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L.S. 585.01 Regolamenti dwar Basic Safety Standards for Ionising Radiation

BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 SUBSIDIARY LEGISLATION 585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION REGULATIONS 6th February, 2018 LEGAL NOTICE 210 of 2018, as amended by Legal Notice 184 of 2020 and 139 of 2022 and Act XXXIII of 2024. Arrangement of Regulations Part I GENERAL PROVISIONS 1 2 3 Citation and commencement Subject Matter and Scope Enforcement Part II DEFINITIONS 4 Definitions Part III SYSTEM Of RADIATION PROTECTION 5 6 7 General Principles Optimisation - use of dose constraints Optimisation - use of Reference levels in existing and emergency situations. Dose limitation - age limit for exposed workers Dose limits for occupational exposure Dose limitation for pregnancy and breastfeeding Dose limitation for apprentices and students Dose limitation for public exposure Estimation of the effective and equivalent dose 8 9 10 11 12 13 Part IV RADIATION PROTECTION EDUCATION, TRAINING AND INFORMATION 14 15 16 17 18-22 General training in radiation protection Work specific training of exposed workers and information provided to them Information and training of workers potentially exposed to orphan sources Prior information and training for emergency Approval, Education, information and training in the field of medical exposure 1 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 27 28 29-31 Justification Practices involving consumer products Prohibited Practices Deliberate Exposures of humans for non-medical purposes (SECTION 2) REGULATORY CONTROL 32 33 34 35 36 37 38 39 Graded approach to regulatory control Identification of practices involving naturally-occurring radioactive material Notification Exemption from notification Registration versus licensing Licensing Authorisation Release from regulatory control Part VI OCCUPATIONAL EXPOSURES 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 Responsibilities Operational protection of exposed workers Operational protection of apprentices and students Consultations with a radiation protection expert Arrangements in workplaces Classification of workplaces Controlled areas Supervised areas Radiological surveillance of the workplace Categorisation of exposed workers Individual monitoring Dose assessment in the case of accidental exposure Recording and reporting of results Access to the results of individual monitoring Data on outside workers to be supplied Medical surveillance of exposed workers Medical classification Prohibition to employ or classify unfit workers Medical records Special medical surveillance Appeals Protection of outside workers Specially authorised exposures BASIC SAFETY STANDARDS FOR IONISING RADIATION 63 64 [ S.L.585.01 Emergency occupational exposure Radon in workplaces Part VII MEDICAL EXPOSURES 65 66 67-69 70 71 72-80 81 82 83 84 Justification Optimisation Approval & Responsibilities Procedures Training and recognition Equipment Special practices Special protection during pregnancy and breastfeeding Accidental and unintended exposures Estimates of population doses Part VIII PUBLIC EXPOSURES (SECTION 1) PROTECTION OF MEMBERS OF THE PUBLIC AND LONGTERM HEALTH PROTECTION IN NORMAL CIRCUMSTANCE 85 86 87 88 Operational protection of members of the public Estimation of doses to the members of the public Radioactive discharges Tasks for the undertaking (SECTION 2) EMERGENCY EXPOSURE SITUATIONS 89-92 93 94 Emergency response Information to the members of the public likely to be affected in the event of an emergency Information to the members of the public actually affected in the event of an emergency (SECTION 3) EXISTING EXPOSURE SITUATIONS 95 96 97 98 Environmental monitoring programme Contaminated areas Indoor exposure to radon Gamma radiation from building materials Part IX RESPONSIBILITIES AND OTHER ELEMENTS OF REGULATORY CONTROL (SECTION 1) GENERAL RESPONSIBILITIES OF UNDERTAKINGS 99 Safety Culture 3 4 [ S.L.585.01 100 101 BASIC SAFETY STANDARDS FOR IONISING RADIATION Radiation Protection Programmes Safety Assessments (SECTION 2) GENERAL RESPONSIBILITIES OF UNDERTAKINGS 102 Recognition of services and experts 103 Occupational health services 104 Dosimetry services 105-106 Radiation protection expert 107-109 Medical physics expert 110-111 Radiation protection officer (SECTION 3) CONTROL OF RADIOACTIVE SOURCES 112 113 114 115 116 General requirements for unsealed sources General requirements for sealed sources Requirements for control of high-activity sealed sources Record keeping by the undertaking Control of high-activity sealed sources identification and marking (SECTION 4) ORPHAN SOURCES 117 118 119 120 Detection of orphan sources Metal contamination Recovery, management, control and disposal of orphan sources Financial security for orphan sources (SECTION 5) SIGNIFICANT EVENTS 121 122 123 Notification and recording of significant events National Emergency preparedness International cooperation (SECTION 6) EXISTING EXPOSURE SITUATIONS 124 125 126 127 Programmes on existing exposure situations Establishment of strategies Implementation of strategies Radon action plan (SECTION 7) SYSTEM OF ENFORCEMENT 128 129 Inspections Enforcement BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 FIRST SCHEDULE Radiation and tissue weighting factors SECOND SCHEDULE Activity of high-activity sealed sources and security values THIRD SCHEDULE Justification of new classes or types of practices involving consumer products FOURTH SCHEDULE List of justifiable practices involving ionizing radiation FIFTH SCHEDULE List of industrial sectors involving naturally-occurring radioactive material SIXTH SCHEDULE Exemption and clearance criteria SEVENTH SCHEDULE Definition and use of the activity concentration index for the gamma radiation emitted by building materials EIGHTH SCHEDULE List of information for licence applications NINTH SCHEDULE Data system for individual radiological monitoring TENTH SCHEDULE Emergency management systems and emergency response plans ELEVENTH SCHEDULE Information to members of the public about health protection measures to be applied and steps to be taken in the event of an emergency TWELVE SCHEDULE Indicative list of types of building materials considered with regard to their emitted gamma radiation THIRTEENTH SCHEDULE Standard record sheet for high-activity sealed sources FOURTEENTH SCHEDULE Security measures for high activity sources FIFTEENTH SCHEDULE Indicative list of types of existing exposure situations 5 6 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION SIXTEENTH SCHEDULE List of items to be considered in preparing the national action-plan to address long-term risks from radon exposures SEVENTEENTH SCHEDULE Qualification and experiences for persons involved in medical exposures EIGHTEENTH SCHEDULE Information to be supplied to the secretariat each time an acceptance test is performed NINETEENTH SCHEDULE Exposure to ionising radiation to an extent much greater than intended TWENTIETH SCHEDULE Requirements for medical 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 1.

(1)The title of these regulations is the Basic Safety Standards for Ionising Radiation Regulations. Citation.
(2)These regulations implement Directive 2013/59/ Euratom, Basic Safety Standards for Protection Against the Dangers Arising From Exposure to Ionising Radiation. 2.
(1)These regulations establish the basic safety standards for the protection of the health of individuals subject to occupational, medical and public exposures against the dangers arising from ionising radiation.
(2)These regulations apply to any planned, existing or emergency exposure situation which involves a risk from exposure to ionising radiation which cannot be disregarded from a radiation protection point of view or with regard to the environment in view of long-term human health protection.
(3)These regulations also provide for the security of radioactive material and define specific requirements ensuring that each such source is kept under control.
(4)These regulations in particular apply to: (
  1. a)the manufacture, production, processing, handling, disposal, use, storage, holding, transport, import to, and export from Malta of radioactive material; (
  2. b)the manufacture and the operation of electrical equipment emitting ionising radiation and containing components operating at a potential difference of more than 5 kilovolt (kV); (
  3. c)human activities which involve the presence of natural radiation sources that lead to a significant increase in the exposure of workers or members of the public, in particular: (
  4. i)the operation of aircraft in relation to the exposure of crews; (
  5. ii)the processing of materials containing naturally-occurring radionuclides; (
  6. d)the exposure of workers or members of the public to indoor radon, the external exposure from building materials and cases of lasting exposure resulting from the after-effects of an emergency or a past human activity; (
  7. e)the preparedness for, the planning of response to Subject matter and scope. 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 of the public or workers.
