Statutory Instrument 1988 No. 778

The Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988

---

© Crown Copyright 1988

Statutory Instruments printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Queen's Printer of Acts of Parliament.

The legislation contained on this web site is subject to Crown Copyright protection. It may be reproduced free of charge provided that it is reproduced accurately and that the source and copyright status of the material is made evident to users.

It should be noted that the right to reproduce the text of Statutory Instruments does not extend to the Queen's Printer imprints which should be removed from any copies of the Statutory Instrument which are issued or made available to the public. This includes reproduction of the Statutory Instrument on the Internet and on intranet sites. The Royal Arms may be reproduced only where they are an integral part of the original document.

The text of this Internet version of the Statutory Instrument which is published by the Queen's Printer of Acts of Parliament has been prepared to reflect the text as it was Made. A print version is also available and is published by The Stationery Office Limited as the The Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988, ISBN 0110867785. The print version may be purchased by clicking here. Braille copies of this Statutory Instrument can also be purchased at the same price as the print edition by contacting TSO Customer Services on 0870 600 5522 or e-mail:customer.services@tso.co.uk.

Further information about the publication of legislation on this website can be found by referring to the Frequently Asked Questions.

To ensure fast access over slow connections, large documents have been segmented into "chunks". Where you see a "continue" button at the bottom of the page of text, this indicates that there is another chunk of text available.

1988 No. 778

HEALTH AND SAFETY

The Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988

The Secretary of State, being the Minister designated^[1] for the purposes of section 2(2) of the European Communities Act 1972^[2] in relation to the making of safety measures in regard to radioactive substances and the emission of ionising radiation, in exercise of the powers conferred by that section, hereby makes the following Regulations:

Citation and commencement
    1.    These Regulations may be cited as the Ionising Radiation (Protection of Persons Undergoing Medical Examination or Treatment) Regulations 1988 and shall come into force on 1st June 1988.

Interpretation
    2.    —(1)  In these Regulations, unless the context otherwise requires—
"adequate training" means tuition leading to competence in radiation protection and appropriate instruction, including practical experience, in the diagnostic or therapeutic techniques to be used; and the expression "adequately trained" shall be similarly construed;



"clinically directing" means having clinical responsibility for the decision to effect a medical exposure;

"medical exposure" means exposure of a person to ionising radiation for a diagnostic or therapeutic purpose;

"patient" means a person undergoing medical examination or treatment;

"physically directing" means effecting the medical exposure; and the expression "a person physically directing a medical exposure" shall include a person acting in accordance with the directions of a doctor or dentist for the purposes of regulation 2 of the Medicines (Administration of Radioactive Substances) Regulations 1978^[3];

"radioactive medicinal product" has the meaning ascribed to it in the Medicines (Administration of Radioactive Substances) Regulations 1978.

    (2)  For the purposes of these Regulations any reference to an employer shall include a reference to a self-employed person and any duty imposed by these Regulations on an employer in respect of an employee shall extend to a self-employed person in respect of himself.

Application of these Regulations
    3.—(1)  These Regulations shall apply to all types of procedures resulting in a medical exposure.

    (2)  These Regulations shall not extend to the use of ionising radiation in the field of scientific research.

Requirement for medical exposures
    4.—(1)  Every medical exposure shall be carried out under the responsibility of a person who is clinically directing it and who shall see to it that the requirements of this regulation are satisfied.

    (2)  No person shall clinically or physically direct a medical exposure except in accordance with accepted diagnostic or therapeutic practice.

    (3)  Persons physically directing a medical exposure shall select procedures such as to ensure a dose of ionising radiation to the patient as low as reasonably practicable in order to achieve the required diagnostic or therapeutic purpose.

Training requirements for persons directing medical exposures
    5.—(1)  Subject to the following provisions of this regulation a person clinically or physically directing a medical exposure shall have received adequate training.

    (2)  Nothing in paragraph (1) above shall prevent a person from physically directing a medical exposure as part of practical training if this is done under the supervision of a person who himself has had adequate training.

    (3)  Within two years of the coming into force of these Regulations, medical, dental and other practitioners who, prior to the coming into force of these Regulations, have been clinically or physically directing medical exposures, but who were not adequately trained, either during their basic training or subsequently, shall take steps to acquire a core of knowledge in accordance with the Schedule to these Regulations.

    (4)  The Schedule to these Regulations, in which there is set out the core of knowledge as to the radiation protection of patients requisite for persons clinically or physically directing medical exposures shall have effect for purposes of this regulation and of regulation 6 below.

Proof of training
    6.    A certificate issued by an institute or person competent to award degrees or diplomas or to provide other evidence of training shall—
 (a) if such certificate attests that the person to whom it has been issued has received tuition in radiation protection to the extent set out in the Schedule to these Regulations be sufficient proof that such person has acquired competence in radiation protection; or
 (b) if such certificate so attests, be sufficient proof that the person to whom it has been issued has received instruction, including practical experience, in the techniques appropriate to his work.

Duty to ensure compliance with training requirements
    7.    It shall be the duty of every employer of persons clinically or physically directing medical exposures to ensure that such persons comply with the provisions of regulation 5 above.

Duty to keep record of training particulars
    8.    Within 1 year of the coming into force of these Regulations every employer of persons clinically or physically directing medical exposures shall put into effect procedures for recording and keeping up-to-date particulars showing the date or dates on which training qualifying as adequate training was completed by such persons before, and subsequent to, taking up employment with such employer, and the nature of the training.

Duty to record information concerning radiation equipment
    9.—(1)  Every employer of persons using radiation equipment shall keep and preserve at his place of work the information specified for the purposes of this paragraph and, when so requested, shall furnish it to the Secretary of State for the purposes of an inventory of radiation equipment to be drawn up and kept up-to-date by the Secretary of State.

    (2)  The following information is specified for the purposes of paragraph (1) of this regulation in relation to any equipment which delivers ionising radiation to a person undergoing a medical exposure and equipment which directly controls the extent of such exposure—
 (a) Name of manufacturer
 (b) Model number
 (c) Serial number or other unique identifier
 (d) Year of manufacture
 (e) Year of installation.

Duty to provide expert advice
    10.    Every employer of persons treating patients by radiotherapy or administering radioactive medicinal products to patients shall ensure that every such person has available to him the services of a person who holds a science degree, or its equivalent, awarded by the United Kingdom or other member State of the Communities (or a comparable overseas qualification) and who is experienced in the application of physics to the diagnostic and therapeutic uses of ionising radiation.

Enforcement
    11.—(1)  The provisions of these Regulations shall be enforced as if they were health and safety regulations made under section 15 of the Heath and Safety at Work etc Act 1974^[4] and, except as provided in paragraph (2) below, the provisions of that Act, as regards enforcement and offences, shall apply for the purposes of these Regulations.

    (2)  The enforcing authority for the purposes of regulation 4 of these Regulations, and as respects the application of these Regulations to the administration of any radioactive medicinal product, shall be the Secretary of State.

Defence of due diligence
    12.    In any proceedings against any person for an offence consisting of the contravention of any of these Regulations it shall be a defence for that person to show that he took all reasonable steps and exercised all due diligence to avoid committing the offence.

John Moore

One of Her Majesty's Principal Secretaries of State

26th April 1988

[1] S.I. 1977/1718. back

[2] 1972 c. 68. back

[3] S.I. 1978/1006. back

[4] 1974 c. 37. back

Explanatory Note