The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2024

Amendments to regulation 2 of the 2017 Regulations (interpretation)

2.—(1) Regulation 2(1) of the 2017 Regulations (interpretation) is amended as follows.

(2) In the definition of “accidental exposure”, for “as a result of an accident” substitute “in error when no exposure was intended”.

(3) After the definition of “clinical audit”, insert—

““clinical evaluation” means interpretation of the information resulting from an exposure, including the outcome and implications;”.

(4) After the definition of “diagnostic reference levels”, insert—

““dose reference levels” means dose levels in radiotherapeutic practices for typical localisation or verification exposures for groups of standard-sized individuals or standard phantoms for broadly defined types of equipment;”.

(5) In the definition of “employer”, for “regulation 3” substitute “regulation 3(1)”;

(6) In the definition of “equipment”—

(a) after “means equipment”, insert “(including any software)”;

(b) omit the “or” after paragraph (a);

(c) in paragraph (b), omit “which”;

(d) after paragraph (b), insert—

“; or

(c) directly assists an operator in carrying out a clinical evaluation;”.

(7) After the definition of “equipment”, insert—

““ethics committee” means—

(a)

an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004(1);

(b)

the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000(2); or

(c)

any other committee established to advise on the ethics of research investigations in human beings, and recognised for that purpose by or on behalf of the Secretary of State, the Scottish Ministers or the Welsh Ministers;”.

(8) Omit the definition of “evaluation”.

(9) After the definition of “health screening”, insert—

““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;”.

(10) In the definition of “medical exposure”, for “regulation 3” substitute 3(1)”;

(11) In the definition of “non-medical imaging exposure”, after “purposes”, insert “using medical radiological equipment,”.

(12) In the definition of “practical aspect”—

(a) for “a medical exposure” substitute “an exposure to which these Regulations apply”;

(b) for “medical radiological equipment” substitute “equipment”;

(c) omit “and maintenance”.

(13) In the definition of “practitioner”, after “for”, insert “the justification of”.

(14) After the definition of “quality control”, insert—

““radiation protection adviser” means an individual who, or a body which is competent to advise on radiation protection in relation to occupational and public exposures;”.

(15) After the definition of “radioactive substance”, insert—

““radioactive waste adviser” means an individual who, or a body which is competent to provide expert advice on radioactive waste management and environmental radiation protection;”.

(1)

S.I. 2004/1031.

(2)

2000 asp 4.