Law 25/1964 of 29 April on Nuclear Energy, in Article 28 thereof, except for the system of authorizations for the construction and assembly of nuclear installations or radioactive installations, the apparatus of X-ray for medical purposes, referring the regulation of these devices to a standard of regulatory range, without prejudice " that, in any case, the facilities used by such apparatus, because of their radioactive condition, are subject to the Regulation of Health protection against ionizing radiation.

Moreover, Law 14/1986 of 25 April, General of Health, in its Article 40 and in the fourth final provision, requires the establishment of minimum technical requirements for the approval and approval of the centres and services and to assess, on the part of the Health Administration, according to Article 110, the safety, efficacy and efficiency of the relevant health and health care technologies.

The Directives of the European Communities 84 /466/EURATOM, 80 /836/EURATOM and 84 /467/EURATOM should also be taken into account as a result of the obligation to adapt Spanish law to Community legislation.

In line with the above and in order to regulate the installation and use of X-ray equipment for medical purposes, this standard establishes the procedures necessary for the Administration to exercise the appropriate control of These devices shall be used for the correct operation.

In its virtue, on the proposal of the Ministers of Industry, Commerce and Tourism and of Health and Consumer, after approval by the Ministry for Public Administrations, seen the report of the Superior Council of Industry, with the Nuclear Security Council, heard by the Council of State, having regard to the recommendations of the Commission of the European Communities, pursuant to Article 33 of the Euratom Treaty and after deliberation by the Council of Ministers at its meeting of the day 27 December 1991,

DISPONGO:

CHAPTER FIRST

Object and definitions

Article 1. º

This Royal Decree aims to regulate the use of X-ray equipment and facilities for medical diagnosis.

X-ray installations applied to the medical diagnosis of humans or animals shall be governed by the provisions set out in the following Articles.

Installations consisting of particle accelerators, X-ray equipment for therapy and other ionising radiation generating equipment used for medical purposes, not included in the preceding paragraph, shall be governed by: General provisions for all radioactive installations in the Regulation of Nuclear and Radioactive Facilities, approved by Decree 2869 of 21 July 1972.

Art. 2. º

For the purposes of this Royal Decree the following definitions are set out:

1. X-ray equipment: These are electrical equipment comprising an X-ray generated and one or more X-ray tubes.

2. Fixed X-ray equipment: These are those that are used with a stationary character in premises or vehicles.

3. Mobile X-ray equipment: Those who are susceptible to moving to places where their use is required.

4. X-ray installations: It is equipment or X-ray equipment and the premises or vehicles where they are used.

5. Holder of an X-ray installation for medical diagnosis is the natural or legal person to exploit the facility.

CHAPTER II

Requirements for the equipment and responsibilities of the facility owner

Art. 3. º

X-ray equipment to be used for medical diagnostic facilities must be of a mandatory nature for approved models.

Art. 4. º

The holder of X-ray installations for medical diagnosis purposes shall be responsible for the compliance with the technical specifications contained in the ane xo I of this Royal Decree, as well as the provisions of the Regulation of Health Protection against Ionising Radiation, approved by Royal Decree 2519/1982 of 12 August, and Royal Decree 1753/1987 of 25 November 1987, which are applicable.

CHAPTER III

From Income and Technical Assistance Companies

Art. 5. º

1. Any performance related to the sale and technical assistance of X-ray equipment and installations for medical diagnosis purposes shall be performed by Companies or Entities authorized for this purpose.

2. The Companies or Entities that wish to obtain the authorization referred to in the previous paragraph must make the corresponding application to the Provincial Directorate of the Ministry of Industry, Commerce and Tourism, in whose demarcation they have their addresses, by stating in detail the activities for which they are requested and presenting the documentation of their technical capacity to develop them, which should be extended to the following:

Company or Entity identification: Social reason, tax identification number, and address.

Memory of the activities to be developed.

Where appropriate, Company experience in the same type of work.

Organization of the Company's personnel and operating rules.

Relationship of the technical staff of staff, with the expression of their qualifications, qualifications and professional experience.

Relationship of the facilities, equipment and material resources available to the Company or Entity to develop its actions.

Where appropriate, procedure to ensure the radiation protection of exposed workers by reason of the tasks to be developed.

3. The Provincial Directorate of the Ministry of Industry, Commerce and Tourism will raise the file to the Directorate-General for Energy, which is the subject of a report by the Nuclear Safety Council, which will be binding within the meaning of Article 2 (2) of the Treaty. Law 15/1980, of 22 April, will dictate the resolution that proceeds.

Art. 6. º

The authorised companies or entities, as provided for in the previous article, shall be registered in a register which for this purpose is created in the Directorate General of Energy, called " Registration of Companies of Sale and technical assistance of equipment c X-ray installations for medical diagnostic purposes ". Such undertakings shall, within 30 days, communicate to the authorising body the cessation of their activities in order to be discharged from the register, which shall be notified to the Nuclear Safety Board.

