10 000
Rh-105 100 I-123 100 Pm-147 1 000Pd-103  (
a) 1 000 I-125 100 Pm-149 1 000
Pd-109  (a) 100 I-126 10 Sm-151 1 000
Ag-105 1 I-129 0.01 Sm-153 100
Ag-110m  (a)0.1 I-130 10 Eu-152 0 1
Ag-111 100 I-131 10 Eu-152m 100
Cd-109  (a) 1 I-132 10 Eu-154 0 1
Cd-115  (a) 10 I-133 10 Eu-155 1
Cd-115m  (a)100 I-134 10 Gd-153 10
In-111 10 I-135 10 Gd-159 100
In-113m 100 Cs-129 10 Tb-160 1
In-114m  (a) 10 Cs-131 1 000 Dy-165 1 000
In-115m 100 Cs-132 10 Dy-166 100Sn-113  (
a) 1 Cs-134 0,1 Ho-166 100
Sn-125 10 Cs-134m 1 000 Er-169 1 000
Sb-122 10 Cs-135 100 Er-171 100Sb-124 1 Cs-136 1 Tm-170 100
Sb-125  (
a) 0.1 Cs-137  (a) 0.1 Tm-171 1 000
Te-123m 1 Cs-138 10 Yb-175 100
Te-125m 1 000 Ba-131 10 Lu-177 100
Te-127 1 000 Ba-140 1 Hf-181 1
Te-127m  (a) 10 La-140 1 Ta-182 0 1
Te-129 100 Ce-139 1 W-181 10
Te-129m  (a) 10 Ce-141 100 W-185 1 000
Te-131 100 Ce-143 10 W-187 10
Te-131m  (a) 10 Ce-144 10 Re-186 1 000
Te-132  (a) 1 Pr-142 100 Re-188 100
Te-133 10 Pr-143 1 000 Os-185 1
Te-133m 10 Nd-147 100 Os-191 100Te-134 10 Nd-149 100 Os-191m 1 000
Os-193 100 U-230 10 Cm-246 0.1
Ir-190 1 U-231  (
a) 100 Cm-247  (a) 0.1RadionuclideActivity 
concentration
(kBq kg-1)RadionuclideActivity 
concentration
(kBq kg-1)RadionuclideActivity 
concentration
(kBq kg-1)
92 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(a) Parent radionuclides, and thei r progeny whose dose contributi ons are taken into account in
the dose calculation (thus requi ring only the exemption level o f the parent radionuclide to
be considered), are liste d in the following table.Ir-192 1 U-232  (a) 0.1 Cm-248 0.1
Ir-194 100 U-233 1 Bk-249 100
Pt-191 10 U-236 10 Cf-246 1 000
Pt-193m 1 000 U-237 100 Cf-248 1Pt-197 1 000 U-239 100 Cf-249 0.1Pt-197m 100 U-240  (
a) 100 Cf-250 1
Au-198 10 Np-237  (a) 1C f - 2 5 1 0 . 1
Au-199 100 Np-239 100 Cf-252 1
Hg-197 100 Np-240 10 Cf-253 100Hg-197m 100 Pu-234 100 Cf-254 1Hg-203 10 Pu-235 100 Es-253 100Tl-200 10 Pu-236 1 Es-254  (
a) 0.1
Tl-201 100 Pu-237 100 Es-254m  (a) 10
Tl-202 10 Pu-238 0.1 Fm-254 10 000
Tl-204 1 Pu-239 0.1 Fm-255 100Pb-203 10 Pu-240 0.1
Bi-206 1 Pu-241 10
Bi-207 0.1 Pu-242 0,1Po-203 10 Pu-243 1 000Po-205 10 Pu-244  (
a) 0.1
Po-207 10 Am-241 0.1
At-211 1 000 Am-242 1 000Ra-225 10 Am-242   (
a) 0.1
Ra-227 100 Am-243  (a) 0.1
Th-226 1 000 Cm-242 10
Th-229 0.1 Cm-243 1Pa-230 10 Cm-244 1Pa-233 10 Cm-245 0.1RadionuclideActivity 
concentration
(kBq kg
-1)RadionuclideActivity 
concentration
(kBq kg-1)RadionuclideActivity 
concentration
(kBq kg-1)
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 93
For radionuclides not listed in Table A, Part 1 the Commission shall assign
appropriate values for the quanti ties and concentrations of act ivity per unit mass
where the need arises. Values thus assigned shall be complement ary to those in
Table A, Part 1
TABLE A PART 2
 Naturally occurring radionuclides
Values for exemption o r clearance for natu rally occurring radio nuclides in solid 
materials in secular equilibrium with their progeny:Parent 
RadionuclideProgenyParent 
