COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 24.11.1995 
COM(95) 560 final 
Draft 
Proposal for a 
COUNCIL DIRECTIVE 
on health protection of individuals against the dangers of ionizing radiation 
in relation to medical exposures, replacing Directive 84/466/Euratom 
(presented by the Commission) 

NOTE 
In accordance with the procedure laid down in Article 31 of the Euratom Treaty, the present 
text is submitted to the Economic and Social Committee for opinion. The Commission will 
present a proposal to the Council after having considered this opinion. 
EXPLANATORY MEMORANDUM 
1. BACKGROUND 
1.1. In 1984 the Council adopted Directive 84/466/Euratom Laying Down Basic Measures 
for the Radiation Protection of Persons Undergoing Medical Examination or 
Treatment1. The Council thereby acknowledged that medical practices utilizing 
ionizing radiation were developing rapidly and this led to the finding that, apart from 
the largely unavoidable exposure to natural radiation sources, medical exposure was 
by far the major source of exposure to ionizing radiation for the citizens of the 
European Community. The Directive laid down basic measures with the objective of 
improving the radiation protection of patients without jeopardizing the benefits -
whether early recognition, diagnosis or therapy - obtainable from radiation. 
1.2. The Directive completed, on the particular point of protection of patients, the Council 
Directive Laying Down the Basic Safety Standards for the Health Protection of the 
General Public and Workers Against the Dangers of Ionizing Radiation2 which applies 
to any activity which involves a hazard arising from ionizing radiation. 
Article 2(b) of the Euratom Treaty provides in fact for the establishment within the 
Community of uniform basic safety standards to protect the health of workers and of 
the general public against the dangers of ionizing radiation. These basic safety 
standards were first adopted in 1959 by means of a Council Directive3 and have 
subsequently been amended on several occasions to take account of developments in 
scientific knowledge in the field of radiation protection. 
A proposal for a revision of the Basic Safety Standards Directive was submitted to the 
Council in 19934. An amended proposal which takes account of the opinion of the 
European Parliament, was put forward in 19945. These proposals, however, do not 
deal with radiation protection as regards medical exposures. 
1 O.J. L 265 of 05.10.1984 
2 O.J. L 246 of 17.09.1980 and O.J. L 265 of 05.10.1984 
3 
A O.JN° 11 of 20.02.1959 
O.J. C245 of 09.09.1993 
O.J. C 224 of 12.08.1994 
1.3. Since 1984 the use ôf ionizing radiation in medical practice has continued to develop 
and the number of related installations to increase. The objective, set out in 
Directive 84/466/Euratom, of eliminating unnecessary exposures in this specific field 
remains therefore valid today, particularly as measures aimed at reducing exposures 
without losing the efficacy of the related practice could be the most cost effective in 
this field when compared to other sectors of the utilization of ionizing radiation. 
Nevertheless, the requirements of the 1984 Directive need to be reformulated taking 
into account the scientific/technical progress, the proposed revision of the Basic Safety 
Standards Directive and the experience acquired in the implementation of the 1984 
Directive. This will ensure that the unity of radiation protection doctrine and 
methods in relation to medical exposures is maintained. 
1.4. The above considerations show that it is appropriate for the Community to revise 
Directive 84/466/Euratom and to give updated guidance in the particular field of 
medical exposure to ionizing radiation. 
As regards the cost of implementing the Directive, in some cases the introduction of 
quality assurance and quality control measures may require some cost for the operator 
of the radiological installation. However, these costs will bring benefits in terms of 
reduced exposures. Increased attention to the justification of each individual 
radiological examination is likely to reduce their number and the associated cost for 
society. A direct cost benefit analysis is impossible, without agreeing on a value of 
the man sievert averted. Several figures for such values can be found in the literature, 
ranging from 5,000 to several million ECU/man sievert according to the 
circumstances. No international agreement could be reached so far on these figures. 
1.5. At international level, the proposal is consistent with the 1990 Recommendations of 
the International Commission on Radiological Protection (ICRP)6 and with the 
International Basic Safety Standards for Protection Against Ionizing Radiation and for 
the Safety of Radiation Sources, jointly sponsored by six international organisations7, 
issued in December 1994 which deal with all aspects of radiation protection including 
medical exposures. 
