79C3C34C52B45572883A05D425EB0F82
Ionising Radiation (MedicalExposure) Regulations (2017)
https://www.legislation.gov.uk/uksi/2017/1322/pdfs/uksi_20171322_en.pdf
http://leaux.net/URLS/ConvertAPI Text Files/35F14ACD1B820BA5AA708BC86A9B46D0.en.txt
Examining the file media/Synopses/35F14ACD1B820BA5AA708BC86A9B46D0.html:
This file was generated: 2020-12-01 07:20:07
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
Searching for indicator substance:
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p.000002: aspects including those to whom practical aspects have been allocated, medical physics experts and, except
p.000002: where they do so under the direct supervision of a person who is adequately trained, persons participating in
p.000002: practical aspects as part of practical training;
p.000002: “patient dose” means the dose concerning patients or other individuals undergoing exposures to which these Regulations
p.000002: apply;
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: “practical aspect” means the physical conduct of a medical exposure and any supporting aspects, including
p.000002: handling and use of medical radiological equipment, the assessment of technical and physical parameters
p.000002: (including radiation doses), calibration and maintenance of equipment, preparation and administration of
p.000002: radio-pharmaceuticals, clinical evaluation and image processing;
p.000002: “practitioner” means a registered health care professional who is entitled in accordance with the employer’s procedures
p.000002: to take responsibility for an individual exposure;
p.000002: “quality assurance” means all those planned and systematic actions necessary to provide adequate assurance
p.000002: that a structure, system, component or procedure will perform satisfactorily in compliance with
p.000002: generally applicable standards and quality control is a part of quality assurance;
p.000002: “quality control” means the set of operations (programming, coordinating, implementing) intended to
p.000002: maintain or to improve quality and includes monitoring, evaluation and maintenance at required levels
p.000002: of all characteristics of performance of equipment that can be defined, measured, and controlled;
p.000002: “radioactive substance” means any substance that contains one or more radionuclides the activity or activity
p.000002: concentration of which cannot be disregarded from a radiation protection point of view;
p.000002: “radiodiagnostic” means pertaining to in-vivo diagnostic nuclear medicine, medical diagnostic radiology using ionising
p.000002: radiation, and dental radiology;
p.000002: “radiological installation” means a facility where exposures to which these Regulations apply are performed;
p.000002: “radiotherapeutic” means pertaining to radiotherapy, including nuclear medicine for therapeutic
p.000002: purposes;
p.000002: “referrer” means a registered health care professional who is entitled in accordance with the employer’s procedures to
p.000002: refer individuals for exposure to a practitioner;
p.000002: “registered health care professional” means a person who is a member of a profession regulated by a body
p.000002: mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002(a);
p.000002: “relevant enforcing authority” means—
p.000002: (a) in England, the Care Quality Commission(b);
p.000002: (b) in Scotland, the Scottish Ministers; and
p.000002: (c) in Wales, the Welsh Ministers;
p.000002: “unintended exposure” means any exposure to ionising radiation which is significantly different from the
p.000002: exposure intended for a given purpose.
p.000002: (2) In these Regulations, where an individual is—
p.000002: (a) an employer;
p.000002: (b) a referrer;
p.000002: (c) an operator; or
p.000002: (d) a practitioner,
p.000002: and is also an individual coming within at least one other of sub-paragraphs (a) to (d), that
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p.000017:
p.000017:
p.000017:
p.000017: SCHEDULE 4 Regulation 21
p.000017: Consequential amendments
p.000017: Amendment of the Justification of Practices Involving Ionising Radiation Regulations 2004 1.—(1) The Justification of
p.000017: Practices Involving Ionising Radiation Regulations 2004(a) are
p.000017: amended as follows.
p.000017: (2) For regulation 21 (saving for medical practices) substitute—
p.000017: “21. Nothing in regulation 4(5) of 5(3) shall prevent anything permitted under regulation 11 of the Ionising Radiation
p.000017: (Medical Exposure) Regulations 2017.”.
p.000017:
p.000017: Amendment of the Human Medicines Regulations 2012
p.000017: 2.—(1) The Human Medicines Regulations 2012(b) are amended as follows.
p.000017: (2) In regulation 173 (exemption for certain radiopharmaceuticals)—
p.000017: (a) in paragraph (d), at the beginning insert “in Northern Ireland”;
p.000017: (b) after paragraph (d) insert—
p.000017: “(e) in England and Wales and Scotland, for administration in accordance with a licence issued under the
p.000017: Ionising Radiation (Medical Exposure) Regulations 2017”
p.000017: .
p.000017: (3) In regulation 240 (radioactive medicinal products)—
p.000017: (a) for paragraph (1)(a) substitute—
p.000017:
p.000017:
p.000017: (a) S.I. 2004/1769; there are amending instruments but none is relevant.
p.000017: (b) S.I. 2012/1916 as amended by S.I. 2014/490; there are other amending instruments but none is relevant.
p.000017:
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: “(a) either—
p.000018: (i) in Northern Ireland, a radioactive medicinal product, administration of which results in a medical exposure; or
p.000018: (ii) in England and Wales and Scotland, a radioactive substance, administration of which results in a medical
p.000018: exposure; or”;
p.000018: (b) in paragraph (2), after “Condition A” insert “in Northern Ireland”;
p.000018: (c) after paragraph (2) insert—
p.000018: “(2A) Condition A in England and Wales and Scotland is that the prescription only medicine is
p.000018: administered by an operator acting in accordance with the procedures and protocols referred to in
p.000018: regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations 2017.”;
p.000018: (d) in paragraph (4), after “condition C” insert “in Northern Ireland”;
p.000018: (e) after paragraph (4A) inert—
p.000018: “(4) Condition C in England and Wales and Scotland is that the IRME practitioner mentioned in paragraph (a)
p.000018: or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations
p.000018: 2017.”;
p.000018: (f) in paragraph (6) after “Condition C” insert “in Northern Ireland;
p.000018: (g) after paragraph (6) insert—
p.000018: “(6A) Condition D in England and Wales and Scotland is that the prescription only medicine is not a
p.000018: radioactive substance.”.
p.000018: (h) for paragraph (7) substitute— “(7) In this regulation—
p.000018: “IRME practitioner” means—
p.000018: (a) in Northern Ireland, in relation to a medical exposure, a practitioner for the purposes of the
p.000018: Ionising Radiation (Medical Exposure) Regulations 2000;
p.000018: (b) in England and Wales and Scotland, in relation to a medical exposure, a practitioner
p.000018: for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2017;
p.000018: “medical exposure”—
p.000018: (a) in Northern Ireland has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations
p.000018: 2000; and
p.000018: (b) in England and Wales and Scotland has the same meaning as in the Ionising Radiation (Medical
p.000018: Exposure) Regulations 2017; and
p.000018: “radioactive medicinal product” means a medicinal product which consists of, contains or generates a radioactive
p.000018: substance so that, when the product is administered, the radiation it emits may be used.”.
p.000018:
p.000018: Amendment of the Ionising Radiations Regulations 2017
p.000018: 3.—(1) The Ionising Radiations Regulations 2017(a) are amended as follows.
p.000018: (2) In regulation 2(1) (interpretation)—
p.000018: (a) omit the definition of “carers and comforters”;
p.000018: (b) insert after the definition of “calendar year”—
p.000018: ““carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation
p.000018: by helping, other than as part of their occupation, in the
p.000018:
p.000018:
p.000018:
p.000018: (a) S.I. 2017/1075.
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: support and comfort of individuals undergoing or having undergone a medical exposure (other than as a carer and
p.000019: comforter);”;
p.000019: (c) in the definition of “medical exposure”, after paragraph (d), insert— “(e) carers and comforters;”.
p.000019: (3) In regulation 3 (application)—
p.000019: (a) in paragraph (2), omit “33”;
p.000019: (b) omit paragraph (4).
p.000019: (4) Omit regulation 33 (equipment used for medical exposure).
p.000019: (5) In regulation 35(6) (duties of employees)—
p.000019: (a) in sub-paragraph (a), after “overexposure;” insert “or”;
p.000019: (b) in sub-paragraph (b), omit “or” the second time it appears;
p.000019: (c) omit sub-paragraph (c).
p.000019: (6) In regulation 38(2)(d) (exemption certificates)—
p.000019: (a) before “25(2)” insert “and”;
p.000019: (b) omit “and 33(1)”.
p.000019: EXPLANATORY NOTE
p.000019: (This note is not part of the Regulations)
p.000019: These Regulations implement, as respects Great Britain, some of the provisions of Council Directive
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Health / Pregnant
Searching for indicator pregnant:
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p.000005: information or medical records) relevant to the exposure requested by the referrer to enable the practitioner to
p.000005: decide whether there is a sufficient net benefit as required by regulation 11(1)(b).
p.000005: (6) The practitioner and the operator must cooperate, regarding practical aspects, with other specialists
p.000005: and staff involved in an exposure, as appropriate.
p.000005:
p.000005: Justification of individual exposures
p.000005: 11.—(1) A person must not carry out an exposure unless—
p.000005: (a) in the case of the administration of radioactive substances, the practitioner and employer are licensed to
p.000005: undertake the intended exposure;
p.000005: (b) it has been justified by the practitioner as showing a sufficient net benefit giving appropriate
p.000005: weight to the matters set out in paragraph (2);
p.000005: (c) it has been authorised by the practitioner or, where paragraph (5) applies, the operator;
p.000005: (d) in the case of an exposure taking place in the course of a research programme under regulation
p.000005: 3(c), that programme has been approved by an ethics committee and, in the case of the administration of
p.000005: radioactive substances, approved by an expert committee who can advise on the administration of radioactive
p.000005: substances to humans;
p.000005: (e) in the case of an exposure falling within regulation 3(f) (non-medical imaging), it complies with the
p.000005: employer’s procedures for such exposures; and
p.000005: (f) in the case of an individual of childbearing potential, the person has enquired whether that individual is
p.000005: pregnant or breastfeeding, if relevant.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: (2) The matters referred to in paragraph (1)(b) are—
p.000006: (a) the specific objectives of the exposure and the characteristics of the individual involved;
p.000006: (b) the total potential diagnostic or therapeutic benefits, including the direct health benefits to the individual
p.000006: and the benefits to society, of the exposure;
p.000006: (c) the individual detriment that the exposure may cause; and
p.000006: (d) the efficacy, benefits and risk of available alternative techniques having the same objective but
p.000006: involving no or less exposure to ionising radiation.
p.000006: (3) In considering the weight to be given to the matters referred to in paragraph (2), the practitioner
p.000006: justifying an exposure in accordance with paragraph (1)(b) must have regard, in particular to—
p.000006: (a) recommendations from appropriate medical scientific societies or relevant bodies where a procedure is to be
p.000006: performed as part of any health screening programme;
p.000006: (b) whether in circumstances where there is to be an exposure to a carer or comforter such an exposure would show a
p.000006: sufficient net benefit taking into account—
p.000006: (i) the likely direct health benefits to a patient;
p.000006: (ii) the possible benefits to the carer or comforter; and
p.000006: (iii) the detriment that the exposure might cause;
p.000006: (c) in the case of asymptomatic individuals where a medical radiological procedure—
p.000006: (i) is to be performed for the early detection of disease;
p.000006: (ii) is to be performed as part of a health screening programme; or
...
p.000200: (i) refusing to issue a licence;
p.000200: (ii) imposing a limit of time upon a licence; or
p.000200: (iii) revoking a licence; or
p.000200: (b) the terms of any conditions attached to a licence by the Licensing Authority, may ask the Licensing Authority for
p.000200: a review.
p.000200: (2) Any aggrieved person seeking a review must—
p.000200: (a) within 28 days of the date that the person was notified of the decision, or the terms, which caused them to
p.000200: become an aggrieved person request the Licensing Authority to undertake a review described in paragraph (1) ; and
p.000200: (b) must particularise in writing the reasons for seeking the review.
p.000200:
p.000200:
p.000014: 14
p.000014:
p.000014: (3) The Licensing Authority must undertake a review, and provide the results of that review in writing to the aggrieved
p.000014: person.
p.000014:
p.000014: Destination of fees
p.000014: 6. A fee payable under these Regulations is payable to the Secretary of State.
p.000014:
p.000014:
p.000014:
p.000014: SCHEDULE 2 Regulation 6
p.000014: Employer’s Procedures
p.000014: 1. The employer’s written procedures for exposures must include procedures—
p.000014: (a) to identify correctly the individual to be exposed to ionising radiation;
p.000014: (b) to identify individuals entitled to act as referrer or practitioner or operator within a specified
p.000014: scope of practice;
p.000014: (c) for making enquiries of individuals of childbearing potential to establish whether the individual is
p.000014: or may be pregnant or breastfeeding;
p.000014: (d) to ensure that quality assurance programmes in respect of written procedures, written protocols, and
p.000014: equipment are followed;
p.000014: (e) for the assessment of patient dose and administered activity;
p.000014: (f) for the use and review of such diagnostic reference levels as the employer may have established
p.000014: for radiodiagnostic examinations falling within regulation 3(a), (b), (e) and (f);
p.000014: (g) for determining whether the practitioner or operator is required to effect one or more of the matters set out in
p.000014: regulation 12(4) including criteria on how to effect those matters and in particular procedures for the use of dose
p.000014: constraints established by the employer for biomedical and medical research programmes falling within regulation 3(c)
p.000014: where no direct medical benefit for the individual is expected from the exposure;
p.000014: (h) for the giving of information and written instructions as referred to in regulation 12(6);
p.000014: (i) providing that wherever practicable, and prior to an exposure taking place, the individual to be exposed or
p.000014: their representative is provided with adequate information relating to the benefits and risks associated with the
p.000014: radiation dose from the exposure;
p.000014: (j) for the carrying out and recording of an evaluation for each exposure including, where appropriate, factors
p.000014: relevant to patient dose;
p.000014: (k) to ensure that the probability and magnitude of accidental or unintended exposure to individuals from
p.000014: radiological practices are reduced so far as reasonably practicable;
p.000014: (l) to ensure that the referrer, the practitioner, and the individual exposed or their
...
p.000020: Regulation 10 sets out the respective responsibilities of practitioners, operators and referrers.
p.000020: Practitioners and operators are required to follow the framework of procedures provided by the employer. The
p.000020: practitioner is responsible for the justification of a medical exposure. Authorisation of exposures is addressed here
p.000020: and in regulation 11. The operator is responsible for each practical aspect he or she carries out. The referrer must
p.000020: provide medical data as required by the practitioner in order that appropriate justification can take place.
p.000020: Regulation 11 prohibits any medical exposure which has not been justified and authorised and sets out matters to be
p.000020: taken into account for justification. These include requirements relating to licensing and approval by an
p.000020: expert advisory committee, in the case of research, for exposures involving administration of radioactive
p.000020: substances. Justification of the exposure of carers and comforters is also required and recommendations or
p.000020: guidelines should be considered as part of justification of the exposure of asymptomatic individuals.
p.000020: Regulation 12 provides for the optimisation process, and specifies the elements that are the
p.000020: responsibilities of the operator and the practitioner, depending on their involvement. Specific requirements
p.000020: are included for exposures in research, for carers and comforters and for exposures involving radioactive substances.
p.000020: Particular regard should be given to the exposures of children, exposures involving high doses, exposures of
p.000020: individuals involved in health screening programmes and pregnant or potentially pregnant or breastfeeding
p.000020: individuals. Regulation 12 also requires the employer to take steps to ensure that a clinical evaluation is recorded of
p.000020: each medical exposure.
p.000020: Regulation 13 requires employers to provide when requested, to the Secretary of State data relating to
p.000020: dose estimates from diagnostic and interventional medical exposures.
p.000020: Regulation 14 provides for suitable medical physics experts to be appointed and involved in relation to
p.000020: medical exposures.
p.000020: Regulation 15 sets out general duties of the employer with respect to medical radiological equipment.
p.000020: These include requirements for quality assurance programmes, appropriate testing of equipment, performance criteria
p.000020: and actions to be taken when equipment does not perform appropriately.
p.000020: Regulation 16 sets out additional requirements for equipment installed when the Regulations come into force including
p.000020: the transfer of information relating to patient dose where appropriate.
p.000020: Regulation 17 prohibits a practitioner or operator from carrying out a medical exposure without having been
p.000020: adequately trained, except if supervised appropriately for practical aspects when undergoing training. The
p.000020: employer must keep and make available training records during inspections undertaken by the relevant
p.000020: enforcing authority. Further information regarding adequate training is set out in Schedule 3.
p.000020: Regulation 18 provides that the Regulations are made enforceable as health and safety regulations under the Health and
p.000020: Safety at Work etc. Act 1974 (c. 37).
