GENERAL REGULATION ON RADIATION SAFETY

RADIOLOGICAL SECURITY GENERAL RULE

Published in the DOF on November 22, 1988

Fe de errata DOF 14 December 1988

Fe de errata DOF 9 January 1989

On the sidelines, a seal with the National Shield, which says: The United Mexican States. Presidency of the Republic.

MIGUEL DE LA MADRID H., Constitutional President of the United Mexican States, exercising the power conferred on me by the fraction I of the Article 89 of the Political Constitution of the United Mexican States and based on articles 1o., 2, 4, 18, 19, 21, 22, 23, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 and 50 of the Regulatory Law of Article 27 Constitutional on Nuclear Matter, and

CONSIDERING

That within the permanent objectives assumed by the government in my office, it highlights the strengthening of the legal framework that regulates the activities In order to promote the changes that the thesis of moral renewal of society imposes in practice, it translates as the granting of the mechanisms through which the State promotes the satisfaction of the needs collective;

That for the achievement of these objectives, in the National Development Plan 1981-1988 it is stated as a strategy, in order to face the great challenges of the country, thoroughly review the national regulatory system and simplify administrative procedures, proposing and, where appropriate, sponsoring the necessary legal and regulatory reforms;

That the direct domain of the Nation on our natural resources and the right to regulate their exploitation, use and use are shaped in a way In the article 27 Constitutional and in its opportunity, the Executive to my office proposed the adequacy to the Legal Order to which the Nuclear Matter is governed;

That on February 4, 1985, the Regulatory Law of Article 27 Constitutional on Nuclear Matters was published in the Official Journal of the Federation, The following day of its publication:

That the Law mentioned is a regulation of Article 27 Constitutional and regulates the exploration, exploitation and benefit of radioactive minerals, the the use of nuclear fuels, the uses of radioactive material and nuclear energy, the research of nuclear science and techniques, the nuclear industry and everything related to it;

That the same law states that security is paramount in all activities involving nuclear energy, and should be taken into account from the planning until the dismantling of nuclear and radioactive installations and the final destination of these wastes, defining the radiological security in accordance with the guidelines of the National System of Civil Protection, such as that which aims to protect workers, the population and their property, as well as the environment in general by preventing and limiting the effects that may result from exposure to ionizing radiation;

That the Regulatory Law of Article 27 Constitutional on Nuclear Matters states that nuclear and radioactive installations must have (a) the system of radiation safety systems and their operation shall require the satisfaction of the requirements set out above in the same law and in the respective regulatory provisions, and it is therefore appropriate to provide for the regulatory instruments to make the provisions of the regulation effective Ordering, I have had to issue the following

RADIOLOGICAL SECURITY GENERAL RULE

TITLE FIRST

GENERALATIONS

ONLY CHAPTER

Article 1o.- This Regulation governs throughout the national territory and aims to provide in the administrative sphere to the observance of the Law Regulation of the Article 27 Constitutional on Nuclear Safety in relation to radiation safety.

Article 2o.- The Secretariat of Energy, Mines and ParaState Industry is empowered to issue through the National Nuclear Safety and Safeguards Commission, the appendices, technical, manual and instructional standards, as well as its updates, necessary to develop, make explicit and determine how the provisions of this Regulation should be complied with.

Article 3o.- Both the documents referred to in the previous article, and their updates, for enforcement and general observance they must invariably be published in the Official Journal of the Federation.

Article 4o.- The Secretariat of Energy, Mines and ParaState Industry, through the National Nuclear Safety and Safeguards Commission, is the authority to interpret and implement this Regulation, as well as the appendices, technical, instructional, manuals and conditions of licences, authorizations and permits which are issued on the basis of the same and, in order to determine the standards of radiological security which are applicable without prejudice to the jurisdiction of the law, corresponds to other Secretaries of State.

Article 5o.- In all cases where this Regulation refers to the Law, it will be understood to be the Regulatory Law of Article 27 Constitutional on Nuclear Matter. When referring to the Secretariat, it will be the Secretariat of Energy, Mines and ParaState Industry, and when I mention the Commission, it will be the National Nuclear Safety and Safeguards Commission under the terms of Article 50 of the Law of the Article 27 Constitutional on Nuclear Matter.

