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Royal Decree 53/1992, Of 24 January, Which Approves The Regulation On Health Protection Against Ionizing Radiation.

Original Language Title: Real Decreto 53/1992, de 24 de enero, por el que se aprueba el Reglamento sobre Protección Sanitaria contra Radiaciones Ionizantes.

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TEXT

By Royal Decree 2519/1982 of 12 August, the Regulation on Health Protection against Ionising Radiation, established under Law 25/1964 of 29 April, on Nuclear Energy was adopted. This Royal Decree was partially amended by Royal Decree 1753/1987 of 25 November 1987 in order to bring it into full compliance with the European system of the right to radiation protection, in particular Directives 80 /836/EURATOM and 84 /467/EURATOM, relating to the health protection of the population and workers against the dangers arising from ionising radiation.

Studied the need to modify certain aspects of its content in the light of the results of its practical application since its publication, as well as to give the recipients of the same text easily accessible, considers it appropriate to give a new wording to the aforementioned Regulation on Health Protection against Ionising Radiation.

in addition to the strict health guidance of this Regulation, which contains protective measures for the population as a whole, the specific protective measures for the protection of the population should be highlighted. professional exposed workers, therefore the present loyal Decree is dictated by the provisions of article 149.1, 7. and 16. of the Constitution.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs, of Labor and Social Security and of Industry, Commerce and Tourism, in accordance with the Regulations proposed by the Council of Nuclear Safety, according to the Council of State, after deliberation by the Council of Ministers at its meeting on 24 January 1992,

DISPONGO:

Single item.

The Deputy Regulation on Health Protection against Ionising Radiation is hereby approved.

REGULATION ON HEALTH PROTECTION AGAINST IONISING RADIATION

TITLE FIRST

General provisions

CHAPTER FIRST

Object and Scope

Article 1. º

This Regulation aims to establish the basic standards of radiation protection to prevent the production of non-stochastic biological effects and to limit the likelihood of occurrence of stochastic biological effects, up to securities deemed acceptable to professionally exposed workers and members of the public as a result of activities involving a risk of exposure to ionising radiation.

The regime for measures to protect against ionising radiation provided for in Law 25/1964 of 29 April on Nuclear Energy will be constituted by the provisions of this Regulation and those of this Regulation.

Art. 2. º

This Regulation shall apply to all types of nuclear and radioactive activities, including the holdings of radioactive minerals, the production, processing, handling, use, possession, storage and transport of natural or artificial radioactive materials and the apparatus producing ionising radiation, and the disposal of such substances and, in general, any activity involving a risk arising from radiation ionising.

For the purposes of this Regulation, the definitions contained in Appendix I shall be used.

CHAPTER II

Authorities and administrative bodies

Art. 3. º

It is for the competent administration in each case for the matter and the Nuclear Safety Board in the field of their duties to ensure compliance with the provisions of this Regulation.

TITLE II

Basic protection rules

CHAPTER FIRST

Basic Principles

Art. 4. º

The number of people exposed to ionizing radiation will be the least possible.

The limitation of individual and collective doses resulting from controllable exposures should be based on the following principles:

(a) The different types of activities involving exposure to ionising radiation must be justified in advance by the advantages they provide.

(b) All exposures shall be kept at the lowest level that is reasonably possible.

(c) Without prejudice to Article 8. º, the sum of doses received and committed should not exceed the dose limits set out in Appendix II to this Regulation for professionally exposed workers and members of the public.

The criteria defined in paragraphs (a) and (b) apply to all exposures to ionising radiation, including medical exposures.

criterion (c) does not apply to the exposure to which individuals may be subject to medical examinations or treatments.

The holder of the activity will be responsible for the principles that are set out here to be applied in the scope of their installation or activity.

CHAPTER II

Protection rules for professionally exposed workers

Art. 5. º

The work shall be carried out under conditions such that, under normal working conditions, the doses received are the lowest possible and, in any case, less than the dose limits set out in this Regulation.

For the determination of the total doses the doses due to the internal and external sources of ionising radiation will be taken into account. The use of the doses due to the natural radioactive background, the results of medical examinations or treatments (as patients), or the individual received as members of the public, shall not be included in the calculation.

In the case of an external exposure of the whole body or an important part thereof, the dose limits shall be considered to be respected when the conditions defined in Appendix VI are met.

In cases of internal exposure only, in the case of a mixture of radionuclides, the methods to be used are indicated in Appendix III, point 2.

In the event of an external exposure of the whole body or of an important part thereof, and internal radioactive contamination by one or more radionuclides, the dose limits shall be considered to be observed when the conditions laid down in Appendix VI are met.

Art. 6. º

The limits of annual incorporation by inhalation and the limits derived from the concentration of radionuclide activities in the inhaled air shall be those set out in Appendix III for the professional workers. exposed.

The annual intake limits per ingestion shall be the same as for members of the public, which are also set out in Appendix III.

Art. 7. º

No person under eighteen years of age shall be assigned to a job that involves his or her qualification as a professionally exposed worker.

Breastfeeding women will not perform jobs that pose a significant risk of contamination. In such cases, adequate monitoring of the possible radioactive contamination of the organism shall be ensured.

Art. 8. º

When a situation arises, the solution of which makes it necessary to expose people to the risk of receiving a higher dose than one of the annual dose limits for professionally exposed workers, specified in Appendix II, the operation involving this risk shall be considered as a planned special operation and shall be programmed in such a way as to meet the conditions set out in paragraph 1.4 of Appendix II.

Any dose received as a result of a planned special operation should be recorded as such in the dosimetric history, specifying, where appropriate, the incorporation of radionuclides in the body.

Art. 9. º

When in the event of an accident and exceptionally there are situations giving rise to exposures involving the receipt of doses higher than the dose limits set for normal working conditions, these exposures shall be considered exceptional exposures and shall be classified as:

1. Emergency exposures: Those on a voluntary basis where the annual dose limits set out in Appendix II are exceeded and which are justified in the case of providing assistance to individuals in distress, to avoid exposure to a large number of people or to save a valuable facility. Persons providing for this purpose shall be informed of the risks involved before they are involved in such operations.

2. Accidental exposures: Aachellas of a fortuitous and involuntary nature, in which one of the annual dose limits set out in Appendix II is exceeded.

The doses received as a result of exceptional exposures shall be evaluated, whether total exposures or partial exposures. If the doses received as a result of these exceptional exposures exceed the corresponding annual dose limits, the case shall be immediately brought to the attention of:

The medical service referred to in Article 40.

The Nuclear Security Council.

The affected worker.

CHAPTER III

Student protection rules

Art. 10.

The dose limits for students who are going to engage in a profession involving exposure to ionizing radiation or who have to manage radioactive sources due to their studies will be:

When students are eighteen or older: Equal to the limits set for professionally exposed workers.

When students are more than sixteen and under eighteen years old: Three we say of the limits set for professionally exposed workers.

Art. 11.

Annual dose limits for students under the age of 16 years and for those who, exceptionally, are subject to the risk of exposure to ionising radiation without the conditions laid down in the Previous article, they will be the same as those established for members of the public. However, contributions to the annual doses which they may receive for their training must not exceed a tenth of the annual dose limits for members of the public, without the dose in the course of a single exposure exceeding a hundredth of such dose limits.

CHAPTER IV

Protection rules for members of the public

Art. 12.

The dose limits for members of the public are those listed in Appendix II.