RadionuclideProgenyParent 
RadionuclideProgeny
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, 
Nb-97Cd-115m In-115m Np237 Pa-233
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
Natural radionuclide s from the U-238 series 1 kBq kg
-1
Natural radionuclides from the Th-232 series 1 kBq kg-1
94 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
TABLE B
Total activity values for exemp tion (column 3) and exemption va lues for the activity 
concentration in moderate amount s of any type of material (colu mn 2)K-40 10 kBq kg-1
RadionuclideActivity 
concentration
(kBq kg-1)Activity
(Bq)RadionuclideActivity 
concentration
(kBq kg-1)Activity
(Bq)
H-3 1x1061x109 Mn-56 1x1011x105
Be-7 1x1031x107 Fe-52 1x1011x106
C-14 1x1041x107 Fe-55 1x1041x106
O-15 1x1021x109 Fe-59 1x1011x106
F-18 1x1011x106 Co-55 1x1011x106
Na-22 1x1011x106 Co-56 1x1011x105
Na-24 1x1011x105 Co-57 1x1021x106
Si-31 1x1031x106 Co-58 1x1011x106
P-32 1x1031x105 Co-58m 1x1041x107
P-33 1x1051x108 Co-60 1x1011x105
S-35 1x1051x108 Co-60m 1x1031x106
Cl-36 1x1041x106 Co-61 1x1021x106
Cl-38 1x1011x105 Co-62m 1x1011x105
Ar-37 1x1061x108 Ni-59 1x1041x108
Ar-41 1x1021x109 Ni-63 1x1051x108
K-40 (1) 1x1021x106 Ni-65 1x1011x106
K-42 1x1021x106 Cu-64 1x1021x106
K-43 1x1011x106 Zn-65 1x1011x106
Ca-45 1x1041x107 Zn-69 1x1041x106
Ca-47 1x1011x106 Zn-69m 1x1021x106
Sc-46 1x1011x106 Ga-72 1x1011x105
Sc-47 1x1021x106 Ge-71 1x1041x108
Sc-48 1x1011x105 As-73 1x1031x107
V-48 1x1011x105 As-74 1x1011x106
Cr-51 1x1031x107 As-76 1x1021x105
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 95
Mn-51 1x1011x105 As-77 1x1031x106
Mn-52 1x1011x105 Se-75 1x1021x106
Mn-52m 1x1011x105 Br-82 1x1011x106
Mn-53 1x1041x109 Kr-74 1x1021x109
Mn-54 1x1011x106 Kr-76 1x1021x109
Kr-77 1x1021x109 Mo-93 1x1031x108
Kr-79 1x1031x105 Mo-99 1x1021x106
Kr-81 1x1041x107 Mo-101 1x1011x106
Kr-83m 1x1051x1012 Tc-96 1x1011x106
Kr-85 1x1051x104 Tc-96m 1x1031x107
Kr-85m 1x1031x1010 Tc-97 1x1031x108
Kr-87 1x1021x109 Tc-97m 1x1031x107
Kr-88 1x1021x109 Tc-99 1x1041x107
Rb-86 1x1021x105 Tc-99m 1x1021x107
Sr-85 1x1021x106 Ru-97 1x1021x107
Sr-85m 1x1021x107 Ru-103 1x1021x106
Sr-87m 1x1021x106 Ru-105 1x1011x106
Sr-89 1x1031x106Ru-106(b) 1x1021x105
Sr-90 (b) 1x1021x104 Rh-103m 1x1041x108
Sr-91 1x1011x105 Rh-105 1x1021x107
Sr-92 1x1011x106 Pd-103 1x1031x108
Y-90 1x1031x105 Pd-109 1x1031x106
Y-91 1x1031x106 Ag-105 1x1021x106
Y-91m 1x1021x106 Ag-108m 1x1011x106
Y-92 1x1021x105 Ag-110m 1x1011x106
Y-93 1x1021x105 Ag-111 1x1031x106
Zr-93(b) 1x1031x107 Cd-109 1x1041x106
Zr-95 1x1011x106 Cd-115 1x1021x106
Zr-97(b) 1x1011x105 Cd-115m 1x1031x106
Nb-93m 1x1041x107 In-111 1x1021x106
Nb-94 1x1011x106 In-113m 1x1021x106
Nb-95 1x1011x106 In-114m 1x1021x106
Nb-97 1x1011x106 In-115m 1x1021x106
Nb-98 1x1011x105 Sn-113 1x1031x107
Mo-90 1x1011x106 Sn-125 1x1021x105
Sb-122 1x1021x104 Cs-132 1x1011x105RadionuclideActivity 
concentration
(kBq kg-1)Activity
(Bq)RadionuclideActivity 
concentration
(kBq kg-1)Activity
(Bq)
96 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