(5)These regulations shall not apply to: (
  1. a)exposure to the natural level of radiation, such as radionuclides contained in the human body and cosmic radiation prevailing at ground level; (
  2. b)exposure to cosmic radiation in flight by members of the public or workers other than aircrew; (
  3. 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. requires: In these regulations, unless the context otherwise "acceptance test" means is a test to check the compliance of equipment, used in connection with medical exposure, with specified tolerances; "accident" shall mean any unintended event, including operating errors, equipment failures and other mishaps, the consequences or potential consequences of which are not negligible from the point of view of radiation protection or safety; Cap. 585. "Act" means the Nuclear Safety and Radiation Protection Act; "absorbed dose" (D) means the energy absorbed per unit mass Where is the mean energy imparted by ionizing radiation to the matter in a volume element, dm is the mass of the matter in this volume element. In these regulations, absorbed dose denotes the dose averaged over a tissue or an organ. The unit for absorbed dose is the gray (Gy) where one gray is equal to one joule per kilogram; "accelerator" means equipment or installation, in which BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 particles are accelerated, emitting ionizing radiation with an energy higher than 1 mega-electron volt (MeV); "accidental exposure" means an exposure of individuals, other than emergency workers, as a result of an accident; "activation" means a process through which a stable nuclide is transformed into a radionuclide by irradiating with particles or highenergy photons the material in which it is contained; "activity" (A) is the activity of an amount of a radionuclide in a particular energy state at a given time. It is the quotient of dN by dt, where dN is the expectation value of the number of nuclear transitions from that energy state in the time interval dt: The unit of activity is the Becquerel (Bq); "apprentice" means a person receiving training or instruction within an undertaking with a view to exercising a specific skill; "applicant" means a legal person who applies to Secretariat filing a application to the Secretariat for the purpose of obtaining the authorisation for undertaking of specific activities; "authorisation" means a permission granted in a document by the Secretariat to carry out a practice or any other action within the scope of these regulations. Authorisations can take the form of a registration or a licence. "becquerel" (Bq) is the special name of the unit of activity. One becquerel is equivalent to one nuclear transition per second; "building material" means any construction product for incorporation in a permanent manner in a building or parts thereof and the performance of which has an effect on the performance of the building with regard to exposure of its occupants to ionising radiation; "carers and comforters" means individuals knowingly and willingly incurring an exposure to ionising radiation by helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having undergone medical exposure; "clearance levels" means values, established by the Commission, and expressed in terms of activity concentrations at or below which materials arising from any practice subject to notification or authorisation may be released from the requirements of these regulations; "clinical audit" means a systematic examination or review of 9 10 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION medical radiological procedures which seeks to improve the quality and outcome of patient care through structured review, whereby medical radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices, where appropriate, and the application of new standards if necessary; "clinical responsibility" means responsibility of a practitioner for individual medical exposures, in particular, justification; optimisation; clinical evaluation of the outcome; cooperation with other specialists and staff, as appropriate, regarding practical aspects of medical radiological procedures; obtaining information, if appropriate, on previous examinations; providing existing medical radiological information and/or records to other practitioners and/or the referrer, as required; and giving information on the risk of ionising radiation to patients and other individuals involved, as appropriate; "Commission" means the Commission for the Protection from Ionising and Non-Ionising Radiation, as established by article 10 of the Act, which acts as the regulatory authority in the field of nuclear safety and radiation protection and has the legal authority for the purpose of these regulations; "committed effective dose" (E(τ)) is the sum of the committed organ or tissue equivalent doses HT(τ) resulting from an intake, each multiplied by the appropriate tissue weighting factor wT. It is defined by: In specifying E(τ), is given in the number of years over which the integration is made. For the purpose of complying with dose limits specified in these regulations, is a period of 50 years following intake for adults and up to the age of 70 for infants and children. The unit for committed effective dose is the sievert (Sv); "committed equivalent dose" (HT(τ)) is the integral over time (
  4. t)of the equivalent dose rate in tissue or organ T that will be received by an individual as a result of an intake. It is given by: for an intake at time t0 where T (
  5. t)is the relevant equivalent dose rate in organ or tissue T at BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 time t, τ is the time over which the integration is performed. In specifying HT(τ), is given in number of years over which the integration is made. For the purpose of complying with dose limits specified in these regulations, τ is a period of 50 years for adults and up to the age of 70 for infants and children. The unit for committed equivalent dose is the sievert (Sv); "consumer product" means a device or manufactured item into which one or more radionuclides have deliberately been incorporated or produced by activation, or which generates ionising radiation, and which can be sold or made available to members of the public without special surveillance or regulatory control after sale; "constancy test" means a test intended to monitor the constancy of the functional performance of the equipment used in connection with medical exposures; "contamination" means the unintended or undesirable presence of radioactive substances on surfaces or within solids, liquids or gases or on the human body; "controlled area" means an area subject to special rules for the purpose of protection against ionising radiation or preventing the spread of radioactive contamination and to which access is controlled; "diagnostic reference levels" means dose levels in medical radiodiagnostic or interventional radiology practices, or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment; "disused source" means a sealed source which is no longer used or intended to be used for the practice for which authorisation was granted but continues to require safe management; "dose constraint" means a constraint set as a prospective upper bound of individual doses, used to define the range of options considered in the process of optimisation for a given radiation source in a planned exposure situation; "dose limit" means the value of the effective dose (where applicable, committed effective dose) or the equivalent dose in a specified period which shall not be exceeded for an individual; "dosimetry service" means a body or an individual competent to calibrate, read or interpret individual monitoring devices, or to measure radioactivity in the human body or in biological samples, or to assess doses, whose capacity to act in this respect is recognised by the Commission; 11 12 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION "effective dose" (E) is the sum of the weighted equivalent doses in all the tissues and organs of the body from internal and external exposure. It is defined by the expression: Where is the absorbed dose averaged over tissue or organ T, due to radiation R, is the radiation weighting factor and is the tissue weighting factor for tissue or organ T is the equivalent dose absorbed by tissue T The values for and are specified in the First Schedule. The unit for effective dose is the sievert (Sv); "emergency" means a non-routine situation or event involving a radiation source that necessitates prompt action to mitigate serious adverse consequences for human health and safety, quality of life, property or the environment, or a hazard that could give rise to such serious adverse consequences; "emergency exposure situation" means a situation of exposure due to an emergency; "emergency management system" means the elements listed in Section A of the Tenth Schedule, as incorporated in the national radiological emergency plan, for emergency preparedness and response, and arrangements for decision making in the event of an emergency exposure situation; "emergency occupational exposure" means exposure received in an emergency exposure situation by an emergency worker; "emergency response plan" means those elements listed in Section B of the Tenth Schedule to plan for adequate response in the event of an emergency exposure situation on the basis of postulated events and related scenarios; "emergency worker" means any person having a defined role in an emergency and who might be exposed to radiation while taking action in response to the emergency; BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 "environmental monitoring" means the measurement of external dose rates due to radioactive substances in the environment or of concentrations of radionuclides in environmental media; "equivalent dose" (HT) is the absorbed dose, in tissue or organ T weighted for the type and quality of radiation R. It is given by: where is the absorbed dose averaged over tissue or organ T, due to radiation R, is the radiation weighting factor. When the radiation field is composed of types and energies with different values of , the total equivalent dose, , is given by: The values for are specified in Section A of the First The unit for equivalent dose is the sievert (Sv); "exemption level" means a value established the Commission and expressed in terms of activity concentration or total activity at or below which a radiation source is not subject to notification or authorisation; "existing exposure situation" means an exposure situation that already exists when a decision on its control has to be taken and which does not call or no longer calls for urgent measures to be taken; "exposed worker" means a person, either self-employed or working under an employer, who is subject to exposure at work carried out within a practice regulated by these regulations and who is liable to receive doses exceeding any one of the dose limits for public exposure; "exposure" means the act of exposing or condition of being exposed to ionising radiation emitted outside the body (external exposure) or within the body (internal exposure); "extremities" means the hands, forearms, feet and ankles; "graded approach" means a structured method by which the 13 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 life occurring in a population following exposure, including those arising from tissue reactions, cancer and severe genetic disorder; "health screening" means a procedure using medical radiological installations for early diagnosis in population groups at risk; "high-activity sealed source" means a sealed source for which the activity of the contained radionuclide is equal to or exceeds the relevant activity value laid down in the fourth column of the table of the Second Schedule; "individual detriment" means clinically observable deleterious effects in individuals or their descendants, the appearance of which is either immediate or delayed and, in the latter case, implies a probability rather than a certainty of appearance; "inspection" means an investigation by the Secretariat to verify regulatory compliance; "intake" means the total activity of a radionuclide entering the body from the external environment; "interventional radiology" means the use of X-ray imaging techniques to facilitate the introduction and guidance of devices in the body for diagnostic or treatment purposes; "ionising radiation" means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly; "licence" means permission granted in a document by the Secretariat to carry out a practice in accordance with specific conditions laid down in that document; "medical exposure" means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, and intended to benefit their health, as well as exposure incurred by carers and comforters and by volunteers in medical or biomedical research; "medical physics expert" means an individual having the knowledge, training and experience to act or give advice on matters relating to radiation physics applied to medical exposure, whose competence in this respect is recognised by the Commission; Cap. 464. "medical radiographer" shall have the meaning ascribed by radiographer under the Health Care Professions Act; BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 "medical radiological" means pertaining to radiodiagnostic and radiotherapeutic procedures, and interventional radiology or other medical uses of ionising radiation for planning, guiding and verification purposes; "medical radiological installation" means a facility where medical radiological procedures are performed; "medical radiological procedure" means any procedure giving rise to medical exposure; "members of the public" means individuals who may be subject to public exposure; "Minister" means the minister responsible for the Nuclear Safety and Radiation Protection Act; "National Radioactivity Monitoring Programme" means the system by which the environment is monitored for ionising radiation and the presence of radioactivity in environmental media, in accordance with regulation 95, in order to assess the levels of radiation and radioactivity in the environment to which the Maltese population is exposed;. "natural radiation source" means a source of ionising radiation of natural, terrestrial or cosmic origin; "non-medical imaging exposure" means any deliberate exposure of humans for imaging purposes where the primary intention of the exposure is not to bring a health benefit to the individual being exposed; "normal exposure" means exposure expected to occur under the normal operating conditions of a facility or activity (including maintenance, inspection, decommissioning), including minor incidents that can be kept under control, i.e. during normal operation and anticipated operational occurrences; "notification" means the requirement of submitting a document to the Secretariat to notify the intention to carry out a practice within the scope of these regulations; "occupational exposure" means exposure of workers, apprentices and students, incurred in the course of their work; "occupational health service" means a health professional or body competent to perform medical surveillance of exposed workers and whose capacity to act in that respect is recognised by the Commission; "orphan source" means a radioactive source which is neither exempted nor under regulatory control, e.g. because it has never been under regulatory control or because it has been abandoned, lost, Cap. 585. 