These Companies are obligated to:

Maintain the conditions with which they were authorized. Any variation in circumstances which may result in a reduction in such technical guarantees shall be subject to new authorisation, subject to the report of the Nuclear Safety Board.

Register how many operations to perform.

Art. 7. º

For the registration in the Registry of Companies or Entities, as referred to in Article 6. and in order to cover the civil liabilities that may be derived from their actions, they must have a policy of insurance for a minimum of 2,000,000 pesetas for those exclusively dedicated to sales operations, of 5,000,000 pesetas for those dedicated exclusively to technical assistance activities and 6,000,000 pesetas for the purposes of carrying out together both operations. The amount of the policy shall be fixed in each authorization in accordance with the risk characteristics of each applicant.

CHAPTER IV

Statement and registration procedure for X-ray equipment and installations for medical diagnosis

Art. 8. º

1. The operation of X-ray installations for medical diagnostic purposes must be declared by their holders to the Provincial Directorate of the Ministry of Industry, Commerce and Tourism in which the demarcation is located. installation. To this end, they shall submit the following documents, using the forms contained in Annexes II and III to this Royal Decree:

(a) Statement on the forecast of use of the facility and its operating conditions.

b) Certificate of approval of the existing X-ray equipment at the installation.

(d) Certificate issued by a Technical Service or Unit for the Protection against ionising radiation to ensure the conformity of the project of the installation with the applicable technical specifications and to verify that the construction and assembly of the facility has been carried out according to the above mentioned project.

(d) Guarantee of risk cover constituted in accordance with the provisions of Article 57 of Law 25/1964 of 29 April and the Nuclear Risk Coverage Regulation, approved by Decree 2177/1967 of 22 July, for Third category radioactive installations.

2. If the Provincial Directorate considers that the documentation submitted is incomplete, erroneous or inaccurate, it shall, within three months, communicate this end to the holder who has submitted the declaration, in order to ensure that in ten days the Deficiencies noted. After this period without the holder having carried out the remedy, he shall be notified that for the purposes of Article 8. the declaration has not been verified, and therefore the registration of the installation in the Registry shall not be carried out Article 9, with the consequences that are dealt with in Chapter VI of this Royal Decree. A copy of that communication shall be forwarded to the Nuclear Safety Board.

Art. 9. º

The declarations will be entered in a Register that is created for this purpose in the Directorate General of Energy, called "Registry of X-ray installations for medical diagnosis". The information contained in the register shall be sent periodically to the competent bodies.

The Provincial Directorate shall transmit a copy of the declarations to the Nuclear Safety Board so that the Council may verify that compliance with the provisions of Article 4. and other provisions resulting from it are deemed necessary. application.

Art. 10.

The cessation of the use of X-ray facilities for medical diagnosis, as well as the extension or reduction of X-ray equipment of the same, and, in general, any modification affecting substantially the Project or operating conditions initially declared shall require a declaration and registration procedure similar to that set out in the preceding articles.

The Registry update will be performed without modifying the registry number of the installation.

Art 11.

The registration of X-ray installations for medical diagnostic purposes will occur after the voluntary cessation of the operator's use of the facility, or when it is agreed on a temporary or permanent basis such as consequence of a sanctioning case.

Art. 12.

The Technical Services or Units for the Protection against Ionising Radiation, to be authorized by the Nuclear Safety Council, are required to provide the Directorate-General for Energy and the Council with Nuclear Security as many data and reports are requested in relation to your actions.

CHAPTER V

From Staff

Art. 13.

1. The operation of an X-ray installation for medical diagnostic purposes shall be directed by Doctors, Odontologists or Veterinarians, or the graduates referred to in the second provision of Royal Decree 1132/1990 of 14 May 1990. September, which have both the appropriate knowledge on the design and use of equipment, the associated radiological risk and the means of safety and radiation protection to be adopted, such as training and experience in these scopes.

2. When the operation of the X-ray equipment is not to be carried out directly by the person who directs the operation of the installation, but by personnel under his supervision, the latter must also be capable of doing so.

3. The procedures laid down in accordance with the technical specifications set out in the Annex shall be followed by the staff who lead the operation of the installation and the equipment operating on the installation. I of this Royal Decree.

Art. 14.

To ensure the provision of the above article:

1. Graduates who run the facilities of rare X for the purposes of medical diagnosis and the operators of the equipment operating under their supervision must prove to the Nuclear Safety Board their knowledge, training and experience in the field of Radiological Protection, presenting to the effect how much supporting documentation considers appropriate.