Sb-124 1x1011x106 Cs-134m 1x1031x105
Sb-125 1x1021x106 Cs-134 1x1011x104
Te-123m 1x1021x107 Cs-135 1x1041x107
Te-125m 1x1031x107 Cs-136 1x1011x105
Te-127 1x1031x106Cs-137(b) 1x1011x104
Te-127m 1x1031x107 Cs-138 1x1011x104
Te-129 1x1021x106 Ba-131 1x1021x106
Te-129m 1x1031x106Ba-140(b) 1x1011x105
Te-131 1x1021x105 La-140 1x1011x105
Te-131m 1x1011x106 Ce-139 1x1021x106
Te-132 1x1021x107 Ce-141 1x1021x107
Te-133 1x1011x105 Ce-143 1x1021x106
Te-133m 1x1011x105Ce-144(b) 1x1021x105
Te-134 1x1011x106 Pr-142 1x1021x105
I-123 1x1021x107 Pr-143 1x1041x106
I-125 1x1031x106 Nd-147 1x1021x106
I-126 1x1021x106 Nd-149 1x1021x106
I-129 1x1021x105 Pm-147 1x1041x107
I-130 1x1011x106 Pm-149 1x1031x106
I-131 1x1021x106 Sm-151 1x1041x108
I-132 1x1011x105 Sm-153 1x1021x106
I-133 1x1011x106 Eu-152 1x1011x106
I-134 1x1011x105 Eu-152m 1x1021x106
I-135 1x1011x106 Eu-154 1x1011x106
Xe-131m 1x1041x104 Eu-155 1x1021x107
Xe-133 1x1031x104 Gd-153 1x1021x107
Xe-135 1x1031x1010 Gd-159 1x1031x106
Cs-129 1x1021x105 Tb-160 1x1011x106
Cs-131 1x1031x106 Dy-165 1x1031x106
Dy-166 1x1031x106 Hg-203 1x1021x105
Ho-166 1x1031x105 Tl-200 1x1011x106
Er-169 1x1041x107 Tl-201 1x1021x106
Er-171 1x1021x106 Tl-202 1x1021x106
Tm-170 1x1031x106 Tl-204 1x1041x104
Tm-171 1x1041x108 Pb-203 1x1021x106
Yb-175 1x1031x107Pb-210(b) 1x1011x104RadionuclideActivity 
concentration
(kBq kg-1)Activity
(Bq)RadionuclideActivity 
concentration
(kBq kg-1)Activity
(Bq)
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 97
Lu-177 1x1031x107Pb-212(b) 1x1011x105
Hf-181 1x1011x106 Bi-206 1x1011x105
Ta-182 1x1011x104 Bi-207 1x1011x106
W-181 1x1031x107 Bi-210 1x1031x106
W-185 1x1041x107Bi-212(b) 1x1011x105
W-187 1x1021x106 Po-203 1x1011x106
Re-186 1x1031x106 Po-205 1x1011x106
Re-188 1x1021x105 Po-207 1x1011x106
Os-185 1x1011x106 Po-210 1x1011x104
Os-191 1x1021x107 At-211 1x1031x107
Os-191m 1x1031x107Rn-220(b) 1x1041x107
Os-193 1x1021x106Rn-222(b) 1x1011x108
Ir-190 1x1011x106Ra-223(b) 1x1021x105
Ir-192 1x1011x104Ra-224(b) 1x1011x105
Ir-194 1x1021x105 Ra-225 1x1021x105
Pt-191 1x1021x106Ra-226(b) 1x1011x104
Pt-193m 1x1031x107 Ra-227 1x1021x106
Pt-197 1x1031x106Ra-228(b) 1x1011x105
Pt-197m 1x1021x106 Ac-228 1x1011x106
Au-198 1x1021x106Th-226(b) 1x1031x107
Au-199 1x1021x106 Th-227 1x1011x104
Hg-197 1x1021x107Th-228(b) 1x1001x104
Hg-197m 1x1021x106Th-229(b) 1x1001x103
(b) http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/
?uri=OJ:L:2014:013:FULL&from=EN  - ntr3-L_2014013EN.01004501-E00 03RadionuclideActivity 
concentration
(kBq kg-1)Activity
(Bq)RadionuclideActivity 
concentration
(kBq kg-1)Activity
(Bq)
98 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
SEVENTH SCHEDULE 
(Regulation 98) 
DEFINITION AND USE OF T HE ACTIVITY CONCENTRATION INDEX FOR THE 
GAMMA RADIATION EMITTED BY BUILDING MATERIALS
For the purposes of regulation 98(2),for identified types of bu ilding materials, the
activity concentrations of primordial radionuclides Ra-226, Th- 232 (or its decay product
Ra-228) and K-40 sha ll be determined.