6 International Commission on Radiological Protection, 1990 
Recommendations of the International Commission on Radiological Protection, Publication 
N° 60, Pergamon Press, Oxford and New York (1991) 
International Basic Safety Standards for Protection Against Ionizing Radiation and for the 
Safety of Radiation Sources, jointly sponsored by: Food and Agriculture Organization of the 
United Nations, International Atomic Energy Agency, International Labour Organisation, 
Nuclear Energy Agency of the Organisation for Economic Co-operation and Development, Pan 
American Health Organization, World Health Organization - Interim Edition 
Safety Series N° 115, International Atomic Energy Agency, Vienna, 1994. 
1.6. The protection of workers, including medical and paramedical staff, and of members 
of the public is not affected by the Directive on medical exposures and is ensured by 
the Basic Safety Standards Directive mentioned above. Health and safety 
requirements including radiation protection aspects regarding the design, manufacture, 
placing on the market, of the medical devices utilized, are covered by Council 
Directive 93/42/EEC of 14 June 1993 concerning Medical Devices8 
1.7. Since the coming into effect of the Treaty on European Union a specific competence 
in the field of the public health was introduced in the EC Treaty. With Articles 3(o) 
and 129, the Community was set the task of making "a contribution to the attainment 
of a high level of health protection". The provisions of Article 129 led to the 
development of a framework for Community action in the field of public health 
placing an emphasis on the prevention of disease and the promotion of health. 
Moreover, Article 129 provides "that health protection requirements shall form a 
constituent part of the Community's other policies". The present proposal gives effect 
to the provision, by laying down requirements for the protection of persons undergoing 
medical examinations or treatments involving their exposure to ionising radiation. 
2. MODIFICATIONS PROPOSED 
Taking into account the above mentioned factors and since some recommendations of 
the annex of the existing Directive are given a legally binding character, the whole 
text of the existing directive has been reformulated. 
With respect to the Directive presently in force, the main modifications introduced are 
as follows. 
2.1. The scope of the Directive has been more clearly defined as regards exposures of 
individuals as part of medico-legal insurance or legal procedures. It has also been 
enlarged to include volunteers in research and individuals helping in the support and 
comfort of patients. 
2.2. The 1984 Directive imposed the application of the principle of justification and 
optimisation to medical exposures. The proposal expands these provisions and sets 
out several specific requirements. 
2.3. In addition to the requirement that any use of ionizing radiation in medical procedures 
is effected under the responsibility of a practitioner, as it is in the 1984 Directive, the 
proposal foresees that practical aspects of the medical procedure could be delegated 
to other individuals authorized by the competent national authorities. The 
requirements for the training of the practitioners and other individuals are explicitly 
set out. Such requirements include continuing education and training. 
O.J. L 169 of 12.07.1993 
2.4. The proposal expands the existing requirements on quality control of the installations 
and supplements them by requiring the establishment quality assurance programmes 
which also include assessments of the doses received by the patient. 
2.5. Additional requirements are introduced which apply to paediatric exposures, health 
screening programmes, practices involving high doses, the exposure of pregnant and 
breast feeding women, the exposure of helping persons and of volunteers. 
2.6. The proposal introduces the concept of potential exposures, together with the 
requirement of keeping their probability and magnitude as low as reasonably 
achievable. 
2.7. Finally, Member States are requested to ensure the establishment of processes for 
auditing the implementation of the requirements of the Directive. 
Draft 
Proposal for a 
COUNCIL DIRECTIVE 
on health protection of individuals against the dangers of ionizing radiation 
in relation to medical exposures, replacing Directive 84/466/Euratom 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European Atomic Energy Community, and in 
particular Article 31 thereof, 
Having regard to the proposal from the Commission, drawn up after obtaining the opinion of 
a group of persons appointed by the Scientific and Technical Committee, 
Having regard to the opinion of the European Parliament9, 
Having regard to the opinion of the Economic and Social Committee10, 
Whereas the Council has adopted Directives Laying Down the Basic Safety Standards for the 
Health Protection of the General Public and Workers Against the Dangers of Ionizing 
Radiation, as last amended by Directives 80/836/Euratom and 84/467/Euratom11 
Whereas, on 3 September 1984 the Council adopted Directive 84/466 Euratom Laying Down 
the Basic Measures for the Radiation Protection of Persons Undergoing Medical Examination 
or Treatment; 