...
Health / breastfeeding
Searching for indicator breastfeeding:
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p.000004: (b) establish quality assurance programmes for written procedures and written protocols;
p.000004: (c) regularly review and make available to an operator, diagnostic reference levels in respect of an exposure falling
p.000004: within—
p.000004: (i) regulation 3(a)—
p.000004: (aa) where the exposure involves interventional radiology procedures, in which case, diagnostic references
p.000004: levels are to be provided where appropriate; and
p.000004: (bb) where the exposure does not involve interventional radiology procedures, in which cases regard must be had to
p.000004: European and national diagnostic reference levels where available;
p.000004: (ii) regulation 3(b) or (e) in which cases regard must be had to European and national diagnostic reference levels
p.000004: where available;
p.000004: (iii) regulation 3(f) where practicable;
p.000004: (d) establish dose constraints—
p.000004: (i) for biomedical and medical research programmes falling within regulation 3(c) where no direct medical
p.000004: benefit for the individual is expected from the exposure; and
p.000004: (ii) with regard to the protection of carers and comforters falling within regulation 3(d).
p.000004: (6) A dose constraint must be established by the employer in terms of individual effective or equivalent doses
p.000004: over a defined appropriate time period.
p.000004: (7) The employer must ensure appropriate reviews are undertaken whenever diagnostic reference levels
p.000004: are consistently exceeded and ensure that corrective action is taken where appropriate.
p.000004: (8) The employer must take measures to raise awareness of the effects of ionising radiation amongst
p.000004: individuals capable of childbearing or breastfeeding.
p.000004:
p.000004: Employer’s duties: clinical audit
p.000004: 7. The employer’s procedures must include provision for the carrying out of clinical audit as appropriate.
p.000004:
p.000004: Employer’s duties: accidental or unintended exposure
p.000004: 8.—(1) The employer’s procedures must provide that the referrer, the practitioner, and the individual
p.000004: exposed or their representative (if there is one) are informed of the occurrence of a clinically
p.000004: significant unintended or accidental exposure and of the outcome of the analysis of this exposure.
p.000004: (2) The employer’s quality assurance programme must, in respect of radiotherapeutic practices, include a study of the
p.000004: risk of accidental or unintended exposures.
p.000004: (3) The employer must establish a system for recording analyses of events involving or potentially
p.000004: involving accidental or unintended exposures proportionate to the radiological risk posed by the practice.
p.000004: (4) Where the employer knows or has reason to believe that an accidental or unintended exposure has or may
p.000004: have occurred in which a person, while undergoing—
p.000004: (a) any exposure, was or could have been exposed to levels of ionising radiation significantly greater than those
p.000004: generally considered to be proportionate in the circumstances;
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: (b) a radiotherapeutic exposure was or could have been exposed to levels of ionising radiation
p.000005: significantly lower than those generally considered to be proportionate in the circumstances,
p.000005: the employer must—
p.000005: (i) undertake an immediate preliminary investigation of the incident;
...
p.000005: information or medical records) relevant to the exposure requested by the referrer to enable the practitioner to
p.000005: decide whether there is a sufficient net benefit as required by regulation 11(1)(b).
p.000005: (6) The practitioner and the operator must cooperate, regarding practical aspects, with other specialists
p.000005: and staff involved in an exposure, as appropriate.
p.000005:
p.000005: Justification of individual exposures
p.000005: 11.—(1) A person must not carry out an exposure unless—
p.000005: (a) in the case of the administration of radioactive substances, the practitioner and employer are licensed to
p.000005: undertake the intended exposure;
p.000005: (b) it has been justified by the practitioner as showing a sufficient net benefit giving appropriate
p.000005: weight to the matters set out in paragraph (2);
p.000005: (c) it has been authorised by the practitioner or, where paragraph (5) applies, the operator;
p.000005: (d) in the case of an exposure taking place in the course of a research programme under regulation
p.000005: 3(c), that programme has been approved by an ethics committee and, in the case of the administration of
p.000005: radioactive substances, approved by an expert committee who can advise on the administration of radioactive
p.000005: substances to humans;
p.000005: (e) in the case of an exposure falling within regulation 3(f) (non-medical imaging), it complies with the
p.000005: employer’s procedures for such exposures; and
p.000005: (f) in the case of an individual of childbearing potential, the person has enquired whether that individual is
p.000005: pregnant or breastfeeding, if relevant.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: (2) The matters referred to in paragraph (1)(b) are—
p.000006: (a) the specific objectives of the exposure and the characteristics of the individual involved;
p.000006: (b) the total potential diagnostic or therapeutic benefits, including the direct health benefits to the individual
p.000006: and the benefits to society, of the exposure;
p.000006: (c) the individual detriment that the exposure may cause; and
p.000006: (d) the efficacy, benefits and risk of available alternative techniques having the same objective but
p.000006: involving no or less exposure to ionising radiation.
p.000006: (3) In considering the weight to be given to the matters referred to in paragraph (2), the practitioner
p.000006: justifying an exposure in accordance with paragraph (1)(b) must have regard, in particular to—
p.000006: (a) recommendations from appropriate medical scientific societies or relevant bodies where a procedure is to be
p.000006: performed as part of any health screening programme;
p.000006: (b) whether in circumstances where there is to be an exposure to a carer or comforter such an exposure would show a
p.000006: sufficient net benefit taking into account—
p.000006: (i) the likely direct health benefits to a patient;
p.000006: (ii) the possible benefits to the carer or comforter; and
p.000006: (iii) the detriment that the exposure might cause;
p.000006: (c) in the case of asymptomatic individuals where a medical radiological procedure—
p.000006: (i) is to be performed for the early detection of disease;
p.000006: (ii) is to be performed as part of a health screening programme; or
p.000006: (iii) requires specific documented justification for that individual by the practitioner, in consultation with the
p.000006: referrer,
p.000006: any guidelines issued by appropriate medical scientific societies, relevant bodies or published by the
p.000006: Secretary of State;
p.000006: (d) the urgency of the exposure, where appropriate, in cases involving—
p.000006: (i) an individual where pregnancy cannot be excluded, in particular if abdominal and pelvic regions are
p.000006: involved, taking into account the exposure of both the person concerned and any unborn child; and
p.000006: (ii) an individual who is breastfeeding and who undergoes an exposure involving the administration of
p.000006: radioactive substances, taking into account the exposure of both the individual and the child.
p.000006: (4) In deciding whether to justify an exposure under paragraph (1)(b) the practitioner must take account of any data
p.000006: supplied by the referrer pursuant to regulation 10(5) and must consider such data in order to avoid unnecessary
p.000006: exposure.
p.000006: (5) Where it is not practicable for the practitioner to authorise an exposure as required by paragraph
p.000006: (1)(c), the operator must do so in accordance with guidelines issued by the practitioner.
p.000006: (6) In this regulation—
p.000006: “ethics committee” means—
p.000006: (a) an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical
p.000006: Trials) Regulations 2004(a);
p.000006: (b) the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of
p.000006: the Adults with Incapacity (Scotland) Act 2000(b); or
p.000006: (c) any other committee established to advise on the ethics of research investigations in human beings,
p.000006: and recognised for that purpose by or on behalf of the Secretary of State, the Scottish Ministers or the Welsh
p.000006: Ministers; and
p.000006:
p.000006:
p.000006: (a) S.I. 2004/1031.
p.000006: (b) 2000 asp 4.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
...
p.000007: (7) The instructions and information referred to in paragraph (6) must—
p.000007:
p.000007: (a) 2005 c. 9; see section 2 as to the meaning of “capacity”.
p.000007: (b) 1989 c. 41; see section 3 as to the meaning of “parental responsibility”.
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: (a) specify how doses resulting from the patient’s exposure can be restricted as far as reasonably
p.000008: possible so as to protect persons in contact with the patient;
p.000008: (b) set out the risks associated with ionising radiation; and
p.000008: (c) be provided to the patient or other person specified in paragraph (6) as appropriate prior to the patient leaving
p.000008: the radiological installation where the exposure was carried out.
p.000008: (8) In complying with the obligations under this regulation, the practitioner and the operator must pay
p.000008: particular attention in relation to—
p.000008: (a) medical exposures of children;
p.000008: (b) medical exposures as part of a health screening programme;
p.000008: (c) medical exposures involving high doses to the individual being exposed;
p.000008: (d) where appropriate, individuals in whom pregnancy cannot be excluded and who are undergoing a medical
p.000008: exposure, in particular if abdominal and pelvic regions are involved, taking into account the exposure of both
p.000008: the individual and any unborn child; and
p.000008: (e) where appropriate, individuals who are breastfeeding and who are undergoing a medical exposure involving the
p.000008: administration of radioactive substances, taking into account the exposure of both the individual and the child.
p.000008: (9) The employer must take steps to ensure that a clinical evaluation of the outcome of each exposure,
p.000008: other than where the person subject to the exposure is a carer or a comforter, is recorded in accordance with the
p.000008: employer’s procedures including, where appropriate, factors relevant to patient dose.
p.000008:
p.000008: Estimates of population doses
p.000008: 13. The employer must collect dose estimates from medical exposures for radiodiagnostic and interventional procedures,
p.000008: taking into consideration the distribution by age and gender of the exposed population and, when so
p.000008: requested, must provide the dose estimates to the Secretary of State.
p.000008:
p.000008: Expert advice
p.000008: 14.—(1) The employer must ensure that a suitable medical physics expert is appointed and involved, in
p.000008: accordance with paragraph (2), in relation to every type of exposure to which these Regulations apply.
p.000008: (2) A medical physics expert must—
p.000008: (a) be closely involved in every radiotherapeutic practice other than standardised therapeutic nuclear medicine
p.000008: practices;
p.000008: (b) be involved in practices including standardised therapeutic nuclear medicine practices, diagnostic
p.000008: nuclear medicine practices and high dose interventional radiology and high dose computed tomography;
p.000008: (c) be involved as appropriate for consultation on optimisation, in all other radiological practices not
...
p.000200: (ii) imposing a limit of time upon a licence; or
p.000200: (iii) revoking a licence; or
p.000200: (b) the terms of any conditions attached to a licence by the Licensing Authority, may ask the Licensing Authority for
p.000200: a review.
p.000200: (2) Any aggrieved person seeking a review must—
p.000200: (a) within 28 days of the date that the person was notified of the decision, or the terms, which caused them to
p.000200: become an aggrieved person request the Licensing Authority to undertake a review described in paragraph (1) ; and
p.000200: (b) must particularise in writing the reasons for seeking the review.
p.000200:
p.000200:
p.000014: 14
p.000014:
p.000014: (3) The Licensing Authority must undertake a review, and provide the results of that review in writing to the aggrieved
p.000014: person.
p.000014:
p.000014: Destination of fees
p.000014: 6. A fee payable under these Regulations is payable to the Secretary of State.
p.000014:
p.000014:
p.000014:
p.000014: SCHEDULE 2 Regulation 6
p.000014: Employer’s Procedures
p.000014: 1. The employer’s written procedures for exposures must include procedures—
p.000014: (a) to identify correctly the individual to be exposed to ionising radiation;
p.000014: (b) to identify individuals entitled to act as referrer or practitioner or operator within a specified
p.000014: scope of practice;
p.000014: (c) for making enquiries of individuals of childbearing potential to establish whether the individual is
p.000014: or may be pregnant or breastfeeding;
p.000014: (d) to ensure that quality assurance programmes in respect of written procedures, written protocols, and
p.000014: equipment are followed;
p.000014: (e) for the assessment of patient dose and administered activity;
p.000014: (f) for the use and review of such diagnostic reference levels as the employer may have established
p.000014: for radiodiagnostic examinations falling within regulation 3(a), (b), (e) and (f);
p.000014: (g) for determining whether the practitioner or operator is required to effect one or more of the matters set out in
p.000014: regulation 12(4) including criteria on how to effect those matters and in particular procedures for the use of dose
p.000014: constraints established by the employer for biomedical and medical research programmes falling within regulation 3(c)
p.000014: where no direct medical benefit for the individual is expected from the exposure;
p.000014: (h) for the giving of information and written instructions as referred to in regulation 12(6);
p.000014: (i) providing that wherever practicable, and prior to an exposure taking place, the individual to be exposed or
p.000014: their representative is provided with adequate information relating to the benefits and risks associated with the
p.000014: radiation dose from the exposure;
p.000014: (j) for the carrying out and recording of an evaluation for each exposure including, where appropriate, factors
p.000014: relevant to patient dose;
p.000014: (k) to ensure that the probability and magnitude of accidental or unintended exposure to individuals from
p.000014: radiological practices are reduced so far as reasonably practicable;
p.000014: (l) to ensure that the referrer, the practitioner, and the individual exposed or their
p.000014: representative are informed of the occurrence of any relevant clinically significant unintended or accidental
p.000014: exposure, and of the outcome of the analysis of this exposure;
p.000014: (m) to be observed in the case of non-medical imaging exposures;
p.000014: (n) to establish appropriate dose constraints and guidance for the exposure of carers and comforters.