For the determination of the total doses the doses due to the internal and external sources of ionising radiation will be taken into account. The use of the doses due to the natural radioactive background and the resulting medical examination or treatment shall not be included in the calculation.

Art. 13.

The annual intake limits per ingestion and the annual inhalation incorporation limits for members of the public are those set out in Appendix III.

CHAPTER V

Protection rules for the population as a whole

Art. 14.

The collective dose received by the population as a whole, and in particular the resulting genetic dose of each activity, will be as low as reasonably possible, taking into account the principles contained in the (a) and (b) of Article 4. of this Regulation. For the estimation of the genetic dose, account should be taken of all activities involving a risk of exposure to the population as a whole.

TITLE III

Fundamental surveillance measures for the protection of professionally exposed workers

CHAPTER FIRST

General rules

Art. 15.

The Nuclear Safety Board, taking into account the radiological risk of the activities referred to in Article 2, shall decide on the cases in which the radiation protection functions which fall to the holder of the installation they must be entrusted to a Radiological Protection Service, their own organisation, or a Technical Unit for Radiological Protection contracted for this purpose. In such cases the Radiological Protection Services or Units shall be proposed by the holder to the Nuclear Security Council for acceptance.

Art. 16.

Radiation Protection Technical Services or Units shall be expressly authorized and supervised by the Nuclear Safety Board.

The holder's own Radiological Protection Services shall be organized and acted independently of the other functional units of the activity and shall maintain a direct functional dependency with the holder of the activity or, in their case, the person to whom the maximum responsibility falls within the establishment or the Centre.

Radiation Protection Technical Services and Units may act in more than one facility or activity when they are authorized to do so by the Nuclear Safety Board.

The functions described in Articles 21 to 26 and 28 of this Regulation shall be entrusted to the Technical Radiological Protection Services or Units.

Art. 17.

In any case, whoever holds the post of Head of Service or Radiological Protection Unit shall be in possession of a diploma issued by the Nuclear Security Council which enables him to do so.

Art. 18.

Before starting their activity, the professionally exposed workers and students must receive adequate training in the field of radiation and, in addition, be informed and instructed, at an appropriate level to their responsibility and the risk of exposure to ionising radiation in your workplace, on:

(a) Risks of ionising radiation and its biological effects.

b) General rules for the protection against radiation and precautions to be taken under normal working conditions and in the event of an accident.

c) Specific rules, means, and working methods for their protection in the operations to be performed.

(d) Types and use of instruments for the detection and measurement of radiation and of personal protective equipment and equipment.

e) Need to undergo medical examinations to determine their health status and specific examinations to assess possible internal contamination.

f) Acting in emergency situation.

g) Responsibilities arising from your job with respect to radiation protection.

h) Importance of meeting technical and medical measures.

CHAPTER II

Prevention of exposure

Art. 19.

The radiation protection of the exposed professional workers, as far as the incidence of ionizing radiation on health is concerned, will be based on the following measures:

Classification of professionally exposed workers according to their working conditions.

Classification of workplaces in different zones.

Application of the rules and control measures in the different areas and the different categories of professionally exposed workers.

These measures will apply equally to students.

Art. 20.

For reasons of surveillance and radiological control, professionally exposed workers will be classified into two categories:

Category B: Those persons who, by the conditions in which their work is performed, are highly unlikely to receive doses higher than 3/10 of any of the annual dose limits set in the Appendix II.

Category B: Those persons who, by the conditions in which their work is performed, are highly unlikely to receive doses higher than 3/10 of any of the annual dose limits set in the Appendix II.

Art. 21.

Workplaces will be classified according to the risk of exposure, in the following areas:

Controlled area: This is where it is not unlikely to receive doses higher than 3/10 of the annual dose limits set in Appendix II.

Monitored area: This is where it is not unlikely to receive doses higher than 1/10 of the annual dose limits set in Appendix II, with doses higher than 3/10 of those annual limits being highly unlikely to be received. dose.

Free Access Zone: It is very unlikely to receive doses higher than 1/10 of the annual dose limits set in Appendix II. It shall not be necessary to provide for special radiation protection measures.

Art. 22.

The classification of workplaces in the established areas should always be up to date in accordance with the actual conditions.

Art. 23.

In controlled and monitored areas, surveillance shall be carried out, with equipment of the appropriate type and sensitivity, of:

a) The dose and yield rates, specifying the nature and quality of the radiation emitted.

(b) The atmospheric and surface concentrations of the radioactive radioactive substances, specifying their nature and physical and chemical states.

The documents relating to the registration, evaluation and outcome of such surveillance shall be filed by the holder of the activity, who shall have them at the disposal of the competent authority.

When appropriate, the results of these measures will be used to estimate individual doses.

Art. 24.

The controlled and monitored areas shall be adequately demarcated and marked in such a way as to demonstrate the risk of exposure to them. This signalling shall be carried out in accordance with the requirements of Appendix IV.

Art. 25.

Access to controlled and monitored areas will be limited to those authorised for this purpose. Working procedures adapted to the existing radiological risk shall be established within the controlled and monitored areas.

Art. 26.

At the exit of the controlled and monitored areas where there is a risk of contamination, appropriate detectors shall be available to check for possible contamination and, where appropriate, to be able to take appropriate measures.

Art. 27.

In controlled areas, the use of individual dosimeters and, where there is a risk of contamination, the use of personal protective equipment appropriate to the existing specific risk shall be mandatory.

Art. 28.

In the monitored areas, an estimate of the doses that can be received should be performed using area dosimetry. If there is a risk of contamination, the use of appropriate personal protective equipment shall be mandatory.

Art. 29.

The examinations and controls of the protection devices and the measuring instruments must be carried out by qualified experts for these purposes, who will have to check their effectiveness, good health and safety on a regular basis. operation, as well as its correct use, according to the forecasts established for this purpose.

The examinations and controls carried out by qualified experts will also include the prior critical examination of the installation projects and the reception of new installations, from the point of view of radiation protection. These requirements shall be understood to be completed when the activity has been submitted to an authorisation file.

The training of such experts will be evaluated and accredited by the Nuclear Safety Board in accordance with the regulatory provisions that apply.

CHAPTER III

Determination of doses

Art. 30.

The doses received by the professionally exposed workers should be determined, when the working conditions are normal, with a periodicity not exceeding one month, for the external dosimetry, and with the periodicity. In each case they are established for the internal dosimetry of those who are exposed to the risk of the incorporation of radionuclides. All this in order to keep the metered track record of them up to date and to check compliance with the basic standards of protection laid down in Title II.

The dosimetric system used for the determination of individual doses will be appropriate for the types and energies of the radiation to which the workers are exposed, whether they are from internal sources or from sources. external.

The individual dosimetry, both. external as internal, shall be effected by Entities or Institutions expressly authorized and supervised by the Nuclear Security Council.

Art. 31.

For professionally exposed workers belonging to category A it shall be mandatory:

(a) The use of individual dosimeters that measure the external dose, representative of the dose for the entire body throughout the working day.

(b) In the case of risk of partial or non-homogeneous exposure of the body, the use of appropriate dosimeters in the potentially most affected parts.

(c) In the case of risk of internal contamination, the relevant measures or analyses shall be carried out to assess the corresponding doses.

Art. 32.

For professionally exposed workers belonging to category B, the use of personal dosimeters shall not be required, provided that area or area dosimetry is available at the workplace, which allows for control that the doses received are less than 3/10 of the annual dose limits set in Appendix II.