TITLE SECOND

TERMINOLOGY

ONLY CHAPTER

Article 6o.- For the purposes of this Regulation:

ACCIDENT AND/OR INCIDENT: Any abnormal event involving sources of ionizing radiation.

ACTIVITY: The number of spontaneous nuclear transitions that occur per unit of time in a given amount of radioactive material. Formally, activity A, of a given amount of radioactive material, is the ratio of dN between dt, being dN the number of spontaneous nuclear transitions occurring in the dt interval.

The activity unit is the becquerel (Bq), where 1 Bq = 1 disintegration s (-1) (1 Ci = 3.7 X 10 (10) disintegration S (-1).

TEMPORARY STORAGE: The radioactive installation authorized by the Commission to store sources of ionising radiation for limited time and which will be necessarily determined in express form in the corresponding authorisation.

STORE IN: The areas used during the:

TRANSIT: Transport of radioactive material in which packages, containers, packages and uncontrolled areas are stored, such as: parking; terminal station; warehouse room or loading and unloading yard.

AUDIT: The examination of the records, documents, programs and procedures related to the radiological security of the radioactive installation, as well as the inventory of radioactive material or equipment containing it in accordance with the authorisation, permit or licence concerned, as well as in the provisions of this Regulation.

DERIVED CONCENTRATION IN AIR: The air-derived concentration (CDA) for a given radionuclide is a derivative limit that designates the air concentration which, if breathed by a worker during a working year of 2,000 hours at a breathing rate of 1.2 m (3) h-(1) would be reached the annual limit of incorporation (LAI).

SURFACE RADIOACTIVE CONTAMINATION: The presence of a radioactive substance on a surface in amounts greater than: 4X10 (3) Bq m-³ (10) 5) uCi/cm³) in the case of beta and gamma emissions, or 4 X 10³ Bq m-³ (10 (-6) uCi/cm³), in the case of alpha emissions, this can be fixed or removable.

DECONTAMINATION: The process by which radioactive contamination is reduced or eliminated.

RADIOACTIVE WASTE: Any material containing or contaminated with radionuclides or concentrations or levels of radioactivity, greater than those identified by the Commission in the relevant technical standard and for which no use is foreseen. They are classified in low, intermediate and high level radioactive waste.

IONIZING RADIATION GENERATOR: It is the equipment that produces ionizing radiation in a controlled manner.

ABSORBED DOSE: The energy deposited by ionizing radiation in the matter. Technically, the absorbed dose, D, is defined as the dE ratio between dm, where dE is the average energy deposited by ionizing radiation in a mass dm. The unit is the gray (Gy), where: 1 Gy = 1 J kg (-1) (1 rad = 10-³ J kg (-1))

THRESHOLD DOSE: The value of the dose below which a particular non-stochastic effect is considered not to be manifested.

EMERGENCY: Act, omission, situation or event that causes a significant risk and, for whose control or removal action is required immediate corrective action.

PLACEMENT: The process of selecting an appropriate site for the location of a radioactive installation and the determination of the physical and demographic characteristics of the same, in order to assess and adequately define the basis for the design, construction and operation of the same, in order to ensure that these are not translated into an appreciable detriment to the safety of the people and the quality of the environment.

DOSE EQUIVALENT: For radiation protection purposes, it has been found appropriate to introduce a physical magnitude that correlates the dose absorbed with the most important deleterious effects of radiation exposure, in particular with late stochastic effects.

The dose equivalent is the amount that results from the equation: H = DQN, where D is the absorbed dose in Gy, Q is the quality factor and N is the product of all other modifying factors, taking for now a value for N equal to the unit. The special name for the dose equivalent unit is the sievert (Sv). The rem can be used temporarily.

EFFECTIVE DOSE EQUIVALENT: The effective dose equivalent, H (E) is the weighted sum of the dose equivalents for the different tissues. HT, both by extreme irradiation and by incorporation of radionuclides. It is defined as: View image (double click with the mouse) /d/ 22118801 where W (T) are the weighting factors

COMMITTED EFFECTIVE DOSE EQUIVALENT: The committed effective dose equivalent, H (E,50 ') resulting from a material incorporation radioactive, is the equivalent of effective dose that will be accumulated over 50 years, as a result of incorporation.

