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: 1996-09-26
Institutions: European Commission
Subjects: health control, ionising radiation, medical examination, public health, radiation protection

COMMISSION OF THE EUROPEAN  COMMUNITIES 

Brussels,  26.09.1996 
COM(96) 465 final 

96/0230 (CNS) 

Proposal  for a 

COUNCIL DIRECTIVE 

on Health Protection of Individuals Against the Dangers 

of Ionizing Radiation in Relation to Medical Exposures, 

Replacing the Directive  84/4667Euratom 

(presented by the Commission) 

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.  This Directive (96/29/EURATOM)6, 
adopted by Council on 13 May 1996, however, does 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  O.J N* 11 of 20.02.1959 

4  O.J.C 245 of 09.09.1993 

5  O.J.C 224 of 12.08.1994 

6  OJ. L 159 of 29 June 1996 

1.3. 

Since  1984 the use of 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  and 
since alternative techniques involving no exposure to ionizing radiation become more 
and more available and in some cases are first choice.  Nevertheless, the requirements 
of 
the 
scientific/technical  progress, the 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. 

the  1984  Directive  need 

to  be  reformulated 

into  account 

taking 

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 holders 
of the radiological  installations concerned. 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 
mansievert  averted  by the introduction  of measures pursuant  to the provisions  of the 
proposed  Directive.  Several  figures  for  such  values  can  be  found  in  the  literature, 
ranging from  5,000 to several million ECU/mansievert 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  (ÎCRP)7  and  with  the 
International  Basic Safety  Standards for Protection Against Ionizing Radiation and for 
the Safety  of Radiation  Sources, jointly  sponsored  by six international  organisations8, 
issued in December  1994 which deal with all aspects of radiation protection  including 
medical  exposures. 

7 

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  -  other  than  the  individuals  whose  protection  is  the  object  of  the 
proposed  Directive  -  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  Devices9. 

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  ionizing  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. 

2.1. 

2.2. 

2.3. 

With respect to the Directive presently in force, the main modifications  introduced are 
as  follows. 

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. 

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. 

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 of 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. 

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 

THE COUNCIL OF THE EUROPEAN UNION, 

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 Parliament10, 

Having regard to the opinion of the Economic and Social Committee11, 

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 Directive  96/29/Euratom  of  13 May  1996. 

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; 

10 

11  OJ.C 212 of 22.07.1996 

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  members  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). 

13  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. 

W^hereas 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; 

W^hereas the  Committee  of  Ministers  of  the  Council  of  Europe  adopted  on  6  February  1990 

Recommendation  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 

8 

Article  1  -  Purpose  :  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  -  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. 

-  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. 

-  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  man  a  certainty  of 

appearance. 

Health Screening  : A procedure using radiological  installations for early diagnosis in 

asymptomatic population groups, also called mass screening. 

Holder  : Any  natural or legal  person who  has the legal responsibility  under national 

law for the use and holding of a given radiological installation. 

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 ionizing 

radiation for medical  purposes. 

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. 

Prescriber  : A medical  doctor, dentist  or other health professional,  who is entitled to 

refer  individuals for medical  exposures, in accordance with national  legislation. 

10 

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. 

11 

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: 

JL  All  individual  medical  exposures  shall  be justified  taking  into  account  the  specific 

objectives  of the exposure  and the efficacy  and availability of alternative techniques. 

The prescriber and the practitioner will always check if previous diagnostic information or 

medical  records  relevant to  the planned  exposure  are available  and consult these  data to 

avoid unnecessary  examinations. 

Z 

All  new medical  radiological  practices  shall be justified  in advance by their potential 

benefits  in relation to alternative practices having the same objective but not involving 

exposure to ionizing radiation and 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. 

^  Member States shall  take measures to avoid unnecessary proliferation  of  installations 

for radiodiagnostic  and radiotherapeutic purposes. 

12 

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. 

5. 

The prescriber as well  as the practitioner shall be involved in the justification process, 

at the appropriate level. 

6. 

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 R(90)3 of the Committee of Ministers of the 

Council  of Europe. 

7. 

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,  on  the  basis  of 

European reference levels where available, 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. 

13 

c 

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 ionizing  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  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. 

3.  Member  States  shall  lay  down  procedures  to  determine  responsibilities  in  case  of 

medico-legal,  insurance or legal examinations. 

14 

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. 

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. 

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 24 January  1989 (89/48/CEE) 
Council Directive of 24 July  1992 (92/51/CEE) 
Council  Directive  of  5 April  1993 (93/16/CEE) 

15 

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: 

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 

-  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. 

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 

16 

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. 

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. 

17 

Article  14 - Estimates of population doses 

Member  States  shall  ensure  that  individual  dose  and  collective  dose  estimates  from 

practices  referred  to  in  article  3  are  made  for  the  whole  population  and  for  relevant 

reference  groups of the population. 

Article  15 - Audit 

In order to assure the implementation of the preceeding articles, Member States shall ensure 

that appropriate processes  for audit are adopted. 

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. 

18 

ISSN 0254-1475 

COM(96) 465  final 

DOCUMENTS 

EN 

IS  05  12 

Catalogue number  : CB-CO-96-474-EN-C 

ISBN 92-78-09091-3 

Office  for Official Publications of the European Communities 

L-2985 Luxembourg