Art. 33.

When, as a result of a planned special operation, the annual dose limits set out in Appendix II have been exceeded, as well as in the case of exceptional exposures, a study shall be carried out for assess, as accurately as possible, the doses received in the whole body or in the affected regions or bodies.

CHAPTER IV

Record individual doses

Art. 34.

It will be mandatory to register all the doses received during the working life of the professionally exposed workers, in an individual dosimetric history that will be, at all times, at the disposal of the worker himself. In the event that this cessation of employment, the holder of the activity must provide him with a certified copy of that history.

Art. 35.

In the dosimetric history for category A workers, at least the monthly doses and the cumulative doses during each 12-month period shall be recorded. In the case of category B workers, the specified or estimated annual doses shall be recorded.

Art. 36.

The doses received for exceptional exposures shall be in the dosimetric history, recorded separately from those received during the work under normal conditions. The same way they will be due to scheduled special operations.

Art. 37.

Professionally exposed workers who are in more than one activity or facility will be obliged to give express account of such circumstance to those in charge of the protection of each of the Centers in which they work, to the purpose of the fact that, in all of them, its individual dosimetric history is present, updated and complete. To this end, the worker shall communicate in each activity the dosimetric results provided to him in the other activities.

When professionally exposed workers who are dependent on more than one holder are present in the same workplace, the latter will be obliged to agree on how to determine and communicate the doses received. as a result of this activity.

Art. 38.

The dosimetric history of professionally exposed workers, the documents corresponding to the dose assessment and the measures of the surveillance teams, and the reports concerning the circumstances and measures adopted in the case of exceptional exposure, as referred to in Article 9. of this Regulation, must be filed by the holder of the activity in which they serve, for a period of at least 30 years, from the date of termination of the worker in those activities which put his classification as professionally exposed.

The holder of the activity will have this documentation at the disposal of the Nuclear Security Council, and must provide the information contained in it to the public administrations that request it, according to its own competencies.

Except as provided in the preceding paragraph, the holder of the activity may not provide this information without the express consent of the worker.

When the definitive cessation of activities covered by this Regulation occurs, the holders of such activities shall deliver to the Nuclear Security Council, the files referred to in the first paragraph of this Article.

The activity holder will transmit the results of the dosimetric controls to the medical service, to whom it will be appropriate to interpret them from the health point of view. In case of urgency, such transmission shall be immediate.

Art. 39.

The metered history of any professionally exposed worker should also be included in the medical protocol.

CHAPTER V

Medical surveillance

Art. 40.

The medical surveillance of professionally exposed workers shall be carried out by a specialised, own or contracted medical service with a capacity officially recognised for this purpose by the Community body. Competent authority in the field of health, prior to the report of the Nuclear Safety Council, without prejudice to the provisions of the regulatory standards on the services of Company and Professional Diseases. The authorisations granted under this paragraph shall be communicated to the Nuclear Safety Board.

In the performance of their duties medical services will follow the guidelines or criteria set out in the Nuclear Safety Council Guide 7.4 which contains the basis for medical surveillance of exposed workers. to ionising radiation.

Medical services in the light of the working history, age and health status of the worker shall take the measures they deem appropriate. In case of exceeding the corresponding dose limits, they shall carry out an exceptional review of the person concerned, lay down the criteria for subsequent exposure and establish their possible medical attention, including, if necessary, their treatment at the centres of assistance referred to in Article 52 of this Regulation.

Medical services will have access to all information they deem necessary to assess the health status of professionally exposed workers who monitor and assess the conditions in the workplace. work to the extent that they can affect people's ability to perform the tasks assigned to them.

Art. 41.

Any person who is to be assigned to a work place involving a risk of exposure must be subject to a prior health examination to enable him to prove that he is not in any of the incompatibilities which he or she are legally determined and decide on their suitability for the work to which they are intended.

Professionally exposed workers will also be subject to health screening to check that they are still fit to perform their duties. These tests will be done once a year and more often if you need the health status of the worker, your working conditions or the incidents that may occur.

Art. 42.

The prior health medical examination of any person to be assigned to a job that involves risk of exposure shall be aimed at obtaining a complete medical history which, in addition, includes:

The knowledge of the type of work performed above and the risks to which it has been exposed as a result of it and, where appropriate, the dosimetric history to be contributed by the worker.

Possible exposures incurred as a result, either of the functions exercised or of medical treatments and diagnoses, with specification of their causes, doses received, exposed areas and type of clinical manifestations observed.

The outcome of a general clinical examination and of those specific tests necessary to assess the general health status and the condition of the organs or devices which, depending on the risk arising from the specific work to be performed, it is estimated that they may be more likely to be affected.

Art. 43.

The periodic medical examinations of professionally exposed workers will be adapted to the characteristics of exposure to ionising radiation or possible internal or external contamination and comprise a general clinical examination and those other tests necessary to determine the status of the exposed organs and their functions.

Art. 44.

From a medical point of view, and according to the result of the appropriate recognition, the professionally exposed workers will be classified into the following categories:

Suitable: Those who can perform activities that involve risk of exposure associated with the job.

Eligible, under certain conditions: Those who may carry out the activities involving the risk of exposure associated with the job, provided that the conditions which are established on the basis of medical criteria.

Unfit: Those who must be kept separate from positions that involve a certain risk of exposure.

No worker can be employed as professionally exposed if the medical conclusions are opposed to it. Statements on the fitness of workers and the resources to be made against them shall be based on the rules in force on the qualification and diagnosis of occupational diseases and on the provisions of employment law. applicable.

Art. 45.

Each professionally exposed worker will be opened a medical protocol that will contain, at least, the information concerning their job destinations, the results of their previous medical examination, their recognitions medical or periodic medical records and the dose history of your entire professional life.

These protocols will be closed for at least thirty years after the cessation of the activity, in the medical services corresponding to the Centers in which those persons lend or have provided their services, and will be the provision of the competent authority and the worker himself.

Art. 46.

The specialized medical service may determine the convenience of the extension of the duration of the medical surveillance of workers who have been professionally exposed to medical surveillance. not fit or have ceased in such professional activity.

TITLE IV

Fundamental surveillance measures for the protection of the public

Art. 47.

The protection of members of the public and of the population as a whole shall be carried out by means of the necessary measures and controls to ensure that the operations of production and use of radioactive substances and radiation ionising is carried out with appropriate guarantees.

Art. 48.

The monitoring will be based primarily on the assessment of the doses that could be received under normal operating conditions and, in the event of an accident, by the potentially affected population and will be appropriate to the risk involved. involve the activities.

The estimates of the doses to be made will take into account among other aspects:

(a) The assessment of external exposures, indicating, as the case may be, the type and quality of the radiation in question.

(b) The assessment of radioactive pollutants, indicating the nature and physical and chemical states of radioactive radioactive substances, as well as the determination of the activity of radioactive substances and their activity concentration.

c) The specification of the characteristics of the reference groups of the population and the assessment of the doses that may receive the same in normal and exceptional circumstances.

d) Where appropriate, the assessment of the genetic dose and the annual genetically significant dose, taking into account the demographic characteristics and the sum of the doses due to the different sources.

The frequency of the evaluations shall be determined in such a way as to ensure, in each case, compliance with this Regulation.

The documents relating to the measurement of external exposure and radioactive contamination, as well as the results of the assessment of the doses received by the population, should be kept and archived, including references to exceptional exposures.