SOURCE OPEN: All radioactive material that during use can come into direct contact with the environment.

IONIZING RADIATION SOURCE: Any device or material that emits ionizing radiation in a quantifiable manner.

SEALED SOURCE: All radioactive material permanently incorporated into a material enclosed in a hermetic capsule with mechanical strength sufficient to prevent the release of the radioisotope or the dispersion of the radioactive substance under the foreseeable conditions of use and wear.

DOSE EQUIVALENT INDEX: In the case of external irradiation of the entire body, the concepts are applied:

a) DOSE EQUIVALENT SURFACE INDEX: The surface index of dose equivalent H (I, S) at one point is the maximum dose equivalent within the volume between 0,07 mm and 1 cm, measured from the surface of a sphere of 30 cm in diameter centred on that point and formed by material equivalent to soft tissue with a density of 1 g cm (-3).

b) DEEP DOSE EQUIVALENT INDEX: The deep dose equivalent H (I, P ') index is the maximum dose equivalent within the core of the 28 cm in diameter, registered in a sphere of 30 cm in diameter centred on that point and formed by material equivalent to soft tissue and with a density of 1 g cm (-3).

INSPECTION: The examination of the physical and radiological security conditions of a radioactive installation, its systems, equipment, and the application of the procedures for operation, documents and records.

ANNUAL ENROLLMENT LIMIT: Is the secondary limit for internal occupational irradiation and is the smallest value of the incorporation of a radionuclide determined in one year by the Reference Man, which would be either a committed effective dose equivalent of 50 mSv (5 rem) or a committed dose equivalent in the lens of 150 mSv (15 rem) or a Equivalent dose equivalent to any other organ or tissue of 500 mSv (50 rem).

RADIOLOGICAL SECURITY MANUAL: Document which aims to ensure that all actions involving radiation sources are executed under and adequate radiation protection procedures, to reduce occupational and public exposures to values as low as reasonably achievable.

PERMISIONARY: A physical or moral person who owns the entitlement of the authorization, permit, or license issued by the Commission to develop a activity authorised by the same.

OCCUPATIONAL PERSONNEL EXPOSED: The person who is in exercise and on the occasion of his occupation is exposed to ionizing radiation or the incorporation of radioactive material. Workers who occasionally in the course of their work may be exposed to this type of radiation are excluded, provided that the equivalent annual effective dose they receive does not exceed the limit laid down in this Regulation for the public.

IONIZING RADIATION: Any electromagnetic or corpuscular radiation capable of producing ions, directly or indirectly, due to their interaction with the material.

RECOGNITION: The examination and verification of the information provided to the Commission of facts or circumstances that might be a risk Radiation to persons and properties.

VERIFY: The review and examination of the information provided to the Commission for the activities covered by this Regulation and corrective actions resulting from deficiencies or anomalies which have been found as a result of the inspections or audits.

BIOLOGICAL LIFE: It is the time required for half of a given substance to be excreted from the body of an organ or tissue.

PHYSICAL LIFE: It is the time required for a radionuclide to lose 50% of its activity, by radioactive decay. Each radionuclide has a physical half-life of its own.

CONTROLLED ZONE: Is the zone subject to monitoring and special controls for radiation protection purposes.

THIRD TITLE

OF THE DOSE LIMITATION SYSTEM

CHAPTER I

GENERAL PROVISIONS

Article 7o.- The doses received as a result of exposure to sources of ionizing radiation and practices involving irradiation with ionising radiation or the incorporation of radioactive material, shall be subject to a dose limitation system whose foundations are:

I).- No practice will be approved unless your application produces a positive net benefit;

II).- The design, planning, use and subsequent application of sources and practices must be carried out in such a way as to ensure that exposures remain as low as reasonably achievable, taking into account social and economic factors;

III).- Setting limits for dose equivalents.

Article 8o.- The dose limitation system aims to avoid non-stochastic effects and limit the occurrence of stochatics to an acceptable level, and therefore limits are established for each case, which should be the most restrictive for the irradiated organ or tissue.