15 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 and controlled areas, but performs activities in those areas, including, apprentices and students; "planned exposure situation" means an exposure situation that arises from the planned operation of a radiation source or from a human activity which alters exposure pathways, so as to cause the exposure or potential exposure of people or the environment. Planned exposure situations may include both normal exposures and potential exposures; "potential exposure" means exposure that is not expected with certainty but may result from an event or sequence of events of a probabilistic nature, including equipment failures and operating errors; "practical aspects of medical radiological procedures" means the physical conduct of a medical exposure and any supporting aspects, including handling and use of medical radiological equipment, the assessment of technical and physical parameters (including radiation doses), calibration and maintenance of equipment, preparation and administration of radio-pharmaceuticals, and image processing; "practice" means a human activity that can increase the exposure of individuals to radiation from a radiation source and is managed as a planned exposure situation; "practitioner" means a medical doctor, dentist or other health professional who is entitled to take clinical responsibility and is approved by an undertaking in accordance with regulation 67; "processing" means chemical or physical operations on radioactive material including the mining, conversion, enrichment of fissile or fertile nuclear material and the reprocessing of spent fuel; "protective measures" means measures, other than remedial measures, for the purpose of avoiding or reducing doses that might otherwise be received in an emergency exposure situation or an existing exposure situation; "public exposure" means exposure of individuals, excluding any occupational or medical exposure; "quality assurance" means all those planned and systematic actions necessary to provide adequate assurance that a structure, system, component or procedure will perform satisfactorily in compliance with agreed standards. Quality control is a part of quality assurance; "quality control" means the set of operations (programming, BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 coordinating, implementing) intended to maintain or to improve quality. It includes monitoring, evaluation and maintenance at required levels of all characteristics of performance of equipment that can be defined, measured, and controlled; "radiation generator" means a device capable of generating ionising radiation, such as X-rays, neutrons, electrons or other charged particles; "radiation protection" means protection of people from the harmful effects of exposure to ionising radiation, and the means for achieving of this protection; "radiation protection expert" means an individual having the knowledge, training and experience needed to give radiation protection advice in order to ensure the effective protection of individuals, and whose competence in this respect is recognised by the Commission; "radiation protection officer" means a individual designated by an undertaking, who is technically competent in radiation protection matters relevant for a given type of practice to supervise or perform the implementation of the radiation protection arrangements given in an undertaking’s radiation protection programme; "radiation protection programme" means the systemic arrangements that are aimed at providing adequate consideration of radiation protection; "radiation source" means an entity that may cause exposure, such as by emitting ionising radiation or by releasing radioactive material; "radioactive material" radioactive substances; means material incorporating "radioactive source" means a radiation source incorporating radioactive material for the purpose of utilising its radioactivity; "radioactive substance" means any substance that contains one or more radionuclides the activity or activity concentration of which cannot be disregarded from a radiation protection point of view; "radioactive waste" means radioactive material in gaseous, liquid or solid form for which no further use is foreseen or material that the Commission requires to be regulated as radioactive waste; "radiodiagnostic" means pertaining to in-vivo diagnostic nuclear medicine, medical diagnostic radiology using ionising radiation, and dental radiology; "radiotherapeutic" means pertaining to radiotherapy, including nuclear medicine for therapeutic purposes; 17 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 exposure to radon progeny; "reference level" means in an emergency exposure situation or in an existing exposure situation, the level of effective dose or equivalent dose or activity concentration above which it is judged inappropriate to allow exposures to occur as a result of that exposure situation, even though it is not a limit that may not be exceeded; "referrer" means a medical doctor, dentist or other health professional who is authorised, in accordance with the undertakings procedures, to refer individuals for medical radiological procedures to a practitioner; "registration" means permission granted in a document by the Secretariat, through a simplified procedure, to carry out a practice in accordance with conditions laid by the Commission for this type or class of practice; "regulatory control" means any form of control or regulation applied to human activities for the enforcement of radiation protection requirements; "remedial measures" means the removal of a radiation source or the reduction of its magnitude (in terms of activity or amount) or the interruption of exposure pathways or the reduction of their impact for the purposes of avoiding or reducing doses that might otherwise be received in an existing exposure situation; "representative person" means an individual receiving a dose that is representative of the more highly exposed individuals in the population, excluding those individuals having extreme or rare habits; "safety assessment" means an assessment of all aspects of a practice that are relevant to radiation protection; for an authorised facility, this includes siting, design and operation of the facility in accordance with regulation 101; "safety culture" means the assembly of characteristics and attitudes in organizations and individuals, which establishes that as an overriding priority, protection and safety issues receive the attention warranted by their significance. Safety culture includes: (
  6. a)individual and collective commitment to safety on the part of the leadership, the management and personnel at all levels; (
  7. b)accountability of organizations and of individuals at all levels for safety; BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 (
  8. c)measures to encourage a questioning and learning attitude and to discourage complacency with regard to safety; "Secretariat" means the Secretariat of the Commission as established by article 12 of the Act; "security" means the prevention and detection of, and response to, theft, sabotage, unauthorised access, illegal transfer or other malicious acts involving nuclear or other radioactive material, or their associated facilities; "security culture" means characteristics and attitudes in organisations and of individuals which establish that security issues receive the attention warranted by their significance; "sealed source" means a radioactive source in which the radioactive material is permanently sealed in a capsule or incorporated in a solid form with the objective of preventing, under normal conditions of use, any dispersion of radioactive substances; "sievert" (Sv) is the special name of the unit of equivalent or effective dose. One sievert is equivalent to one joule per kilogram: 1 Sv =1 J kg-1 ; "spacecraft" means a manned vehicle designed to operate at an altitude of more than 100 km above sea level; "storage" means the holding of radioactive material, including spent fuel, a radioactive source or radioactive waste, in a facility with the intention of retrieval; "supervised area" means an area subject to supervision for the purpose of protection against ionising radiation; "source container" means an assembly of components intended to guarantee the containment of a sealed source, where it is not an integral part of the source but is meant for shielding the source during its transport and handling; "standard values and relationships" means values and relationships recommended in chapters 4 and 5 of ICRP Publication 116 for the estimation of doses from external exposure and chapter 1 of ICRP Publication 119 for the estimation of doses from internal exposure, including updates approved by the Commission. The Commission may approve the use of specific methods in specified cases relating to the physico-chemical properties of the radionuclide or other features of the exposure situation or of the exposed individual; "thoron" means the radionuclide Rn-220 and its progeny, as appropriate; 19 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 calibration and testing services; "undertaking" means a natural or legal person who has legal responsibility under national law for carrying out a practice, or for a radiation source (including cases where the owner or holder of a radiation source does not conduct related human activities); "unintended exposure" means medical exposure that is significantly different from the medical exposure intended for a given purpose. Part III SYSTEM OF RADIATION PROTECTION General principles. 5.
(1)The regulatory control regime is based on the principles of justification, optimisation and dose limitation as follows: (
  1. a)Justification: Decisions introducing a practice shall be justified in the sense that such decisions shall be taken with the intent to ensure that the individual or societal benefit resulting from the practice outweighs the health detriment that it may cause. Decisions introducing or altering an exposure pathway for existing and emergency exposure situations shall be justified in the sense that they should do more good than harm. (
  2. b)Optimisation: Radiation protection of individuals subject to public or occupational exposure shall be optimised with the aim of keeping the magnitude of individual doses, the likelihood of exposure and the number of individuals exposed as low as reasonably achievable taking into account the current state of technical knowledge and economic and societal factors. The optimisation of the protection of individuals subject to medical exposure shall apply to the magnitude of individual doses and be consistent with the medical purpose of the exposure, as described in regulation 66. This principle shall be applied not only in terms of effective dose but also, where appropriate, in terms of equivalent doses, as a precautionary measure to allow for uncertainties as to health detriment below the threshold for tissue reactions. (
  3. c)Dose limitation: In planned exposure situations, the sum of doses to an individual shall not exceed the dose limits laid down for occupational exposure or public exposure. Dose limits shall not apply to medical exposures.
(2)The regulatory control regime shall make use of the graded approach.
(3)The prime responsibility for the safety and security of BASIC SAFETY STANDARDS FOR IONISING RADIATION [ 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 cannot be delegated and includes responsibility for the activities of contractors and sub-contractors whose activities might affect safety and security. 6. Dose constraints for the purpose of prospective optimisation of protection shall be:
(1)(
  1. a)for occupational exposure, the dose constraint shall be established as an operational tool for optimisation by the undertaking and shall be one third of any dose limits specified in regulations 9,10 and 11. In the case of outside workers the dose constraint shall be established in cooperation between the employer of the outside worker and the undertaking; Optimisation - use of dose constraints. Substituted by: L.N. 184 of 2020. (
  2. b)for public exposure, the dose constraint shall be 0.25mSv per year for the individual dose that members of the public receive from the planned operation of a specified radiation source; (
  3. c)for medical exposure, dose constraints shall apply only with regard to the protection of carers and comforters, which shall be 1.5mSv per five years pursuant to regulation 66
(6a)and volunteers participating in medical or biomedical research pursuant to regulation 66
(4c).
(2)In the event that any dose constraint is exceeded the undertaking is to immediately inform the Commission and then produce a report detailing the event and doses received. 7.
(1)Without prejudice to reference levels set for equivalent doses, that may be specified by the Commission, the reference levels for any persons expressed in effective doses shall be: 1mSv per year for existing exposure situations and 20mSv (acute or annual) for emergency exposure situations. Provided that optimization of protection shall give priority to exposures above these reference levels and shall continue to be implemented below the reference level. Provided that in specific situations the Commission may lower the reference levels taking into account optimisation and shall give due consideration to: (
  1. a)a reference level below 20mSv may be set in an emergency exposure situation where appropriate protection can be provided without causing a disproportionate detriment from the corresponding countermeasures or an excessive cost; (
  2. b)a reference level below 1mSv per year may be set, where appropriate, in an existing exposure situation for Optimisation - use of Reference levels in existing and emergency situations. Amended by: L.N. 184 of 2020. 22 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION specific source-related exposures or pathways of exposure
(2)For the transition from an emergency exposure situation to an existing exposure situation, appropriate reference levels shall be set, in particular upon the termination of long-term countermeasures.
(3)The reference levels set shall take account of the features of prevailing situations as well as societal criteria, which may include the following: (
  1. a)for exposures below or equal to 1mSv per year, general information on the level of exposure, without specific consideration of individual exposures; (
  2. b)in the range up to or equal to 20mSv per year, specific information to enable individuals to manage their own exposure, if possible (
  3. c)in the range up to or equal to 100 mSv per year, assessment of individual doses and specific information on radiation risks and on available actions to reduce exposures.
(4)For existing exposure situations involving exposure to radon, the reference levels shall be set in terms of radon activity concentration in air of 300 Bqm-3 for members of the public and workers. Dose limitation age limit for exposed workers. Substituted by: L.N. 184 of 2020. Dose limits for occupational exposure. Amended by: L.N. 139 of 2022. 8.
(1)Persons under 18 years of age may not be assigned to any work which would result in them as being classed as an exposed worker subject to regulation 11
(2).
(2)No person under 16 years of age shall be allowed to be subject to any form of occupational exposure. 9.
(1)The dose limits for occupational exposure apply to the sum of annual occupational exposures of a worker from all authorised practices, occupational exposure to radon in workplaces requiring notification in accordance with regulation 64
(3), and other occupational exposure from existing exposure situations in accordance with regulation 124
(3). For emergency occupational exposure regulation 63 shall apply.
(2)The limit on effective dose for occupational exposure shall be 20mSv in any single year. In special circumstances or for certain exposure situations where the Secretariat is satisfied that a dose in excess of the annual limit is appropriate, the Secretariat may authorise a higher effective dose of up to 50mSv in a single year, provided that the average annual dose over any five
(5)consecutive years, including the years for which the limit has been exceeded, does not exceed 20mSv.
(3)In addition to the limits on effective dose laid down in sub-regulation
(2), the following limits on equivalent dose shall apply: BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 23 (
  1. a)the limit on the equivalent dose for the lens of the eye shall be 20mSv in a single year or 100mSv in any five consecutive years subject to a maximum dose of 50mSv in a single year; (
  2. b)the limit on the equivalent dose for the skin shall be 500mSv in a year, this limit shall apply to the dose averaged over any area of 1 cm2, regardless of the area exposed; (
  3. c)the limit on the equivalent dose for the extremities shall be 500mSv in a year. 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 undertaking, and the employer of the outside worker, shall ensure that the employment conditions for the pregnant worker are such that the protection of the unborn child is comparable with that provided for members of the public and the equivalent dose to the unborn child is as low as reasonably achievable and unlikely to exceed 1mSv during at least the remainder of the pregnancy. Dose limitation for pregnancy and breastfeeding. S.L. 646.07 Amended by: L.N. 184 of 2020; XXXIII.2024. First Schedule.
(2)As soon as workers inform the undertaking, or in case of outside workers, the employer of the outside worker, that they are breastfeeding an infant, they shall not be employed in work involving a significant risk of intake of radionuclides or of bodily contamination. 11.
(1)The dose limits for apprentices aged 18 years or over and students aged 18 years or over who, in the course of their studies, are obliged to work with radiation sources, shall be the same as the dose limits for occupational exposure laid down in regulation 9.
(2)The limit on the effective dose for apprentices aged between 16 and 18 years and for students aged between 16 and 18 years who, in the course of their studies, are obliged to work with radiation sources, shall be 6mSv in a year.