Art. 49.

For the purpose of obtaining the administrative authorisation which enables the exercise of nuclear or radioactive activities, the applicant shall provide the appropriate studies for each case leading to the determination of the risk of exposure to the population may be subject to such activities, both in normal operation and in the event of an accident.

Art. 50.

In those activities where the results of the safety study advise it, an emergency plan should be proposed where the rules for the performance of personnel in an accident situation are specified, In the light of the criteria which the Nuclear Safety Council would have established. In this case, the interconnections with the Basic Nuclear Emergency Plan and the corresponding Provincial Plans should be taken into account.

Art. 51.

In the relevant administrative authorisation, in the light of the studies referred to in the previous Article, it shall be specified whether a specific surveillance system should be available to monitor, during the exercise of the activity, the doses that may be received by the public.

In this case, the dose estimates will be made at a minimum annual frequency and their results will be sent to the Nuclear Safety Board and recorded in copy to be archived by the activity holder together with the data that served as the basis for their determination.

Art. 52.

The medical attention of irradiated or contaminated persons shall be the responsibility of the Centers for Assistance to which they are authorized, prior to the report of the Nuclear Safety Council, by the organ of the Autonomous Community of health matters.

The Ministry of Health and Consumer Affairs will maintain a catalogue and general registration of these Centers for the purposes of Articles 15.2 and 40.9 of Law 14/1986 of 25 April, General of Health.

TITLE V

Radioactive waste

Art. 53.

The activities falling within the scope of this Regulation should be adequately designed to prevent or minimise the disposal of radioactive waste into the environment, both under the conditions of the normal operation as in the event of an accident, at least such activities shall comply with the rules of this Title without prejudice to the application of the existing legal and regulatory provisions on such waste.

Art. 54.

Activities that may give rise to radioactive waste involving a significant radiological risk must be equipped with the necessary storage, treatment and evacuation systems. These systems will be independent of other storage, treatment and evacuation systems. The operation of those will be the subject of appropriate checks to avoid escapes.

Art. 55.

The limits for the emission of effluent from radioactive waste into the environment must be such that the concentrations of radionuclide activity in them contained and the doses likely to be received by the the population to which it could potentially affect the lowest possible. Such levels shall always be less than the limits specified in Appendices II and III respectively of this Regulation and, where appropriate, those other lower limits which are established by the Nuclear Safety Board for each activity.

Art. 56.

Any disposal of radioactive waste into the environment shall require express administrative authorisation and shall be carried out under the conditions specified in that authorisation.

For this purpose, the applicant for the authorisation shall attach appropriate studies in each case concerning the discharge of radioactive effluents into the environment and the capacity to receive radioactive pollutants from the area in question. function of its characteristics.

Art. 57.

For the purposes of not reaching the limits specified in Appendices II and III of this Regulation, or those other lower limits established, where applicable, by the Nuclear Safety Board, in the authorizations the limits and conditions for the emission of radioactive effluents shall be established, taking into account the characteristics of the installation or activity concerned. In addition, the total activity of the radioactive effluents to be evacuated per year may be limited.

Art. 58.

The storage of radioactive waste must be carried out by confining them to vessels whose characteristics provide sufficient protection against ionising radiation, taking into account the conditions of the place of storage and possible dispersion or leakage of radioactive material.

Art. 59.

Containers containing radioactive waste will be properly signposted.

A duplicate record shall also be kept, in files located in independent locations, in which the most relevant physical-chemical data and, at least, the maximum values of the content of the vessel shall be recorded for each vessel. level of exposure in contact and one meter away from the surface, as well as the date of the last measurement and, if possible, the activity.

TITLE VI

Inspection

Art. 60.

All the activities referred to in Article 2 of this Regulation shall be subject to an inspection regime from the point of view of the protection against ionising radiation. The inspection shall be carried out by optional staff designated by the Nuclear Safety Board, without prejudice to the specific functions of the competent administrations.

Shall also be inspected by the Nuclear Safety Council the Technical Services or Units of Radiological Protection, the Entities or Institutions that perform the individual dosimetry of the workers professionally (a) to ensure that the conditions under which they were authorised and the adequacy of their actions are maintained, to ensure that the conditions under which they are authorised are maintained.

The inspectors shall be considered as agents of the authority for the purposes indicated in the Criminal Code, in all matters relating to the exercise of their office.

Art. 61.

The inspectors shall verify compliance with the legal provisions on radiation protection and all the specifications set by the Administration in the relevant authorisations. regulations.

Art. 62.

The holder of an activity falling within the scope of this Regulation shall be obliged to permit or facilitate the inspectors:

a) Access to places deemed necessary for the performance of their work.

b) The installation of the equipment or instrumentation that is required to perform the necessary tests and checks.

c) Information, documentation, equipment and existing elements that are accurate for the performance of your mission.

d) Taking sufficient samples to perform the relevant tests and checks. At the request of the holder of the activity, a duly sealed and marked contrast sample shall be left in the power of the activity holder.

Art. 63.

The inspectors of the Nuclear Safety Board shall be empowered to require the immediate suspension of the work or activities which, being carried out without observing the provisions of this Regulation, involve, in their opinion, manifest danger to persons, animals or property. Such actions shall be recorded in the minutes with the necessary details.

TITLE VII

Sanctions

Art. 64.

1. Without prejudice to any civil, criminal or other order in which they may incur, the offences referred to in this Regulation shall be sanctioned by the competent authority in each case in accordance with the provisions of this Regulation. Articles 91 et seq. of Law 25/1964 of 29 April on Nuclear Energy, in Article 2 (d), and second provision of Law 15/1980 of 22 April of the establishment of the Nuclear Safety Council and Articles 32 and The following of Law 14/1986, of 25 April, General of Health.

2. Infringements of the provisions of this Regulation shall be classified as minor, serious and very serious.

2.1 Mild violations are considered:

(a) The lack of information to the Administration or the sending of incomplete or delayed information, provided that it does not constitute another infringement and lacks serious significance for radiation protection.

(b) Failure to comply with statutory or regulatory requirements or the mandatory content of authorisations, provided that it does not have a serious significance for radiation protection.

(c) Not to facilitate the inspection activities in the case of a mere delay in the performance of reporting, communication or appearance obligations.

2.2 Serious violations are considered:

(a) Not count, in the cases necessary in accordance with the provisions of this Regulation, with a Service or Technical Unit for Protection against Radiation.

(b) Not to perform the individual dosimetry through an Entity or Institution authorized by the Nuclear Safety Board, in accordance with the requirements of Article 30.

(c) Not to carry out the medical surveillance of the professional workers exposed in the terms prevented in this Regulation including their non-performance through an officially recognized medical service, in accordance with the provisions of Article 40, or hinder the actions of that medical service.

d) Not having properly classified workplaces or professionally exposed workers.

e) Failure to comply with information and training obligations in terms of risks and protective measures.

(f) Failure to comply with statutory or regulatory requirements or the mandatory content of authorisations provided that a serious risk to radiation protection is generated, in particular in the case of:

-Communication of notifiable events in accordance with the provisions of this Regulation.

-Application of the radiation protection criteria set out in Article 4. of this Regulation, so that the number of persons exposed and the doses thereof received is not the minimum possible.

-Work procedures and equipment utilization.

-Dose, record, and file determination measures of the results.

-Individual or collective protection measures for professionally exposed workers or members of the public.

