CELEX: 51997PC0315
Language: en
Date: 1997-06-19
Title: 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

<tt*-tt        COMMISSION OF THE EUROPEAN COMMUNITIES
•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)
 ---pagebreak---  ---pagebreak---                         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
 ---pagebreak---    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>
 ---pagebreak---    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
 ---pagebreak---                                       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                                         Article 1
 This Directive lays down the general              This Directive lays down the general
 principles of the radiation protection of         principles of the radiation protection of
individuals undergoing medical exposures           individuals undergoing medical exposures
and associated practices involving ionizing        and associated practices involving ionizing
radiation.                                         radiation.
The purpose of this Directive is to                The purpose of this Directive is to
supplement Directive 80/836/Euratom on the         supplement Directive 96/29/Euratom on the
basic safety standards as regards medical         basic safety standards as regards medical
exposures.                                        exposures.
                     Article 2                                         Article 2
Potential exposures: exposure with a              Potential exposures: exposure resulting from
probability of occurrence that can be             events such as equipment failure or faults, or
estimated in advance for accidents and            a human error and with a probability of
incidents, such as a failure of equipment, a      occurrence that can be assessed in advance;
misadministration. a human error or a
computer failure;
Medical Physicist: an expert in radiation         Medical Physicist: an expert in radiation
physics applied to medical exposures whose        physics applied to medical exposures whose
training and competence to act is recognized      training and competence to act is recognized
by the competent authorities and who, as          by the competent authorities and who, as
appropriate, gives advice on patient              appropriate, gives advice on patient
dosimetry, on the development and use of          dosimetry, on the development and use of
complex techniques and equipment and on           complex techniques and equipment and on
optimization, on quality assurance, including     optimization, on quality assurance, including
quality control, and on matters relating to       quality control, and on matters relating to
radiation protection as defined in Article 3,      radiation protection as defined in Article 3,
as appropriate. This expert might also give        as appropriate.
advice on radiation protection aspects as
 regards workers and the public;
 Quality Assurance: all those planned and          Quality Assurance: all those planned and
 systematic actions necessary to provide           systematic actions necessary to provide
 adequate confidence that a structure, system      adequate confidence that a structure, system
 or component will perform satisfactorily in       or component will perform satisfactorily in
 service. Satisfactory performance in service      service. Satisfactory performance in service
 implies the optimum quality of the entire         implies the optimum quality of the entire
 procedure.                                        procedure.
                                                •r
 ---pagebreak--- In the case of radiodiagnostic procedure, the    By optimum quality is meant:
consistent production of adequate diagnostic     (a) in the case of radiodiagnostic procedure,
information with minimum exposure of both        the consistent production of adequate
patients and personnel.                          diagnostic information with minimum
in the case of a radiotherapeutic procedure      exposure of patients.
optimum exposure of patients and minimum         (b) in the case of radiotherapeutic procedure,
exposure of personnel.                           the optimum exposure of patients.
                   Article 4.4                                      Article 4.4
Special attention shall be given for those        Special attention shall be given for those
exposures where there is no direct health         exposures where there is no direct health
benefit for the person undergoing the             benefit for the person undergoing the
exposure and especially for exposures on          exposure and especially for exposures on
medico-legal, insurance and legal grounds.        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        The prescriber as well as the practitioner
shall be involved in the justification process,   shall be involved in the process of
at the appropriate level.                        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         In radiotherapeutic practices, a medical
physicist shall be closely involved. In          physicist shall be closely involved and he
diagnostic nuclear medicine practices, a         must check the equipment used for
medical physicist shall be involved as           radiotherapy after any major maintenance
appropriate. For other radiodiagnostic           procedure. In diagnostic nuclear médecine
practices, a medical physicist shall be          practices, a medical physicist shall be
available for consultation on optimization       involved as appropriate. For other
and quality assurance, including quality         radiodiagnostic practices, a medical physicist
control, as appropriate, and also to give        shall be available for consultation on
advice on matters relating to radiation          optimization and quality assurance, including
protection concerning medical exposures, as      quality control, as appropriate, and also to
required.                                        give advice on matters relating to radiation
                                                 protection concerning medical exposures, as
                                                 required.
                                                G
 ---pagebreak---                    Article 9.b                                       Article 9b
Competent authorities shall at regular           Competent authorities shall at regular
intervals perform inspections of radiological    intervals perform inspections of radiological
installations. They shall ensure that            installations. They shall ensure that
necessary measures are taken by the holder       necessary measures are taken by the holder
of the installation to improve inadequate or     of the installation to improve inadequate or
defective features of the installation.          defective features of the installation.
They shall ensure that all installations which   Member States shall adopt measures to
do not or no longer meet specific criteria       ensure that equipment and installations which
adopted by competent authorities for this        do not meet predetermined acceptability
purpose are taken out of service.                criteria are taken out of service or replaced.
                                                                     Article 10.1
                   Article 10.1
                                                 Member States shall ensure that medical and
Member States shall ensure that medical and      paramedical staff performing
paramedical staff performing
- frequent paediatric medical exposures          - frequent paediatric medical exposures
- exposures as part of a health screening        - exposures as part of a health screening
     programme                                        programme
- examinations involving high doses to the       - examinations involving high doses to the
     patient and the medical staff, such as           patient and the medical staff, such as
     interventional radiology and Computed            interventional     radiology,     Computed
     Tomography                                       Tomography and radiotherapy
 receive specific training on the relevant        receive specific training on the relevant
 radiological practices and on the relevant       radiological practices and on the relevant
 radiation protection aspects.                    radiation protection aspects.
                   Article 11.2                                      Article 11.2
 If pregnancy cannot be excluded, depending       If pregnancy cannot be excluded, depending
 on the type of medical exposures, special        on the type of medical exposures, in
 attention shall be given to the justification,  particular those involving the pelvic and
 particularly the urgency, and to the            abdominal regions, special attention shall be
 optimization of the medical exposure both       given to the justification, particularly the
for the mother and the unborn child.             urgency, and to the optimization of the
                                                 medical exposure both for the mother and
                                                 the unborn child.
                                                V
 ---pagebreak---  ---pagebreak---                                                                   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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