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: SCHEDULE 3 Regulation 17
p.000015: Adequate Training
p.000015: 1. Practitioners and operators must have successfully completed training, including theoretical knowledge and practical
p.000015: experience, in—
p.000015: (a) such of the subjects detailed in Table 1 as are relevant to their functions as practitioner or operator; and
p.000015: (b) such of the subjects detailed in Table 2 as are relevant to their specific area of practice.
p.000015:
p.000015: Table 1
p.000015: Radiation production, radiation protection and statutory obligations relating to ionising radiations
p.000015: Fundamental Physics of Radiation
p.000015:
p.000015: Properties of Radiation
p.000015: Excitation and ionisation Attenuation of ionising radiation Scattering and absorption
p.000015: Radiation Hazards and Dosimetry Biological effects of radiation – stochastic and
p.000015: deterministic
p.000015: Risks and benefits of radiation
p.000015: Absorbed dose, equivalent dose, effective dose, other dose indicators and their units
p.000015: Management and Radiation Protection of the individual being exposed
p.000015: Special Attention Areas Pregnancy and potential pregnancy Asymptomatic
p.000015: individuals Breastfeeding
p.000015: Infants and children
p.000015: Medical and biomedical research Health screening
p.000015: Non-medical imaging Carers and comforters High dose techniques
p.000015: Justification Justification of the individual exposure Use
p.000015: of existing appropriate radiological information
p.000015: Alternative techniques
p.000015: Radiation Protection Diagnostic reference levels Dose Constraints
p.000015: Dose Optimisation
p.000015: Dose reduction devices and techniques Dose recording and dose audit General radiation protection
p.000015: Quality Assurance and Quality Control including routine inspection and testing of equipment
p.000015: Risk communication
p.000015: Use of radiation protection devices
p.000015: Statutory Requirements and Non-Statutory Regulations
p.000015: Regulations
p.000015: Non-statutory guidance
p.000015: Local procedures and protocols
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: Individual responsibilities relating to exposures Responsibility for radiation safety
p.000016: Clinical audit
p.000016:
p.000016: Table 2
p.000016: Diagnostic radiology, radiotherapy and nuclear medicine
p.000016: All Modalities
p.000016: General Fundamentals of radiological anatomy Factors
p.000016: affecting radiation dose Dosimetry
p.000016: Fundamentals of clinical evaluation Identification of the individual being exposed
p.000016: Diagnostic radiology
...
p.000016: Radiobiological Aspects for Radiotherapy Fractionation
p.000016: Dose rate Radiosensitisation Target volumes
p.000016: Practical Aspects for Radiotherapy Localisation equipment selection
p.000016: Therapy equipment selection
p.000016: Verification techniques including on-treatment imaging
p.000016: Treatment planning systems
p.000016:
p.000016: Radiation Protection Specific to Radiotherapy
p.000016:
p.000016: Nuclear Medicine
p.000016: Side effects—early and late Toxicity
p.000016: Assessment of efficacy
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: General Atomic structure and radioactivity
p.000017: Radioactive decay
p.000017: Principles of molecular imaging and non- imaging exposures
p.000017: Principles of molecular radiotherapy
p.000017: Molecular Radiotherapy Dose rate Fractionation Radiobiology aspects
p.000017: Radiosensitisation
p.000017: Specialised techniques Quantitative imaging – advanced applications Hybrid
p.000017: imaging – advanced applications Selective Internal Radiation Therapy
p.000017:
p.000017: Principles of Radiation Detection, Instrumentation and Equipment
p.000017: Types of detection systems
p.000017: Optimisation of image quality and radiation dose
p.000017: Image acquisition, artefacts, processing, display and storage
p.000017: Radiopharmaceuticals Calibration
p.000017: Working practices in the radiopharmacy Preparation of individual doses
p.000017:
p.000017: Radiation Protection Specific to Nuclear Medicine
p.000017: Conception, pregnancy and breastfeeding Arrangements for radioactive individuals
p.000017:
p.000017:
p.000017:
p.000017: SCHEDULE 4 Regulation 21
p.000017: Consequential amendments
p.000017: Amendment of the Justification of Practices Involving Ionising Radiation Regulations 2004 1.—(1) The Justification of
p.000017: Practices Involving Ionising Radiation Regulations 2004(a) are
p.000017: amended as follows.
p.000017: (2) For regulation 21 (saving for medical practices) substitute—
p.000017: “21. Nothing in regulation 4(5) of 5(3) shall prevent anything permitted under regulation 11 of the Ionising Radiation
p.000017: (Medical Exposure) Regulations 2017.”.
p.000017:
p.000017: Amendment of the Human Medicines Regulations 2012
p.000017: 2.—(1) The Human Medicines Regulations 2012(b) are amended as follows.
p.000017: (2) In regulation 173 (exemption for certain radiopharmaceuticals)—
p.000017: (a) in paragraph (d), at the beginning insert “in Northern Ireland”;
p.000017: (b) after paragraph (d) insert—
p.000017: “(e) in England and Wales and Scotland, for administration in accordance with a licence issued under the
p.000017: Ionising Radiation (Medical Exposure) Regulations 2017”
p.000017: .
p.000017: (3) In regulation 240 (radioactive medicinal products)—
p.000017: (a) for paragraph (1)(a) substitute—
p.000017:
p.000017:
p.000017: (a) S.I. 2004/1769; there are amending instruments but none is relevant.
p.000017: (b) S.I. 2012/1916 as amended by S.I. 2014/490; there are other amending instruments but none is relevant.
p.000017:
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: “(a) either—
p.000018: (i) in Northern Ireland, a radioactive medicinal product, administration of which results in a medical exposure; or
...
p.000019: exposures.
p.000019: These Regulations revoke other Regulations relating to medical exposures and prior-authorisation for the
p.000019: administration of radioactive substances for the purposes of diagnosis, treatment and research.
p.000019: Regulation 2 is an interpretation provision. Regulation 3 sets out the medical exposures to which the Regulations
p.000019: apply.
p.000019: Regulation 4 sets out conditions under which the Licensing Authority may issue a licence for the administration of
p.000019: radioactive substances. Further provisions relating to the application for and the issuing of such licences are
p.000019: contained in Schedule 1.
p.000019: Regulation 5 requires the employer and the practitioner who wish to administer radioactive substances to
p.000019: hold a valid licence issued by the Licensing Authority. Such licences will specify the radiological installation and
p.000019: purposes as appropriate.
p.000019: Regulation 6 requires the employer to establish a framework of general procedures, protocols and quality assurance
p.000019: programmes. The procedures must cover the matters set out in Schedule 2 as a minimum. Written protocols, where
p.000019: appropriate, must be in place for standard radiological practices. The employer must establish recommendations
p.000019: regarding referral guidelines, establish quality assurance programmes for standard operating procedures, review
p.000019: and make available diagnostic reference levels, establish dose constraints where appropriate and raise awareness of
p.000019: the effects of ionising radiation amongst individuals capable of childbearing or breastfeeding.
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Regulation 7 requires the employer’s procedures to include provision for clinical audit to be carried out.
p.000020: Regulation 8 sets out the duties of the employer in relation to accidental or unintended medical exposures including
p.000020: provisions for providing information about clinically significant exposures, quality assurance programmes for
p.000020: radiotherapy, analysis and recording of events involving or potentially involving accidental or unintended
p.000020: exposures and processes for investigating and notifying the relevant enforcing authority when significant events
p.000020: have occurred.
p.000020: Regulation 9 sets out the duties of the enforcing authority with regard to timely dissemination of information relating
p.000020: to significant accidental or unintended exposures.
p.000020: Regulation 10 sets out the respective responsibilities of practitioners, operators and referrers.
p.000020: Practitioners and operators are required to follow the framework of procedures provided by the employer. The
p.000020: practitioner is responsible for the justification of a medical exposure. Authorisation of exposures is addressed here
p.000020: and in regulation 11. The operator is responsible for each practical aspect he or she carries out. The referrer must
p.000020: provide medical data as required by the practitioner in order that appropriate justification can take place.
p.000020: Regulation 11 prohibits any medical exposure which has not been justified and authorised and sets out matters to be
p.000020: taken into account for justification. These include requirements relating to licensing and approval by an
p.000020: expert advisory committee, in the case of research, for exposures involving administration of radioactive
p.000020: substances. Justification of the exposure of carers and comforters is also required and recommendations or
p.000020: guidelines should be considered as part of justification of the exposure of asymptomatic individuals.
p.000020: Regulation 12 provides for the optimisation process, and specifies the elements that are the
p.000020: responsibilities of the operator and the practitioner, depending on their involvement. Specific requirements
p.000020: are included for exposures in research, for carers and comforters and for exposures involving radioactive substances.
p.000020: Particular regard should be given to the exposures of children, exposures involving high doses, exposures of
p.000020: individuals involved in health screening programmes and pregnant or potentially pregnant or breastfeeding
p.000020: individuals. Regulation 12 also requires the employer to take steps to ensure that a clinical evaluation is recorded of
p.000020: each medical exposure.
p.000020: Regulation 13 requires employers to provide when requested, to the Secretary of State data relating to
p.000020: dose estimates from diagnostic and interventional medical exposures.
p.000020: Regulation 14 provides for suitable medical physics experts to be appointed and involved in relation to
p.000020: medical exposures.
p.000020: Regulation 15 sets out general duties of the employer with respect to medical radiological equipment.
p.000020: These include requirements for quality assurance programmes, appropriate testing of equipment, performance criteria
p.000020: and actions to be taken when equipment does not perform appropriately.
p.000020: Regulation 16 sets out additional requirements for equipment installed when the Regulations come into force including
p.000020: the transfer of information relating to patient dose where appropriate.
p.000020: Regulation 17 prohibits a practitioner or operator from carrying out a medical exposure without having been
p.000020: adequately trained, except if supervised appropriately for practical aspects when undergoing training. The
p.000020: employer must keep and make available training records during inspections undertaken by the relevant
p.000020: enforcing authority. Further information regarding adequate training is set out in Schedule 3.
p.000020: Regulation 18 provides that the Regulations are made enforceable as health and safety regulations under the Health and
p.000020: Safety at Work etc. Act 1974 (c. 37).
p.000020: Regulation 19 provides there is a defence of due diligence to proceedings for an offence under the Regulations that all
...
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p.000008: the radiological installation where the exposure was carried out.
p.000008: (8) In complying with the obligations under this regulation, the practitioner and the operator must pay
p.000008: particular attention in relation to—
p.000008: (a) medical exposures of children;
p.000008: (b) medical exposures as part of a health screening programme;
p.000008: (c) medical exposures involving high doses to the individual being exposed;
p.000008: (d) where appropriate, individuals in whom pregnancy cannot be excluded and who are undergoing a medical
p.000008: exposure, in particular if abdominal and pelvic regions are involved, taking into account the exposure of both
p.000008: the individual and any unborn child; and
p.000008: (e) where appropriate, individuals who are breastfeeding and who are undergoing a medical exposure involving the
p.000008: administration of radioactive substances, taking into account the exposure of both the individual and the child.
p.000008: (9) The employer must take steps to ensure that a clinical evaluation of the outcome of each exposure,
p.000008: other than where the person subject to the exposure is a carer or a comforter, is recorded in accordance with the
p.000008: employer’s procedures including, where appropriate, factors relevant to patient dose.
p.000008:
p.000008: Estimates of population doses
p.000008: 13. The employer must collect dose estimates from medical exposures for radiodiagnostic and interventional procedures,
p.000008: taking into consideration the distribution by age and gender of the exposed population and, when so
p.000008: requested, must provide the dose estimates to the Secretary of State.
p.000008:
p.000008: Expert advice
p.000008: 14.—(1) The employer must ensure that a suitable medical physics expert is appointed and involved, in
p.000008: accordance with paragraph (2), in relation to every type of exposure to which these Regulations apply.
p.000008: (2) A medical physics expert must—
p.000008: (a) be closely involved in every radiotherapeutic practice other than standardised therapeutic nuclear medicine
p.000008: practices;
p.000008: (b) be involved in practices including standardised therapeutic nuclear medicine practices, diagnostic
p.000008: nuclear medicine practices and high dose interventional radiology and high dose computed tomography;
p.000008: (c) be involved as appropriate for consultation on optimisation, in all other radiological practices not
p.000008: mentioned in sub-paragraphs (b) and (c); and
p.000008: (d) give advice on—
p.000008: (i) dosimetry and quality assurance matters relating to radiation protection concerning exposures;
p.000008: (ii) physical measurements for the evaluation of dose delivered;
p.000008: (iii) medical radiological equipment.
p.000008: (3) A medical physics expert must also contribute to the following matters—
p.000008: (a) optimisation of the radiation protection of patients and other individuals subject to exposures,
p.000008: including the application and use of diagnostic reference levels;
p.000008: (b) the definition and performance of quality assurance of the equipment;
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: (c) acceptance testing of equipment;
...
Social / Child
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p.000006: involving no or less exposure to ionising radiation.
p.000006: (3) In considering the weight to be given to the matters referred to in paragraph (2), the practitioner
p.000006: justifying an exposure in accordance with paragraph (1)(b) must have regard, in particular to—
p.000006: (a) recommendations from appropriate medical scientific societies or relevant bodies where a procedure is to be
p.000006: performed as part of any health screening programme;
p.000006: (b) whether in circumstances where there is to be an exposure to a carer or comforter such an exposure would show a
p.000006: sufficient net benefit taking into account—
p.000006: (i) the likely direct health benefits to a patient;
p.000006: (ii) the possible benefits to the carer or comforter; and
p.000006: (iii) the detriment that the exposure might cause;
p.000006: (c) in the case of asymptomatic individuals where a medical radiological procedure—
p.000006: (i) is to be performed for the early detection of disease;
p.000006: (ii) is to be performed as part of a health screening programme; or
p.000006: (iii) requires specific documented justification for that individual by the practitioner, in consultation with the
p.000006: referrer,
p.000006: any guidelines issued by appropriate medical scientific societies, relevant bodies or published by the
p.000006: Secretary of State;
p.000006: (d) the urgency of the exposure, where appropriate, in cases involving—
p.000006: (i) an individual where pregnancy cannot be excluded, in particular if abdominal and pelvic regions are
p.000006: involved, taking into account the exposure of both the person concerned and any unborn child; and
p.000006: (ii) an individual who is breastfeeding and who undergoes an exposure involving the administration of
p.000006: radioactive substances, taking into account the exposure of both the individual and the child.
p.000006: (4) In deciding whether to justify an exposure under paragraph (1)(b) the practitioner must take account of any data
p.000006: supplied by the referrer pursuant to regulation 10(5) and must consider such data in order to avoid unnecessary
p.000006: exposure.
p.000006: (5) Where it is not practicable for the practitioner to authorise an exposure as required by paragraph
p.000006: (1)(c), the operator must do so in accordance with guidelines issued by the practitioner.
p.000006: (6) In this regulation—
p.000006: “ethics committee” means—
p.000006: (a) an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical
p.000006: Trials) Regulations 2004(a);
p.000006: (b) the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of
p.000006: the Adults with Incapacity (Scotland) Act 2000(b); or
p.000006: (c) any other committee established to advise on the ethics of research investigations in human beings,
p.000006: and recognised for that purpose by or on behalf of the Secretary of State, the Scottish Ministers or the Welsh
p.000006: Ministers; and
p.000006:
p.000006:
p.000006: (a) S.I. 2004/1031.
p.000006: (b) 2000 asp 4.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: “individual detriment” means clinically observable deleterious effects in individuals or their descendants, the
p.000007: appearance of which is either immediate or delayed and, in the latter case, implies a probability rather than a
p.000007: certainty of appearance.
p.000007:
p.000007: Optimisation
...
p.000007: (c) adherence to such diagnostic reference levels for radiodiagnostic examinations falling within regulation
p.000007: 3(a), (b), (e) and (f) as the employer may have established,
p.000007: as set out in the employer’s procedures.
p.000007: (4) For each medical or biomedical research programme falling within regulation 3(c), the employer’s
p.000007: procedures must provide that—
p.000007: (a) the individuals concerned participate voluntarily in the research programme;
p.000007: (b) the individuals concerned are informed in advance about the risks of the exposure;
p.000007: (c) the dose constraint set down in the employer’s procedures for individuals for whom no direct medical benefit is
p.000007: expected from the exposure is adhered to; and
p.000007: (d) individual target levels of doses are planned by the practitioner, either alone or with the input of the
p.000007: referrer, for patients who voluntarily undergo an experimental diagnostic or therapeutic practice from which the
p.000007: patients are expected to receive a diagnostic or therapeutic benefit.
p.000007: (5) In the case of regulation 3(d), the employer’s procedures must provide that appropriate guidance is
p.000007: established for the exposure of carers and comforters.
p.000007: (6) In the case of patients undergoing treatment or diagnosis with radioactive substances, the employer’s
p.000007: procedures must provide that, where appropriate, written instructions and information are provided to—
p.000007: (a) the patient, where the patient has capacity to consent to the treatment or diagnostic procedure;
p.000007: (b) where the patient is a child who lacks capacity (within the meaning of the Mental Capacity Act
p.000007: 2005(a) in the case of a child aged sixteen or seventeen) so to consent, a person with parental responsibility (within
p.000007: the meaning of the Children Act 1989(b)) for the child; or
p.000007: (c) where the patient is an adult who lacks capacity (within the meaning of the Mental Capacity Act
p.000007: 2005) so to consent, the person who appears to the practitioner to be the most appropriate person.
p.000007: (7) The instructions and information referred to in paragraph (6) must—
p.000007:
p.000007: (a) 2005 c. 9; see section 2 as to the meaning of “capacity”.
p.000007: (b) 1989 c. 41; see section 3 as to the meaning of “parental responsibility”.