-Medical surveillance, evaluation, recording and archiving measures of the results.

-Senalization of workplaces, equipment, sources, and radioactive waste.

-Control and maintenance measures for control devices and measuring instruments.

-Disposal of radioactive waste or waste, provided that it is not to be sanctioned in accordance with the provisions of paragraph 2.3 (c) of this Article.

(g) To prevent or delay the inspection of activities with actions or omissions, provided that they do not have to be classified as minor in accordance with paragraph 2.1 (c) of this Article.

h) Not to report to the Administration or to send false information or manifest errors when it involves an absence of due diligence in the elaboration and control of documents or poses a serious risk to the protection (a) a radiological condition, provided that it is not to be sanctioned in accordance with the provisions of paragraph 2.1 (a) of this Article.

2.3 Serious violations are considered:

(a) The non-observance of the precepts relating to the protection of students or women in conditions of procreation or in periods of pregnancy and lactation.

b) Give employment to people as professionally exposed workers when medical conclusions are opposed.

(c) To exceed the dose limits laid down in this Regulation, except for the derogations provided for in this Regulation, where they involve a serious risk of radiation protection.

d) Carry out discharges of radioactive waste that violate the emission limits and conditions and constitute a serious risk from the point of view of radiation protection.

e) Not to paralyze or suspend at the request of the Nuclear Security Council immediately, the works which in the judgment of the Council imply a probability of serious radiological risk.

f) Exercise any form of pressure on the inspectors of the Nuclear Security Council, such as repeated resistance, coercion, threat, violence or contempt.

(g) Any infringement involving the failure to comply with statutory, regulatory or mandatory requirements for authorisations, provided that they create a serious and imminent risk of radiation protection.

2.4 Graduation of violations and penalties:

The offences referred to above shall be graduated for the purposes of their respective sanction, in respect of minimum, medium-grade and maximum degree infringements in the light of the negligence or intentionality of the subject. infringer, fraud or connivance, failure to comply with previous warnings and requirements of the Nuclear Safety Board, business figure of the Company, number of workers affected, injury caused, as well as other conditions which they are appreciated in the execution of the activities developed, permanence or transience of the risks inherent in such activities, measures or protective elements adopted and instructions given in order to prevent such risks, such as circumstances which may mitigate or aggravate the offence committed.

2.4.1 The minor infractions will be sanctioned with a fine of at least 25,000 to 200,000 pesetas; in their average grade of 200,001 to 500,000 pesetas, and in their maximum grade of 500,001 to 1,000,000 pesetas.

2.4.2 Serious infringements shall be punishable by a fine of at least 1,000,001 to 2,500,000 pesetas; in their average grade of 2,500,001 to 5,000,000 pesetas, and to a maximum of 5,000,001 to 7,000,000 pesetas.

2.4.3 Very serious infringements will be sanctioned with a fine of at least 7,000,001 to 10,000,000 pesetas; in its average grade, from 10,000,001 to 25,000,000 pesetas, and to its maximum degree, from 25,000,001 to 100,000,000 pesetas.

2.4.4 The fines provided for in the previous paragraphs may be imposed together with the penalties for temporary suspension or cancellation of permits, licences or authorisations.

2.4.5 There is a recurrence when an infringement of the same type and rating is committed as the result of a previous sanction within the three hundred and sixty five days following the notification of the same type; in such a case require the sanctioning resolution to have become firm.

If recidivism is assessed, the amount of the fine may be increased up to the double of the amount that would have corresponded to the infringement committed in accordance with the above paragraphs.

2.4.6 When the circumstances of the case so advise and provided that no direct damage or damage is caused to the professionally exposed workers or to the students or the population, the Nuclear Safety Council may advise and advise the holder of the activity, rather than propose the imposition of sanctions on the competent sanctioning authority, giving account to the competent sanctioning authority.

ADDITIONAL PROVISIONS

First.

The transport of radioactive material, in all the non-expressly regulated by its specific legislation, shall be governed by the provisions of this Regulation as soon as it is applicable to it, interpreted and supplemented by the rules protection techniques contained in the latest edition of the Regulation for the Non-Risk Transport of Radioactive Material, prepared by the International Atomic Energy Agency.

Second.

The business duties on safety and hygiene contained in Articles 4.2, d) and 19 of the Workers ' Statute (Law 8/1980 of 10 March) will include compliance with the requirements of the This Regulation.

in the field of health protection for workers against ionising radiation, the provisions of the labour order in the field of monitoring compliance with the rules, the participation of workers and the workers and their representatives and business responsibilities and obligations.

Third.

The Appendix to the Regulation on Nuclear and Radiactive Facilities, approved by Decree 2869/1972 of 21 June 1972, is hereby replaced by Appendix V to this Regulation, as provided for in this Regulation.

TRANSIENT DISPOSITION

The prohibitions set out in paragraphs 6.1 and 6.2 of Appendix V shall apply from 1 January 1993.

REPEAL PROVISION

The Royal Decrees 2519/1982 of 12 August and 1753/1987 of 25 November 1987, for which the Regulation on Health Protection against Radiation is adopted and partially amended, are hereby repealed. Ionising.

FINAL PROVISIONS

First.

This Regulation is dictated by the provisions of Article 149.1.7. and 16. of the Constitution.

Second.

The competent Ministers may lay down appropriate provisions for the development and implementation of this Regulation.

Dado en Madrid a 24 de enero de 1992.

JOHN CARLOS R.

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

VIRGILIO ZAPATERO GOMEZ

APPENDIX I

Definitions and other terms of interest

A) Physical Terms, Measures, and Units

Ionizing radiation. -It is radiation composed of photons or particles capable of producing ions directly or indirectly.

Activity (A) -Cociente dN per dt, where dN is the number of spontaneous nuclear transformations that occur in an amount of a radionuclide during the time dt.

Imagen: img/disp/1992/037/03084_001.png

The unit of activity in the international system is the Becquerel (Bq).

1 Bq = 1 s -1

Absorbed dose (D) -It is the dε coefficient per dm, where dε is the average energy given by the radiation to the matter in a volume element and dm the mass of matter contained in said volume element.

Imagen: img/disp/1992/037/03084_003.png

The unit of absorbed dose in the international system is the Gray (Gy).

1 Gy = 1 J/kg

Linear transfer of power or linear braking power by collision (LΔ). -Is the dE ratio per dl, where dl is the distance travelled by a charged particle in a medium and dE the loss of average energy due to the collisions, with energy transfer less than a given value.

Imagen: img/disp/1992/037/03084_004.png

For purposes of radiation protection all the transferred energies are included such that:

LΔ= L

Creep (of particles) (Ø). -It is the ratio of dN per day, where dN is the number of particles that penetrate into a sphere and gives the area of the normal section of that sphere.

Imagen: img/disp/1992/037/03084_005.png

Creep rate, or flow density (φ). -It is the ratio of dØ per dt, where dØ is the increase of yield in the time interval dt.

Imagen: img/disp/1992/037/03084_006.png

B) Radiological, biological and medical terms

Exposure. -It is the action and effect of subjecting people to ionizing radiation.

External exposure. -It is the body's exposure to sources outside it.

Internal exposure. -It is the body's exposure to internal sources to it.

Total exposure. -This is the sum of the external and internal exposures.

Exposure continues. -It is the prolonged external exposure whose rate can, however, vary over time, or the internal exposure resulting from a permanent incorporation whose intensity varies over time.