The activity concentration index I is given by the following fo rmula:
I = CRa226 /300 Bq/kg + CTh232 /200 Bq/kg + CK40/3000 Bq/kg
where CRa226 , CTh232 and CK40are the activity concentrations in Bq/kg of the
corresponding radionuclides in the building material.
The index relates to the gamma r adiation dose, in excess of typ ical outdoor
exposure, in a building construc ted from a specified building m aterial. The index applies
to the building material, not to its constituents except when t hose constituents are
building materials themselves and are separately assessed as su ch. For application of the
index to such constituents, in particular residues from industr ies processing naturally-
occurring radioactive material recycled into building materials , an appropriate
partitioning factor needs to be a pplied. The activity concentra tion index value of 1 can be
used as a conservative screening tool for identifying materials  that may cause the
reference level laid down in re gulation 98(1) to be exceeded. T he calculation of dose
needs to take into account other factors such as density, thick ness of the material as well
as factors relating to the type of building and the intended us e of the material (bulk or
superficial).
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 99
EIGHTH SCHEDULE
(Regulation 38) 
LIST OF INFORMATION FO R LICENCE APPLICATIONS
(a) Responsibilities and organisatio nal arrangements for protect ion and safety
(b) Staff competences, including information and training
(c) Design features of the fa cility and of radiation sources
(d) Anticipated occupational and public exposures in normal oper ation
(e) Safety assessment of th e activities and the facility. 
(f) Emergency procedures.(g) Maintenance, testing, inspection and servicing so as to ensu re that the
radiation source and the facility continue to meet the design r equirements, operational
limits and conditions of opera tion throughout their lifetime.
(h) Management of radioactive waste and arrangements for the dis posal of
such waste, in accordance with a pplicable regulatory requiremen ts
(i) Management of disused sources.
(j) Quality assurance programmes.
100 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
NINTH SCHEDULE 
(Regulation 52)
DATA SYSTEM FOR INDIVIDUAL  RADIOLOGICAL MONITORING 
(1) Individual monitoring data t o be kept by the undertaking/em ployer 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 4 9 
(h) Particulars of any Medical su rveillance required under the r egulations 
(i) Results of individual monitoring of the exposed worker pursu ant to regulations
50, 51, 61, 62, 63 and, if decided by the Commission pursuant t o regulations
44(2), 64(3)
(j) The starting date of individua l monitoring and where availab le the end date
(k) Data on the undertaking, including the name, address, Commis sion reference
number for undertaking.
(2) Data to be sent in the form of an annual return to the Secr etariat.
The Secretariat will specify the f ormat in which the data is to  be sent.
(a) Name of the undertaking/em ployer of the outside worker
(b) Report year (c) Dosimetry service provider a nd any local agents for dosimetr y service provider
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 101
(d) Surname
(e) First Name(f) Maltese ID number or other overseas unique personal ID
(g) Categorisation of the worker in accordance with regulation 4 9 
(h) Results of individual mon itoring 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 4 9 
(j) Particulars of any Medical surveillance required under the r egulations and if the
worker is classed fit, fit s ubject to conditions or unfit.
(k) Any restrictions of working with ionizing radiation and if s o specify them
(l) Date of last periodic health r eview and the period of the va lidity of result
(m) Results of individual monitoring of the exposed worker over the preceding 5
year period.
102 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
EMERGENCY MANAGE MENT SYSTEMS 
AND EMERGENCY RESPONSE PLANS 
A. Elements to be included in an emergency management system
(1) Assessment of potential emergency exposure situations and as sociated public and
emergency occupational exposures;
(2) Clear allocation of the respon sibilities of persons and orga nisations having a role
in preparedness and re sponse arrangements;
(3) Establishment of emergency response plans at appropriate lev els and related to a
specific facility or human activity;
(4) Reliable communications and efficient and effective arrangem ents for
cooperation and coordination at the installation and at appropr iate national and
international levels;
(5) Health protection of emergency workers;(6) Arrangements for the provision of prior information and trai ning for emergency
workers and all other persons with duties or responsibilities i n emergency
response, including regular exercises;
(7) Arrangements for individual m onitoring or assessment of indi vidual doses of
emergency workers and th e recording of doses; 
(8) Public information arrangements; 
(9) Involvement of stakeholders; (10) Transition from an emergency exposure situation to an exist ing exposure
situation including re covery and remediation.