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: (a) specify how doses resulting from the patient’s exposure can be restricted as far as reasonably
p.000008: possible so as to protect persons in contact with the patient;
p.000008: (b) set out the risks associated with ionising radiation; and
p.000008: (c) be provided to the patient or other person specified in paragraph (6) as appropriate prior to the patient leaving
p.000008: the radiological installation where the exposure was carried out.
p.000008: (8) In complying with the obligations under this regulation, the practitioner and the operator must pay
p.000008: particular attention in relation to—
p.000008: (a) medical exposures of children;
p.000008: (b) medical exposures as part of a health screening programme;
p.000008: (c) medical exposures involving high doses to the individual being exposed;
p.000008: (d) where appropriate, individuals in whom pregnancy cannot be excluded and who are undergoing a medical
p.000008: exposure, in particular if abdominal and pelvic regions are involved, taking into account the exposure of both
p.000008: the individual and any unborn child; and
p.000008: (e) where appropriate, individuals who are breastfeeding and who are undergoing a medical exposure involving the
p.000008: administration of radioactive substances, taking into account the exposure of both the individual and the child.
p.000008: (9) The employer must take steps to ensure that a clinical evaluation of the outcome of each exposure,
p.000008: other than where the person subject to the exposure is a carer or a comforter, is recorded in accordance with the
p.000008: employer’s procedures including, where appropriate, factors relevant to patient dose.
p.000008:
p.000008: Estimates of population doses
p.000008: 13. The employer must collect dose estimates from medical exposures for radiodiagnostic and interventional procedures,
p.000008: taking into consideration the distribution by age and gender of the exposed population and, when so
p.000008: requested, must provide the dose estimates to the Secretary of State.
p.000008:
p.000008: Expert advice
p.000008: 14.—(1) The employer must ensure that a suitable medical physics expert is appointed and involved, in
p.000008: accordance with paragraph (2), in relation to every type of exposure to which these Regulations apply.
p.000008: (2) A medical physics expert must—
p.000008: (a) be closely involved in every radiotherapeutic practice other than standardised therapeutic nuclear medicine
p.000008: practices;
p.000008: (b) be involved in practices including standardised therapeutic nuclear medicine practices, diagnostic
p.000008: nuclear medicine practices and high dose interventional radiology and high dose computed tomography;
p.000008: (c) be involved as appropriate for consultation on optimisation, in all other radiological practices not
p.000008: mentioned in sub-paragraphs (b) and (c); and
p.000008: (d) give advice on—
p.000008: (i) dosimetry and quality assurance matters relating to radiation protection concerning exposures;
...
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p.000002: purposes;
p.000002: “referrer” means a registered health care professional who is entitled in accordance with the employer’s procedures to
p.000002: refer individuals for exposure to a practitioner;
p.000002: “registered health care professional” means a person who is a member of a profession regulated by a body
p.000002: mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002(a);
p.000002: “relevant enforcing authority” means—
p.000002: (a) in England, the Care Quality Commission(b);
p.000002: (b) in Scotland, the Scottish Ministers; and
p.000002: (c) in Wales, the Welsh Ministers;
p.000002: “unintended exposure” means any exposure to ionising radiation which is significantly different from the
p.000002: exposure intended for a given purpose.
p.000002: (2) In these Regulations, where an individual is—
p.000002: (a) an employer;
p.000002: (b) a referrer;
p.000002: (c) an operator; or
p.000002: (d) a practitioner,
p.000002: and is also an individual coming within at least one other of sub-paragraphs (a) to (d), that
p.000002: individual is subject to each of the duties applying to every person described in a sub-paragraph which also describes
p.000002: that individual.
p.000002:
p.000002:
p.000002:
p.000002: (a) 2002 c. 17. Section 25 has been amended by paragraph 17 of Schedule 10 and Part 2 of Schedule 15 the Health and
p.000002: Social Care Act 2008 (c. 14), sections 220, 222 and 224 of and paragraphs 56 and 62 of Schedule 15 to the Health and
p.000002: Social Care act 2012 (c. 7), section 5(1) of the Health and Social Care (Safety and Quality) Act 2015 (c. 28),
p.000002: paragraph 1 and 2 of Schedule 4 to the Children and Social Work Act 2017 (c. 16).
p.000002: (b) Established by section 1 of the Health and Social Care Act 2008 (c. 14).
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Application
p.000003: 3. These Regulations apply to the exposure of ionising radiation in England and Wales and Scotland—
p.000003: (a) to patients as part of their own medical diagnosis or treatment;
p.000003: (b) to individuals as part of health screening programmes;
p.000003: (c) to patients or other persons voluntarily participating in medical or biomedical, diagnostic or therapeutic,
p.000003: research programmes;
p.000003: (d) to carers and comforters;
p.000003: (e) to asymptomatic individuals;
p.000003: (f) to individuals undergoing non-medical imaging using medical radiological equipment.
p.000003:
p.000003: The Licensing Authority
p.000003: 4.—(1) The Licensing Authority may upon payment of a fee (where required) issue a licence to a person required by these
p.000003: Regulations to hold a licence.
p.000003: (2) A licence described in paragraph (1) may be—
p.000003: (a) issued for such period as the Licensing Authority considers appropriate;
p.000003: (b) subject to such conditions as the Licensing Authority may consider appropriate; and
p.000003: (c) varied or revoked at any time.
p.000003: (3) Schedule 1 makes further provision relating to the application for, and the issue of, a licence described in
p.000003: paragraph (1).
p.000003:
p.000003: Requirement to hold a licence
p.000003: 5.—(1) A person must hold a valid licence issued by the Licensing Authority if that person—
...
p.000007: (c) the dose constraint set down in the employer’s procedures for individuals for whom no direct medical benefit is
p.000007: expected from the exposure is adhered to; and
p.000007: (d) individual target levels of doses are planned by the practitioner, either alone or with the input of the
p.000007: referrer, for patients who voluntarily undergo an experimental diagnostic or therapeutic practice from which the
p.000007: patients are expected to receive a diagnostic or therapeutic benefit.
p.000007: (5) In the case of regulation 3(d), the employer’s procedures must provide that appropriate guidance is
p.000007: established for the exposure of carers and comforters.
p.000007: (6) In the case of patients undergoing treatment or diagnosis with radioactive substances, the employer’s
p.000007: procedures must provide that, where appropriate, written instructions and information are provided to—
p.000007: (a) the patient, where the patient has capacity to consent to the treatment or diagnostic procedure;
p.000007: (b) where the patient is a child who lacks capacity (within the meaning of the Mental Capacity Act
p.000007: 2005(a) in the case of a child aged sixteen or seventeen) so to consent, a person with parental responsibility (within
p.000007: the meaning of the Children Act 1989(b)) for the child; or
p.000007: (c) where the patient is an adult who lacks capacity (within the meaning of the Mental Capacity Act
p.000007: 2005) so to consent, the person who appears to the practitioner to be the most appropriate person.
p.000007: (7) The instructions and information referred to in paragraph (6) must—
p.000007:
p.000007: (a) 2005 c. 9; see section 2 as to the meaning of “capacity”.
p.000007: (b) 1989 c. 41; see section 3 as to the meaning of “parental responsibility”.
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: (a) specify how doses resulting from the patient’s exposure can be restricted as far as reasonably
p.000008: possible so as to protect persons in contact with the patient;
p.000008: (b) set out the risks associated with ionising radiation; and
p.000008: (c) be provided to the patient or other person specified in paragraph (6) as appropriate prior to the patient leaving
p.000008: the radiological installation where the exposure was carried out.
p.000008: (8) In complying with the obligations under this regulation, the practitioner and the operator must pay
p.000008: particular attention in relation to—
p.000008: (a) medical exposures of children;
p.000008: (b) medical exposures as part of a health screening programme;
p.000008: (c) medical exposures involving high doses to the individual being exposed;
p.000008: (d) where appropriate, individuals in whom pregnancy cannot be excluded and who are undergoing a medical
p.000008: exposure, in particular if abdominal and pelvic regions are involved, taking into account the exposure of both
p.000008: the individual and any unborn child; and
p.000008: (e) where appropriate, individuals who are breastfeeding and who are undergoing a medical exposure involving the
p.000008: administration of radioactive substances, taking into account the exposure of both the individual and the child.
p.000008: (9) The employer must take steps to ensure that a clinical evaluation of the outcome of each exposure,
p.000008: other than where the person subject to the exposure is a carer or a comforter, is recorded in accordance with the
p.000008: employer’s procedures including, where appropriate, factors relevant to patient dose.
p.000008:
p.000008: Estimates of population doses
p.000008: 13. The employer must collect dose estimates from medical exposures for radiodiagnostic and interventional procedures,
p.000008: taking into consideration the distribution by age and gender of the exposed population and, when so
p.000008: requested, must provide the dose estimates to the Secretary of State.
p.000008:
p.000008: Expert advice
...
p.000014: (m) to be observed in the case of non-medical imaging exposures;
p.000014: (n) to establish appropriate dose constraints and guidance for the exposure of carers and comforters.
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: SCHEDULE 3 Regulation 17
p.000015: Adequate Training
p.000015: 1. Practitioners and operators must have successfully completed training, including theoretical knowledge and practical
p.000015: experience, in—
p.000015: (a) such of the subjects detailed in Table 1 as are relevant to their functions as practitioner or operator; and
p.000015: (b) such of the subjects detailed in Table 2 as are relevant to their specific area of practice.
p.000015:
p.000015: Table 1
p.000015: Radiation production, radiation protection and statutory obligations relating to ionising radiations
p.000015: Fundamental Physics of Radiation
p.000015:
p.000015: Properties of Radiation
p.000015: Excitation and ionisation Attenuation of ionising radiation Scattering and absorption
p.000015: Radiation Hazards and Dosimetry Biological effects of radiation – stochastic and
p.000015: deterministic
p.000015: Risks and benefits of radiation
p.000015: Absorbed dose, equivalent dose, effective dose, other dose indicators and their units
p.000015: Management and Radiation Protection of the individual being exposed
p.000015: Special Attention Areas Pregnancy and potential pregnancy Asymptomatic
p.000015: individuals Breastfeeding
p.000015: Infants and children
p.000015: Medical and biomedical research Health screening
p.000015: Non-medical imaging Carers and comforters High dose techniques
p.000015: Justification Justification of the individual exposure Use
p.000015: of existing appropriate radiological information
p.000015: Alternative techniques
p.000015: Radiation Protection Diagnostic reference levels Dose Constraints
p.000015: Dose Optimisation
p.000015: Dose reduction devices and techniques Dose recording and dose audit General radiation protection
p.000015: Quality Assurance and Quality Control including routine inspection and testing of equipment
p.000015: Risk communication
p.000015: Use of radiation protection devices
p.000015: Statutory Requirements and Non-Statutory Regulations
p.000015: Regulations
p.000015: Non-statutory guidance
p.000015: Local procedures and protocols
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: Individual responsibilities relating to exposures Responsibility for radiation safety
p.000016: Clinical audit
p.000016:
p.000016: Table 2
p.000016: Diagnostic radiology, radiotherapy and nuclear medicine
p.000016: All Modalities
p.000016: General Fundamentals of radiological anatomy Factors
p.000016: affecting radiation dose Dosimetry
p.000016: Fundamentals of clinical evaluation Identification of the individual being exposed
p.000016: Diagnostic radiology
p.000016: General Principles of radiological techniques
p.000016: Production of X-rays
...
p.000020: to significant accidental or unintended exposures.
p.000020: Regulation 10 sets out the respective responsibilities of practitioners, operators and referrers.
p.000020: Practitioners and operators are required to follow the framework of procedures provided by the employer. The
p.000020: practitioner is responsible for the justification of a medical exposure. Authorisation of exposures is addressed here
p.000020: and in regulation 11. The operator is responsible for each practical aspect he or she carries out. The referrer must
p.000020: provide medical data as required by the practitioner in order that appropriate justification can take place.
p.000020: Regulation 11 prohibits any medical exposure which has not been justified and authorised and sets out matters to be
p.000020: taken into account for justification. These include requirements relating to licensing and approval by an
p.000020: expert advisory committee, in the case of research, for exposures involving administration of radioactive
p.000020: substances. Justification of the exposure of carers and comforters is also required and recommendations or
p.000020: guidelines should be considered as part of justification of the exposure of asymptomatic individuals.
p.000020: Regulation 12 provides for the optimisation process, and specifies the elements that are the
p.000020: responsibilities of the operator and the practitioner, depending on their involvement. Specific requirements
p.000020: are included for exposures in research, for carers and comforters and for exposures involving radioactive substances.
p.000020: Particular regard should be given to the exposures of children, exposures involving high doses, exposures of
p.000020: individuals involved in health screening programmes and pregnant or potentially pregnant or breastfeeding
p.000020: individuals. Regulation 12 also requires the employer to take steps to ensure that a clinical evaluation is recorded of
p.000020: each medical exposure.
p.000020: Regulation 13 requires employers to provide when requested, to the Secretary of State data relating to
p.000020: dose estimates from diagnostic and interventional medical exposures.
p.000020: Regulation 14 provides for suitable medical physics experts to be appointed and involved in relation to
p.000020: medical exposures.
p.000020: Regulation 15 sets out general duties of the employer with respect to medical radiological equipment.
p.000020: These include requirements for quality assurance programmes, appropriate testing of equipment, performance criteria
p.000020: and actions to be taken when equipment does not perform appropriately.
p.000020: Regulation 16 sets out additional requirements for equipment installed when the Regulations come into force including
p.000020: the transfer of information relating to patient dose where appropriate.
p.000020: Regulation 17 prohibits a practitioner or operator from carrying out a medical exposure without having been
p.000020: adequately trained, except if supervised appropriately for practical aspects when undergoing training. The
p.000020: employer must keep and make available training records during inspections undertaken by the relevant
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000007: (a) the patient, where the patient has capacity to consent to the treatment or diagnostic procedure;
p.000007: (b) where the patient is a child who lacks capacity (within the meaning of the Mental Capacity Act
p.000007: 2005(a) in the case of a child aged sixteen or seventeen) so to consent, a person with parental responsibility (within
p.000007: the meaning of the Children Act 1989(b)) for the child; or
p.000007: (c) where the patient is an adult who lacks capacity (within the meaning of the Mental Capacity Act
p.000007: 2005) so to consent, the person who appears to the practitioner to be the most appropriate person.
p.000007: (7) The instructions and information referred to in paragraph (6) must—
p.000007:
p.000007: (a) 2005 c. 9; see section 2 as to the meaning of “capacity”.
p.000007: (b) 1989 c. 41; see section 3 as to the meaning of “parental responsibility”.