(3)In addition to the limits on effective dose laid down in sub-regulation
(2), the following limits on equivalent dose shall apply: (
  1. a)the limit on the equivalent dose for the lens of the eye shall be 15mSv in a year; (
  2. b)the limit on the equivalent dose for the skin shall be 150mSv in a year, this limit shall apply to the dose averaged over any area of 1cm2, regardless of the area exposed; (
  3. c)the limit on the equivalent dose for the extremities shall be 150mSv in a year Dose limitation for apprentices and students. 24 [ S.L.585.01 Dose limitation for public exposure. Amended by: L.N. 139 of 2022. BASIC SAFETY STANDARDS FOR IONISING RADIATION
(4)The dose limits for apprentices and students who are not subject to the provisions of sub-regulations 1, 2 and 3 shall be the same as the dose limits for members of the public as specified in regulation 12 12.
(1)The effective dose limit for the public, applicable to any one authorised practise, shall be 0.25mSv per year.
(2)The limit of the effective dose for public exposure is 1mSv per annum.
(3)In addition to the dose limit referred to in the subregulation
(1), the following limits on the equivalent dose shall apply: (
  1. a)the limit on the equivalent dose for the lens of the eye shall be 15mSv in a year; (
  2. b)the limit on the equivalent dose for the skin shall be 50mSv in a year, this limit shall apply to the dose averaged over any area of 1 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 relationships shall be used. For external radiation, the operational quantities defined in section 2.3 of ICRP Publication 116 shall be used. PART IV RADIATION PROTECTION EDUCATION, TRAINING AND INFORMATION General training in radiation protection. 14.
(1)The undertaking or, in case of outside workers, the employer of the outside worker shall ensure that individuals whose tasks require specific competences in radiation protection shall: (
  1. a)have received appropriate radiation protection training before commencing work; (
  2. b)that the radiation protection training is repeated, at intervals to be determined by the Commission but shall not exceed a period of 5 years; and (
  3. c)keep records of training performed, including the training certificates.
(2)The Commission shall set a date by which all training shall be done in accordance to approved syllabi, as appropriate to field of practice, and delivered by approved organisations or individuals. The Commission shall: (
  1. a)approve syllabi for radiation protection training; (
  2. b)approve organisations or individuals to provide BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 25 training; and (
  3. c)accept as appropriate equivalent alternative radiation safety training where the individual has carried out prior training outside of Malta.
(3)Approved training organization or individual shall issue certificates of evidence that the Commission approved training has been performed. 14A. The Commission shall encourage the introduction of a course on radiation protection in the basic curriculum of medical and dental schools. Courses in medical and dental schools. Added by: L.N. 184 of
  1. 14B. Exposed workers shall make available to the undertaking or the employer of the outside worker information on their past and present work that is relevant for ensuring effective and comprehensive protection and safety for themselves and others. Exposed workers to provide information. Added by: L.N. 184 of
  2. 15.
(1)Undertakings are required to inform exposed workers on: Work specific training of exposed workers and information provided to them. (
  1. a)the radiation health risks involved in their work; (
  2. b)the general radiation protection procedures and precautions to be taken; (
  3. c)the radiation protection procedures and precautions connected with the operational and working conditions of both the practice in general and each type of workstation or work to which they may be assigned; (
  4. d)the relevant parts of the emergency response plans and procedures; (
  5. e)the importance of complying with the technical, medical and administrative requirements. In the case of outside workers, the employer of the outside worker shall ensure that the information required in paragraphs (a), (b), and (
  6. e)is provided.
(2)The undertaking or, in case of outside workers, the employer of the outside worker, is to inform exposed workers on the importance of making an early declaration of pregnancy in view of the risks of exposure for the unborn child.
(3)The undertaking or, in case of outside workers, the employer of the outside worker, to inform exposed workers on the importance of announcing the intention to breast-feed an infant in view of the risks of exposure for a breast-fed infant after intake of radionuclides or bodily contamination.
(4)The undertaking or, in case of outside workers, the 26 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION employer of the outside worker, provides appropriate radiation protection training and information programmes for exposed workers.
(5)In addition to the information and training in the field of radiation protection as specified in sub-regulations 1, 2, 3 and 4, the undertaking responsible for high-activity sealed sources shall ensure that such training includes specific requirements for the safe and secure management and control of high-activity sealed sources with a view to preparing the relevant workers adequately for any events affecting the radiation protection. The information and training shall place particular emphasis on the necessary safety requirements and shall contain specific information on the possible consequences of the loss of adequate control of high-activity sealed sources. Information and training of workers potentially exposed to orphan sources. 16.
(1)The Secretariat shall keep the customs authorities and metal recycling installations informed of the possibility that they may be confronted with a source.
(2)The Commission shall promote that workers in the customs authorities and in metal recycling installations are: (
  1. a)advised and trained in the visual detection of sources and their containers; (
  2. b)informed of basic facts about ionising radiation and its effects; (
  3. 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)Emergency workers who are identified in an emergency response plan of an undertaking or the employer of an outside worker and persons involved in the national radiological emergency plan as established by article 31 of the Act, shall be given adequate information: (
  1. a)that is regularly updated on the health risks their intervention might involve and on the precautionary measures to be taken in such an event; (
  2. b)on appropriate radiation protection training; (
  3. c)on national radiological emergency plan as set out in regulation 122: Provided that this information shall take into account the range of potential emergencies and the type of intervention.
(2)In the event that an emergency occurs, the information referred to in the regulation 17
(1a)shall be supplemented by Secretariat to emergency workers and any other persons involved, having regard to the specific circumstance. BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 18.
(1)Undertakings shall entitle individuals to act as referrers, practitioners and individuals involved in the practical aspects of medical radiological exposures by approving them and shall establish a procedure within its radiation protection programme for persons to be approved pursuant to the requirements of regulation 19.
(2)Referrers, practitioners and the individuals involved in the practical aspects of medical radiological procedures shall have the qualification and experience stated in the Seventeenth Schedule 19.
(1)Undertakings shall maintain lists of individuals that have been approved. These lists shall specify any limitations of the approval of individuals. Lists of individuals. Amended by: XXXIII.2024. First Schedule.
(2)Undertakings shall maintain the following records for each of its employees involved in medical exposures: (
  1. a)name of individual; (
  2. b)approval area, including: practitioner; person performing the practical aspects of medical equipment for medical purposes; person performing the practical aspects for other purposes; (
  3. c)qualification certificates to demonstrate training (both academic and practical); (
  4. d)examination results if applicable (including vision examinations pursuant to regulation 10 of the Minimum Health and Safety Requirements for Work with Display Screen Equipment Regulations) and their expiry; (
  5. e)documentation of any continuing professional development; (
  6. f)contract or signed statement of employment of the individual to act in the approved capacity.
(3)An undertaking may approve an individual to work in the same capacity on the basis that the individual has been approved by another undertaking provided that: (
  1. a)the individual has proof of prior approval; and (
  2. 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: (
  1. a)employment is terminated; or (
  2. b)preliminary investigations for accidents indicate 27 Approval, Education, information and training in the field of medical exposure. S.L. 646.05. 28 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION gross individual negligence; or (
  3. c)not carrying consecutive months. out approved work for six Training programmes. 20. Individuals undergoing relevant training programmes may participate in practical aspects for the procedures mentioned in regulation 69 provided that they are constantly under direct supervision of a practitioner. 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 further develop expertise and skills required in discharging the Commission’s responsibilities. Clinical use of new techniques. 22. In the case of the clinical use of new techniques the undertaking shall provide training on these techniques and the relevant radiation protection requirements. Part V JUSTIFICATION AND REGULATORY CONTROL OF PRACTICES (SECTION 1) Justification and prohibition of practices Justification. 23.
(1)It is prohibited to perform a class or type of practice that is not justified. A list of classes and types of practice resulting in exposure to ionising radiation that are deemed justified at the time of this regulation being published is given in the Fourth Schedule.
(2)The Commission shall update and keep available a list of classes and types of practice resulting in exposure to ionising radiation that are deemed justified. New class or types of practice.
  1. The Commission shall not allow a new class or types of practice resulting in exposure to ionising radiation unless it deems it to be justified. If justified it shall be added to the list referred to in the regulation
  2. Review of existing classes or types of practices.
  3. The Commission shall consider a review of existing classes or types of practices held on the list referred to in regulation 23 with regard to their justification whenever there is new and important evidence about their efficacy or potential consequences or new and important information about other techniques and technologies, if no longer justified they shall be removed from the list. Medical exposure.
  4. 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
  5. 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 all relevant information, including that listed in Section A of the Third Schedule, so as to allow the implementation of the justification requirement in regulation 25. Practices involving consumer products.
(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 subregulation, informs the point of contact for the competent authorities of other Member States of this receipt and, upon request, of its decision and the basis for that decision.
(4)It is prohibited to sale or the making available to the public of consumer products if their intended use is not justified or their use would not fulfil the criteria for exemption from notification under regulation 35. 28.
(1)It is prohibited to deliberately add radioactive substances in the production of foodstuffs, animal feeding stuffs, and cosmetics, and it is prohibited to import or export of such products. Prohibited practices.
(2)Without prejudice to the Irradiation of Food Regulations, practices involving the activation of material resulting in an increase in activity in a consumer product, which at the time of placing on the market cannot be disregarded from a radiation protection point of view, shall be deemed not to be justified. However, the Commission may evaluate specific types of practices within this class with regard to their justification. S.L. 449.26.
(3)The deliberate addition of radioactive substances in the manufacture of toys and personal ornaments is prohibited and so is the import or export of such products.
(4)Practices involving the activation of materials used in toys and personal ornaments, resulting, at the time of the placing on the market of the products or of their manufacture, in an increase in activity, which cannot be disregarded from a radiation protection point of view is prohibited, and so is the import or export of such products or materials. 29.
(1)With regard to practices and applications involving non-medical imaging exposure the Commission shall: (
  1. a)identify in the list referred to under regulation 23, practices and applications involving non-medical imaging Deliberate exposures of humans for nonmedical purposes. 30 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION exposure which are deemed to be justified; (
  2. b)review the general and particular justification of practices involving non-medical imaging exposures; (
  3. c)regularly review the circumstances warranting non-medical imaging exposures, without individual justification of each exposure.
(2)Each particular application of an accepted type of practice, as stipulated by regulation 23, shall be justified by the undertaking and shall be subject to licensing by the Secretariat.
(3)With regard to practices and applications involving nonmedical imaging exposure undertakings shall give special attention to justification in advance of all individual non-medical imaging exposure procedures using medical radiological equipment, taking into account the specific objectives of the procedure and the characteristics of the individual involved. Justified practices.
  1. Justified practices involving non-medical imaging exposure using medical radiological equipment may be exempted by the Commission from the requirement for dose constraints according to regulation 6(b) and from the dose limits set out in regulation
  2. Practices involving non-medical imaging exposure. Amended by: L.N. 139 of
  3. 31.