B. Elements to be included i n an emergency response plan
For emergency preparedness:
(1) Reference levels for public exposure, taking into account th e 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 wh o may be exposed,
for different postulated events and related scenarios;
(4) Predefined generic criteria fo r particular protective measur es;Amended by:
L.N. 184 of 2020.TENTH SCHEDULE 
(Regulation 91 and 122) 
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 103
(5) Default triggers or operational criteria such as observables  and indicators of on-
scene conditions;
(6) Arrangements for prompt coordination between organisations h aving a role in
emergency preparedness and res ponse and with all other Member S tates and
with third countries which may b e 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 e vents.
Arrangements shall be established i n  a d v a n c e  t o  r e v i s e  t h e s e  e l ements, as
appropriate during an emergency exposure situation, to accommod ate the
prevailing conditions a s these evolve throug hout the response.
For emergency response:The response to an emergency exposure situation shall be undert aken through
the timely implementation of preparedness arrangements, includi ng but not
limited to:
(1) Promptly implementing protective measures, if possible, befo re any exposure
occurs;
(2) Assessing the effectiveness of  strategies and implemented ac tions and adjusting
them as appropriate to the prevailing situation;
(3) Comparing the doses against the applicable reference level, focusing on those
groups whose doses excee d the reference level;
(4) Implementing further protecti on strategies, as necessary, ba sed on prevailing
conditions and available information.
104 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
INFORMATION TO MEMBERS OF THE PUBLIC ABOUT HEALTH PROTECTION 
MEASURES TO BE APPLIED AND STEPS TO BE TAKEN IN THE EVENT OF AN  
EMERGENCY
A. 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 bei ngs and on the
environment;
(2) The various types of emergenc y covered and their consequence s for the public
and the environment;
(3) Emergency measures envisaged to alert, protect and assist th e public in the event
of an emergency.
(4)  Appropriate information on action to be taken by the public  in the event of an
emergency.
B. Information to be provided to  the affected members of the pu blic in the
event of an emergency
(1) On the basis of the emergency response plan previously drawn  up in the Maltese
Radiation Regulatory Body, the members of the public actually a ffected in the
event of an emergency shall ra pidly 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 developme nt);
(b) advice on protection, which, depending on the type of emerge ncy, may:
(i) cover the following: restrictions on the consumption of cert ain foodstuffs and
water likely to be contaminated, simple rules on hygiene and de contamination,
recommendations to stay indoors, d istribution and use of protec tive substances,
evacuation arrangements;
(ii) be accompanied, where necessa ry, by special warnings for ce rtain groups of the
members of the public;
(c) announcements recommending coop eration with instructions or requests by the
competent authority.
(2) If the emergency is preceded by a pre-alarm phase, the membe rs of the public
likely to be affected shall already receive information and adv ice during that
phase, such as:
(a) an invitation to the members of the public concerned to tune  i n  t o  r e l e v a n t
communication channels;
(b) preparatory advice to estab lishments with particular collect ive responsibilities;Amended by:
L.N. 184 of 2020.ELEVENTH SCHEDULE 
(Regulation 93 and 94) 
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 105
(c) recommendations to occupational groups particularly affected .
(3) This information and advice shall be supplemented, if time p ermits, by a
reminder of the basic facts abou t radioactivity and its effects  on human beings
and on the environment.
TWELFTH SCHEDULE 
(Regulation 98) 
INDICATIVE LIST OF T YPES OF BUILDING MATERIALS CONSIDERED WITH 
REGARD TO THEIR EMITT ED GAMMA RADIATION 
1. Natural materials
(a) Alum-shale.
- Building materials or additives  of natural igneous origin, suc h as:
- granitoides (such as granites, syenite and orthogneiss),
- porphyries;
-t u f f ;- pozzolana (pozzolanic ash);
- lava.