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: (a) specify how doses resulting from the patient’s exposure can be restricted as far as reasonably
p.000008: possible so as to protect persons in contact with the patient;
p.000008: (b) set out the risks associated with ionising radiation; and
p.000008: (c) be provided to the patient or other person specified in paragraph (6) as appropriate prior to the patient leaving
p.000008: the radiological installation where the exposure was carried out.
p.000008: (8) In complying with the obligations under this regulation, the practitioner and the operator must pay
p.000008: particular attention in relation to—
p.000008: (a) medical exposures of children;
p.000008: (b) medical exposures as part of a health screening programme;
p.000008: (c) medical exposures involving high doses to the individual being exposed;
p.000008: (d) where appropriate, individuals in whom pregnancy cannot be excluded and who are undergoing a medical
p.000008: exposure, in particular if abdominal and pelvic regions are involved, taking into account the exposure of both
p.000008: the individual and any unborn child; and
p.000008: (e) where appropriate, individuals who are breastfeeding and who are undergoing a medical exposure involving the
p.000008: administration of radioactive substances, taking into account the exposure of both the individual and the child.
p.000008: (9) The employer must take steps to ensure that a clinical evaluation of the outcome of each exposure,
p.000008: other than where the person subject to the exposure is a carer or a comforter, is recorded in accordance with the
...
Social / Occupation
Searching for indicator occupation:
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p.000002:
p.000002: 2017 No. 1322 HEALTH AND SAFETY
p.000002: The Ionising Radiation (Medical Exposure) Regulations 2017
p.000002:
p.000002: Made - - - - 20th December 2017
p.000002: Laid before Parliament 22nd December 2017
p.000002: Coming into force - - 6th February 2018
p.000002:
p.000002: The Secretary of State, being the Minister designated(a) for the purposes of section 2(2) of the European
p.000002: Communities Act 1972(b) in relation to safety measures in regard to radioactive substances and the
p.000002: emission of ionising radiation, in exercise of the powers conferred by that section and by section 56
p.000002: of the Finance Act 1973(c), makes the following Regulations. Regulation 4 and Schedule 1 (the Licensing
p.000002: Authority) are made with the consent of the Treasury.
p.000002:
p.000002: Citation and commencement
p.000002: 1. These Regulations may be cited as the Ionising Radiation (Medical Exposure) Regulations 2017 and come into
p.000002: force on 6th February 2018.
p.000002:
p.000002: Interpretation
p.000002: 2.—(1) In these Regulations—
p.000002: “accidental exposure” means an exposure of an individual as a result of an accident;
p.000002: “adequate training” means training which satisfies the requirements of Schedule 3 and the expression
p.000002: “adequately trained” is to be construed accordingly;
p.000002: “assessment” means prior determination of amount, parameter or method;
p.000002: “carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation by
p.000002: helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having
p.000002: undergone an exposure;
p.000002: “clinical audit” means a systematic examination or review of medical radiological procedures which seeks to improve
p.000002: the quality and outcome of patient care through structured review, whereby medical radiological practices,
p.000002: procedures and results are examined against agreed standards for good medical radiological procedures, with
p.000002: modification of practices, where indicated, and the application of new standards if necessary;
p.000002:
p.000002:
p.000002:
p.000002: (a) S.I. 1977/1718; there are no relevant amendments.
p.000002: (b) 1972 c. 68; section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.
p.000002: 51), and by Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c. 7). In so far as these Regulations
p.000002: deal with matters that are within the devolved competence of Scottish Ministers, the power of the
p.000002: Secretary of State to make regulations in relation to those matters in or as regards Scotland is preserved by
p.000002: section 57(1) of the Scotland Act 1998 (c. 46).
p.000002: (c) 1973 c. 51; amendments have been made to section 56 by S.I. 2011/1043; there are other amendments to that
p.000002: section which are not relevant for the purposes of these Regulations.
p.000002:
p.000002: “diagnostic reference levels” means dose levels in medical radiodiagnostic or interventional radiology practices,
p.000002: or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of
p.000002: standard-sized individuals or standard phantoms for broadly defined types of equipment;
...
p.000018: radioactive substance.”.
p.000018: (h) for paragraph (7) substitute— “(7) In this regulation—
p.000018: “IRME practitioner” means—
p.000018: (a) in Northern Ireland, in relation to a medical exposure, a practitioner for the purposes of the
p.000018: Ionising Radiation (Medical Exposure) Regulations 2000;
p.000018: (b) in England and Wales and Scotland, in relation to a medical exposure, a practitioner
p.000018: for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2017;
p.000018: “medical exposure”—
p.000018: (a) in Northern Ireland has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations
p.000018: 2000; and
p.000018: (b) in England and Wales and Scotland has the same meaning as in the Ionising Radiation (Medical
p.000018: Exposure) Regulations 2017; and
p.000018: “radioactive medicinal product” means a medicinal product which consists of, contains or generates a radioactive
p.000018: substance so that, when the product is administered, the radiation it emits may be used.”.
p.000018:
p.000018: Amendment of the Ionising Radiations Regulations 2017
p.000018: 3.—(1) The Ionising Radiations Regulations 2017(a) are amended as follows.
p.000018: (2) In regulation 2(1) (interpretation)—
p.000018: (a) omit the definition of “carers and comforters”;
p.000018: (b) insert after the definition of “calendar year”—
p.000018: ““carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation
p.000018: by helping, other than as part of their occupation, in the
p.000018:
p.000018:
p.000018:
p.000018: (a) S.I. 2017/1075.
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: support and comfort of individuals undergoing or having undergone a medical exposure (other than as a carer and
p.000019: comforter);”;
p.000019: (c) in the definition of “medical exposure”, after paragraph (d), insert— “(e) carers and comforters;”.
p.000019: (3) In regulation 3 (application)—
p.000019: (a) in paragraph (2), omit “33”;
p.000019: (b) omit paragraph (4).
p.000019: (4) Omit regulation 33 (equipment used for medical exposure).
p.000019: (5) In regulation 35(6) (duties of employees)—
p.000019: (a) in sub-paragraph (a), after “overexposure;” insert “or”;
p.000019: (b) in sub-paragraph (b), omit “or” the second time it appears;
p.000019: (c) omit sub-paragraph (c).
p.000019: (6) In regulation 38(2)(d) (exemption certificates)—
p.000019: (a) before “25(2)” insert “and”;
p.000019: (b) omit “and 33(1)”.
p.000019: EXPLANATORY NOTE
p.000019: (This note is not part of the Regulations)
p.000019: These Regulations implement, as respects Great Britain, some of the provisions of Council Directive
p.000019: 2013/59/Euratom (OJ No L13,17.1.2014, p1) laying down basic safety standards for protection against the
p.000019: dangers from exposure to ionising radiation. The Directive repeals Directives 89/618/Euratom,
p.000019: 90/641/Euratom, 96/26/Euratom, 97/43/Euratom and 20013/122/Euratom.
p.000019: In particular, these Regulations transpose Directive requirements relating to dangers arising from ionising radiation
p.000019: in relation to medical exposure. They impose duties on employers and those with responsibilities for
...
Social / Trade Union Membership
Searching for indicator union:
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p.000002:
p.000002: Citation and commencement
p.000002: 1. These Regulations may be cited as the Ionising Radiation (Medical Exposure) Regulations 2017 and come into
p.000002: force on 6th February 2018.
p.000002:
p.000002: Interpretation
p.000002: 2.—(1) In these Regulations—
p.000002: “accidental exposure” means an exposure of an individual as a result of an accident;
p.000002: “adequate training” means training which satisfies the requirements of Schedule 3 and the expression
p.000002: “adequately trained” is to be construed accordingly;
p.000002: “assessment” means prior determination of amount, parameter or method;
p.000002: “carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation by
p.000002: helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having
p.000002: undergone an exposure;
p.000002: “clinical audit” means a systematic examination or review of medical radiological procedures which seeks to improve
p.000002: the quality and outcome of patient care through structured review, whereby medical radiological practices,
p.000002: procedures and results are examined against agreed standards for good medical radiological procedures, with
p.000002: modification of practices, where indicated, and the application of new standards if necessary;
p.000002:
p.000002:
p.000002:
p.000002: (a) S.I. 1977/1718; there are no relevant amendments.
p.000002: (b) 1972 c. 68; section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.
p.000002: 51), and by Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c. 7). In so far as these Regulations
p.000002: deal with matters that are within the devolved competence of Scottish Ministers, the power of the
p.000002: Secretary of State to make regulations in relation to those matters in or as regards Scotland is preserved by
p.000002: section 57(1) of the Scotland Act 1998 (c. 46).
p.000002: (c) 1973 c. 51; amendments have been made to section 56 by S.I. 2011/1043; there are other amendments to that
p.000002: section which are not relevant for the purposes of these Regulations.
p.000002:
p.000002: “diagnostic reference levels” means dose levels in medical radiodiagnostic or interventional radiology practices,
p.000002: or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of
p.000002: standard-sized individuals or standard phantoms for broadly defined types of equipment;
p.000002: “dose constraint” means a restriction set on the prospective doses of individuals which may result from a given
p.000002: radiation source;
p.000002: “employer” means any person who, in the course of a trade, business or other undertaking, carries out (other
p.000002: than as an employee), or engages others to carry out, those exposures described in regulation 3 or practical
p.000002: aspects, at a given radiological installation;
p.000002: “employer’s procedures” means the procedures established by an employer pursuant to regulation 6(1);
p.000002: “equipment” means equipment which—
p.000002: (a) delivers ionising radiation to a person undergoing exposure; or
p.000002: (b) which directly controls or influences the extent of such exposure;
p.000002: “evaluation” means interpretation of the outcome and implications of, and of the information resulting from, an
p.000002: exposure;
...
Social / education
Searching for indicator education:
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p.000003: paragraph (1).
p.000003:
p.000003: Requirement to hold a licence
p.000003: 5.—(1) A person must hold a valid licence issued by the Licensing Authority if that person—
p.000003: (a) is an employer, in which case that person must hold a licence in respect of each radiological
p.000003: installation at which radioactive substances are to be administered for such purposes as may be specified in that
p.000003: licence; or
p.000003: (b) is a practitioner, in which case that person must hold a licence in order to justify, within the meaning of
p.000003: regulation 11 an exposure involving the administration of radioactive substances for such purposes as may be
p.000003: specified in that licence.
p.000003: (2) In this regulation, “purpose” when describing the purpose for which a licence is issued, means
p.000003: diagnosis, treatment or research.
p.000003:
p.000003: Employer’s duties: establishment of general procedures, protocols and quality assurance programmes
p.000003: 6.—(1) The employer must ensure that written procedures are in place in respect of—
p.000003: (a) those matters described in Schedule 2; and
p.000003: (b) any other matter in relation to which these Regulations mandate the establishment of procedures.
p.000003: (2) The employer must take steps to ensure that any written procedures are complied with by the referrer, practitioner
p.000003: and operator.
p.000003: (3) The employer must take steps to ensure that every practitioner or operator engaged by the employer to carry out
p.000003: exposures or any practical aspect—
p.000003: (a) complies with the provisions of regulation 17(1); and
p.000003: (b) undertakes continuing education and training after qualification including, in the case of clinical use of new
p.000003: techniques, training related to those techniques and the relevant radiation protection requirements.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: (4) The employer must ensure, where appropriate, that written protocols are in place for every type of standard
p.000004: radiological practice coming within these Regulations, including practices involving non-medical imaging.
p.000004: (5) The employer must—
p.000004: (a) establish recommendations concerning referral guidelines for medical exposures, including radiation
p.000004: doses, and ensure that these are available to the referrer;
p.000004: (b) establish quality assurance programmes for written procedures and written protocols;
p.000004: (c) regularly review and make available to an operator, diagnostic reference levels in respect of an exposure falling
p.000004: within—
p.000004: (i) regulation 3(a)—
p.000004: (aa) where the exposure involves interventional radiology procedures, in which case, diagnostic references
p.000004: levels are to be provided where appropriate; and
p.000004: (bb) where the exposure does not involve interventional radiology procedures, in which cases regard must be had to
p.000004: European and national diagnostic reference levels where available;
p.000004: (ii) regulation 3(b) or (e) in which cases regard must be had to European and national diagnostic reference levels
p.000004: where available;
p.000004: (iii) regulation 3(f) where practicable;
p.000004: (d) establish dose constraints—
p.000004: (i) for biomedical and medical research programmes falling within regulation 3(c) where no direct medical
p.000004: benefit for the individual is expected from the exposure; and
...
Social / employees
Searching for indicator employees:
(return to top)
p.000018: “medical exposure”—
p.000018: (a) in Northern Ireland has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations
p.000018: 2000; and
p.000018: (b) in England and Wales and Scotland has the same meaning as in the Ionising Radiation (Medical
p.000018: Exposure) Regulations 2017; and
p.000018: “radioactive medicinal product” means a medicinal product which consists of, contains or generates a radioactive
p.000018: substance so that, when the product is administered, the radiation it emits may be used.”.
p.000018:
p.000018: Amendment of the Ionising Radiations Regulations 2017
p.000018: 3.—(1) The Ionising Radiations Regulations 2017(a) are amended as follows.
p.000018: (2) In regulation 2(1) (interpretation)—
p.000018: (a) omit the definition of “carers and comforters”;
p.000018: (b) insert after the definition of “calendar year”—
p.000018: ““carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation
p.000018: by helping, other than as part of their occupation, in the
p.000018:
p.000018:
p.000018:
p.000018: (a) S.I. 2017/1075.