(1)For practices involving non-medical imaging exposure that are justified: (
  1. a)the practice is subject to licensing by the Commission and shall impose specific requirements, including criteria for individual implementation, that have been established by the Commission, making reference to guidance available from international bodies, in cooperation with Maltese professional bodies of practitioners, other governmental regulatory bodies and any other such persons or bodies that the Commission sees fit as appropriate; (
  2. b)equipment: for procedures using medical radiological (
  3. i)relevant requirements identified for medical exposure as set out in Part VII are applied, including those for equipment, optimisation, responsibilities, training and special protection during pregnancy and the appropriate involvement of the medical physics expert; (
  4. ii)where appropriate, specific protocols, consistent with the objective of the exposure and required image quality, are put in place; (iii) where practicable, specific diagnostic reference levels are put in place; BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 31
(2)For procedures not using medical radiological equipment, shall have dose constraints that shall be established by the Commission and its value shall not exceed an effective dose of 0.005mSv per procedure with a limit of 0.1mSv per year for the individual exposed to that procedure and;
(3)Information is provided to and consent sought from the individual to be exposed, allowing for cases where the law enforcement authorities may proceed without consent of the individual according to Maltese legislation. (SECTION 2) Regulatory Control 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 process shall use a graded approach. 32A. The Secretariat shall be responsible for maintaining a registers of:
(1)Graded approach to regulatory control. Substituted by: L.N. 184 of
  1. Registers. Added by: L.N. 184 of
  2. undertakings and employers of outside workers;
(2)equipment regulations; that requires notification under these
(3)radioactive material that requires notification under these regulations, and in particular the following information: (
  1. a)radionuclide involved; (
  2. b)the activity at the time of manufacture or, if this activity is not known, the activity at the time of the first placing on the market; and (
  3. c)the type of source.
(4)Transfers of equipment and radioactive material that requires notification under these regulations. 33. The Commission shall identify classes or types of practice involving naturally–occurring radioactive material and leading to exposure of workers or members of the public which cannot be disregarded from a radiation protection point of view. Such identification shall be carried out by appropriate means taking into account industrial sectors listed in the Fifth Schedule. 34.
(1)Notification is required for all justified practices, including those identified according to regulation 33. The notification shall be made at least thirty
(30)days prior to a practice commencing. Existing practices shall notify within thirty
(30)days of the publication of this regulation. The Secretariat shall specify the Identification of practices involving naturally-occurring radioactive material. Amended by: L.N. 139 of 2022. 32 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION information to be provided in conjunction with the notification. Where an application for an authorisation is submitted, no separate notification is needed. An authorisation may lead to the Secretariat issuing the undertaking with either a registration or license.
(2)Undertakings shall immediately notify the Secretariat if there is any change in the information supplied in connection with the above sub-regulation.
(3)Practices may be exempted from notification, as specified in regulation 35.
(4)Notification is required for workplaces specified in regulation 64
(3)and for existing exposure situations that are managed as a planned exposure situation, as specified in regulation 124
(3).
(5)Notwithstanding the exemption criteria laid down in regulation 35, in situations identified by the Commission where there is concern that a practice identified in accordance with regulation 33 may lead to the presence of naturally-occurring radionuclides in water liable to affect the quality of drinking water supplies or affect any other exposure pathways, so as to be of concern from a radiation protection point of view, the Commission may require that the practice be subject to notification.
(6)Human activities involving radioactively contaminated materials resulting from authorised releases or materials cleared in accordance with regulation 39 shall not be managed as a planned exposure situation and, hence, are not required to be notified. Exemption from notification. 35. notified:
(1)The following justified practices do not need to be (
  1. a)radioactive materials where the quantities of the activity involved do not exceed in total the exemption values set out in Table B, Activity Column (Bq), of the Sixth Schedule, or higher values that, for specific applications, are approved by the Commission and satisfy the general exemption and clearance criteria set out in the Sixth Schedule ; or (
  2. b)without prejudice to regulation 34
(6)radioactive materials where the activity concentrations do not exceed the exemption values set out in Table A, Activity Concentration Column (kBq kg-1), of the Sixth Schedule, or higher values that, for specific applications, are approved by the Commission and satisfy the general exemption and clearance criteria set out in the Sixth Schedule; or (
  1. c)apparatus containing a sealed source, provided that: (
  2. i)the apparatus is of a type approved by the BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 33 Commission; (
  3. ii)the apparatus does not cause, in normal operating conditions, a dose rate exceeding 1 μSv h-1 at a distance of 10cm from any accessible surface; and (iii) conditions for recycling or disposal have been specified by the Commission; or (
  4. d)any electrical apparatus provided that: (
  5. i)it is a cathode ray tube intended for the display of visual images, or other electrical apparatus operating at a potential difference not exceeding 30 kilo volt (kV), or it is of a type approved by the Commission; and (
  6. ii)it does not cause, in normal operating conditions, a dose rate exceeding 1 μSv h-1 at a distance of 10cm m from any accessible surface.
(2)The Commission may exempt specific types of practices from the notification requirement subject to compliance with the general exemption criteria established in paragraph 3 of the Sixth Schedule, on the basis of an assessment showing that exemption is the best option. 36.
(1)The Commission shall require either registration or licensing of the following practices: (
  1. a)the operation of radiation generators or accelerators or radioactive sources for medical exposures or for nonmedical imaging exposure purposes; and (
  2. b)the operation of radiation generators or accelerators, except electron microscopes, or radioactive sources for purposes not covered by sub-paragraph (a).
(2)The Commission may require registration or licensing of other types of practices.
(3)Subject to regulation 37, the Commission shall, in accordance with sub-regulations
(1)and
(2), determine which practices are subject to registration or licensing. The Commission shall base its decision to submit a type of practice to registration or licensing, using a graded approach and based on regulatory experience taking into account: (
  1. a)the magnitude of expected or potential doses resulting from the practice; (
  2. b)the impact that regulatory control may have in reducing such doses or improving radiological safety; (
  3. c)the complexity of the practice; and (
  4. d)safety and security having regard to the circumstances in which the relevant practice is proposed to be carried Registration versus licensing. Substituted by: L.N. 139 of 2022. 34 [ S.L.585.01 Licensing. BASIC SAFETY STANDARDS FOR IONISING RADIATION out. 37. Licensing is required for the following practices: (
  5. a)the deliberate administration of radioactive substances to persons and, in so far as the radiation protection of human beings is concerned, animals for the purpose of medical or veterinary diagnosis, treatment or research; (
  6. b)facility; the operation and decommissioning of any nuclear (
  7. c)the deliberate addition of radioactive substances in the production or manufacture of consumer products or other products, including medicinal products, and the import of such products; (
  8. d)source; any practice involving a high-activity sealed (
  9. e)the operation, decommissioning and closure of any facility for the long term storage or disposal of radioactive waste, including facilities managing radioactive waste for this purpose; the operation, decommissioning and closure of any facility for the long term storage or disposal of radioactive waste, including facilities managing radioactive waste for this purpose; (
  10. f)practices discharging significant amounts of radioactive material with airborne or liquid effluent into the environment. Authorisation. 38.
(1)In order to apply for a registration or license, applicants are to provide the Secretariat such information as shall be stipulated by the Secretariat.
(2)The information that the Secretariat will require to be supplied by applicants to apply for a license will include items in the indicative list in the Eighth Schedule.
(3)A licence shall include, as appropriate, specific conditions and reference to requirements in these regulations so as to ensure that the elements of the licence are legally enforceable, and impose appropriate restrictions on the operational limits and conditions of operation.
(4)Where applicable, the licence shall include conditions on the discharge of radioactive effluent, in connection with the requirements of regulation 87 for the authorisation of the release of radioactive effluent into the environment.
(5)Licensees shall notify the Secretariat at least one month prior to the expiry of their License to inform the Secretariat if they will BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 35 be seeking a renewal of their license. 39.
(1)Disposal, recycling or reuse of radioactive materials arising from any authorised practice is subject to authorisation. Release from regulatory control.
(2)Materials for disposal, recycling or reuse may be released from regulatory control provided that the activity concentrations: (
  1. a)for solid material do not exceed the clearance levels (kBq kg-1) set out in Table A of the Sixth Schedule; or (
  2. b)comply with specific clearance levels and associated requirements for specific materials or for materials originating from specific types of practices; these specific clearance levels shall be established by the Commission, following the general exemption and clearance criteria set out in paragraph 3 of Sixth Schedule, and taking into account technical guidance provided by the European Union.
(3)The clearance of materials containing naturallyoccurring radionuclides, where these result from authorised practices in which natural radionuclides are processed for their radioactive, fissile or fertile properties, the clearance levels comply with the dose criteria for clearance of materials out in paragraph 3 of Sixth Schedule ,
(4)It shall not be permitted to deliberately dilute radioactive materials for the purpose of them being released from regulatory control. The mixing of materials that takes place in normal operations where radioactivity is not a consideration is not subject to this prohibition. The Commission may authorise, in specific circumstances, the mixing of radioactive and non-radioactive materials for the purposes of re-use or recycling. PART VI OCCUPATIONAL EXPOSURES 40.
(1)Undertakings are responsible for assessing and implementing arrangements for the radiation protection of exposed workers.
(2)In the case of outside workers, the responsibilities of the undertaking and the employer of outside workers are stipulated in regulation 61.
(3)Without prejudice to sub-regulations 1 and 2, there shall be a clear allocation of responsibilities, specified within radiation protection programme of the undertaking , for the protection of workers in any exposure situation, to an undertaking, an employer of the outside worker or any other organisation, in particular for the Responsibilities. 36 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION protection of: (a) emergency workers; (b) workers involved in the remediation contaminated land, buildings and other constructions; of (c) workers who are exposed to radon at work, in the situation specified in regulation 64
(3), This shall also apply to the protection of self-employed individuals and individuals who work on a voluntary basis.
(4)Employers of outside workers shall ensure that they have access to information on the possible exposure of their employees under the responsibility of another employer or undertaking. Operational protection of exposed workers. 41.
(1)be based on: Operational protection of exposed workers shall (
  1. a)prior evaluation to identify the nature and magnitude of the radiological risk to exposed workers as part of the safety assessment required by regulation 101; (
  2. b)conditions; optimisation of radiation protection in all working (
  3. c)classification of exposed workers as either category A worker or category B worker; (
  4. d)control measures and monitoring relating to the different areas and working conditions, including, where necessary, individual monitoring; Operational protection of apprentices and students. (
  5. e)medical surveillance; (
  6. f)education and training. 42.
(1)Exposure conditions and operational protection of apprentices and students aged 18 years or over referred to regulation 11
(1)is equivalent to that of exposed workers of category A or B as appropriate.