2. Materials incorporating residues from industries processing naturally-occurring
radioactive material, such as:
-f l y  a s h ;- phosphogypsum;
- phosphorus slag;
- tin slag;- copper slag;
- red mud (residue from aluminium production);
- residues from steel production
106 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
THIRTEENTH SCHEDULE 
(Regulation 115)
STANDARD RECORD SHEET FOR HIGH-AC TIVITY SEALED SOURCES (HASS) 
(optional in italics)
1. HASS identification 
number2. Identification of the 
licensed undertaking3. Location of HASS if not the 
same as in 2
Name: Name:
Manufacturer device 
number:Address: Address:
Field of use: Country: Country:
Manufacturer □ Supplier □ 
User□Fixed use □ Storage □ Mobile 
use□
4. Recording 5. Lic ence 6. Operation al controls of 
HASS
Date of start of recording: Number: Date:
Date of transfer of records 
to historic file:Date of issue: Date:
Date of expiry: Date:
7. HASS charac teristics 8. Receipt of HASS Date:
Year of manufacture Date of Receipt: Date:
Radionuclide: Receipt from: Date:
Activity at the date of 
manufacturing:Name: Date:
Activity reference date: Address: Date:
Manufacturer/Supplier (*): Date:
 Name: Country: Date:
 Address: Manufactu rer □ Supplier □ 
User□Date:
9. Transfer of HASS 10.  Further information
 Country: Date of transfe r: Loss □ Date of Loss:
Physical and chemical 
characteristicsName: Theft □ Date of theft:
Source type Identification A ddress: 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 [S.L.585.01 107
 (*)Where the manufacturer of th e source is estab lished outside  the community the 
name and address of the importer- supplier may be provide instea d
FOURTEENTH SCHEDULE 
(Regulation 114)
SECURITY MEASURES FOR HIGH ACTIVITY SOURCES
Table1 Type of secur ity measures required 
Administrative Measures
Holders should have the following administrative procedures in order to comply
with these regulations
• access control procedures;
• key control procedures;• adequate surveillance fo r activity levels 1 & 2;
• records related to man agement of sources;
• inventories;• reliability and trustw orthiness of personnel;
• information security for activity levels 1 & 2;• quality assurance measures; and• establishment of a safet y 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. Neutron source target: Ma nufacturer □ Supplier □ 
Other undertaking □
 Neutron flux: Facility f or long term storage 
or disposal □
Security Level 
C SourcesSecurity Level
 B SourcesSecurity Level 
A Sources
Safe management and protect as an asset
Deter unauthorised access
Timely detection of unauthorised access
Timely detecti on of unauthorised acquisition
Delay acquisition until 
response is possible
108 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
Technical measures are generally hardware or security devices a nd include
• fences;
•w a l l s ;• 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 
A SourcesSecurity Level
B SourcesSecurity Level
C Sources
General administrative measures:
Daily accounting Wee kly accounting Semi- annual accounting
 Access control to source locat ion allowing timel y detection of  
unauthorised accessAccess control to source 
location
Deterrence provided by:
Two technical measures 
separating the source from 
unauthorised personnelTwo measures (one technical) 
separating the source from 
unauthorised personnelOne technical measure 
separating the source from 
unauthorised personnel
Specific emergency response plan Generic em ergency plan
Background check
Security plan
Information security
Upgrade security for increased threat
Timely Detection provided by:
Remotely monitored 
intruder alarmLocal Alarm
Timely response to an alarm
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 109
FIFTEENTH SCHEDULE 
(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 contro l or were not
regulated in accordance with the requirements laid down by thes e
regulations;
(ii) an emergency, after the emergency exposure situation has be en
declared ended, as provided for in the emergency managementsystem;
(iii) residues from past activities for which the undertaking is  no longer
legally accountable;
(a) Exposure to natural rad iation sources, including:
(i) indoor exposure to radon and thoron, in workplaces, dwelling s and
other buildings;
(ii) indoor external exposure from building materials;
(b) Exposure to commodities excluding food, animal feeding stuff s and drinking
water incorporating
(i) radionuclides from contaminated areas specified in paragraph  (a), or
(ii) naturally-occurring radionuclides.
110 [S.L.585.01 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-TE RM RISKS FROM RADON EXPOSURES 
1. Strategy for conducting surveys of indoor radon concentration s or soil gas
concentrations for the purpose of estimating the distribution o f indoor radon
concentrations, for the manageme nt of measurement data and for the
establishment of other relevant parameters (such as soil and ro ck types,
permeability and radium-226 c ontent of rock or soil).
2. Approach, data and criteria us ed for the delineation of areas  or for the definition of
other parameters that can be use d as specific indicators of sit uations with
potentially high exposure to radon.
3. Identification of types of workplaces and buildings with publ ic access, such as
schools, underground wor kplaces, and those in certain areas, wh ere 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 dwell ings and workplaces.
If applicable, the basis for the establishment of different ref erence levels for
different uses of buildings (dwellings, buildings with public a ccess, workplaces)
as well as for existing and for new buildings.
5. Assignment of responsibilities (governmental and non-governme ntal),
coordination mechanisms and ava ilable resources for implementat ion of the action
plan.
6. Strategy for reducing radon exposure in dwellings and for giv ing priority to
addressing the situations i dentified under paragraph 2.
7. Strategies for facilitating post construction remedial action .
8. Strategy, including methods and tools, for preventing radon i ngress 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,  i n c l u d i n g  i n
relation to smoking.
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 111
11. Guidance on methods and tools for measurements and remedial measures.
Criteria for the accreditation of  measurement and remediation s ervices shall also
be considered.
12. Where appropriate, provision of financial support for radon surveys and for
remedial measures, in particular for private dwellings with ver y high radon
concentrations.
13. Long-term goals in terms of reducing lung cancer risk attrib utable 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 q uality. 