Unique exposure. -It is the short-duration external exposure or the internal exposure resulting from a radionuclide incorporation for a short period of time.

Global exposure. -It is the exposure considered as homogeneous in the entire body.

Partial exposure. -It is the exposure located essentially on a part of the organism or on one or more organs or tissues, or the exposure of the whole body considered as non-homogeneous.

Quality Factor (Q). -It is a function of the linear transfer of energy (Loo) used to weight the absorbed doses in order to take into account its significance for the purposes of radiation protection. The values of the quality factors to be used to assess the equivalent dose are set out in Appendix VI.

Effective Quality Factor (Q) -It is the value of the quality factor when the absorbed dose is released by particles having different Loo values. Calculated according to the equation:

Imagen: img/disp/1992/037/03084_007.png

Equivalent dose (H). -It is the product of the absorbed dose (D), the quality factor (Q) and the product of the other modifying factors (N) that take into account the characteristics of the radiation and the distribution of the radionuclides. It is normally considered N=1. When only the word "dose" is used, it is always "equivalent dose".

The equivalent dose unit in the international system is the Sievert (Sv).

1 Sv = 1 J/kg

Deep equivalent dose index (HI, p) at one point. -It is the maximum equivalent dose in the central volume of 28 centimeters in diameter of a sphere of 30 centimeters in diameter with center at that point and consisting of a material equivalent to soft tissue with a density of 1 g cm-3 .

Supercial equivalent dose index (HI, s) at one point. -It is the maximum equivalent dose in the volume between 0.07 millimeters and 1 centimeter of the surface of a sphere of 30 centimeters in diameter. with a center at that point and consisting of a material equivalent to soft tissue with a density of 1 g cm-3. It is not necessary to evaluate the equivalent dose in the outer layer of 0.07 millimeters thick.

Effective Dosage (Hc). -It is the weighted sum of the average equivalent doses, received in the various organs or tissues.

Integrated internal dose or compromised dose. -It is the dose that will be received in fifty years in an organ or tissue, as a consequence of the incorporation of one or more radionuclides.

Genetic Dosage. -It is the dose that, if it was actually received by each individual of a given population, from conception to the average age of procreation, would imply the same genetic burden for the population as a whole the doses actually received by the individuals of this population. The genetic dose is calculated by making the product of the annual genetically significant dose by the mean age of procreation (thirty years).

Genetically significant annual dose. -For a population it is equal to the average of the individual doses received in the gonads. Each individual dose will be weighted by a factor taking into account the likely number of children that may be engendered after exposure.

Collective Dose (S). -Collective dose (S) for a population or group is given by the summatorium:

Imagen: img/disp/1992/037/03084_008.png

where Hi is the mean of the overall doses or doses to a given organ in the Pi members of the i-th subgroup of the population or group.

Collective Effective Dosage (Se). -It is the integral of the effective doses caused by an installation or activity on the population affected by it, and it is defined by the expression:

Imagen: img/disp/1992/037/03084_009.png

where Pi (He) dHe is the number of individuals receiving an effective dose between He and He+ dHe.

This magnitude is expressed in sievert person (Sv p).

radioactive contamination. -It is the undesirable presence of radioactive substances in a matter, a surface; any medium or in a person.

In the particular case of the human organism, this contamination may be external or skin, when it has been deposited on the outer surface, or internal when the radionuclides have penetrated the organism by any means. (inhalation, ingestion, percutaneous, etc.).

Dose limit. -These are the limits set in this Regulation for doses resulting from the exposure of professionally exposed workers and members of the public, not taking into account the resulting doses. of the natural radioactive background and the exposure suffered as a result of medical examinations and treatments. The dose limits are applied to the sum of the doses received by external exposure during the period considered and the integrated internal dose resulting from the incorporation of radionuclides during the same period.

Incorporation. -It is the activity that penetrates the organism from the outside.

Annual incorporation limits. -It is the activity that, introduced into the organism of a given individual, causes an integrated internal dose equal to the appropriate annual dose limit set in Appendix II.

Limit derived from the concentration of a radionuclide in the inhaled air. -It is the mean annual concentration in the inhaled air expressed in units of activity per unit of volume, to be inhaled by the standard man during a Two-thousand-hour work year results in an addition equal to the annual enrollment limit.

Radiotoxicity. -It is the toxicity due to ionising radiation emitted by a built-in radionuclide and its descendants; the radiotoxicity depends not only on its radioactive characteristics but also on its state. physico-chemical and the metabolism of the element in the body or in a given organ.

Stochastic biological effects. -They are the ones that are characterized by a dose-effect relationship of probabilistic nature. Properties of these stochastic biological effects are the lack of threshold doses and their severity does not depend on the dose received.

Non-stochastic biological effects. -They are the ones that are characterized by a deterministic causal relationship between the dose and the effect. They only manifest when the received dose reaches or exceeds a certain threshold dose. Its severity depends on the dose received.

C) Other terms of interest

Source. -Aparate or substance capable of emitting ionising radiation.

Encapsulated source. -Source consisting of radioactive substances firmly incorporated in solid and effectively inactive materials, or enclosed in an inactive envelope that has sufficient resistance to prevent any dispersion of such radioactive substances under normal conditions of use.

Radioactive substance.-Any substance containing one or more radionuclides whose activity or concentration should be taken into account for the purpose of radiation protection.

Natural radioactive waste. -It is constituted by the set of ionising radiations from natural sources of earth or cosmic (in so far as the exposure of them is not increased in a way significant by human action).

Professionally exposed workers.-Those who are subjected, due to the circumstances in which their work is carried out, either in a normal way or in an occasional way, at a risk of exposure to radiation ionising, which may involve annual doses in excess of one tenth of the annual dose limits set for workers.

Students. -Persons who are trained and taught in the breast or outside a company to exercise a trade or profession, directly or indirectly related to activities that may involve exposure to radiation ionising.

Members of the public. -Individuals of the population, with the exception of exposed workers and students during their usual working hours.

Population as a whole.-The entire population, comprising professionally exposed workers, students and members of the public.

Reference group (critical groups) of the population. -Groups formed by persons whose exposure is reasonably homogeneous and representative of that of the most exposed individuals of the population.

Accident. -Unanticipated occurrence causing damage to a facility or disturbance to the smooth running of this facility and which may involve, for one or more people, receiving a dose higher than the dose limits.

APPENDIX II

Dose limits

The dose limits apply to the sum of the doses received by external exposure during the period considered and the integrated internal dose resulting from the incorporation of radionuclides during the same period.

Dose limits are values that should not be exceeded, and lower values may be established taking into account the evolution of scientific knowledge and in accordance with the EURATOM Directives.

1. Annual dose limits for professionally exposed workers

1.1 Annual limit for the case of total and homogeneous exposure of the body. The annual dose limit for the whole body, for any period of 12 consecutive months, is 50 mSv.

1.2 Annual limits for the case of partial exposure of the body. -In the case of total non-homogeneous or partial exposure of the organism are:

1.2.1 The annual effective dose limit, for any period of 12 consecutive months, is 50 mSv.

12.2 The annual dose limit for the lens is 150 mSv.

The annual dose limit for the skin is 500 mSv. When exposure results from skin radioactive contamination, this limit applies to the average dose on a surface area of 100 square centimeters in the region it receives. the highest dose.

The annual dose limit for hands, forearms, feet, and ankles is 500 mSv.