Article 9o.- Non-stochastic effects are those in which the severity of the effect is function of the dose and are presented from a value threshold. These effects are presented in the exposed individual. Stochastic effects are those in which the probability that the effect is present is considered to be a function of the dose, without a threshold dose and can manifest both in the exposed individual and in their offspring.

Article 10.- For the exclusive purposes of this Regulation, in the calculation of the dose equivalents, the factors that are set out in the relevant technical standard.

CHAPTER II

OF THE DOSE LIMITATION SYSTEM APPLICATION

Article 11.- For the application of the Dose Limitation System limits and reference levels will be set:

A limit is the value of a magnitude that must not be exceeded. A reference level is not a limit, but the value of a magnitude that serves to decide a particular behavior.

The limits may be primary, secondary, derived, and authorized. The reference levels may be of registration, of investigation and of intervention.

Article 12.- The primary limits are defined for the dose equivalent, the effective dose equivalent, the committed dose equivalent, or the equivalent of the committed effective dose, depending on the circumstances of the exposure. These limits apply to each individual, and in case of irradiation of the public, to the critical group.

Article 13.- The secondary limits are used when the primary dose equivalent limits cannot be applied directly. In the case of external irradiation, the secondary limits may be expressed according to the deep index of dose equivalent or the superficial rate of dose equivalent. In the case of internal irradiation, secondary limits may be expressed according to the annual limits of incorporation.

Article 14.- The derived limits apply to measures different from those of the primary limits, determined from these by a defined model, such that, if the derived limits are satisfied, the primary limits are also met. For example, for quantities such as the rapidity of exposure in a workplace, air, water and surface pollution, among others, may be established.

Article 15.- The permitted limits are those set by the Commission for any magnitude and are generally lower than the limits derivatives, although in exceptional cases they may be the same. These limits apply only to limited circumstances which must be clearly defined. Authorized limits take precedence over derivatives.

Article 16.- For the purposes of Article 11, above, the permit as part of its radiation protection program must be established reference levels, including at least the following: level of registration, level of investigation and level of intervention.

Article 17.- The level of registration is a value defined by the Commission for the equivalent dose, equivalent of effective dose or the incorporation of radionuclides, above which the information is of sufficient interest, from the point of view of radiation safety, for registration and preservation.

The level of research is a value of the dose equivalent, the equivalent of effective dose or incorporation, which is considered sufficiently important to justify an investigation of the causes for which it was exceeded.

The level of intervention is the value previously set for any magnitude used in radiation security, which is exceeded to indicate a situation which requires corrective action.

CHAPTER III

OF THE DOSE EQUIVALENT LIMITS

Article 18.- No person shall receive a dose equivalent exceeding the corresponding limits indicated in this Title.

Article 19.- The dose equivalent limits indicated in this Title do not apply to the medical exposure of patients, nor to the exposure of patients. natural radiation. However, they should be applied in the case of irradiation for medical research purposes where there is no direct benefit to the individual exposed, and in the case of irradiation due to natural sources of increased radiation by technological reasons, for which the Commission shall establish the limits in each case.

Article 20.- For the occupational staff exposed, the limit of the annual effective dose equivalent H (E, L) for stochastic effects is 50 mSv (5 rem).

Article 21.- For the occupational staff exposed the annual dose equivalent limit for non-stochastic effects is 500 mSv (50%). rem), regardless of whether the tissues are irradiated in isolation or in conjunction with other organs. This limit does not apply to the lens, for which a limit of 150 mSv (15 rem) is set

Article 22.- The dose equivalent of any organ or tissue as a result of irradiation will include the dose equivalent due to external sources and the committed dose equivalent due to embedded internal sources in the same time interval.

Article 23.- The limit for the control of stochastic effects is expressed in function of the effective dose equivalent, due to compliance which:

Where H (E, L) is the annual effective dose equivalent limit and whose value is 50 mSv (5 rem); w (T) is the weight factor of the T-tissue; and H (T) is the annual dose equivalent of the T tissue

Article 24.- In the event that the exposed personnel are irradiated internally and externally and with the object that the annual limits of dose equivalent, the following two conditions must be met:

Being: H (I, s) the surface index of dose equivalent.

H (I, p) the deep index of dose equivalent.