112 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
SEVENTEENTH SCHEDULE 
(Regulation 18 and 67) 
QUALIFICATION AND EXPE RIENCES FOR PERSONS 
INVOLVED IN MEDICAL EXPOSURES
1. Referrers shall have the followi ng qualification and experie nce as detailed
below
Practitioners shall have the following qualification and experi ence as detailed
below:
2. Practitioners qualific ation and experience 
Practitioners shall have the fo llowing qualification and experi ence as detailed
below:Amended by:
L.N. 184 of 2020.SEVENTEENTH SCHEDULE 
(Regulation 18 and 67) 
Qualification Registered medical doctors, or
dentists, or
Practitioners whe n additional exposures ar e clinically indicate d
Experience No initial  experience needed
Qualification Medical doctors who are on the Specialist Register s held by the Medical
Council for:
Radiology; 
Radiotherapy; 
Nuclear Medicine,
or
Medical doctors who are on the Sp ecialist Register held by the Medical
Council for: 
Cardiology; Gastroenterology; Respiratory Medicine; Rheumatology; Orthopedic Surgery; and 
General Surgery 
Oral and maxillo-facial  surgery while carry ing out intervention s, 
or
Dental surgeons, 
or
Medical radiographers registere d with Council for Professions 
complimentary to medicine
Experience At least one month on the job e xperience under the su pervision of an 
approved practiti oner, excluding de ntal surgeons. 
No initial experience for dental work performed by dental surge ons.
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 113
3. Categorization of  medical exposures
As the practical aspects of different procedures for medical ex posures carry
different levels of risk, both to  the person performing the pra ctical aspects and to
the patient, the Commission has categorised medical exposures a s shown in the
below table using the graded approach. This categorisation is b eing done in
relation to persons performi ng the practical aspects only
4. Qualification and experience f or persons performing the prac tical aspects
Persons performing the practical aspects shall have the followi ng qualification
and experience a s detailed below:
(i) Persons performing the prac tical aspects of radiation produ cing medical
equipment for medical purposes:Risk Level Type of medical exposure
High Radiotherapy 
BrachytherapyNuclear Medicine (dia gnostic and therapeutic)
Interventional Radiology Fluoroscopic Techniques
CT Mammography 
Medium General Dia gnostic Radiography
Dental Radiography
Low Low output Diagnostic Radi ography (e.g. bone density)
High Risk 
ProceduresQualification Practitioners with the proviso that a registered m edical 
radiographer is in attenda nce during any form of 
intervention by medical doctors  who are on the specialist 
registers listed in the tabl e in part 1 of this Schedule.
Other persons appr oved under regulation 69 as long as a 
practitioner is available 
Experience First time registered medical radiogra phers shall hav e at 
least three months  on the job orie ntation under the 
supervision of a registe red medical radiographer 
approved to work in t he specific area.
Persons approved by under regul ation 69 shall have three 
months on the job training under the supervision of a 
Practitioner 
114 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(ii) Persons performing the practical aspects administering seal ed or unsealed
radioactive sources for me dical exposure purposes:
(iii) Persons performing the prac tical aspects of other aspects of medical exposures:Medium Risk
ProceduresQualification Practitioners, or
Dentists for dental medical exposures 
Other persons approve d under regulation 69
Experience First time registered medical radiogra phers, Practiti oners, 
shall have at least one month on the job orientation under 
the supervision of an approv ed individual in  the specific 
area. No initial experience for denta l work performed by dental 
surgeons specific area. 
Persons approved by under regul ation 69 shall have two 
months on the job training under the supervision of a 
Practitioner
Low Risk
ProceduresQualification Practitioners, or
Other persons approve d under regulation 69
Experience No initial experi ence for practitioners 
Persons approved by under regul ation 69 shall have two 
months on the job training under the supervision of a 
Practitioner.
Brachytherapy Qualification Regis tered on the specialist register  for oncology and 
radiotherapy or 
Medical radiographer 
Experience One month or sever al procedures of on the job 
orientation under the supe rvision of an approved 
individual in the  specific area. 
Therapeutic and 
Diagnostic Nuclear MedicineQualification Registered on specialist register for nuclear medi cine or
registered medical docto r or registered medical 
radiographer , registered med ical physicist as directed by 
an individual registered on specialist register for nuclear 
medicine
Experience One month or several p rocedures on the job orientatio n 
under the supervision of an approved indivi dual in the 
specific area.
Gamma Camera/
Positron 
Emission 
TomographyQualification Registered on specialist register for nuclear medi cine or 
medical radiographer
Experience Three months on th e job orientation under the 
supervision of registered indi vidual on specia list register 
for nuclear medicine or  medical radiographer.