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: support and comfort of individuals undergoing or having undergone a medical exposure (other than as a carer and
p.000019: comforter);”;
p.000019: (c) in the definition of “medical exposure”, after paragraph (d), insert— “(e) carers and comforters;”.
p.000019: (3) In regulation 3 (application)—
p.000019: (a) in paragraph (2), omit “33”;
p.000019: (b) omit paragraph (4).
p.000019: (4) Omit regulation 33 (equipment used for medical exposure).
p.000019: (5) In regulation 35(6) (duties of employees)—
p.000019: (a) in sub-paragraph (a), after “overexposure;” insert “or”;
p.000019: (b) in sub-paragraph (b), omit “or” the second time it appears;
p.000019: (c) omit sub-paragraph (c).
p.000019: (6) In regulation 38(2)(d) (exemption certificates)—
p.000019: (a) before “25(2)” insert “and”;
p.000019: (b) omit “and 33(1)”.
p.000019: EXPLANATORY NOTE
p.000019: (This note is not part of the Regulations)
p.000019: These Regulations implement, as respects Great Britain, some of the provisions of Council Directive
p.000019: 2013/59/Euratom (OJ No L13,17.1.2014, p1) laying down basic safety standards for protection against the
p.000019: dangers from exposure to ionising radiation. The Directive repeals Directives 89/618/Euratom,
p.000019: 90/641/Euratom, 96/26/Euratom, 97/43/Euratom and 20013/122/Euratom.
p.000019: In particular, these Regulations transpose Directive requirements relating to dangers arising from ionising radiation
p.000019: in relation to medical exposure. They impose duties on employers and those with responsibilities for
p.000019: administering ionising radiation to protect persons undergoing medical exposures whether as part of their
p.000019: own medical diagnosis or treatment, as part of research, as asymptomatic individuals, as those undergoing
p.000019: non-medical imaging using medical radiological equipment or as carers and comforters of persons undergoing medical
p.000019: exposures.
p.000019: These Regulations revoke other Regulations relating to medical exposures and prior-authorisation for the
p.000019: administration of radioactive substances for the purposes of diagnosis, treatment and research.
...
Social / gender
Searching for indicator gender:
(return to top)
p.000008: (8) In complying with the obligations under this regulation, the practitioner and the operator must pay
p.000008: particular attention in relation to—
p.000008: (a) medical exposures of children;
p.000008: (b) medical exposures as part of a health screening programme;
p.000008: (c) medical exposures involving high doses to the individual being exposed;
p.000008: (d) where appropriate, individuals in whom pregnancy cannot be excluded and who are undergoing a medical
p.000008: exposure, in particular if abdominal and pelvic regions are involved, taking into account the exposure of both
p.000008: the individual and any unborn child; and
p.000008: (e) where appropriate, individuals who are breastfeeding and who are undergoing a medical exposure involving the
p.000008: administration of radioactive substances, taking into account the exposure of both the individual and the child.
p.000008: (9) The employer must take steps to ensure that a clinical evaluation of the outcome of each exposure,
p.000008: other than where the person subject to the exposure is a carer or a comforter, is recorded in accordance with the
p.000008: employer’s procedures including, where appropriate, factors relevant to patient dose.
p.000008:
p.000008: Estimates of population doses
p.000008: 13. The employer must collect dose estimates from medical exposures for radiodiagnostic and interventional procedures,
p.000008: taking into consideration the distribution by age and gender of the exposed population and, when so
p.000008: requested, must provide the dose estimates to the Secretary of State.
p.000008:
p.000008: Expert advice
p.000008: 14.—(1) The employer must ensure that a suitable medical physics expert is appointed and involved, in
p.000008: accordance with paragraph (2), in relation to every type of exposure to which these Regulations apply.
p.000008: (2) A medical physics expert must—
p.000008: (a) be closely involved in every radiotherapeutic practice other than standardised therapeutic nuclear medicine
p.000008: practices;
p.000008: (b) be involved in practices including standardised therapeutic nuclear medicine practices, diagnostic
p.000008: nuclear medicine practices and high dose interventional radiology and high dose computed tomography;
p.000008: (c) be involved as appropriate for consultation on optimisation, in all other radiological practices not
p.000008: mentioned in sub-paragraphs (b) and (c); and
p.000008: (d) give advice on—
p.000008: (i) dosimetry and quality assurance matters relating to radiation protection concerning exposures;
p.000008: (ii) physical measurements for the evaluation of dose delivered;
p.000008: (iii) medical radiological equipment.
p.000008: (3) A medical physics expert must also contribute to the following matters—
p.000008: (a) optimisation of the radiation protection of patients and other individuals subject to exposures,
p.000008: including the application and use of diagnostic reference levels;
p.000008: (b) the definition and performance of quality assurance of the equipment;
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: (c) acceptance testing of equipment;
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000006: Secretary of State;
p.000006: (d) the urgency of the exposure, where appropriate, in cases involving—
p.000006: (i) an individual where pregnancy cannot be excluded, in particular if abdominal and pelvic regions are
p.000006: involved, taking into account the exposure of both the person concerned and any unborn child; and
p.000006: (ii) an individual who is breastfeeding and who undergoes an exposure involving the administration of
p.000006: radioactive substances, taking into account the exposure of both the individual and the child.
p.000006: (4) In deciding whether to justify an exposure under paragraph (1)(b) the practitioner must take account of any data
p.000006: supplied by the referrer pursuant to regulation 10(5) and must consider such data in order to avoid unnecessary
p.000006: exposure.
p.000006: (5) Where it is not practicable for the practitioner to authorise an exposure as required by paragraph
p.000006: (1)(c), the operator must do so in accordance with guidelines issued by the practitioner.
p.000006: (6) In this regulation—
p.000006: “ethics committee” means—
p.000006: (a) an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical
p.000006: Trials) Regulations 2004(a);
p.000006: (b) the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of
p.000006: the Adults with Incapacity (Scotland) Act 2000(b); or
p.000006: (c) any other committee established to advise on the ethics of research investigations in human beings,
p.000006: and recognised for that purpose by or on behalf of the Secretary of State, the Scottish Ministers or the Welsh
p.000006: Ministers; and
p.000006:
p.000006:
p.000006: (a) S.I. 2004/1031.
p.000006: (b) 2000 asp 4.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: “individual detriment” means clinically observable deleterious effects in individuals or their descendants, the
p.000007: appearance of which is either immediate or delayed and, in the latter case, implies a probability rather than a
p.000007: certainty of appearance.
p.000007:
p.000007: Optimisation
p.000007: 12.—(1) In relation to all exposures to which these Regulations apply except radiotherapeutic exposures, the
p.000007: practitioner and the operator, to the extent of their respective involvement in an exposure, must ensure
p.000007: that doses arising from the exposure are kept as low as reasonably practicable consistent with the intended
p.000007: purpose.
p.000007: (2) In relation to all radiotherapeutic exposures the practitioner must ensure that exposures of target volumes
p.000007: are individually planned and their delivery appropriately verified taking into account that doses to
p.000007: non-target volumes and tissues must be as low as reasonably practicable and consistent with the intended
p.000007: radiotherapeutic purpose of the exposure.
p.000007: (3) Without prejudice to paragraphs (1) and (2), the operator must select equipment and methods to ensure that for
p.000007: each exposure the dose of ionising radiation to the individual undergoing the exposure is as low as
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000012: (b) upon request in writing, any other information which the Licensing Authority requires for the purpose of
p.000012: considering the licence application; and
p.000012: (c) the fee specified in paragraph 4.
p.000012: (3) A person issued a licence under these Regulations (“the licensee”) must apply to the Licensing
p.000012: Authority if the licensee seeks a material change to the licence in respect of any matter dealt with by that licence.
p.000012:
p.000012: Licence applications: indicative list of information
p.000012: 2. The information referred to in paragraph 1(2) is information relating to—
p.000012: (a) responsibilities and organisational arrangements for protection and safety;
p.000012: (b) staff competences, including information and training;
p.000012: (c) design features of the radiological installation and of radiation sources;
p.000012: (d) anticipated occupational and public exposures in normal operation;
p.000012: (e) safety assessment of the activities and the facility in order to—
p.000012: (i) identify ways in which potential exposures or accidental and unintended medical exposures could occur;
p.000012: (ii) estimate, to the extent practicable, the probabilities and magnitude of potential exposures;
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: (iii) assess the quality and extent of protection and safety provisions, including engineering
p.000013: features, as well as administrative procedures;
p.000013: (iv) define the operational limits and conditions of operation;
p.000013: (f) emergency procedures;
p.000013: (g) maintenance, testing, inspection and servicing so as to ensure that the radiation source and the
p.000013: facility continue to meet the design requirements, operational limits and conditions of operation
p.000013: throughout their lifetime;
p.000013: (h) management of radioactive waste and arrangements for the disposal of such waste, in accordance with
p.000013: applicable regulatory requirements;
p.000013: (i) management of disused sources;
p.000013: (j) quality assurance.
p.000013:
p.000013: Licence applications: urgent cases
p.000013: 3. The licensing authority may, on a case by case basis, relax any of the requirements relating to the making of an
p.000013: application for a licence in respect of a proposed urgent medical radiological exposure.
p.000013:
p.000013: Licence applications: employer fees
p.000013: 4.—(1) The fee payable by a person described in column 1 of Table 1 in respect of an application type
p.000013: specified in column 2 of that table is the corresponding amount in column 3.
p.000013: (2) No fee is payable where the amount specified in column 2 is “0”.
p.000013: Table 1
p.000013: Licence type (1) Application type (2) Fee (£) (3)
p.000013: Employer New 250
p.000013:
p.000013: Amendment of an existing licence
p.000200: 200
p.000200: Renewal of an existing licence 200 Notification 0
p.000200: Practitioner New 0
p.000200: Amendment of an existing 0
p.000200: licence
p.000200: Renewal of an existing licence 0 Particular patient request 0
p.000200:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000002:
p.000002: S T A T U T O R Y I N S T R U M E N T S
p.000002:
p.000002:
p.000002: 2017 No. 1322 HEALTH AND SAFETY
p.000002: The Ionising Radiation (Medical Exposure) Regulations 2017
p.000002:
p.000002: Made - - - - 20th December 2017
p.000002: Laid before Parliament 22nd December 2017
p.000002: Coming into force - - 6th February 2018
p.000002:
p.000002: The Secretary of State, being the Minister designated(a) for the purposes of section 2(2) of the European
p.000002: Communities Act 1972(b) in relation to safety measures in regard to radioactive substances and the
p.000002: emission of ionising radiation, in exercise of the powers conferred by that section and by section 56
p.000002: of the Finance Act 1973(c), makes the following Regulations. Regulation 4 and Schedule 1 (the Licensing
p.000002: Authority) are made with the consent of the Treasury.
p.000002:
p.000002: Citation and commencement
p.000002: 1. These Regulations may be cited as the Ionising Radiation (Medical Exposure) Regulations 2017 and come into
p.000002: force on 6th February 2018.
p.000002:
p.000002: Interpretation
p.000002: 2.—(1) In these Regulations—
p.000002: “accidental exposure” means an exposure of an individual as a result of an accident;
p.000002: “adequate training” means training which satisfies the requirements of Schedule 3 and the expression
p.000002: “adequately trained” is to be construed accordingly;
p.000002: “assessment” means prior determination of amount, parameter or method;
p.000002: “carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation by
p.000002: helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having
p.000002: undergone an exposure;
p.000002: “clinical audit” means a systematic examination or review of medical radiological procedures which seeks to improve
p.000002: the quality and outcome of patient care through structured review, whereby medical radiological practices,
p.000002: procedures and results are examined against agreed standards for good medical radiological procedures, with
p.000002: modification of practices, where indicated, and the application of new standards if necessary;
p.000002:
p.000002:
p.000002:
p.000002: (a) S.I. 1977/1718; there are no relevant amendments.
p.000002: (b) 1972 c. 68; section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.
...
p.000002: or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of
p.000002: standard-sized individuals or standard phantoms for broadly defined types of equipment;
p.000002: “dose constraint” means a restriction set on the prospective doses of individuals which may result from a given
p.000002: radiation source;
p.000002: “employer” means any person who, in the course of a trade, business or other undertaking, carries out (other
p.000002: than as an employee), or engages others to carry out, those exposures described in regulation 3 or practical
p.000002: aspects, at a given radiological installation;
p.000002: “employer’s procedures” means the procedures established by an employer pursuant to regulation 6(1);
p.000002: “equipment” means equipment which—
p.000002: (a) delivers ionising radiation to a person undergoing exposure; or
p.000002: (b) which directly controls or influences the extent of such exposure;
p.000002: “evaluation” means interpretation of the outcome and implications of, and of the information resulting from, an
p.000002: exposure;
p.000002: “health screening” means a procedure for early diagnosis in population groups at risk;
p.000002: “interventional radiology” means the use of X-ray imaging techniques to facilitate the introduction and
p.000002: guidance of devices in the body for diagnostic or treatment purposes;
p.000002: “ionising radiation” means the transfer of energy in the form of particles or electromagnetic waves of a wavelength of
p.000002: 100 nanometres or less or a frequency of 3 × 1015 hertz or more capable of producing ions directly or indirectly;
p.000002: “Licensing Authority”—
p.000002: (a) for the purpose of licensing any practitioner in respect of the administration of radioactive substances means
p.000002: the Secretary of State;
p.000002: (b) for the purpose of licensing any employer in respect of the administration of radioactive substances means—
p.000002: (i) in England, the Secretary of State;
p.000002: (ii) in Scotland, the Scottish Ministers; and
p.000002: (iii) in Wales, the Welsh Ministers;
p.000002: “medical exposure” means an exposure coming within any of paragraphs (a) to (e) of regulation 3;
p.000002: “medical physics expert” means an individual or a group of individuals, having the knowledge,
p.000002: training and experience to act or give advice on matters relating to radiation physics applied to exposure,
p.000002: whose competence in this respect is recognised by the Secretary of State;
p.000002: “medical radiological” means pertaining to radiodiagnostic and radiotherapeutic procedures, and interventional
p.000002: radiology or other medical uses of ionising radiation for planning, guiding and verification purposes;
p.000002: “medical radiological procedure” means any procedure giving rise to a medical exposure;
p.000002: “non-medical imaging exposure” means any deliberate exposure of humans for imaging purposes where the primary
p.000002: intention of the exposure is not to bring a health benefit to the individual being exposed;
p.000002: “operator” means any person who is entitled, in accordance with the employer’s procedures, to carry out practical
p.000002: aspects including those to whom practical aspects have been allocated, medical physics experts and, except
p.000002: where they do so under the direct supervision of a person who is adequately trained, persons participating in
p.000002: practical aspects as part of practical training;
...
p.000002: that a structure, system, component or procedure will perform satisfactorily in compliance with
p.000002: generally applicable standards and quality control is a part of quality assurance;
p.000002: “quality control” means the set of operations (programming, coordinating, implementing) intended to
p.000002: maintain or to improve quality and includes monitoring, evaluation and maintenance at required levels
p.000002: of all characteristics of performance of equipment that can be defined, measured, and controlled;
p.000002: “radioactive substance” means any substance that contains one or more radionuclides the activity or activity
p.000002: concentration of which cannot be disregarded from a radiation protection point of view;
p.000002: “radiodiagnostic” means pertaining to in-vivo diagnostic nuclear medicine, medical diagnostic radiology using ionising
p.000002: radiation, and dental radiology;
p.000002: “radiological installation” means a facility where exposures to which these Regulations apply are performed;
p.000002: “radiotherapeutic” means pertaining to radiotherapy, including nuclear medicine for therapeutic
p.000002: purposes;
p.000002: “referrer” means a registered health care professional who is entitled in accordance with the employer’s procedures to
p.000002: refer individuals for exposure to a practitioner;
p.000002: “registered health care professional” means a person who is a member of a profession regulated by a body
p.000002: mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002(a);
p.000002: “relevant enforcing authority” means—
p.000002: (a) in England, the Care Quality Commission(b);
p.000002: (b) in Scotland, the Scottish Ministers; and
p.000002: (c) in Wales, the Welsh Ministers;
p.000002: “unintended exposure” means any exposure to ionising radiation which is significantly different from the
p.000002: exposure intended for a given purpose.
p.000002: (2) In these Regulations, where an individual is—
p.000002: (a) an employer;
p.000002: (b) a referrer;
p.000002: (c) an operator; or
p.000002: (d) a practitioner,
p.000002: and is also an individual coming within at least one other of sub-paragraphs (a) to (d), that
p.000002: individual is subject to each of the duties applying to every person described in a sub-paragraph which also describes
p.000002: that individual.
p.000002:
p.000002:
p.000002:
p.000002: (a) 2002 c. 17. Section 25 has been amended by paragraph 17 of Schedule 10 and Part 2 of Schedule 15 the Health and
p.000002: Social Care Act 2008 (c. 14), sections 220, 222 and 224 of and paragraphs 56 and 62 of Schedule 15 to the Health and
p.000002: Social Care act 2012 (c. 7), section 5(1) of the Health and Social Care (Safety and Quality) Act 2015 (c. 28),
p.000002: paragraph 1 and 2 of Schedule 4 to the Children and Social Work Act 2017 (c. 16).
p.000002: (b) Established by section 1 of the Health and Social Care Act 2008 (c. 14).