I (j) the annual incorporation due to ingestion and inhalation of the radioisotope j.

I (j, L= the annual incorporation limit for the radioisotope j.

Article 25.- The secondary limits of incorporation for the occupational staff exposed will be those set out in the technical standard corresponding to this Regulation.

Article 26.- When a limit is expressed as the average value for a period, the actual value of the magnitude is understood Limited fluctuations may occur in shorter periods of time.

Article 27.- The irradiation to be received by women in occupation with reproductive capacity should be distributed as uniformly possible in time, in order to protect the embryo during the period of organogenesis before the pregnancy is known.

Article 28.- Occupationally exposed women who are pregnant will only be able to work in conditions where irradiation is distribute as evenly as possible over time and that the probability of receiving an annual dose equivalent greater than 15 mSv (1.5 rem) is very low.

Article 29.- Occupational women exposed to pregnancy or breast-feeding should not be required to work in places where there is a risk of incorporation of radioactive materials.

Article 30.- Students who by the nature of learning should conduct experiments with sources of ionizing radiation will be considered as individuals from the public, however only they will be allowed to receive on the occasion of the teaching, the tenth of the limits set forth in this Regulation for the individuals of the public.

Article 31.- Students taking courses at a professional or technical level, the purpose of which is training for the use of radiation sources ionising, will be subject to the following rules:

I).- If they are 18 years of age or older, they will be considered to be occupationally exposed persons and therefore subject to the equivalent of annual doses corresponding to that quality, as set out in this Regulation, and

II).- If they are under 18 years of age, but greater than 16 years, they will be considered as occupational exposed persons, however, they will not be able to receive an annual equivalent of more than 15 mSv (1.5 rem).

Article 32.- Outside of the cases referred to in the previous Article, no person under the age of 18 may be considered to be occupationally exposed.

Article 33.- Students who are considered to be occupational personnel exposed, will be subject to the requirements, obligations, supervision and individual and medical radiological surveillance which are established for this quality in this Regulation.

Article 34.- In order to maintain a permanent monitoring of the trends of the dose equivalent received by the occupational staff In order to optimise the safety conditions at work, a record of the monthly dose equivalent, of the accumulated during the previous 12 months and of the total accumulated during the working life of the staff, must be recorded. exposed, of which you must be informed.

Article 35.- Any irradiation received by the occupational staff exposed must be based on the registration of the dose equivalent of the individual.

Article 36.- Non-occupationally exposed persons who work in the proximity of controlled areas or occasionally in the course of their work enter a controlled area, they are considered as individuals of the public.

Article 37.- The dose equivalent limits for individuals in the public are one-tenth of the limits stipulated in Articles 20 and 21. These limits should apply to the critical group of the population or the individual most exposed.

Article 38.- When the same individuals in the public may be exposed for extended periods to an equal effective dose equivalent to the annual or near limit, measures shall be taken to reduce the equivalent of the effective dose for all life to a value corresponding to an annual average of 1 mSv (0.1 rem).

Article 39.- In the calculation of the dose equivalent for individuals from the public due to the incorporation of radioactive material, they must be account for biological and metabolic parameters, as well as other factors that are characteristic of the critical group, such as food customs, demographic distribution and land use.

CHAPTER IV

IRRADIATION CONDITIONS

Article 40.- The conditions under which an individual may be exposed to ionizing radiation are classified as normal and abnormal.

The normal irradiation conditions are those in which the occurrence of irradiation is foreseeable and may be limited by control of the the source and by application of the dose limitation system, in particular by establishing satisfactory operating procedures.

The abnormal irradiation conditions are those in which the source of radiation is not subject to control, so the magnitude of all Resulting irradiation can only be limited, eventually, by corrective measures.

Article 41.- If, as a result of abnormal situations, certain occupational exposed persons receive higher dose equivalents than the limits referred to in Articles 20 and 21, the permit shall take the following measures:

I).- Reunite information that helps to estimate dose equivalents and the incorporation of radioactive material;

II).- Obtain, as appropriate, excreta samples for bioanalysis;

III).- Start medical tests and make subsequent diagnoses, and

IV).- Collect information about the circumstances of the accident.

The need to control pollution must not hinder or deter from dispensing first aid and the treatment of individuals in a row. requiring medical assistance for other reasons.

