<tt*-tt 
•Cr -tt COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 19.06.1997 
COM(97) 315 final 
96/0230 (CNS) 
Amended proposal for a 
COUNCIL DIRECTIVE 
on Health Protection of Individuals Against the Dangers 
of Ionizing Radiation in Relation to Medical Exposures, 
Replacing the Directive 84/466/Euratom 
(presented by the Commission pursuant to Article 189 a (2) 
of the EC-Treaty) 

EXPLANATORY MEMORANDUM 
1. INTRODUCTION 
At its sitting of 14 May 1997, the European Parliament gave its opinion 
on a proposal for a Council Directive (Euratom) on the health protection 
of individuals against the dangers of ionizing radiation in relation to 
medical exposures. 
The proposal was adopted by the Commission on 26 September 1996^ 
having considered the opinion given by the Economic and Social 
Committee on 29 May 1996^ on a draft proposal put forward on 
24 November 19953. 
The present modified proposal takes account of the amendments 
requested by the European Parliament where the Commission has been 
able to accept them. 
2. ACCEPTED AMENDMENTS 
The Commission accepts amendments n° 1, 2, 3, 4, 5, 7, 8, 9, 10 and 11. 
The modified Article 1 takes account of amendment 1 in making 
reference to Directive 96/29/Euratom that shall replace Directive 
80/836/Euratom. 
The modification in Article 2 of the definition of potential exposures 
simplifies the text as requested by amendment 2. 
1 COM(96)465 final, O.J. C341 of 13 November 1996 
2 CES 695/96, O.J. C212 of 22.07.1996 
3 COM(95)560 final 
21 
Amendment 3 nfodifîes the definition of Medical Physicist in Article 2 by 
deleting the reference to his responsibilities regarding the protection of 
Workers and the public. This modification is in line with the aim of this 
/Directive which is to ensure the protection of persons undergoing 
medical exposures. Protection of workers and the public in general is 
ensured by Directive 96/29/Euratom. 
The simplification of the definition of Quality Assurance in Article 2, as 
requested by amendment 4, takes account of the fact that the reference to 
the personnel is redundant because protection of personnel is already 
covered by Directive 96/29/Euratom. J 
/' ' 
The modifîeç} Artièîe 4 takes account of the reference to provisions laid 
down b/ife Member States as regards the responsibilities of practitioner 
./••/ -; 
/aadprescriber as requested by amendment 5. 
On the basis of amendment 7, the modification in Article 4, which deals 
with exposures without direct health benefit for the person undergoing 
the exposure, prohibits these exposures if they are not justified. 
The modification in Article 9, regarding the taking out of service or 
replacing equipments and instaîlaîio&s which do not comply with 
acceptability criteria, takes account of amendment 8. 
The role of the medical physicist in checking equipment used in 
radiotherapy is strengthened in the modified Article 5, in line with 
amendment 9. 
The modified Article 10 includes exposures for radiotkefapeutic 
purposes as requested by amendment 10. 
3> 
Protection of women in case of exposures of the pelvic and abdominal 
regions is strengthened in the modified Article 11 as requested by 
amendment 11. 
3. AMENDMENTS WHICH ARE NOT ACCEPTED 
The Commission cannot accept amendments n° 6 and 12. 
Amendment 6 proposes to introduce in Article 4 the possibility for every 
radiological unit to consult a medical physicist. The Commission 
believes that the procedures for consultation of the medical physicist is 
sufficiently covered by Article 5, which is more in line with the actual 
availability of qualified medical physicists in the Union. 
Amendment 12 replaces the term "practitioner" with "examining doctor" 
in Article 13. The definition of practitioner given in Article 2, already 
includes the concept of "examining doctor". 
H 
Amended proposal for a 
COUNCIL DIRECTIVE 
on Health Protection of Individuals Against the Dangers 
of Ionizing Radiation in Relation to Medical Exposures, 
Replacing the Directive 84/466/Euratom 
COMMISSION'S ORIGINAL AMENDED PROPOSAL 
PROPOSAL 
Article 1 
This Directive lays down the general 
principles of the radiation protection of 
individuals undergoing medical exposures 
and associated practices involving ionizing 
radiation. 
The purpose of this Directive is to 
supplement Directive 80/836/Euratom on the 
basic safety standards as regards medical 
exposures. 