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Application
p.000003: 3. These Regulations apply to the exposure of ionising radiation in England and Wales and Scotland—
p.000003: (a) to patients as part of their own medical diagnosis or treatment;
p.000003: (b) to individuals as part of health screening programmes;
p.000003: (c) to patients or other persons voluntarily participating in medical or biomedical, diagnostic or therapeutic,
p.000003: research programmes;
p.000003: (d) to carers and comforters;
p.000003: (e) to asymptomatic individuals;
p.000003: (f) to individuals undergoing non-medical imaging using medical radiological equipment.
p.000003:
p.000003: The Licensing Authority
p.000003: 4.—(1) The Licensing Authority may upon payment of a fee (where required) issue a licence to a person required by these
p.000003: Regulations to hold a licence.
p.000003: (2) A licence described in paragraph (1) may be—
p.000003: (a) issued for such period as the Licensing Authority considers appropriate;
p.000003: (b) subject to such conditions as the Licensing Authority may consider appropriate; and
p.000003: (c) varied or revoked at any time.
p.000003: (3) Schedule 1 makes further provision relating to the application for, and the issue of, a licence described in
p.000003: paragraph (1).
p.000003:
p.000003: Requirement to hold a licence
p.000003: 5.—(1) A person must hold a valid licence issued by the Licensing Authority if that person—
p.000003: (a) is an employer, in which case that person must hold a licence in respect of each radiological
p.000003: installation at which radioactive substances are to be administered for such purposes as may be specified in that
p.000003: licence; or
p.000003: (b) is a practitioner, in which case that person must hold a licence in order to justify, within the meaning of
p.000003: regulation 11 an exposure involving the administration of radioactive substances for such purposes as may be
p.000003: specified in that licence.
p.000003: (2) In this regulation, “purpose” when describing the purpose for which a licence is issued, means
p.000003: diagnosis, treatment or research.
p.000003:
p.000003: Employer’s duties: establishment of general procedures, protocols and quality assurance programmes
p.000003: 6.—(1) The employer must ensure that written procedures are in place in respect of—
p.000003: (a) those matters described in Schedule 2; and
p.000003: (b) any other matter in relation to which these Regulations mandate the establishment of procedures.
p.000003: (2) The employer must take steps to ensure that any written procedures are complied with by the referrer, practitioner
p.000003: and operator.
p.000003: (3) The employer must take steps to ensure that every practitioner or operator engaged by the employer to carry out
p.000003: exposures or any practical aspect—
p.000003: (a) complies with the provisions of regulation 17(1); and
p.000003: (b) undertakes continuing education and training after qualification including, in the case of clinical use of new
p.000003: techniques, training related to those techniques and the relevant radiation protection requirements.
p.000003:
p.000003:
p.000003:
...
p.000004: 8.—(1) The employer’s procedures must provide that the referrer, the practitioner, and the individual
p.000004: exposed or their representative (if there is one) are informed of the occurrence of a clinically
p.000004: significant unintended or accidental exposure and of the outcome of the analysis of this exposure.
p.000004: (2) The employer’s quality assurance programme must, in respect of radiotherapeutic practices, include a study of the
p.000004: risk of accidental or unintended exposures.
p.000004: (3) The employer must establish a system for recording analyses of events involving or potentially
p.000004: involving accidental or unintended exposures proportionate to the radiological risk posed by the practice.
p.000004: (4) Where the employer knows or has reason to believe that an accidental or unintended exposure has or may
p.000004: have occurred in which a person, while undergoing—
p.000004: (a) any exposure, was or could have been exposed to levels of ionising radiation significantly greater than those
p.000004: generally considered to be proportionate in the circumstances;
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: (b) a radiotherapeutic exposure was or could have been exposed to levels of ionising radiation
p.000005: significantly lower than those generally considered to be proportionate in the circumstances,
p.000005: the employer must—
p.000005: (i) undertake an immediate preliminary investigation of the incident;
p.000005: (ii) unless that investigation shows beyond a reasonable doubt that no such exposure has occurred, immediately notify
p.000005: the relevant enforcing authority;
p.000005: (iii) conduct or arrange for a detailed investigation of the circumstances of the exposure and an assessment of the
p.000005: dose received; and
p.000005: (iv) notify the relevant enforcing authority, within the time period specified by the relevant enforcing
p.000005: authority, of the outcome of the investigation and any corrective measures adopted.
p.000005:
p.000005: Relevant enforcing authority’s duties: accidental or unintended exposure
p.000005: 9. The relevant enforcing authority must put in place mechanisms enabling the timely
p.000005: dissemination of information, relevant to radiation protection in respect of medical exposures, regarding
p.000005: lessons learned from significant events.
p.000005:
p.000005: Duties of the practitioner, operator and referrer
p.000005: 10.—(1) The practitioner and the operator must comply with the employer’s procedures.
p.000005: (2) The practitioner is responsible for the justification of an exposure and such other aspects of an exposure as is
p.000005: provided for in these Regulations.
p.000005: (3) Practical aspects of an exposure or part of it may be allocated in accordance with the employer’s
p.000005: procedures by the employer or the practitioner, as appropriate, to one or more individuals entitled to act
p.000005: in this respect in a recognised field of specialisation.
p.000005: (4) The operator is responsible for each practical aspect which the operator carries out as well as for any
p.000005: authorisation given pursuant to regulation 11(5).
p.000005: (5) The referrer must supply the practitioner with sufficient medical data (such as previous diagnostic
p.000005: information or medical records) relevant to the exposure requested by the referrer to enable the practitioner to
p.000005: decide whether there is a sufficient net benefit as required by regulation 11(1)(b).
p.000005: (6) The practitioner and the operator must cooperate, regarding practical aspects, with other specialists
p.000005: and staff involved in an exposure, as appropriate.
p.000005:
p.000005: Justification of individual exposures
p.000005: 11.—(1) A person must not carry out an exposure unless—
p.000005: (a) in the case of the administration of radioactive substances, the practitioner and employer are licensed to
...
p.000009: (i) the provision of advice to an employer relating to compliance with these Regulations.
p.000009: (4) The medical physics expert must, where appropriate, liaise with a radiation protection adviser and a
p.000009: radioactive waste adviser.
p.000009: (5) In this regulation—
p.000009: (a) “radiation protection adviser” means an individual who, or a body which is competent to advise on radiation
p.000009: protection in relation to occupational and public exposures;
p.000009: (b) “radioactive waste adviser” means an individual who, or a body which is competent to provide expert advice on
p.000009: radioactive waste management and environmental radiation protection.
p.000009:
p.000009: Equipment: general duties of the employer
p.000009: 15.—(1) An employer who has control over any equipment must—
p.000009: (a) implement and maintain a quality assurance programme in respect of that equipment which must as a
p.000009: minimum permit—
p.000009: (i) the assessment of the dose of ionising radiation that a person may be exposed to from an exposure to
p.000009: which these Regulations apply, by way of the ordinary operation of that equipment; and
p.000009: (ii) the administered activity to be verified;
p.000009: (b) draw up, keep up-to-date and preserve at each radiological installation an inventory of equipment at
p.000009: that installation and, when so requested, must provide it to the relevant enforcing authority.
p.000009: (2) The inventory referred to in paragraph (1)(b) must contain the following information—
p.000009: (a) name of manufacturer;
p.000009: (b) model number;
p.000009: (c) serial number or other unique identifier;
p.000009: (d) year of manufacture; and
p.000009: (e) year of installation.
p.000009: (3) An employer must undertake adequate—
p.000009: (a) testing of any equipment before it is first used for a medical radiological purpose;
p.000009: (b) performance testing at regular intervals;
p.000009: (c) performance testing following a maintenance procedure which is capable of affecting the equipment’s performance.
p.000009: (4) A person must not use fluoroscopy equipment unless that equipment features—
p.000009: (a) a device to control automatically the dose rate; or
p.000009: (b) an image intensifier or equivalent device.
p.000009: (5) Equipment used for interventional radiology and computed tomography must have a device or other feature capable
p.000009: of informing the practitioner, at the end of an exposure of relevant parameters for assessing the patient
p.000009: dose.
p.000009: (6) An employer must—
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: (a) put in place any measures necessary to improve inadequate or defective performance of equipment;
p.000010: (b) specify acceptable performance criteria for equipment; and
p.000010: (c) specify what corrective action is necessary when, following the application of any criteria specified under
p.000010: paragraph (b), equipment is ascertained to be defective; such corrective action may include taking the equipment out of
p.000010: service.
p.000010:
p.000010: Equipment installed on or after 6th February 2018 16.—(1) This regulation only applies in respect of—
p.000010: (a) equipment installed on or after 6th February 2018; and
...
p.000010: informing the practitioner, at the end of an exposure, of relevant parameters for assessing the dose.
p.000010: (5) Equipment used for interventional radiology and computed tomography must have the capacity to transfer,
p.000010: to the record of a person’s exposure, information relating to relevant parameters for assessing the dose.
p.000010: (6) Insofar as not already provided in this regulation, any equipment producing ionising radiation must—
p.000010: (a) have a device, or other feature, capable of informing the practitioner of relevant parameters for
p.000010: assessing the patient dose; and
p.000010: (b) where appropriate, have the capacity to transfer this information to the record of a person’s
p.000010: exposure.
p.000010:
p.000010: Training
p.000010: 17.—(1) Subject to the following provisions of this regulation a practitioner or operator must not carry out any
p.000010: exposure or any practical aspect without having been adequately trained.
p.000010: (2) A certificate issued by an institute or person competent to award degrees or diplomas or to provide other evidence
p.000010: of adequate training is, if such certificate so attests, sufficient proof that the person to whom it has been issued
p.000010: has been adequately trained.
p.000010: (3) Nothing in paragraph (1) above prevents a person from participating in practical aspects of the procedure as part
p.000010: of practical training if this is done under the supervision of a person who is adequately trained.
p.000010: (4) The employer must keep and have available for inspection by the relevant enforcing authority an
p.000010: up-to-date record of all relevant training undertaken by all practitioners and operators engaged by the employer to
p.000010: carry out any exposures or any practical aspect of such exposures showing the date or dates on which training
p.000010: qualifying as adequate training was completed and the nature of the training.
p.000010: (5) Where the employer (“employer A”) enters into a contract with another employer (“employer
p.000010: B”) to engage a practitioner or operator otherwise employed by that employer B, employer B is responsible
p.000010: for keeping the records required by paragraph (4) and must supply such records to employer A immediately upon request.
p.000010: (6) Schedule 3 makes further provision about the training of practitioners and operators.
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: Enforcement
p.000011: 18. These Regulations are to be enforced by the relevant enforcing authority as if they were health and
p.000011: safety regulations made under section 15 of the Health and Safety at Work etc. Act 1974(a) and the provisions of
p.000011: that Act, as regards enforcement and offences, are to apply for the purposes of these Regulations.
p.000011:
p.000011: Defence of due diligence
p.000011: 19. In any proceedings against any person for an offence consisting of the contravention of these Regulations it is a
p.000011: defence for that person to show that the person took all reasonable steps and exercised all due diligence to avoid
p.000011: committing the offence.
p.000011:
p.000011: Revocation and transitional provision
p.000011: 20.—(1) The Ionising Radiation (Medical Exposure) Regulations 2000(b) are revoked.
p.000011: (2) Subject to the transitional provisions in paragraph (3), the Medicines (Administration of Radioactive
p.000011: Substances) Regulations 1978(c) and the Medicines (Radioactive Substances) Order 1978(d) are also revoked to the extent
p.000011: that they apply in England and Wales and Scotland.
p.000011: (3) Any certificate issued to a person under the Medicines (Administration of Radioactive Substances)
p.000011: Regulations 1978 which is valid on 6th February 2018 is deemed—
p.000011: (a) to be a licence issued under these Regulations for as long as that certificate remains valid; and
p.000011: (b) to license the employer responsible for the medical radiological installation for the matters
p.000011: specified in that certificate.
p.000011: (4) Nothing in paragraph (3) prevents a person from applying for a licence under these Regulations on or
p.000011: after the date that they come into force.
p.000011:
p.000011: Consequential amendments
p.000011: 21. Schedule 4 sets out amendments consequential on the making of these Regulations.
p.000011:
p.000011: Review
...
p.000011: (5) Section 30(4) of the Small Business, Enterprise and Employment Act 2015 requires that a report published under this
p.000011: regulation must, in particular—
p.000011:
p.000011: (a) 1974 c. 37; section 15(1) was substituted by paragraph 6 of Schedule 15 to the Employment Protection Act 1975
p.000011: (c. 71) and amended by S.I. 2002/794. There are other amendments to section 15 not relevant for the purposes of these
p.000011: Regulations.
p.000011: (b) S.I. 2000/1059; amended by paragraph (1) of Schedule 8 to the Care Act 2014 (c. 23), S.I. 2004/1031, S.I.
p.000011: 2006/2523, S.I. 2006/2806, S.I. 2007/1898, S.I. 2009/462, S.I. 2011/1567 and S.I. 2012/1916.
p.000011: (c) S.I. 1978/1006, amended by S.I. 1995/2147, 2005/2754 and 2006/2407. (d) S.I. 1978/1004, amended by S.I.
p.000011: 2006/2407.
p.000011: (e) 2015 c. 26. Section 30(3) was amended by the Enterprise Act 2016 (c. 12), section 19. (f) OJ No
p.000011: L13,17.1.2041, p1.