The annual dose limit for any other organ or tissue, considered individually, is 500 mSv.

1.3 Special Limits.

For women in procreation conditions, the dose in the abdomen should not exceed 13 mSv in one trimester.

For pregnant women, the working conditions must be such that the dose to the fetus from the diagnosis of pregnancy to the end of the pregnancy does not exceed 10 mSv. In general, this limit is ensured by placing the woman in the working conditions of the professionally exposed workers belonging to category B.

1.4 Scheduled special operations.

1.4.1 Only professionally exposed workers belonging to category A as defined in Article 20 shall be admitted to planned special operations.

Any scheduled special operation must be properly self-rized. Such authorisation shall not be more than in exceptional situations arising in the course of normal operations, where it is impossible to use other techniques which do not involve such exposures. The age and health status of the persons involved will be taken into account in order to give this authorisation.

1.4.2 The doses received or the integrated internal dose as a result of a planned special operation should not exceed in one year twice the annual dose limits set in this appendix, and throughout life of each worker, the five-fold of these dose limits.

1.4.3 Participation in scheduled special operations will not be authorized to:

-professionally exposed workers who have received a dose higher than the annual dose limit in the previous 12 months.

-professionally exposed workers who have previously received doses higher than five times the annual dose limit, as a result of exceptional exposures.

-Women in a position to procreate.

-Children under eighteen years.

1.4.4 Exceeding the dose limits as a result of a planned special operation will not in itself be a reason to exclude the professionally exposed worker from his usual occupations. Subsequent exposure conditions shall be subject to the criterion of the specialised medical service.

1.4.5 Before participating in a planned special operation, professionally exposed workers shall receive appropriate information on the risks and precautions relating to such operation.

2. Annual dose limits for members of the public

2.1 Annual limit for the case of total homogeneous exposure of the body. The annual dose limit for the whole body, for any period of 12 consecutive months, is 5 mSv.

2.2 Annual limits for the case of total non-homogeneous or partial exposure of the body.

2.2.1 The annual effective dose limit, referred to any period of twelve consecutive months, is 5 mSv.

2.2.2 The annual dose limit for the lens is 15 mSv.

The annual dose limit for the skin is 50 mSv. When exposure results from skin radioactive contamination, this limit applies to the average dose on a surface area of 100 square centimeters in the region it receives. the highest dose.

The annual limit for hands, forearms, feet, and ankles is 50 mSv.

The annual dose limit for any other organ or tissue, considered individually, is 50 mSv.

APPENDIX III

1. Limits for annual incorporation by inhalation and limits derived from the concentration of radionuclides in the air inhaled for the professionally exposed workers and limits of annual incorporation by inhalation and ingestion for the members of the public.

The values listed in Table A correspond to the annual dose limits set out in Appendix Il for professionally exposed workers and members of the public.

These values in Table A refer to adults. In the case of children, the anatomical and physiological characteristics must be taken into account, which may make it necessary to modify these values.

2. Mixture of radionuclides.

a) If the composition of the mixture is unknown, but the presence of certain radionuclides may be excluded with certainty, the lower of the limits set for radionuclides that may be present shall be used.

b) If the detailed composition of the mixture is unknown, but the radionuclides of that mixture have been identified, the lower of the limits set for the radionuclides present shall be used.

(c) If the concentration and toxicity of one of the radionuclides predominates in the mixture, the annual incorporation limits set for that radionuclide shall be used.

d) If the composition of the radionuclide mixture is known, one of the following conditions must be met:

Imagen: img/disp/1992/037/03084_010.png

where:

j

is the annual incorporation of the radionuclide j.

l L

is the annual incorporation limit for this radionuclide.

j

the average annual air concentration of the radionuclide j.

Cj. L

the limit derived from the concentration of this radionuclide in the air

APPENDIX IV

Zoning signage

The risk of exposure shall be marked by using its international symbol, a "clover" framed by a rectangular orla of the same colour of the symbol and of the same width as the diameter of the inner circumference of the symbol. symbol.

1. Controlled areas. -In the contralted areas, this clover shall be green on white background.

1.1 Limited permanence zones. -These are those where there is a risk of receiving a higher dose than the annual dose limits set in Appendix II.

In the limited stay zone the clover will be yellow on white background.

1.2 Access zones prohibited. -These are those where there is a risk of receiving in a single exposure dose higher than the annual dose limits set in Appendix II.

In the forbidden access zones, the clover will be red on white background.

2. Areas under surveillance.-In the areas covered by the clover, it will be blue-blue on white background.

3. If in any of the areas there is only a risk of external exposure, the general clover of the area bordered from radial points shall be used; if there is a risk of contamination and the risk of external exposure is negligible, it shall be used. the general clover of the area in field dotted: and if there is a joint risk of contamination and exposure, the general clover of the area bordered from radial points in dotted field shall be used.

4. All the signals for controlled, limited-stay, prohibited access and surveillance zones shall be placed in a visible manner at the entrance and in the significant places thereof.

5. For all types of areas, the above signalisations shall be supplemented at the top with a legend indicative of the area type, and at the bottom of the risk type.

6. Where the boundaries of an area are to be marked on a temporary basis, fences, articulated metal bars or supports for passing ropes, chains, tapes, etc., shall be used which shall have the colour corresponding to the area where they are treat.

7. In places of access between adjacent areas of different characteristics, the corresponding limits may be marked on the ground by lines clearly visible with the colours correlated to the areas concerned. Such signalling may be supplemented by lighting of the appropriate colour to the areas concerned.

8. Within the controlled and monitored areas the sources shall be marked.

APPENDIX V

1. For the purposes laid down in the Regulation on Nuclear and Radioactive Facilities, approved by Decree 2869/1972 of 21 July, the principal radionuclides shall be classified in four categories or groups--a, b, c and d- relative radiotoxicity, as follows:

MISSING TEXT

2. In each case, and where necessary, the Nuclear Safety Board shall be attached to the radionuclides not listed in this Appendix to one of the radiotoxicity groups.

3. Without prejudice to points 5, 6 and 7 of this Appendix, the activities in which they are used shall be exempt from any type of declaration or authorisation:

a) radioactive substances, where the quantity does not exceed the following values in total:

Very High Radiotoxicity Nucleids (Group 1): 5 103 Bq.

High Radiotoxicity Nucleids (Group 2): 5-104 Bq.

Moderate Radiotoxicity Nucleids (Group 3): 5-105 Bq.

Low Radiotoxicity Nucleids (Group 4): 5 . 106 Bq.

(b) radioactive substances whose concentration is less than 100 Bq. g-1; or solid natural radioactive substances whose concentration is less than 500 Bq. g. g-1

(c) Navigation instruments and watchmaking apparatus containing radioluminescent paints.

(d) Emitters of ionising radiation containing radioactive substances, in quantities exceeding the values referred to in paragraph (a), under the following conditions:

Be of a type authorized by the competent authority.

Present benefits which, in relation to the potential risk and the opinion of the competent authority, justify their use.

Be constructed in the form of encapsulated sources in such a way as to ensure effective protection against all contact with radioactive substances and against any escape or leakage thereof.

Not present at any point located 0.1 meters from the accessible surface of the apparatus and under normal operating conditions, a dose rate higher than

1 µ Sv h-1

(e) Other equipment which emits ionising radiation and which is not referred to in paragraph 1), under the following conditions:

Be of a type authorized by the competent authority.

Present benefits which, in relation to the potential risk and the opinion of the competent authority, justify their use.