11 O.J. L 246 of 17.09.1980 and O.J. L 265 of 05.10.1984. 
7 
Whereas, as in 1984, medical exposures continue to constitute the major source of exposure 
to artificial ionizing radiation of the European Union citizens; whereas the use of ionizing 
radiation has enabled great progress to be made in many aspects of medicine; whereas 
practices causing medical exposures need to be carried out in optimised radiation protection 
conditions. 
Whereas, recognizing the development of scientific knowledge in the field of radiation 
protection applied to medical exposures, the International Commission on Radiological 
Protection reviewed the subject in its 1990 Recommendations12; whereas the International 
Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of 
Radiation Sources13 recommend measures in the field; 
Whereas such developments make it necessary to revise Directive 84/466/Euratom; 
Whereas the Basic Safety Standards Directive ensures the protection of the workers 
administering the medical exposures and of the member of the public; whereas the same 
Directive ensures that the total of contributions to the exposure of the population as a whole, 
is kept under review; 
12 International Commission on Radiological Protection, 1990 
Recommendations of the International Commission on Radiological Protection, Publication 
N° 60, Pergamon Press, Oxford and New York (1991). 
International Basic Safety Standards for Protection Against Ionizing Radiation and for the 
Safety of Radiation Sources, jointly sponsored by the Food and Agriculture Organization of 
the United Nations, the International Atomic Energy Agency, the International Labour 
Organization, the Nuclear Energy Agency of the Organization for Economic Cooperation and 
Development, the Pan American Health Organization, and the World Health Organisation -
Interim Edition Safety Series N° 115, International Atomic Energy Agency, Vienna 1994. 
8 
Whereas health and safety requirements, including radiation protection aspects, regarding the 
design, manufacture and placing on the market of the medical devices are dealt with by 
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices14. Whereas it is 
necessary to set out radiation protection requirements for the medical use of radiological 
installations from the date of the commencement of their operation; 
Whereas the concept of medical exposure has to be defined so as to include exposures 
incurred by volunteers and persons knowingly and willingly helping persons undergoing 
medical examination or treatment; 
Whereas the Committee of Ministers of the Council of Europe adopted on 6 February 1990 
Recommendation N° R(90)3 on Medical Research on Human Beings; 
Whereas detailed requirements are needed for the correct application of the justification and 
optimisation principles in relation to medical exposures; 
Whereas responsibilities for administering medical exposures need to be set out; 
Whereas appropriate training for the staff involved, the establishment of quality assurance and 
audit programmes, and inspections by the competent authorities are necessary to ensure that 
medical exposures are delivered under good radiation protection conditions; 
Whereas specific provisions are necessary as regards to special practice, pregnant and 
breastfeeding women, volunteers in research and helping persons; 
Whereas potential exposures need to be taken into account; 
HAS ADOPTED THIS DIRECTIVE 
O.J. L 169 of 12.07.1993 
Article 1 - Purpose : This Directive lays down the general principals of the radiological 
protection of individuals undergoing medical exposures and associated practices involving 
ionising radiation. 
The purpose of this directive is to supplement Directive 80/836/EURATOM on the Basic 
Safety Standards as regards medical exposures. 
Article 2 - Definitions : For the. purpose of this Directive, the following terms have the 
meaning hereby assigned to them: 
- Audit : A systematic and independent examination to determine whether the measures 
taken and the related results comply with prescribed criteria. 
- Competent Authorities : Any authority responsible in a Member State for the 
application of any part of this Directive, or any body or bodies designated by the 
Member State for this purpose. 
- Exposure : Process of being exposed to ionizing radiation 
- Health detriment : Clinically observable deleterious effects that are expressed in 
individuals or their descendants the appearance of which is either immediate or delayed 
and, in the latter case, implies a probability rather than a certainty of appearance. 