(2)Exposure conditions and operational protection of apprentices and students aged between 16 and 18 years referred to in regulation 11
(2)is equivalent to that of exposed workers of category B. Consultations with a radiation protection expert. 43. Undertakings shall seek advice from a radiation protection expert within the radiation protection expert’s areas of competence (as outlined in regulation 105), on the issues below that are relevant to the practice: (
  1. a)the examination and testing of protective devices [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION 37 and measuring instruments; (
  2. b)prior critical review of plans for installations from the point of view of radiation protection; (
  3. c)the acceptance into service of new or modified radiation sources from the point of view of radiation protection; (
  4. d)regular checking of protective devices and techniques; the effectiveness of (
  5. e)regular calibration of measuring instruments and regular checking that they are serviceable and correctly used; (
  6. f)radiation undertaking. protection programme of the 44.
(1)Undertakings shall give careful consideration and implement radiation protection arrangements as regards all workplaces where workers are liable to receive an exposure greater than an effective dose of 1mSv per year or an equivalent dose of 15mSv per year for the lens of the eye or 50mSv per year for the skin and extremities. Such arrangements shall use the graded approach.
(2)For workplaces specified in regulation 64
(3)and where the exposure of workers is liable to exceed an effective dose of 6mSv per year or a corresponding time-integrated radon exposure value to be determined by the Commission based on international guidance, these shall be managed as a planned exposure situation and the Commission shall determine which requirements set out in this Part VI are appropriate. For workplaces specified in regulation 64
(3), and where the effective dose to workers is less than or equal to 6mSv per year, or the exposure less than the corresponding time integrated radon exposure value for the workers, the Commission shall require that exposures are kept under review.
(3)For an undertaking operating aircraft where the effective dose to the crew from cosmic radiation is liable to exceed 6mSv per year, the relevant requirements set out in this Part VI shall apply, allowing for the specific features of this exposure situation. In the case that an effective dose to the crew is liable to be above 1mSv per year, the undertaking is take appropriate measures, in particular: (
  1. a)to assess the exposure of the crew concerned; (
  2. b)to take into account the assessed exposure when organising working schedules with a view to reducing the doses of highly exposed crew; (
  3. c)to inform the workers concerned of the health Arrangements in workplaces. Amended by: L.N. 139 of 2022. 38 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION risks their work involves and their individual dose; (
  4. d)Classification of workplaces. Substituted by: L.N. 139 of 2022. to apply regulation 10
(1)to pregnant air crew. 45.
(1)Undertakings shall ensure that workplaces are designated as either controlled or supervised, where appropriate, on the basis of the safety assessment, made pursuant to regulation 101, of the expected annual doses and the probability and magnitude of potential exposures.
(2)Undertakings shall refer to the Commission guidance on the classification of controlled and supervised areas with regard to particular circumstances.
(3)Undertakings shall designate as a controlled area any area under their control which: (
  1. a)it is necessary for any person who enters or works in the area to follow special procedures designed to restrict significant exposure to ionising radiation in that area or prevent or limit the probability and magnitude of radiation accidents or their effects; or (
  2. b)any person working in the area is likely to receive an effective dose greater than 6mSv a year or an equivalent dose greater than three-tenths of any relevant dose limit referred to in these regulations.
(4)Undertakings shall designate as a supervised area any area under their control, not being an area designated as a controlled area: (
  1. a)(
  2. b)Controlled areas. where it is necessary to keep the conditions of the area under review to determine whether the area should be designated as a controlled area; or in which any person is likely to receive an effective dose greater than 1mSv a year or an equivalent dose greater than one-tenth of any relevant dose limit referred to in these regulations.
(5)On the basis of the documentation supplied, including the Safety Assessment, by the undertaking to the Commission, the Secretariat shall confirm that the appropriate area classification has been made. 46.
(1)The minimum requirements for a controlled area are the following: (
  1. a)The controlled area shall be delineated and access to it shall be restricted to individuals who have received appropriate instructions and shall be controlled in accordance with written procedures provided by the undertaking. Wherever there is a significant risk of the spread of radioactive contamination, specific arrangements shall be made, including for the access and exit of individuals and goods and for monitoring contamination within the controlled area and, where appropriate, in the adjacent area. (
  2. b)Taking into account the nature and extent of BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 39 radiological risks in the controlled area, radiological surveillance of the workplace shall be organised in accordance with the provisions of regulation 48. (
  3. c)Signs indicating that the area is Controlled, the nature of the sources and their inherent risks shall be displayed. (
  4. d)Working instructions appropriate to the radiological risk associated with the sources and the operations involved shall be laid down. (
  5. e)The worker shall receive specific training in connection with the characteristics of the workplace and the activities. (
  6. f)The worker shall be provided with the appropriate personal protective equipment.
(2)The undertaking is responsible for implementation of these duties taking into account the advice provided by the radiation protection expert. 47. following:
(1)The requirements for a supervised area are the Supervised areas. (
  1. a)taking into account the nature and extent of radiological risks in the supervised area, radiological surveillance of the workplace shall be organised in accordance with the provisions of regulation 48; (
  2. b)signs indicating that the area is Supervised, the nature of the sources and their inherent risks shall be displayed; (
  3. c)if appropriate, working instructions appropriate to the radiological risk associated with the sources and the operations involved shall be laid down.
(2)The undertaking is responsible for implementation of these duties taking into account the advice provided by the radiation protection expert. 48.
(1)Undertakings shall ensure that the radiological surveillance of the workplace referred to in paragraph (b) of regulation 46
(1)and paragraph (a) of regulation 47
(1)comprises, where appropriate: (
  1. a)the measurement of external dose rates, indicating the nature and quality of the radiation in question; (
  2. b)the measurement of the activity concentration in air and the surface density of contaminating radionuclides, indicating their nature and their physical and chemical states. Radiological surveillance of the workplace. Amended by: L.N. 184 of 2020. 40 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION
(2)Results of these measurements shall be recorded and shall be used, if necessary, for estimating individual doses, as provided for regulation 50.
(3)The results of radiological surveillance of the workplace shall be kept for a minimum of two years.
(4)Monitoring equipment used for radiological surveillance of the workplace shall be annually recalibrated and the calibration shall be traceable to an accredited standards laboratory. Categorisation of exposed workers. 49.
(1)For the purposes of monitoring and surveillance, every undertaking shall designate exposed workers into one of two categories: (
  1. a)category A: those exposed workers who are liable to receive an effective dose greater than 6mSv per year or an equivalent dose greater than 15mSv per year for the lens of the eye or greater than 150mSv per year for skin and extremities; (
  2. b)category B: those exposed workers who are not classified as category A workers.
(2)The undertaking or, in the case of outside workers, the employer of the outside worker, shall decide on the categorisation of individual workers prior to their taking up work that may give rise to exposure, and to regularly review this categorisation on the basis of working conditions and medical surveillance. The distinction shall also take into account potential exposures. Individual monitoring. 50.
(1)Undertakings shall ensure that category A workers are systematically monitored based on individual measurements performed by a dosimetry service. In cases where category A workers are liable to receive significant internal exposure or significant exposure of the lens of the eye or extremities, an adequate system for monitoring shall be set up.
(2)Undertakings shall ensure that monitoring for category B workers is at least sufficient to demonstrate that such workers are correctly classified in category B. The Secretariat may require the undertaking to perform individual monitoring and if necessary individual measurements, by a dosimetry service, for category B workers.
(3)In cases where individual measurements are not possible or inadequate, the individual monitoring shall be based on an estimate arrived at from individual measurements made on other exposed workers, from the results of the surveillance of the workplace provided for in regulation 48 or on the basis of calculation methods approved by the Secretariat. BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 51.
(1)In the case of accidental exposure, the undertaking is required to assess the relevant doses and their distribution in the body.
(2)In the case of accidental exposure, the undertaking is required to obtain the results of dose assessments as soon as practically possible. 52.
(1)Undertakings and the employer of any outside workers shall record the data specified in paragraph 1 of the Ninth Schedule for the individual monitoring that is made for category A workers and any individual monitoring that is performed on category B workers. Recording and reporting of results.
(2)For the purposes of sub-regulation
(1), the following information on exposed workers shall be retained: (a) a record of the exposures measured or estimated, as the case may be, of individual doses pursuant to regulations 50, 51, 61, 62, 63 and, if required by the Secretariat pursuant to regulations 44
(2), 64
(3); (
  1. b)in the case of exposures as referred to in regulations 51, 62, 63, the reports relating to the circumstances and the action taken; (
  2. c)the results of workplace monitoring used to assess individual doses where necessary.
(3)The information referred to in sub-regulation
(1)shall be retained during the period of their working life involving exposure to ionising radiation and afterwards until they have or would have attained the age of 75 years, but in any case not less than 30 years after termination of the work involving exposure.
(4)Exposures as referred to in regulations 51, 62, 63, and, if decided by the Secretariat pursuant to regulations 44
(2), 64
(3)shall be recorded separately in the dose record referred to in sub-regulation
(1).
(5)The dose record referred to in sub-regulation
(1)shall be submitted to the Secretariat by the thirtieth day of April for the following year in the format specified by the Secretariat and shall consist of the data in Section 2 of the Ninth Schedule.
(6)The Secretariat may seek to verify any of the data supplied 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: (
  1. a)submitted to the Secretariat, to the undertaking, and to the employer of outside workers; 41 Dose assessment in the case of accidental exposure. Access to the results of individual monitoring. 42 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION (
  2. b)made available to the worker concerned in accordance with sub-regulation
(2); (c) submitted to an occupational health service in order for it to interpret the implications of the results for human health, as provided for in regulation 55
(2).
(2)The undertaking, or in case of outside workers, the employer of the outside worker, to grant workers, at their request, access to the results of their individual monitoring, including the results of measurements which may have been used in estimating these results, or to the results of the assessment of their doses made as a result of surveillance of the workplace.
(3)In the case of an accidental exposure, the undertaking shall communicate the results of individual monitoring and dose assessments to the individual and the Secretariat without delay.
(4)It is the responsibility of the undertaking and the employer of the outside worker that arrangements are in place for the appropriate exchange, among the undertaking, in the case of an outside worker, the employer, the Secretariat, occupational health services, radiation protection experts, or dosimetry services of all relevant information on the doses previously received by a worker in order to perform the medical examination prior to employment or classification as a category A worker pursuant to regulation 55 and to control the further exposure of workers. 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 the Ninth Schedule to the undertaking data on the employment of the outside worker.
(2)The following data shall be recorded or have been recorded by the undertaking in the data system for individual radiological monitoring after the end of any activity for the outside worker: (
  1. a)the period covered by the activity; (
  2. b)an estimate of any effective dose received by the outside worker (for the period covered by the activity); (
  3. c)in the event of non-uniform exposure, an estimate of the equivalent doses in the different parts of the body; (
  4. d)in the event of an intake of radionuclides, an estimate of the intake or the committed effective dose. Medical surveillance of exposed workers. 55.
(1)Medical surveillance of exposed workers shall be based on the principles that govern occupational medicine generally.
(2)The medical surveillance of category A workers shall be BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 43 undertaken by an occupational health service. This medical surveillance shall allow for the state of health of workers under surveillance to be ascertained as regards their fitness for the tasks assigned to them. To this end, the occupational health service shall have access to any relevant information they require, including the environmental conditions in the working premises.