Not present at any point located 0.1 meters from the accessible surface of the apparatus and under normal operating conditions, a dose rate higher than

1 µ Sv h-l

f) cathode-ray tubes which provide visual images when they do not present at any point located 0,05 metres from the accessible surface of the apparatus, a dose rate higher than

1 µ Sv h-l

g) Mix of radionuclides, other than Th-natural and U-natura, belonging to different radiotoxicity groups, provided that the sum of the ratios between the overall radionuclide quantity of each group and the limit corresponding to the same set in paragraph (a) is less than or equal to the unit.

h) Radioluminescent paints, if the overall activity in radioactive substances does not exceed 2 109 Bq of tritium, 1 of 108 Bq of Pm-147 or 5 of 105 Bq of Ra-226 and if these paintings are stored or used for the manufacture or repair of the instruments and apparatus referred to in point (c).

i) Indirect paths of the gas appliances impregnated with thorium.

j) Nuclides In-115, Nd-144, Re-187, and Sm-147 are exempt whatever the activities are handled.

4. A procedure for declaration to the Nuclear Safety Board shall be subject to the facilities where they are used, such as chemical reagents, uranium or natural thorium or their compounds in quantities not exceeding 3 kilograms.

5. The activities in which they are involved are subject to an authorisation procedure.

(a) Radionuclides in a quantity greater than that indicated in point 3.a) of this Appendix and equal to or less than 1,000 times the values laid down therein. In this case, the starting-up authorization for the third-category radioactive installation shall be specified.

(b) Radionuclides in a quantity greater than that indicated in paragraph 3 (a) of this Appendix and also more than 1,000 times the values laid down therein. In this case, construction and commissioning authorisations for the second category radioactive installation shall be specified.

c) Mixing of radionuclides, other than Th-natural and U-natural, belonging to different radiotoxicity groups, if the sum of the ratios between the overall amount of radionuclides of each group and the limit corresponding to the same set in paragraph 3.a) of this Appendix is:

Greater than unit, but less than or equal to 1,000. In this case, the following shall be required for the radioactive installation of the third category.

Top 1,000. In this case, construction and commissioning authorisations for the second category radioactive installation shall be specified.

(d) The manufacture, placing on the market and repair of equipment and instruments referred to in paragraph 3.c), when the quantities defined in paragraphs 3 (a) and 3.h are exceeded, as well as the manufacture of shirts Incandescent gas incandescent gas (s).

e) the administration of radioactive substances to persons for the purposes of diagnosis, treatment or research, which may be carried out only on radioactive installations authorised for that purpose.

6. Without prejudice to other prohibitions which may be established:

6.1 The addition of radioactive substances in the production or manufacture of food, toys, cosmetics and personal ornaments, as well as the sale and import of such products when containing substances, shall be prohibited. radioactive.

6.2 The addition of radioactive substances to the production or manufacture of prostheses and other medical devices, household utensils (except those listed in point 3.c) of this Appendix, shall also be prohibited. construction or repair materials, except that their benefits to the Nuclear Safety Board are expressly justified.

7. As regards medicinal products containing radioactive substances, the provisions of Articles 51 to 53 of Law 25/1990 of 20 December 1990 on the medicinal product shall be provided for.

APPENDIX VI

1. Relationship between quality factor Q and linear transfer of energy L:

L in water (keV/m)

7 ...

20

Q

3.5 or less

1

2

23

53

175 or more

20

The intermediate values are obtained from the curve in Figure 1.

2. Values of the effective quality factor Q: The values of the effective quality factor Q depend on the exposure conditions as well as the type of radiation incident and its energy. The values of the following table will be used in case of homogeneous external exposure of the entire body. The same values would generally be appropriate for other exposure conditions. If other values are required, they must be calculated from the Q values indicated in point 1 and from the curves in Figure 2.

Radiations

Q

, gamma, beta, electrons, and positrons

1

energy neutrons

10

3. Conversion factor: [Neutron Yield Rate in cm-2 s.-1 quecorresponds at an equivalent dose rate of 1 Sv h-1 and effective quality factor Q based on neutron energy (1)]. (These factors may also be used to relate the neutron yield rate and the rate of equivalent dose rate).

17

2

5

2

2

energy (MeV)

Conversion factor (2) (3)

(cm-2 s-l) ∙ (µ Sv h -l)

Effective quality factor Q (2) (3)

2.5, 10-8

26

2.3

(neutrons thermal)

1-7-7

24

2

10-6

22

2

1

1, 10

23

2

1-4

24

2

11, 10-3

27

2

1, 10-2

28

2

17

3.3

, 10

17

8.5

5.7

1110-1

1.4

11

0,85

10,6

0.70

0.68

7.8

6.8

0,65

6.0

50

0,56

0.56

3.8

0,36

0.36

1, 10

0.22

2.8

23

0.16

3, 103

0.14

2.5

(1) For unidirectional wide-widths of single-energy neutrons of normal incidence.

(2) At the point where the equivalent dose rate is maximum.

(3) Intermediate values are obtained from the curves of Figures 3 and 4.

4. Conversion factors.-(Proton Yield Rate in cm-2 corresponding to a dose rate equivalent to l µ Sv h-1) and effective quality factor Q based on the energy of protons (1). (These factors may also be used to relate the proton yield rate and the rate of the equivalent dose rate.

1.4

3, 10

Proton Energy (MeV)

Conversion Factor (2) (3)

(cm-2 s-l) ∙ (µ Sv h -l)

Effective quality factor Q (2) (3)

2 to 60

0.040

1, 102

0.041

1.4

1.5

2

0.042

1.4

2

2

0.043

1.4

2.5

2

0.24

4, 102

0,25

62

0.24

8, 10

0,22

1.8

1, 103

0.20

1.9

1.5

33

0.16

2.0

2

3

0.14

2.1

3 ∙ 103

0.11

2.2

(1) For unidirectional widths of single-energy protons of normal incidence.

(2) At the point where the equivalent dose rate is maximum.

(3) The intermediate values are obtained from the curve of Figure 5.

5. Modes of effective dose assessment. -Effective dose is equal to:

Imagen: img/disp/1992/037/03084_011.png

where HT is the mean equivalent dose in the organ or tissue T, WT is the weighting factor relative to the organ or tissue T.

The weight factor values are listed below:

0.15

The Red Bone Marrow

Value

Gonadas

Thyroid

Thyroid (surfaces) bone)

0.03

of body (1)

(1) To determine the contribution of the rest of the body, the mean dose for the five most exposed organs or tissues in the rest of the body (excluding the lens, skin, hands, forearms, feet, and skin) will be evaluated. (ankles), using for each of them a weighting factor 0.06, then the irradiation of the other organs and tissues will be ignored.

6. The dose limits set in Appendix II are considered to be respected if the deep equivalent dose rate does not exceed the dose limit set for the overall exposure and if the surface equivalent dose rate does not exceed the limit of dose fixed for the skin.

7. In the case of associated external and internal exposures, the limits set out in Appendix II are considered to be respected if the following conditions are met:

a)

Imagen: img/disp/1992/037/03084_012.png

where:

J. p

is the annual deep equivalent dose index,

is the annual dose limit for the global exposure

j

is the annual onboarding of radionuclide j,

j.L

is the annual incorporation limit for this radionuclide

(b) The dose limits set according to the cases of points 1.2.2 and 2.2.2 of Appendix II are respected.