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: (a) set out the objectives intended to be achieved by the regulatory provision referred to in paragraph (1)(a);
p.000012: (b) assess the extent to which those objectives are achieved;
p.000012: (c) assess whether those objectives remain appropriate; and
p.000012: (d) if those objectives remain appropriate, assess the extent to which they could be achieved in another way which
p.000012: involves less onerous regulatory provision.
p.000012: (6) In this regulation, “regulatory provision” has the same meaning as in sections 28 to 32 of the Small Business,
p.000012: Enterprise and Employment Act 2015 (see section 32 of that Act).
p.000012:
p.000012: Signed by authority of the Secretary of State for Health.
p.000012: Stephen Brine
p.000012: Parliamentary Under-Secretary of State,
p.000012: 20th December 2017 Department
p.000012: of Health
p.000012:
p.000012: We consent
p.000012: Mark Spencer Heather Wheeler
p.000012: 20th December 2017 Two of the Lords Commissioners of Her Majesty’s Treasury
p.000012:
p.000012:
p.000012: SCHEDULE 1 Regulation 4
p.000012: Licensing
p.000012:
p.000012: Licence applications: general
p.000012: 1.—(1) A person required by regulation 5 to hold a licence must make an application to the Licensing
p.000012: Authority in the form specified from time to time by the Licensing Authority.
p.000012: (2) A person applying for a licence under sub-paragraph (1) must provide to the Licensing Authority—
p.000012: (a) such of the information described in paragraph 2 as the Licensing Authority may from time to time specify
p.000012: necessary to determine the licence application;
p.000012: (b) upon request in writing, any other information which the Licensing Authority requires for the purpose of
p.000012: considering the licence application; and
p.000012: (c) the fee specified in paragraph 4.
p.000012: (3) A person issued a licence under these Regulations (“the licensee”) must apply to the Licensing
p.000012: Authority if the licensee seeks a material change to the licence in respect of any matter dealt with by that licence.
p.000012:
p.000012: Licence applications: indicative list of information
p.000012: 2. The information referred to in paragraph 1(2) is information relating to—
p.000012: (a) responsibilities and organisational arrangements for protection and safety;
p.000012: (b) staff competences, including information and training;
p.000012: (c) design features of the radiological installation and of radiation sources;
p.000012: (d) anticipated occupational and public exposures in normal operation;
p.000012: (e) safety assessment of the activities and the facility in order to—
p.000012: (i) identify ways in which potential exposures or accidental and unintended medical exposures could occur;
p.000012: (ii) estimate, to the extent practicable, the probabilities and magnitude of potential exposures;
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: (iii) assess the quality and extent of protection and safety provisions, including engineering
p.000013: features, as well as administrative procedures;
p.000013: (iv) define the operational limits and conditions of operation;
p.000013: (f) emergency procedures;
p.000013: (g) maintenance, testing, inspection and servicing so as to ensure that the radiation source and the
p.000013: facility continue to meet the design requirements, operational limits and conditions of operation
p.000013: throughout their lifetime;
p.000013: (h) management of radioactive waste and arrangements for the disposal of such waste, in accordance with
p.000013: applicable regulatory requirements;
p.000013: (i) management of disused sources;
p.000013: (j) quality assurance.
p.000013:
p.000013: Licence applications: urgent cases
p.000013: 3. The licensing authority may, on a case by case basis, relax any of the requirements relating to the making of an
p.000013: application for a licence in respect of a proposed urgent medical radiological exposure.
p.000013:
p.000013: Licence applications: employer fees
p.000013: 4.—(1) The fee payable by a person described in column 1 of Table 1 in respect of an application type
p.000013: specified in column 2 of that table is the corresponding amount in column 3.
p.000013: (2) No fee is payable where the amount specified in column 2 is “0”.
p.000013: Table 1
p.000013: Licence type (1) Application type (2) Fee (£) (3)
p.000013: Employer New 250
p.000013:
p.000013: Amendment of an existing licence
p.000200: 200
p.000200: Renewal of an existing licence 200 Notification 0
p.000200: Practitioner New 0
p.000200: Amendment of an existing 0
p.000200: licence
p.000200: Renewal of an existing licence 0 Particular patient request 0
p.000200:
p.000200: Review
p.000200: 5.—(1) A person who is aggrieved (“an aggrieved person”) by—
p.000200: (a) a decision of the Licensing Authority—
p.000200: (i) refusing to issue a licence;
p.000200: (ii) imposing a limit of time upon a licence; or
p.000200: (iii) revoking a licence; or
p.000200: (b) the terms of any conditions attached to a licence by the Licensing Authority, may ask the Licensing Authority for
p.000200: a review.
p.000200: (2) Any aggrieved person seeking a review must—
p.000200: (a) within 28 days of the date that the person was notified of the decision, or the terms, which caused them to
p.000200: become an aggrieved person request the Licensing Authority to undertake a review described in paragraph (1) ; and
p.000200: (b) must particularise in writing the reasons for seeking the review.
p.000200:
p.000200:
p.000014: 14
p.000014:
p.000014: (3) The Licensing Authority must undertake a review, and provide the results of that review in writing to the aggrieved
p.000014: person.
p.000014:
p.000014: Destination of fees
p.000014: 6. A fee payable under these Regulations is payable to the Secretary of State.
p.000014:
p.000014:
p.000014:
p.000014: SCHEDULE 2 Regulation 6
p.000014: Employer’s Procedures
p.000014: 1. The employer’s written procedures for exposures must include procedures—
p.000014: (a) to identify correctly the individual to be exposed to ionising radiation;
p.000014: (b) to identify individuals entitled to act as referrer or practitioner or operator within a specified
p.000014: scope of practice;
p.000014: (c) for making enquiries of individuals of childbearing potential to establish whether the individual is
p.000014: or may be pregnant or breastfeeding;
p.000014: (d) to ensure that quality assurance programmes in respect of written procedures, written protocols, and
p.000014: equipment are followed;
p.000014: (e) for the assessment of patient dose and administered activity;
p.000014: (f) for the use and review of such diagnostic reference levels as the employer may have established
p.000014: for radiodiagnostic examinations falling within regulation 3(a), (b), (e) and (f);
p.000014: (g) for determining whether the practitioner or operator is required to effect one or more of the matters set out in
p.000014: regulation 12(4) including criteria on how to effect those matters and in particular procedures for the use of dose
p.000014: constraints established by the employer for biomedical and medical research programmes falling within regulation 3(c)
p.000014: where no direct medical benefit for the individual is expected from the exposure;
...
p.000019: (a) before “25(2)” insert “and”;
p.000019: (b) omit “and 33(1)”.
p.000019: EXPLANATORY NOTE
p.000019: (This note is not part of the Regulations)
p.000019: These Regulations implement, as respects Great Britain, some of the provisions of Council Directive
p.000019: 2013/59/Euratom (OJ No L13,17.1.2014, p1) laying down basic safety standards for protection against the
p.000019: dangers from exposure to ionising radiation. The Directive repeals Directives 89/618/Euratom,
p.000019: 90/641/Euratom, 96/26/Euratom, 97/43/Euratom and 20013/122/Euratom.
p.000019: In particular, these Regulations transpose Directive requirements relating to dangers arising from ionising radiation
p.000019: in relation to medical exposure. They impose duties on employers and those with responsibilities for
p.000019: administering ionising radiation to protect persons undergoing medical exposures whether as part of their
p.000019: own medical diagnosis or treatment, as part of research, as asymptomatic individuals, as those undergoing
p.000019: non-medical imaging using medical radiological equipment or as carers and comforters of persons undergoing medical
p.000019: exposures.
p.000019: These Regulations revoke other Regulations relating to medical exposures and prior-authorisation for the
p.000019: administration of radioactive substances for the purposes of diagnosis, treatment and research.
p.000019: Regulation 2 is an interpretation provision. Regulation 3 sets out the medical exposures to which the Regulations
p.000019: apply.
p.000019: Regulation 4 sets out conditions under which the Licensing Authority may issue a licence for the administration of
p.000019: radioactive substances. Further provisions relating to the application for and the issuing of such licences are
p.000019: contained in Schedule 1.
p.000019: Regulation 5 requires the employer and the practitioner who wish to administer radioactive substances to
p.000019: hold a valid licence issued by the Licensing Authority. Such licences will specify the radiological installation and
p.000019: purposes as appropriate.
p.000019: Regulation 6 requires the employer to establish a framework of general procedures, protocols and quality assurance
p.000019: programmes. The procedures must cover the matters set out in Schedule 2 as a minimum. Written protocols, where
p.000019: appropriate, must be in place for standard radiological practices. The employer must establish recommendations
p.000019: regarding referral guidelines, establish quality assurance programmes for standard operating procedures, review
p.000019: and make available diagnostic reference levels, establish dose constraints where appropriate and raise awareness of
p.000019: the effects of ionising radiation amongst individuals capable of childbearing or breastfeeding.
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Regulation 7 requires the employer’s procedures to include provision for clinical audit to be carried out.
p.000020: Regulation 8 sets out the duties of the employer in relation to accidental or unintended medical exposures including
p.000020: provisions for providing information about clinically significant exposures, quality assurance programmes for
p.000020: radiotherapy, analysis and recording of events involving or potentially involving accidental or unintended
p.000020: exposures and processes for investigating and notifying the relevant enforcing authority when significant events
p.000020: have occurred.
p.000020: Regulation 9 sets out the duties of the enforcing authority with regard to timely dissemination of information relating
p.000020: to significant accidental or unintended exposures.
p.000020: Regulation 10 sets out the respective responsibilities of practitioners, operators and referrers.
p.000020: Practitioners and operators are required to follow the framework of procedures provided by the employer. The
p.000020: practitioner is responsible for the justification of a medical exposure. Authorisation of exposures is addressed here
p.000020: and in regulation 11. The operator is responsible for each practical aspect he or she carries out. The referrer must
p.000020: provide medical data as required by the practitioner in order that appropriate justification can take place.
p.000020: Regulation 11 prohibits any medical exposure which has not been justified and authorised and sets out matters to be
p.000020: taken into account for justification. These include requirements relating to licensing and approval by an
p.000020: expert advisory committee, in the case of research, for exposures involving administration of radioactive
p.000020: substances. Justification of the exposure of carers and comforters is also required and recommendations or
p.000020: guidelines should be considered as part of justification of the exposure of asymptomatic individuals.
p.000020: Regulation 12 provides for the optimisation process, and specifies the elements that are the
p.000020: responsibilities of the operator and the practitioner, depending on their involvement. Specific requirements
p.000020: are included for exposures in research, for carers and comforters and for exposures involving radioactive substances.
p.000020: Particular regard should be given to the exposures of children, exposures involving high doses, exposures of
p.000020: individuals involved in health screening programmes and pregnant or potentially pregnant or breastfeeding
p.000020: individuals. Regulation 12 also requires the employer to take steps to ensure that a clinical evaluation is recorded of
p.000020: each medical exposure.
p.000020: Regulation 13 requires employers to provide when requested, to the Secretary of State data relating to
p.000020: dose estimates from diagnostic and interventional medical exposures.
p.000020: Regulation 14 provides for suitable medical physics experts to be appointed and involved in relation to
p.000020: medical exposures.
p.000020: Regulation 15 sets out general duties of the employer with respect to medical radiological equipment.
p.000020: These include requirements for quality assurance programmes, appropriate testing of equipment, performance criteria
p.000020: and actions to be taken when equipment does not perform appropriately.
p.000020: Regulation 16 sets out additional requirements for equipment installed when the Regulations come into force including
p.000020: the transfer of information relating to patient dose where appropriate.
p.000020: Regulation 17 prohibits a practitioner or operator from carrying out a medical exposure without having been
p.000020: adequately trained, except if supervised appropriately for practical aspects when undergoing training. The
p.000020: employer must keep and make available training records during inspections undertaken by the relevant
p.000020: enforcing authority. Further information regarding adequate training is set out in Schedule 3.
p.000020: Regulation 18 provides that the Regulations are made enforceable as health and safety regulations under the Health and
p.000020: Safety at Work etc. Act 1974 (c. 37).
p.000020: Regulation 19 provides there is a defence of due diligence to proceedings for an offence under the Regulations that all
p.000020: reasonable steps were taken and due diligence exercised.
p.000020:
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: Regulation 20 revokes the Ionising Radiation (Medical Exposure) Regulations 2000 (SI 2000/1059)
p.000021: and, subject to transitional provisions relating to existing certificates, the Medicines (Administration of Radioactive
p.000021: Substances) Regulations 1978 (S.I. 1978/1006) and the Medicines (Radioactive Substances) Order 1978 (S.I. 1978/1004).
p.000021: Regulation 21 and Schedule 4 make provision consequential on the coming into force of these Regulations.
p.000021: Regulation 22 makes provision for the review of these Regulations at the end of the period of 5 years beginning with
p.000021: the date on which they coming into force.
p.000021: A full impact assessment has not been prepared to accompany this instrument as it has a low cost to business. However,
p.000021: a regulatory triage assessment accompanies this instrument.
p.000021:
p.000021:
p.000021: © Crown copyright 2017
p.000021: Printed and published in the UK by The Stationery Office Limited under the authority and superintendence
p.000021: of Jeff James, Controller of Her Majesty’s Stationery Office and Queen’s Printer of Acts of Parliament.
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...
Orphaned Trigger Words
p.000008: (2) A medical physics expert must—
p.000008: (a) be closely involved in every radiotherapeutic practice other than standardised therapeutic nuclear medicine
p.000008: practices;
p.000008: (b) be involved in practices including standardised therapeutic nuclear medicine practices, diagnostic
p.000008: nuclear medicine practices and high dose interventional radiology and high dose computed tomography;
p.000008: (c) be involved as appropriate for consultation on optimisation, in all other radiological practices not
p.000008: mentioned in sub-paragraphs (b) and (c); and
p.000008: (d) give advice on—
p.000008: (i) dosimetry and quality assurance matters relating to radiation protection concerning exposures;
p.000008: (ii) physical measurements for the evaluation of dose delivered;
p.000008: (iii) medical radiological equipment.
p.000008: (3) A medical physics expert must also contribute to the following matters—
p.000008: (a) optimisation of the radiation protection of patients and other individuals subject to exposures,
p.000008: including the application and use of diagnostic reference levels;
p.000008: (b) the definition and performance of quality assurance of the equipment;
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: (c) acceptance testing of equipment;
p.000009: (d) the preparation of technical specifications for equipment and installation design;
p.000009: (e) the surveillance of the medical radiological installations;
p.000009: (f) the analysis of events involving, or potentially involving, accidental or unintended exposures;
p.000009: (g) the selection of equipment required to perform radiation protection measurements;
p.000009: (h) the training of practitioners and other staff in relevant aspects of radiation protection;
p.000009: (i) the provision of advice to an employer relating to compliance with these Regulations.
p.000009: (4) The medical physics expert must, where appropriate, liaise with a radiation protection adviser and a
p.000009: radioactive waste adviser.
p.000009: (5) In this regulation—
p.000009: (a) “radiation protection adviser” means an individual who, or a body which is competent to advise on radiation
p.000009: protection in relation to occupational and public exposures;
p.000009: (b) “radioactive waste adviser” means an individual who, or a body which is competent to provide expert advice on
p.000009: radioactive waste management and environmental radiation protection.
p.000009:
p.000009: Equipment: general duties of the employer
p.000009: 15.—(1) An employer who has control over any equipment must—
p.000009: (a) implement and maintain a quality assurance programme in respect of that equipment which must as a
p.000009: minimum permit—
p.000009: (i) the assessment of the dose of ionising radiation that a person may be exposed to from an exposure to
p.000009: which these Regulations apply, by way of the ordinary operation of that equipment; and
p.000009: (ii) the administered activity to be verified;
p.000009: (b) draw up, keep up-to-date and preserve at each radiological installation an inventory of equipment at
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| education | education |
| emergency | Public Emergency |
| employees | employees |
| gender | gender |
| incapacity | Incapacitated |
| occupation | Occupation |
| pregnant | Pregnant |
| restricted | Incarcerated |
| substance | Drug Usage |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
Trigger Words
capacity
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input