(3)Medical surveillance shall include: (
  1. a)a medical examination prior to employment or classification as a category A worker to determine the worker's fitness for a post as a category A worker for which the worker is being considered; (
  2. b)periodic reviews of health at least once a year, in order to determine whether the category A workers remain fit to perform their duties. The nature of these reviews, which can be performed as many times as an occupational health service considers necessary, shall depend on the type of work and on the individual worker's state of health.
(4)An occupational health service may indicate the need for medical surveillance to continue after cessation of work for as long as they consider it necessary to safeguard the health of the person concerned. 56. Workers shall have one of the following medical classifications with respect to fitness for work as a category A worker: (
  1. a)a fit; (
  2. b)fit, subject to certain conditions; (
  3. c)unfit. Medical classification. 57. No worker may be employed or classified for any period in a specific post as a category A worker if medical surveillance establishes that the worker is unfit for that specific post. Prohibition to employ or classify unfit workers. 58.
(1)Medical records shall be opened for each category A worker and kept up to date so long as the worker remains a worker in that category. Thereafter, it shall be retained until the individual has or would have attained the age of 75 years, but in any case not less than 30 years after termination of the work involving exposure to ionising radiation. Medical records.
(2)The medical record shall include information regarding the nature of the employment, the results of the medical examinations prior to employment or classification as a category A worker, the periodic reviews of health and the record of doses required by regulation 52. 44 [ S.L.585.01 Special medical surveillance. BASIC SAFETY STANDARDS FOR IONISING RADIATION 59.
(1)In addition to the medical surveillance of exposed workers provided for in regulation 55, provision is made for any further action considered necessary by an occupational health service for the health protection of exposed individuals, such as further examinations, decontamination measures, urgent remedial treatment or other actions identified by the occupational health service.
(2)Special medical surveillance shall be performed in each case where any of the dose limits laid down in regulation 9 has been exceeded.
(3)Subsequent exposure conditions shall be subject to the agreement of the occupational health service. Appeals.
  1. Workers may appeal to the Commission against the findings and decisions made pursuant to regulations 56, 57 and
  2. 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 permanent basis by the undertaking.
(2)The undertaking is responsible, either directly or through contractual agreements with the employer of outside workers, for the operational aspects of the radiation protection of outside workers that are directly related to the nature of their activities in the undertaking.
(3)In particular, as a minimum requirement, the undertaking shall: (
  1. 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; (
  2. b)check whether the categorisation of the outside worker is appropriate in relation to the doses liable to be received within the undertaking; (
  3. c)for entry into controlled areas, ensure that, in addition to the basic training in radiation protection the outside worker has received specific instructions and training in connection with the characteristics of the workplace and the conducted activities, in accordance with paragraphs (
  4. c)and (
  5. d)of regulation 15
(1); (
  1. d)for entry into supervised areas, ensure that the outside worker has received working instructions appropriate to the radiological risk associated with the sources and the operations involved, as required in paragraph (
  2. c)of regulation 47
(1); (
  1. e)ensure that the outside worker has been issued with the necessary personal protective equipment; BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 45 (
  2. f)ensure that the outside worker receives individual exposure monitoring appropriate to the nature of the activities, and any operational dosimetric monitoring that may be necessary; (
  3. g)ensure compliance with the system of protection as defined in Part III; (
  4. h)for entry into controlled areas, ensure or take all appropriate steps to ensure that after every activity the radiological data from individual exposure monitoring of each category A outside worker within the meaning of the regulation 54
(2), are recorded.
(4)Employers of outside workers ensure, either directly or through contractual agreements with the undertaking, that the radiation protection of their workers is in accordance with the relevant provisions of these regulations, in particular by: (
  1. a)ensuring compliance protection as defined in Part III; with the system of (
  2. b)ensuring that the information and training in the field of radiation protection referred to in paragraphs (a), (
  3. b)and (
  4. e)of regulation 15
(1), regulations 15
(2), 15
(3), 15
(4)is provided; (
  1. c)guaranteeing that their workers are subject to appropriate assessment of exposure and, for category A workers, medical surveillance, under the conditions laid down in regulations 48 and 50 to 59; (
  2. d)ensuring that the radiological data from the individual exposure monitoring of each of their category A workers is kept up to date in the data system for individual radiological monitoring referred to in paragraph (
  3. a)of regulation 53. 62.
(1)The Secretariat may decide that in exceptional circumstances evaluated case by case, excluding emergencies, where a specific operation so requires, authorise individual occupational exposures of identified workers exceeding the dose limits set out in regulation 9 provided that such exposures are limited in time, confined to certain working areas and within the maximum exposure levels defined for the particular case by the Secretariat. The following conditions shall be taken into account: (
  1. a)only category A workers as defined in regulation 49 may be subject to such exposures; (
  2. b)apprentices, students, pregnant workers, and, if there is a risk of intake or bodily contamination, breastfeeding workers, are excluded from such exposures; Specially authorised exposures. Amended by: L.N. 184 of 2020. 46 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION (
  3. c)the undertaking justifies such exposures in advance and thoroughly discuss them with the workers, their representatives, an occupational health service and the radiation protection expert; (
  4. d)information about the risks involved and the precautions to be taken during the operation are provided to the relevant workers in advance; (
  5. e)the workers have consented; (
  6. f)all doses relating to such exposures are separately recorded in the medical record referred to in regulation 58 and the individual record referred to in regulation 52.
(2)The exceeding of dose limits as a result of specially authorised exposures shall not necessarily constitute a reason for excluding workers from their usual occupation or relocating them, without their agreement.
(3)The Secretariat shall be informed if the exposure of spacecraft crew is likely to exceed dose limits and shall ensure that it is managed as a specially authorised exposure. 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 down in regulation 9.
(2)For situations where the above condition is not feasible, the following conditions shall apply: (
  1. a)reference levels for emergency occupational exposure shall be an effective dose of 50mSv; (
  2. b)in exceptional situations, in order to save life, prevent severe radiation-induced health effects, or prevent the development of catastrophic conditions, a reference level for an effective dose from external radiation of emergency workers shall be 500mSv.
(3)In areas within workplaces, where the radon concentration (as an annual average), continues to exceed the national reference level, despite the action taken in accordance with the principle of optimisation as set out in Part III and taking into account parameters contained in the national action plan as under point 2 of the Sixteenth Schedule notification in accordance with regulations 34
(4)and 44
(2)shall apply.
(4)In the event of an emergency occupational exposure, radiological monitoring of emergency workers shall be performed. Individual monitoring or assessment of the individual doses shall be carried out as appropriate to the circumstances. BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 47
(5)In the event of an emergency occupational exposure, medical surveillance of emergency workers shall be required, as defined in regulation 59, to be carried out as appropriate to the circumstances. 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 in workplaces. Radon measurements shall be carried out: (a) in workplaces within the areas identified by the Commission in accordance with regulation 127
(3), that are located on the ground floor or basement level or any other subterranean work places; as well as (b) in specific types of workplaces identified in the national action plan taking into account paragraph 3 of the Sixteenth Schedule.
(3)In areas within workplaces, where the radon concentration (as an annual average), continues to exceed the national reference level, despite the action taken in accordance with the principle of optimisation as set out in Part III, notification in accordance with regulations 34
(4)and 44
(2)shall apply. Part VII MEDICAL EXPOSURES 65.
(1)Medical exposure shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct benefits to health of an individual and the benefits to society, against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving no or less exposure to ionising radiation.
(2)Undertakings shall apply the justification principle defined in sub-regulation
(1)is applied and in particular that: (
  1. a)It is ensured that both the referrer and the practitioner shall make reference to referral guidelines. (
  2. b)Undertakings inform and supply supporting justification documentation to the Commission in advance of that undertaking adopting any new types of practices involving medical exposure. (
  3. c)All individual medical exposures are to be justified in advance by a practitioner taking into account the specific objectives of the exposure and the characteristics of the individual involved. Justification. Amended by: L.N. 184 of 2020. 48 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION (
  4. d)Specific individual exposures can be justified, where appropriate, in special circumstances, to be evaluated by a practitioner on a case-by-case basis and documented for practices involving medical exposure that are not justified in general. (
  5. e)The referrer and the practitioner, shall seek, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure. Repeat of medical exposure is not justified if the diagnostic information is already available. (
  6. f)For the justification of any medical exposure for medical or biomedical research undertakings shall obtain clearance from the Commission. Prior to the Commission issuing clearance for any medical exposure for medical or biomedical research the undertakings shall provide confirmation that they have obtained clearance from the ethics committee. (
  7. g)Undertakings shall obtain clearance from the Commission before any type of health screening is performed. The Commission shall seek advice from any appropriate medical scientific societies and health regulatory bodies and shall make reference to any available internationally accepted justification norms for screening. (
  8. h)The exposure of carers and comforters shall show a sufficient net benefit, taking into account the direct health benefits to a patient, the possible benefits to the carer / comforter and the detriment that the exposure might cause. (
  9. i)Medical radiological procedure for the early detection of disease on an asymptomatic individual can only be performed if it is: (
  10. i)part of a health screening programme, or (
  11. ii)requires specific documented justification for that individual by the practitioner, in consultation with the referrer, following guidelines from relevant medical scientific societies and the Commission. Special attention shall be given to the provision of information to the individual subject to medical exposure, as required by paragraph (
  12. e)of regulation 68.
(3)Referrers shall as part of the justification process: (
  1. a)ensure and document that the medical exposure of the patient is warranted based on the medical indications; (
  2. b)make reference to referral criteria; BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 49 (
  3. c)refer the patient to a practitioner, providing adequate clinical details; (
  4. d)state on each individual referral the clinical question to be answered; (
  5. e)where practical, seek, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider this data to avoid unnecessary exposure; and (
  6. f)seek the outcome of the exposure and act on the result. 66.
(1)All doses due to medical exposure for radiodiagnostic, interventional radiology, planning, guiding and verification purposes are to be kept as low as reasonably achievable consistent with obtaining the required medical information, taking into account economic and societal factors.
(2)For all medical exposure of patients for radiotherapeutic purposes, exposures of target volumes shall be individually planned and their delivery appropriately verified taking into account that doses to non-target volumes and tissues shall be as low as reasonably achievable and consistent with the intended radiotherapeutic purpose of the exposure.
(3)(
  1. a)The Commission shall establish and regularly review national diagnostic reference levels for radio-diagnostic examinations, having regard to the current European diagnostic reference levels where available, and where appropriate, for interventional radiology procedures, and the availability of guidance for this purpose. (
  2. b)An undertaking shall ensure that diagnostic reference levels for their radio-diagnostic examinations, and where appropriate for interventional radiology procedures, are established, regularly reviewed and used, having regard to the national diagnostic reference levels where available..