Holder : Any natural or legal person who has the legal responsibility under national 
law for the use and holding of a given radiological installation. 
Health Screening : A procedure using radiological installations for early diagnosis in 
asymptomatic population groups, also called mass screening. 
10 
Medical Physicist : An expert in radiation physics applied to medical exposures whose 
training and competence to act is recognised by the competent authorities and who, 
as appropriate, gives advice on patient dosimetry, on the development and use of 
complex techniques and equipment and on optimisation, on quality assurance, including 
quality control, and on matters relating to radiation protection as defined in article 3, 
as appropriate. This expert might also give advice on radiation protection aspects as 
regards workers and the public. 
Medical Radiological Practice : Each type of activity resulting in exposure to ionising 
radiation for medical purposes. 
Overall Clinical Responsibility : Responsibility regarding individual medical exposures 
attributed to a practitioner, notably : justification ; optimization; clinical evaluation of 
the outcome; cooperation with other specialists and the staff, as appropriate, regarding 
practical aspects; obtaining information, if appropriate, of previous examinations; 
providing existing radiological information and/or records to other practitioners, 
promptly; giving information on the risks of ionizing radiation to patients, as 
appropriate. 
Potential exposures : Exposure with a probability of occurrence that can be estimated 
in advance for accidents and incidents, such as a failure of equipment, a 
misadministration, a human error or a computer failure. 
Practical Aspects : Any aspect associated with the medical practice such as handling 
and use of radiological equipment, measurement of technical and physical parameters 
including radiation doses, calibration and maintenance of equipment, preparation and 
injection of radio-pharmaceuticals, medical informatics. 
Practitioner : A medical doctor, dentist or other health professional, who is entitled 
to take overall clinical responsibility for individual medical exposures in accordance 
with national legislation. 
11 
Prescriber : A medical doctor, dentist or other health professional, who is entitled to 
refer individuals for medical exposures, in accordance with national legislation. 
Quality Assurance : All those planned and systematic actions necessary to provide 
adequate confidence that a structure, system or component will perform satisfactorily 
in service. Satisfactory performance in service implies the optimum quality of the 
entire procedure. In the case of radiodiagnostic procedure, the consistent production of 
adequate diagnostic information with minimum exposure of both patients and 
personnel. In the case of a radiotherapeutic procedure optimum exposure of patients 
and minimum exposure of personnel. 
Quality Control : The set of operations (programming, coordinating, carrying out) 
intended to maintain or to improve quality . It covers monitoring, evaluation, and 
maintenance at optimum levels of all characteristics of performance that can be 
defined, measured, and controlled. 
Radiological : Pertaining to radiodiagnosis, radiotherapy and nuclear medicine. 
Radiodiagnostic : Pertaining to in vivo diagnostic nuclear medicine, diagnostic 
radiology and interventional radiology. 
Radiotherapeutic : Pertaining to therapeutic nuclear medicine and every other type of 
radiotherapy. 
Reference Level : A tool for optimization of radiation protection in medical 
radiodiagnostic practices by specifying dose levels and, in the case of 
radiopharmaceuticals levels of activity, for typical examinations for a standard sized 
patient, taking into account good practice regarding diagnostic and technical 
performance. An investigation may be needed if these levels are exceeded and 
corrective action should be taken, if appropriate. 
12 
Article 3 - Scope: 
1. This Directive shall apply to all medical exposures and associated practices: 
a) the exposure of individuals as part of their own medical diagnosis or treatment; 
b) the exposure of individuals as part of medico-legal, insurance or legal procedures; 
c) the exposure of individuals as part of health screening; 
d) the exposure of individuals knowingly and willingly helping (other than as part of their 
own occupation) in the support and comfort of patients undergoing medical diagnosis 
or treatment; 
e) the exposure of individuals in medical and biomedical research programmes. 
2. This Directive shall not apply to the design and the placing on the market of medical 
devices covered by the Directive 93/42/EEC. 
Article 4 - Justification: 
1. All new medical radiological practices shall be justified in advance by their potential 
benefits in relation to the health detriment they might cause; existing practices shall be 
reviewed whenever new, important evidence about their efficiency or consequences is 
acquired. 