The Nuclear Safety Board will examine the documentation submitted and will be able to perform as many checks as it deems relevant, extending the corresponding certifications when in its judgment it would have been sufficiently demonstrated the capacity of the person concerned.

2. They shall be accredited for the purposes of paragraph 1 above who have exceeded the courses established for that purpose by the Nuclear Safety Board.

For these same purposes, the Nuclear Safety Board may approve academic programmes and specific training and training courses which comprise the knowledge provided in the courses referred to in the paragraph previous.

Art. 15.

The Nuclear Safety Council is empowered to check when circumstances advise, by overcoming the tests which it establishes, the permanent updating of knowledge in the field of nuclear safety. Radiation protection to be provided by personnel who conduct the operation of X-ray facilities for medical diagnosis as well as the equipment operating existing equipment.

CHAPTER VI

Sanctioning Regime

Art. 16.

1. The infringements of the provisions of this Royal Decree shall be sanctioned in accordance with the provisions of Chapter XIV of Law 25/1964 of 29 April on Nuclear Energy, and the second provision of Law 15/1980 of 22 April, the creation of the Nuclear Security Council.

2.1 Mild violations are considered:

(a) Having X-ray installations in operation for medical diagnosis purposes which, while complying with the provisions on safety and radiation protection contained in this Royal Decree, have not been subject to statement.

b) Present, with manifest negligence, erroneous or inaccurate documentation that prevents the timely control of X-ray facilities for medical diagnosis by the Nuclear Safety Board or by the Administration, provided that it does not have any negative consequences for the safety or radiation protection of the installation.

c) Failure to communicate the cessation of the operation of an X-ray facility for medical diagnostic purposes.

(d) Failure to communicate modifications of an X-ray installation for medical diagnostic purposes, provided that the modification complies with the provisions on safety and radiation protection contained in this Royal Decree.

e) Failure to comply with the conditions imposed for the exercise of activities related to the project, repair, maintenance or verification of equipment and/or X-ray installations for medical diagnosis, provided that the non-compliance does not affect the safety of the facilities or the necessary control of the activities by the Nuclear Safety Board or the Administration.

f) Having an X-ray installation in place for medical diagnosis purposes without the personnel directing their operation or operating the existing equipment in the same meeting the conditions set out in this Royal Decree as to its capacity, provided that, in the opinion of the Nuclear Safety Board, the non-compliance does not affect the safety or radiation protection in the facility.

2.2 Serious violations are considered:

(a) Having an X-ray facility in operation for medical diagnosis purposes which, while registered in the relevant register, does not comply with the safety or radiation protection conditions provided for in this Royal Decree, where the non-compliance, in the opinion of the Nuclear Safety Board, affects the safety or radiation protection in the facility.

b) Present, with manifest negligence, erroneous or inaccurate documentation that prevents the timely control of X-ray facilities for medical diagnostic purposes by the Nuclear Safety Board or the Administration that, in the opinion of the Nuclear Safety Board, the consequences for the safety or radiation protection at the facility should not be qualified as serious.

(c) Failure to comply with the conditions imposed for the exercise of the activities related to the project, repair, maintenance or verification of equipment and/or X-ray installations for the purposes of medical diagnosis or conduct them with manifest technical incompetence, in such a way that, in the opinion of the Nuclear Security Council, it has a negative impact on the safety or radiation protection in such facilities.

d) Having an X-ray facility in operation for medical diagnosis, without the personnel operating the equipment existing in the facility meeting the conditions set out in this Royal Decree as regards their capacity, provided that, in the opinion of the Nuclear Safety Board, the non-compliance concerns the safety or radiation protection at the facility.

e) Having an X-ray facility in operation for medical diagnostic purposes without the staff directing the operation of the facility to comply with the provisions laid down in this Royal Decree in respect of its capacity provided that, in the opinion of the Nuclear Safety Board, it may affect the safety or radiation protection at the facility.

2.3 Serious violations are considered:

(a) Having an X-ray facility in operation for medical diagnostic purposes that does not comply with the security conditions provided for in this Royal Decree, where the non-compliance, in the opinion of the Nuclear Safety Board, seriously affect the safety or radiation protection at the installation, provided that the installation has not been the subject of a declaration.

b) Present, with manifest negligence, erroneous or inaccurate documentation that prevents the timely control of X-ray facilities for medical diagnostic purposes by the Nuclear Safety Board or the Administration, that the consequences for the safety or radiation protection at the installation must be qualified as serious.

c) Carry out activities related to the project, repair, maintenance or verification of equipment and/or X-ray installations for medical diagnosis without being registered or to be registered in the corresponding Register with manifest technical incompetence or in breach of the conditions imposed for the exercise of such activities in such a way as to the judgment of the Nuclear Safety Council, has an impact on the safety or radiation protection of the installations.

