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
Date: 1997-06-19
Institutions: European Commission
Subjects: ionising radiation, medical diagnosis, radiation protection, safety standard, therapeutics

COMMISSION OF THE EUROPEAN COMMUNITIES 

<tt*-tt 

•Cr 

-tt 

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 
PROPOSAL 

AMENDED  PROPOSAL 

Article 1 

Article 1 

This Directive lays down the general 
principles of the radiation protection of 
individuals undergoing medical exposures 
and associated practices involving ionizing 
radiation. 

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. 

The purpose of this Directive is to 
supplement Directive 96/29/Euratom on the 
basic safety  standards as regards medical 
exposures. 

Article 2 

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; 

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. 

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. 

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 

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. 

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 

Article 4.5 

The prescriber  as well as the practitioner 
shall be involved in the justification  process, 
at the appropriate level. 

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 

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. 

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. 

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 

Article 10.1 

Member States shall ensure that medical and 
paramedical staff  performing 
- 
frequent  paediatric medical exposures 
-  exposures  as  part  of  a  health  screening 

Member States shall ensure that medical and 
paramedical staff  performing 

-  frequent  paediatric medical exposures 
-  exposures  as  part  of  a  health  screening 

programme 

programme 

-  examinations  involving  high  doses  to the 
patient  and  the  medical  staff,  such  as 
interventional  radiology  and  Computed 
Tomography 

-  examinations  involving  high  doses  to the 
patient  and  the  medical  staff,  such  as 
interventional 
Computed 
radiology, 
Tomography and radiotherapy 

receive specific training on the relevant 
radiological practices and on the relevant 
radiation protection aspects. 

receive specific training on the relevant 
radiological practices and on the relevant 
radiation protection aspects. 

Article 11.2 

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 

Office  for Official  Publications of the European Communities 

L-2985 Luxembourg 

*