2. In these Regulations, unless the context otherwise requires “accident” means any unintended event, including operating errors, equipment failures and other mishaps, the consequences or potential consequences of which are not negligible to ensure protection and safety; “activity” means an amount of radionuclide in a given energy state at a given time; Short title Interpretation “authorised member of staff” means a member of staff in a nuclear medicine facility who is permited to enter into a controlled area or a supervised area; “becquerel” means an activity of a quantity of radioactive material in which one nucleus decays per second; “bolus injection” means the administration of a drug in a single large dose; “calibration” means a set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realised by measurement standards; “carer” means a person who willingly and voluntarily helps in the care, support and comfort of a patient undergoing radiological procedures for medical diagnosis or medical treatment; “commissioning” means the process of systems and components of facilities and activities, which having been constructed, are made operational and verified to be in accordance with the design and they met the required performance criteria; “compulsory standard” has the meaning assigned to the word in the Compulsory Standards Act, 2017; “contamination” means the unintended or undesirable presence of, or the process giving rise to, radioactive substances on surfaces or within solids, liquids or gases; “controlled area” means an area in which specific protection measures and safety provisions are or could be required for controlling exposures or preventing the spread of contamination in normal working conditions, and preventing or limiting the extent of potential radiation exposures; Act No. 3 of 2017 46 Statutory Instruments 19th January, 2024 “decontamination” means the complete or partial removal of contamination by a deliberate physical, chemical or biological process; “diagnostic reference level” means a level used in medical imaging to indicate whether, in routine conditions, the dose to the patient or the amount of radiopharmaceuticals administered in a specified radiological procedure for medical imaging is unusually high or unusually low for that procedure; “discharge” means a planned and controlled release of radioactive substances to the environment; “dose” means a measure of energy deposited by radiation in a target or patient; “dosimetry” means determination and measurement of the amount or dosage of radiation absorbed by a substance; “emergency”means a non-routine situation or event that necessitates prompt action, primarily to mitigate a hazard or adverse consequence to human life, health, property and the environment; “exposure” means the state or condition of being subjected to irradiation; “external exposure” means exposure to radiation from a radioactive material or radiation emitting device outside the body; “half -life” means the time required for the activity to decrease, by a radioactive decay process, by half, or the time taken for the quantity of a radionuclide in a specified place to decrease by half as a result of any specified process or processes that follow exponential patterns similar to radioactive decay; “health facility” has the meaning assigned to the words in the Health Professions Act, 2009; “health professional” means a member of a health profession who is required to be registered under the Health Professions Act, 2009 and includes a dentist, medical physicist, chiropractor, podiatrist, medical radiation technologist, radiopharmacist, occupational health physician and a radiological medical practitioner; “incident” means any unintended event, including operating errors, equipment failures, initiating events, accident precursors, near misses or other mishaps, or unauthorised acts, malicious or non malicious actions, the consequences or potential consequences of which are not negligible to ensure protection and safety; Act No. 24 of 2009 Act No. 24 of 2009 19th January, 2024 Statutory Instruments 47 “individual monitoring” means monitoring using measurements by a device worn by an individual, or measurements of quantities of radioactive substances in or on, or taken into a body of an individual, or measurements of quantities of radioactive substances excreted from the body by an individual; “infusion injection” means administering into a vein or veins of a human body through a continuous means; “ionising radiation” means radiation capable of producing ion pairs in biological material; “internal exposure” means exposure to radiation from a radioactive material or radiation emitting device within the body; “intervention” means any action intended to reduce or avert exposure or the likelihood of exposure due to sources that are not part of a controlled practice or that are out of control as a consequence of an accident; “intravenous” means administering into a vein or veins of the human body; “justification” means the process of determining whether a practice has benefits which outweigh the radiation risk to persons; “maintenance” means the organised activity, both administrative and technical, of keeping structures, systems and components in good operating condition, including both preventive and corrective aspects; “medical exposure” means exposure incurred by a patient for the purposes of that patient’s own medical treatment or diagnostic examination; “medical physicist” means a person with specialist education and training in the concepts and techniques of applying physics in medicine and competent to practice independently in one or more of the subfields of medical physics; “medical radiological equipment” means radiological equipment used in a nuclear medicine facility to perform nuclear medicine procedures that either delivers an exposure to an individual or directly controls or influences the extent of that exposure; “nuclear medicine facility” means a facility in which nuclear medicine procedures are performed; 48 Statutory Instruments 19th January, 2024 “occupationally exposed member of staff” means a member of staff in a nuclear medicine facility likely to be exposed to radiation and includes (a) a medical radiation technologist; (b) a radiopharmacist; (c) a medical physicist; (d) a nuclear medicine physician; and (e) other health professionals and support staff involved in the management of patients who have been administered with radiopharmaceuticals; “occupational exposure” means exposure of workers to radiation incurred in the course of their work; “procedure” means a series of specified actions conducted in a certain order or manner; “protection and safety means the protection of people against exposure to ionising radiation or exposure due to radioactive material and the safety of sources, including the means for achieving safety of those sources, and preventing accidents and mitigating the consequences of accidents if they do occur; “public exposure” means exposure incurred by members of the public due to sources in planned exposure situations, emergency exposure situations and existing exposure situations, excluding any occupational exposure or medical exposure; “quality assurance” means the function of a management system that provides confidence that specified requirements shall be fulfilled; “quality control” means a part of quality management intended to verify that structures, systems and components correspond to predetermined requirements; “qualified expert” means an individual who, by virtue of certification by appropriate professional bodies or associations or academic qualifications and experience, is duly recognised as having expertise in a relevant field of specialisation, such as medical physics, radiation protection, occupational health, fire safety, quality management or any relevant engineering or safety speciality; “radioactive material” means a material designated by the Authority as being subject to regulatory control because of its radioactivity; 19th January, 2024 Statutory Instruments 49 “radiation monitoring” means the measurement of a dose, dose rate or activity for reasons relating to the assessment or control of exposure to radiation or exposure due to radioactive substances, and the interpretation of the results; “radioactive waste” means a material for which no further use is foreseen that contains, or is contaminated with, radionuclides at activity concentrations greater than clearance levels as established by the regulatory body; “radioactivity” means the phenomenon when atoms undergo spontaneous random disintegration accompanied by the emission of radiation; “radiological procedure” means a medical imaging procedure or therapeutic procedure that involves ionising radiation delivered by a radiation generator, a device containing a sealed source or an unsealed source, or by means of a radiopharmaceutical administered to a patient; “radiation emitting devices” means a device capable of generating ionising radiation, such as X-rays, neutrons, electrons or other charged particles, that may be used for scientific, industrial or medical purposes; “radiation protection programme” means a programme developed by a nuclear medicine facility on radiation protection; “radiation safety officer means a radiation safety officer appointed under section 35 of the Act; “radiopharmaceutical therapy” means the delivery of radioactive materials to tumour associated target human body organs or non-tumour cells of interest and their miro- environments; “source” has the meaning assigned to the word in the Act; “supervised areas” means an area not designated as a controlled area but for which occupational exposure conditions are kept under review when specific protection measures or safety provisions are not normally needed; “surgical technique” means a medical procedure involving an incision in a human body;and “unsealed source” means a radioactive material which is neither — (a) permanently sealed in a capsule; or (b) closely bonded and in a solid form. 50 Statutory Instruments 19th January, 2024 Staff of nuclear medicine facility Radiation protection programme PART II RADIATION PROTECTION MANAGEMENT
