CELEX: 51995PC0560
Language: en
Date: 1995-11-24
Title: Draft Proposal for a COUNCIL DIRECTIVE on health protection of individuals against the dangers of ionizings radiation in relation to medical exposures, replacing Directive 84/466/Euratom

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)
 ---pagebreak---  ---pagebreak--- 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.
 ---pagebreak---                             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
        O.JN° 11 of 20.02.1959
     A
        O.J. C245 of 09.09.1993
        O.J. C 224 of 12.08.1994
 ---pagebreak--- 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.
 ---pagebreak--- 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
 ---pagebreak--- 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.
 ---pagebreak---                                             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
 ---pagebreak--- 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
 ---pagebreak--- 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
 ---pagebreak--- 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
 ---pagebreak--- 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
 ---pagebreak---  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
 ---pagebreak--- 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
 ---pagebreak--- 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
 ---pagebreak--- 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
 ---pagebreak--- 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
 ---pagebreak---    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
 ---pagebreak--- 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
 ---pagebreak---  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
 ---pagebreak---  ---pagebreak---                                                                     ISSN 0254-1475
                                                              COM(95) 560 final
                                              DOCUMENTS
EN                                                                         05 15
                                      Catalogue number : CB-CO-95-611-EN-C
                                                               ISBN 92-77-96302-6
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