2. Member States shall take measures to avoid unecessary proliferation of installations for 
radiodiagnostic and radiotherapeutic purpose. 
3. All individual medical exposures shall be justified taking into account the specific 
objectives of the exposure, the availability of previous diagnostic information, when 
appropriate, and the efficacy and availability of alternative techniques. Special attention 
shall be given for those exposures where there is no direct health benefit for the person 
undergoing the exposure. 
13 
4. The prescriber as well as the practitioner shall be involved in the justification process, at 
the appropriate level. 
5. Exposures for biomedical and medical research shall be examined by an officially approved 
ethics committee and/or the competent authorities, taking into account the principles set out 
by the Recommendation n° R(90)3 of the Committee of Ministers of the Council of 
Europe. 
6. In the case of fluoroscopy, examinations without image intensification are not justified and 
shall therefore be prohibited and examinations without an automatic dose rate control shall 
be limited to exceptional circumstances. 
Article 5 - Optimisation: 
1. All medical exposures for radiodiagnostic purposes shall be kept as low as reasonably 
achievable consistent with obtaining the required diagnostic information, taking into 
account economic and social factors. Member States shall promote the establishment and 
use of reference levels for medical exposures and shall ensure the availability of guidance 
for this purpose. 
2. For radiotherapeutic purposes, exposures of target tissues shall be individually planned; 
exposures of non target tissues shall be as low as reasonably achievable, without under­
exposing the target tissues. 
3. Written guidelines for every type of standard radiological practice shall be established for 
each item of radiological equipment. 
4. The optimisation process shall include selection of equipment and both acceptance testing 
before the first use of the installation for clinical purposes, and thereafter performance 
testing on a regular basis, and after any major maintenance procedure. 
14 
5. In radiotherapeutic practices, a medical physicist shall be closely involved. In diagnostic 
nuclear medicine practices, a medical physicist shall be involved as approriate. 
For other radiodiagnostic practices, a medical physicist shall be available for 
consultation on optimisation and quality assurance, including quality control, as 
appropriate, and also to give advice on matters relating to radiation protection 
concerning medical exposures as required. 
6. Member States shall ensure that for each biomedical and medical research project involving 
healthy volunteers, a maximum individual dose level is established. 
These volunteers will be informed about the risks of exposure to ionising radiation. 
7. In the special case of patients, who voluntarily accept to undergo an experimental 
therapeutic or diagnostic practice, optimum dose levels should be established on an 
individual basis by the practitioner. 
Article 6 - Responsibilities: 
1. Member States shall ensure that any medical exposure is effected under the overall clinical 
responsibility of a practitioner. 
2. The practical aspects for the procedure or part of it may be delegated, as appropriate, to 
one or more individuals entitled by the competent authorities to act in this respect in the 
relevant field of specialisation, such as medical physics, radiation and nuclear medicine 
technology, medical-nuclear engineering, radiopharmacy, radiography and medical 
informatics. 
Article 7 - Training: 
1. Member States shall ensure that the practitioners and individuals mentioned in Article 6 
have adequate theoretical and practical training appropriate to the techniques they use in 
medical or dental diagnostic radiology, in nuclear medicine or in radiotherapy, as well as 
relevant competence in radiation protection. 
15 
2. Member States shall ensure the provision of continuing education and training after 
qualification and, in the special case of the clinical introduction of new techniques, the 
prior organisation of training related to these techniques and the relevant radiation 
protection requirements. 
3. For this purpose Member States shall ensure the establishment of appropriate curricula and 
shall recognise the corresponding diplomas, certificates or formal qualifications, in 
accordance with the existing Council Directives15. 
4. Member States shall ensure that adequate referral criteria for medical exposure, including 
radiation doses are provided to the prescribers of medical exposures. 
5. Member States shall ensure that a course on radiation protection is introduced in the basic 
curriculum of schools for practitioners. 
Article 8 - Inventory: 
1. Member States shall ensure the drawing up of an inventory of radiological installations. 
2. This inventory shall be one of the tools used for inspection purposes by the competent 
authorities. 