3. Minor infringements will be punishable by a fine of 50,000 to 1,000,000 pesetas, serious infringements with a fine of 1,000,001 to 2,500,000 pesetas and very serious infractions with mulla from 2,500,001 to 5,000,000 pesetas, with the amount in role of the nature of the infringement. Where the infringement is classified as very serious, the temporary or final suspension of the activities of the facility may be imposed jointly.

4. The recidivism in the infringement may result in the fines provided for in the previous paragraph being doubled.

5. The infringements referred to in this Regulation shall be prescribed at two years. The term of the prescription shall begin to run from the day on which the offence was committed. The prescription shall be interrupted from the time the procedure is directed against the alleged infringer.

The sanctions will be prescribed at two years. The time of limitation shall begin to run from the date on which the sanctioning administrative decision is signed.

The action to prosecute the infringements will lapse, when the Ministry of Industry, Commerce and Tourism, known as the Ministry of Industry, Commerce and Tourism, has been infraction and completed the investigations directed to the clarification. six months without the competent authority having ordered the initiation of the appropriate procedure.

The conflicting requests for analysis that are required will interrupt the expiration times until they are practiced.

6. The penalties shall be imposed upon instruction of the relevant file, which shall be processed and resolved in the manner provided for in Chapter II of Title VI of the Law on Administrative Procedure.

Art. 17.

With the independence of the sanctioning regime established in this Chapter, and in accordance with the provisions of Article 2 (d) of the Law, 15/1980 of 22 April, the Nuclear Safety Council may suspend for reasons of safety of the operation of X-ray installations for medical diagnosis purposes.

TRANSIENT PROVISIONS

First.

The holder of the X-ray installations for medical diagnosis purposes which, at the entry into force of this Royal Decree, have authorization to start up, obtain-in accordance with the provisions of the Regulation Nuclear and radioactive installations shall be exempt from the obligation to declare their use. These facilities shall be registered as a trade in the Register referred to in Article 9. of this Royal Decree.

The Directorate-General of Energy will account for these entries, to the Nuclear Safety Board to the Provincial Directorates of the Ministry of Trade and Tourism.

Second.

The provisions of the First Transitional Provision shall apply in respect of X-ray installations for medical diagnostic purposes for which authorisation has been requested to be put in place without the date of The entry into force of this Royal Decree would have been granted to them. These facilities will be entered in the Register without further requirements than the favorable report of the Nuclear Safety Council, which will be referred to the General Energy Directorate.

Third.

The ability to direct the operation of X-ray installations for medical diagnostic purposes and to operate existing equipment on those of those who enter into force of this Royal is accredited. Decree, be in possession of a supervisor or operator's license for such facilities granted in accordance with the provisions of the Nuclear and Radiactive Facilities Regulations.

Fourth.

The holders of X-ray installations for medical diagnostic purposes that were in operation at the entry into force of this Royal Decree, without having applied for the same authorisation of Puesta en Marcha in accordance with the provisions of the Regulation on Nuclear and Radiactive Installations, they shall submit the declaration of use for registration within the maximum period of two years from the date of publication of this Regulation. Royal Decree.

The documentation to be submitted shall be as laid down in Article 8, with the exception of the document referred to in paragraph 1 (c), which shall be replaced by a certificate issued by a service or Technical Unit of the Protection against ionising radiation by certifying that the installation complies with the technical specifications set out in Annex I to this Royal Decree.

Where it is not possible to submit the approval certificates for the equipment, it shall present a certificate issued by an undertaking or an entity authorised for that purpose as provided for in Article 5. have been verified and have no undue risk of external irradiation for professionally exposed personnel and members of the public.

For the purposes prevented in the second paragraph of this transitional provision fourth, the models contained in Annexes II and III to this Royal Decree shall be used.

Fifth.

The staff who are not in possession of the licence referred to in the third transitional provision, at the entry into force of this Royal Decree, are directing the operation of X-ray installations for the purpose of medical diagnosis and operating the existing equipment in them, must comply with the provisions of Article 14 in the maximum two-year place from the date of publication of this Royal Decree.

FINAL PROVISIONS

First.

The competencies that correspond to the Ministry of Industry, Commerce and Tourism in this Royal Decree will be understood to be attributed to the Autonomous Communities with executive competence in the field of industry.

Second.

The authorizations granted to the sales and technical assistance companies, the declarations of the operation of the X-ray installations, and, in general, the actions of the Autonomous Communities with competence The Executive Board of Directors shall be notified to the General Directorate of Energy

the records referred to in Articles 6 and 9 of this Royal Decree.

Third.

This Royal Decree will enter into force four months after its publication in the "Official Gazette of the State".

Given in Madrid at December 30, 1991.

JOHN CARLOS R.

The Minister of Relations with the Courts and the Government Secretariat,

VIRGILIO ZAPATERO GOMEZ