(4)For each medical or biomedical research project involving medical exposure: (
  1. a)the voluntarily; (
  2. b)exposure; individuals concerned participate these individuals are informed about the risks of (
  3. c)a dose constraint is established for individuals for whom no direct medical benefit is expected from exposure; (
  4. d)in the case of patients who voluntarily accept to undergo an experimental medical practice and who are expected to receive a diagnostic or therapeutic benefit from Optimisation. Amended by: L.N. 184 of 2020; L.N. 139 of 2022. 50 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION this practice, the dose levels concerned shall be considered on an individual basis by the practitioner and/or referrer prior to the exposure taking place.
(5)Undertakings shall ensure that the optimisation includes the selection of equipment, the consistent production of adequate diagnostic information or therapeutic outcomes, the practical aspects of medical radiological procedures, quality assurance, and the assessment and evaluation of patient doses or the verification of administered activities, taking into account economic and societal factors.
(6)Undertakings shall ensure that: (
  1. a)a dose constraints of not more than 1.5mSv per five years is applied exposure of carers and comforters, where appropriate; (
  2. b)appropriate guidance is established for the exposure of carers and comforters.
(7)In the case of a patient undergoing treatment or diagnosis with radionuclides, the undertaking, shall ensure that the patient or their representative is provided with information on the risks of ionising radiation and appropriate instructions with a view to restricting doses to persons in contact with the patient as far as reasonably achievable. For therapeutic procedures these shall be written instructions. These instructions shall be handed out before leaving the hospital or clinic. Approval and responsibilities. 67. The undertaking shall entitle individuals to act in the different aspects of medical exposures by approving these individuals. The undertaking is responsible to approve any individual whose work relates to medical exposure. In making such approvals the undertaking shall ensure that the individual meets the requirements of the Seventeenth Schedule. Undertakings. 68. Undertakings shall ensure that: (
  1. a)medical exposures shall take place under the clinical responsibility of a practitioner; (
  2. b)in medical radiological practices, a medical physics expert shall be appropriately involved, the level of involvement being commensurate with the radiological risk posed and is given in the Table 1 of the Twentieth Schedule; (
  3. c)practitioners, medical physics experts and those entitled to carry out practical aspects of medical radiological procedures shall be involved in the optimization process; BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 51 (
  4. d)referrers and practitioners shall liaise as required with each another in the justification process of individual medical exposures; (
  5. e)wherever practicable and prior to the exposure taking place, the practitioner and the referrer, is to ensure that the patient or their representative is provided with adequate information relating to the benefits and risks associated with the radiation dose from the medical exposure. Similar information as well as relevant guidance shall be given to carers and comforters, in accordance with paragraph (
  6. b)of regulation 66
(6). 69. Practical aspects of medical radiological procedures may be delegated by the undertaking or the practitioner, as appropriate, to one or more individuals entitled to act in this respect in a recognised field of specialization authorised by the Commission to act in this respect. Practical aspects of medical radiological procedures. 70. Undertaking’s radiation protection programmes shall include that: Procedures. (
  1. a)written protocols for every type of standard medical radiological procedure are established for each equipment for relevant categories of patients; (
  2. b)information relating to patient exposure forms part of the report of the medical radiological procedure; (
  3. c)referral guidelines for medical imaging, taking into account the radiation doses, are available to the referrers; (
  4. d)clinical audits are carried out in accordance to the national procedures established by the Commission; (
  5. e)appropriate reviews are undertaken whenever diagnostic reference levels are consistently exceeded and that appropriate corrective action is taken without undue delay; (
  6. f)procedures are in place for: (
  7. i)the correct identification of individuals to be exposed to ionising radiation; (
  8. ii)making enquiries of females of childbearing age to establish whether the individual is or may be pregnant or breastfeeding; (iii) approval of individuals to act as referrers, practitioners, and persons performing the practical aspects; (
  9. iv)quality assurance; 52 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION (
  10. v)the assessment of patient dose and administered activity; (
  11. vi)medical and biomedical research programmes including the use of dose constraints; (vii) giving of information and instructions as referred to in regulation 66
(7); written (viii) recording of doses for each medical exposure including, where appropriate, factors relevant to patient dose; (
  1. ix)ensuring that the probability and magnitude of accidental or unintended doses to patients from radiological practices are reduced as far as reasonably achievable; (
  2. x)accidents; (
  3. xi)responding and reporting of incidents and record keeping; (xii) arrangements for monitoring workers and the workplace; (xiii) education and training programme on the nature of the hazards, protection and safety; (xiv) methods for periodically reviewing and auditing the performance of the radiation protection programme; (
  4. 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 14, for the practitioner, the medical physics expert and the individuals referred to in regulation 69.
(2)Undertakings shall ensure that practitioners and medical physics experts and the individuals referred to in regulation 69 meet the requirements of the above sub-regulation
(1). Equipment. Substituted by: L.N. 184 of 2020. Installation of the equipment. 72.
(1)The responsibility to ensure that the equipment is fit for clinical use resides with the undertaking.
(2)Prior to acquiring medical radiological equipment the undertaking shall ensure that there is adequate information on the radiological risks for patients, and on the clinical evaluation of the its use.. 73. Upon installation of the equipment the supplier/installer has to perform tests to ensure that all the safety features and warning BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 53 devices of the equipment are functioning. During installation, the manufacturer’s instructions for use must be followed. These tests shall be performed whenever new, second hand; refurbished and relocated equipment has been installed, as well as after major maintenance has been performed. These test results have to be kept by the undertaking. 74.
(1)Acceptance testing must be carried out in accordance with international standards. The standard to be used shall be accepted by the Commission. Acceptance testing.
(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: (
  1. a)after major adjustments of functional parameters, repairs or maintenance have been performed; (
  2. b)after components or sub-assemblies have been added, modified, replaced or removed; (
  3. c)after each time the undertaking has to remove the equipment from clinical use due to a malfunction or maintenance that could affect the patient dose; (
  4. d)if tests show that the equipment has or is producing doses other than the acceptable levels.
(3)Acceptance test results should be compared to and meet the manufacturer’s tolerances. In the absence of such, as in the case of aged equipment then European Union criteria for acceptability may be used.
(4)After the acceptance testing is carried out, the test reports and any other relevant documentation has to be passed on the Secretariat. The Information to be supplied to the Secretariat with regard to acceptance tests that have been performed is given in the Eighteenth Schedule
(5)The records for such testing shall be kept for the lifetime of the equipment.
(6)In order to set up the optimal clinical operation of the equipment, certain commissioning tests may be required to be performed, such as setting up exposure protocols. 75.
(1)Constancy testing must be carried out in accordance with international standards. The standard to be used shall be accepted by the Commission.
(2)Constancy tests are to be performed: Constancy testing. 54 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION (
  1. a)immediately after an the initial acceptance test has indicated that the functional performance of the equipment is satisfactory; (
  2. b)as often as the standard stipulates but shall not exceed two years; (
  3. c)immediately after corrective maintenance that could effect the radiation output of the equipment or; (
  4. d)when malfunction of equipment 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
  2. The calibration of equipment used for dosimetry of patients and acceptance or constancy testing shall be traceable to an accredited standards dosimetry laboratory and shall be routinely recalibrated according to its instructions for use. In the absence of any specified dosimeter re-calibration period, the equipment calibration period must not exceed a period of two years. Acceptable levels. 77.
(1)If tests show that the equipment has or is producing doses other than the acceptable levels, or a malfunction has occurred that could affect patient dose, it shall be removed from clinical use and shall be reported to the Secretariat.
(2)Acceptable levels are deemed the tolerances specified in the manufacturer’s specifications or the current European Union Criteria which ever is the most stringent. Clearance for clinical use. 78.
(1)Clearance for the clinical use of the equipment is required from the Secretariat for all instances specified in regulation 74
(2).
(2)Clearance will only be issued after the Secretariat reviews the acceptance tests required by regulation 74
(1). Compliance. Amended by: L.N. 184 of 2020. 79.
(1)The undertaking shall ensure that: (
  1. a)all new equipment has an EC Declaration of conformity; (
  2. b)all new equipment has, where practicable, a device showing the quantity of the radiation produced by the equipment; (
  3. c)an up to date inventory of radiological equipment for each radiological installation is available; (
  4. d)When radiological equipment is not being used it must be left in a safe and secure condition and when it is in use it must be kept under strict surveillance regarding radiation BASIC SAFETY STANDARDS FOR IONISING RADIATION [ S.L.585.01 protection; (
  5. e)when in use the equipment must be adequately supervised to ensure an adequate level of radiation protection; (
  6. f)appropriate routine maintenance is performed (in line with manufactures recommendations); (
  7. g)appropriate quality assurance programmes are in place, including a schedule for testing the equipment; (
  8. h)appropriate quality assurance programmes for assessing patient dose or administered activity; (
  9. i)suitable measures are taken to inadequate or defective features of the equipment; improve (
  10. j)that there are suitable measures for putting equipment into clinical use and removal from clinical use; (
  11. k)there is clear allocation of responsibilities for who can declare that the equipment is fit/unfit for clinical use; (
  12. l)adopt specific criteria of acceptability for equipment in order to indicate when appropriate remedial action is necessary, including, if appropriate, taking the equipment out of service; (
  13. m)reasonably steps to prevent failure of radiation equipment where such failure could result in exposure of patients to ionising radiation greater than intended; (
  14. n)on becoming aware of defects in equipment during use, the undertaking assesses in consultation with the supplier (or where relevant the service agent or original manufacturer) and the medical physics expert, if appropriate, whether any further action is necessary; (
  15. o)shall have a contingency plan for responding to equipment failures or malfunction. Following equipment failure and subsequent repair, the undertaking should consider the likelihood and consequences of recurrence before returning the equipment to clinical use.
(2)If the equipment is going to be taken out of clinical use, with no intention of scrapping, then the undertaking shall remain responsible for that equipment and if the equipment is sold, leased or given to another approved undertaking, than the Secretariat shall be notified prior to this happening. 80. Specific requirements for certain equipment: (
  1. a)the use of fluoroscopy equipment without a device to automatically control the dose rate, or without an Specific requirements. 55 56 [ S.L.585.01 BASIC SAFETY STANDARDS FOR IONISING RADIATION image intensifier or equivalent device, is prohibited. (
  2. b)equipment used for external beam radiotherapy with a nominal beam energy exceeding 1 MeV has a device to verify key treatment parameters. Equipment installed prior to 6 February 2018 may be exempted from this requirement. (
  3. c)any equipment used for interventional radiology has a device or a feature informing the practitioner and those carrying out practical aspects of the medical procedures of quantity of radiation produced by the equipment during the procedure. Equipment installed prior to 6 February 2018 may be exempted from this requirement. (
  4. d)any equipment used for interventional radiology and computed tomography and any new equipment used for planning, guiding and verification purposes has a device or a feature informing the practitioner, at the end of the procedure, of relevant parameters for assessing the patient dose. (
  5. e)equipment used for interventional radiology and computed

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