Article 9 - Surveillance: 
Member States shall ensure that all radiological installations in use are kept under strict 
surveillance regarding radiation protection and quality control. This shall be achieved at two 
levels: 
15 Council Directive of 27 June 1977 (77/452/CEE) 
Council Directive of 25 July 1978 (78/686/CEE) 
Council Directive of 14 December 1981 (81/1057/CEE). 
Council Directive of 16 September 1985 (85/433/CEE) 
Council Directive of 5 April 1993 (93/16/CEE) 
16 
a) The Member States shall ensure that quality assurance programmes including quality 
control measures and patient dose assessment are established by the holder of the 
installation. 
The competent authorities shall be informed about these programmes if they so request. 
b) Competent authorities shall at regular intervals perform inspections of radiological 
installations. They shall ensure that necessary measures are taken by the holder of the 
installation to improve inadequate or defective features of the installation. 
They shall ensure that all installations which do not or no longer meet specific criteria 
adopted by competent authorities for this purpose are taken out of service. 
Article 10 - Special Practices 
1. Member States shall ensure that medical and paramedical staff performing 
- routine paediatric medical exposures 
- exposures as part of a health screening programme 
- exposures involving high dose techniques, such as interventional radiology and 
Computered Tomography 
receive specific training on the relevant radiological practices and on the relevant 
radiation protection aspects. 
2. Member States shall ensure that appropriate radiological installations are used in each case 
for paediatric practices, health screening and high dose techniques and that specific quality 
assurance programmes, including quality control measures and patient dose assessment, are 
adopted for these practices. 
Article 11 - Medical exposures to pregnant and breastfeeding women. 
1. In the case of a female patient of childbearing age, the prescriber and the practitioner shall 
inquire whether the patient is pregnant, or breastfeeding, if relevant. 
17 
2. If pregnancy cannot be excluded, depending on the type of medical exposures, special 
attention shall be given to the justification, particularly the urgency, and to the optimisation 
of the medical exposure both for the mother and the unborn child. 
3. In nuclear medicine for breastfeeding women depending on the type of medical 
examination or treatment, special attention shall be given to the justification, particularly 
the urgency, and to the optimisation of the medical exposure both for the mother and the 
child. 
Article 12 - Potential exposures 
Member States shall ensure that the probability and magnitude of potential exposures of 
patients from medical practices are taken into consideration and kept as low as reasonably 
achievable, economic and social factors being taken into account. 
Article 13 - Helping persons 
1. Member States shall ensure that appropriate guidance for exposures of individuals, who are 
knowingly and willingly helping, other than as part of their occupation, in the support 
and comfort of in-patients or out-patients undergoing medical diagnosis or treatment, is 
established. 
2. In the case of a patient undergoing a treatment with radionuclides Member States shall 
ensure that the practitioner provides the patient or legal guardian before leaving the hospital 
or clinic, with written instructions as appropriate on the reduction of doses to persons in 
contact with the patient and with information on the risks of ionizing radiation. 
Article 14 - Audit 
In order to assure the implementation of the preceeding articles, Member States shall 
ensure that appropriate processes for audit are adopted. 
18 
Article 15 - Estimates of Population Doses 
Member States shall ensure that individual dose and collective dose estimates from 
practices referred to in article 2 are made for the whole population and for relevant 
reference groups of the population. 
Article 16 - Transposition into Member State law 
1. Member States shall bring into force the laws, regulations and administrative provisions 
necessary to comply with this Directive on 1 January 1999. They shall immediately inform 
the Commission thereof. 
When Member States adopt these provisions, these shall contain a reference to this 
Directive or shall be accompanied by such reference at time of their official publication. 
The procedure for such reference shall be adopted by Member States. 
2. Member States shall communicate to the Commission the provisions of national law which 
they adopt in the field covered by this Directive. 
Article 17 - Repeals 
Directive 84/466/Euratom is repealed with effect from 1 January 1999. 
Article 18 -
This Directive is addressed to the Member States. 
19 

ISSN 0254-1475 
COM(95) 560 final 
DOCUMENTS 
EN 05 15 
Catalogue number : CB-CO-95-611-EN-C 
ISBN 92-77-96302-6 
Office for Official Publications of the European Cûmrnunities 
L-2985 Luxembourg