Article 2 
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; 
Medical Physicist: an expert in radiation 
physics applied to medical exposures whose 
training and competence to act is recognized 
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 
optimization, 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; 
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. Article 1 
This Directive lays down the general 
principles of the radiation protection of 
individuals undergoing medical exposures 
and associated practices involving ionizing 
radiation. 
The purpose of this Directive is to 
supplement Directive 96/29/Euratom on the 
basic safety standards as regards medical 
exposures. 
Article 2 
Potential exposures: exposure resulting from 
events such as equipment failure or faults, or 
a human error and with a probability of 
occurrence that can be assessed in advance; 
Medical Physicist: an expert in radiation 
physics applied to medical exposures whose 
training and competence to act is recognized 
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 
optimization, on quality assurance, including 
quality control, and on matters relating to 
radiation protection as defined in Article 3, 
as appropriate. 
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. 
•r 
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. 
Article 4.4 
Special attention shall be given for those 
exposures where there is no direct health 
benefit for the person undergoing the 
exposure and especially for exposures on 
medico-legal, insurance and legal grounds. 
Article 4.5 
The prescriber as well as the practitioner 
shall be involved in the justification process, 
at the appropriate level. 
Article 5.5 
In radiotherapeutic practices, a medical 
physicist shall be closely involved. In 
diagnostic nuclear medicine practices, a 
medical physicist shall be involved as 
appropriate. For other radiodiagnostic 
practices, a medical physicist shall be 
available for consultation on optimization 
and quality assurance, including quality 
control, as appropriate, and also to give 
advice on matters relating to radiation 
protection concerning medical exposures, as 
required. By optimum quality is meant: 
(a) in the case of radiodiagnostic procedure, 
the consistent production of adequate 
diagnostic information with minimum 
exposure of patients. 
(b) in the case of radiotherapeutic procedure, 
the optimum exposure of patients. 
Article 4.4 
Special attention shall be given for those 
exposures where there is no direct health 
benefit for the person undergoing the 
exposure and especially for exposures on 
medico-legal, insurance and legal grounds. 
If such an exposure cannot be justified, it 
should be prohibited 
Article 4.5 
The prescriber as well as the practitioner 
shall be involved in the process of 
justification taking specific responsibility in 
accordance with the provisions laid down by 
the Member State. 
Article 5.5 
In radiotherapeutic practices, a medical 
physicist shall be closely involved and he 
must check the equipment used for 
radiotherapy after any major maintenance 
procedure. In diagnostic nuclear médecine 
practices, a medical physicist shall be 
involved as appropriate. For other 
radiodiagnostic practices, a medical physicist 
shall be available for consultation on 
optimization and quality assurance, including 
quality control, as appropriate, and also to 
give advice on matters relating to radiation 
protection concerning medical exposures, as 
required. 
G 
Article 9.b Article 9b 
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 10.1 
Member States shall ensure that medical and 
paramedical staff performing 
- frequent paediatric medical exposures 
- exposures as part of a health screening 
programme 
- examinations involving high doses to the 
patient and the medical staff, such as 
interventional radiology and Computed 
Tomography 
receive specific training on the relevant 
radiological practices and on the relevant 
radiation protection aspects. 
Article 11.2 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. 
Member States shall adopt measures to 
ensure that equipment and installations which 
do not meet predetermined acceptability 
criteria are taken out of service or replaced. 
Article 10.1 
Member States shall ensure that medical and 
paramedical staff performing 
- frequent paediatric medical exposures 
- exposures as part of a health screening 
programme 
- examinations involving high doses to the 
patient and the medical staff, such as 
interventional radiology, Computed 
Tomography and radiotherapy 
receive specific training on the relevant 
radiological practices and on the relevant 
radiation protection aspects. 
Article 11.2 
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 
optimization of the medical exposure both 
for the mother and the unborn child. If pregnancy cannot be excluded, depending 
on the type of medical exposures, in 
particular those involving the pelvic and 
abdominal regions, special attention shall be 
given to the justification, particularly the 
urgency, and to the optimization of the 
medical exposure both for the mother and 
the unborn child. 
V 

ISSN 0254-1475 
COM(97) 315 final 
DOCUMENTS 
EN «5 06 14 
Catalogue number : CB-CO-97-300-EN-C 
ISBN 92-78-21553-8 
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