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 115
(iv) Persons performing the prac tical aspects of radiation produ cing medical
equipment for non medical purposes:
EIGHTEENTH SCHEDULE Quality Control 
ProceduresQualification Medical physicists  registered with Council for the  
Professions Complemen tary to Medicine, 
Registered Medical  radiographers,
or persons specificall y trained to carry  out the quality 
control of the rel evant equipment.
Experience At lea st nine months on the j ob orientation under the  
supervision of an approved Q C individual or 300 hours of 
training in qua lity control.
Installation and 
MaintenanceQualification Persons specifically  trained by the manufacturer i n the 
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 tr aining under the supervision o f an 
experienced installer
116 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(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, manufactur es specification and other ref erence documents 
if appropriate
• details of test equipment used, including calibration dates
(c) Previous tests
• Details of any on-site/factor y tests performed by manufacturer  and results of 
such tests
 (d)  For each of the r equired parameters t ested the report shou ld include:
• test procedure followed
• measured values • manufacturers specificatio n for that parameter.
• if no manufactures specificati on available, the reason why and  the value the 
measured value was compared to
• statement if the equipm ent passes that parameter
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 117
NINETEENTH SCHEDULE 
(Regulation 83(e)) 
EXPOSURE TO IONISING RADIATI ON TO AN EXTENT MUCH GREATER 
THAN INTENDED
If such an incident has or belie ved to have occurred, the under taking has to carry
out a preliminary investigation. U nless this investigation esta blishes that no such
incident occurred, the Secretariat has to be immediately notifi ed 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 t he patient to the
final reporting) shall be stopped from use until the investigat ion is carried out
and any corrective actions taken. For example, these processes may include all
the steps from patient receip t to the final reporting.
The table below shows the interpretation of the term "much grea ter than intended
Table 1
Any preliminary investigation reports shall be kept by the unde rtaking for a
period of at least 2 years from the date it was made. If a deta iled investigation is
made, the report shall be kept for a period of at least 30 year s from the date it was
made. Medical exposure Much Gr eater than intended
multiplying factor a pplied to intended
dose
Interventional radiology, rad iographic and fluoroscopic
procedures involving contrast  agents, nuclear medicine
with intended dose >5mSv and computed tomographyexaminations1.5
Mammography, nuclear medic ine with intended E≤5mSv
but >0.5mSv, all other radiographic examinations notreferred to elsewhere in this table.10
Radiography of extremities,  skull, dentition, shoulder,
chest, elbow, knee and nuclea r medicine with intended E≤
0.5mSv20
Beam therapy, bra chytherapy 1.1 (whole course) or
1.2 (any fraction)
Unsealed radionuclide thera py 1.2 (any administration)
Procedural failures
Incident Undertaking’s Duty
Incorrect diagnostic procedure Prel iminary investigation and inf orm
the Secretariat 
Wrong patient exposed to a dose of  radiation Preliminary investi gation and inform
the Secretariat
Reject exposures due to othe r parameters resulting in
inadequate diagnos tic information Perform Reject An alyses and take
corrective action. The reports,
analyses and corrective actions to be
documented and made available tothe Secretariat
118 [S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
TWENTIETH SCHEDULE 
(Regulation 68(b))
REQUIREMENTS FORMEDIC AL PHYSICS EXPERTS
Table 1
Undertaking’s requirements for obtaining advice from Medical Ph ysics Experts 
Practice Level of Involvement of the 
medical physics expertContractual agreement 
between undertaking and 
the medical physics 
expert
External Beam Radiothe rapy Close involvement:
To be present on si te for at least 
part of the working day and to be available for c onsultation as 
required for any individual patient-specific issuesDocumented agreement 
between undertaking and medical physics expertBrachytherapy
Other Radiotherapeutic
practices (Excludingstandardized nuclear medicinepractices) 
Standardised nuclear medicine
radiotherapeutic procedures
Shall be involved:
Monitor practices regularly and
be available for consultation as 
required and to respond for any 
individual patient-specific issuesDocumented agreement 
between undertaking and 
medical physics expertDiagnostic nucle ar medicine
procedures
Interventional Radiology
Computed Tomography
Other high dose
radiodiagnostic practices 
Health Screening 
Other medical radiological
practices not covered by abovepointsInvolved as appropriate
None required
BASIC SAFETY STANDARDS FOR IONISING RADIATION [S.L.585.01 119
TWENTY-FIRST SCHEDULE
(Regulation 95(1)(a)
ELEMENTS OF NATIONAL RADIOAC TIVITY MONITORING PROGRAMME
Table 1
Sampling frequency
Ambient gamma dose rate Continuous
Air particulates Continuous
Coastal Waters Quarterly
Soil Annually
Water for human c onsumption Monthly
Food Monthly
Milk Quarterly