Article 42.- If as a result of abnormal situations, certain people in the public receive higher dose equivalents than the limits Under Article 37, the permit must take the following measures:

I).- Reunite information to help estimate dose equivalents and the incorporation of radioactive material from affected people, and

II).- Collect information about the circumstances of the accident.

The need to control pollution should not hinder or deter from dispensing first aid and treatment to individuals requiring medical assistance for other reasons.

CHAPTER V

OF PLANNED AND EMERGENCY RADIATIONS

Article 43.- Planned irradiations will be considered as exceptional cases and will be justified only when techniques that prevent overexposure of the persons concerned are not practicable or available.

These irradiations may be permitted provided that:

I).- In a single event the sum of the dose equivalent due to external irradiation and the committed dose equivalent due to the incorporation of radioactive material, does not exceed twice the corresponding annual dose equivalent limits set out in this Regulation; and

II).- In the life of the staff concerned, the sum of the dose equivalent due to external irradiation and the dose equivalent committed due to the incorporation of radioactive material, do not exceed five times the limits of the corresponding annual dose equivalent.

Article 44.- The personnel involved in the planned irradiations must:

I).- Be consulted for the planning of the operations to be performed;

II).- Be informed about the risks involved in irradiations exceeding the limits of dose equivalents established in this Regulation;

III).- Be trained in the specific operations to be performed;

IV).- Contar with the written compliance of the radiation security officer, and

V).- Be provided with appropriate equipment and clothing for protection, so that external irradiation and contamination are minimal.

Article 45.- The permissioner must first justify before the Commission any planned irradiation.

Article 46.- An individual may receive doses exceeding the dose equivalent limits set forth in this Title, only in emergency operations.

Article 47.- In emergency operations that are intended to save lives or prevent the irradiation of large numbers of people, the limit Estimated effective dose equivalent will be 1 Sv (100 rem), and for hands and forearms it will be 3 Sv (300 rem).

Article 48.- When emergency operations are subject to actions other than those mentioned in the previous Article, such as protect valuable facilities or control fires, the estimated limit of effective dose equivalent shall be 250 mSv (25 rem) and for hands and forearms shall be 1 Sv (100 rem).

Article 49.- The personnel involved in the emergency operations must be in the terms of the Emergency Plan:

I).- Be of preference volunteers and over 45 years old, when they are not required to do so out of their duties or responsibilities;

II).- Be informed about the risks involved in irradiations exceeding the dose equivalent limits set out in this Regulation;

III).- Be trained if possible, in the specific operations to be performed;

IV).- Contar with the written compliance of the radiation security officer;

V).- Be provided with appropriate equipment and clothing for protection, so that external irradiation and contamination are minimal, and

VI).- Avoid procreation for 6 months after irradiation when the effective dose equivalent is 1 Sv (100 rem) or major.

Article 50.- Emergency radiations should be limited to one time in the life of the occupational staff exposed.

Article 51.- Once the control over the initial incident or accident has been achieved, the remainder of the corrective action must be executed in compliance with the dose equivalent limits. Exceptionally, situations may arise requiring consideration of the desirability of authorizing a planned irradiation of a limited number of individuals to carry out various essential operations, leaving the remaining ones to be executed with subject to limits.

Article 52.- Women with reproductive capacity and students who are training in the use of ionizing radiation sources, not may participate in irradiations planned or in emergency operations.

Article 53.- Any equivalent of accidental, planned or emergency dose or incorporation must be settled in the dose equivalent record of the staff involved. But it must be distinguished from normal radiations.

Article 54.- Any accidental or emergency irradiation that reaches or exceeds an effective dose equivalent of 250 mSv (25 rem) shall be to communicate to the Commission the recommendations it considers appropriate to the future work irradiation of staff. The implementation of these recommendations will be the sole responsibility of the permissioner.

Article 55.- The occupational exposed staff who have received an effective dose equivalent of more than 100 mSv (10 rem) corresponding to the double the annual limit for stochastic effects in a single event, must be subject to medical examination in the terms of the corresponding technical standard of this Regulation and may continue in its routine work if there is no objection to it from the medical point of view, taking into account their irradiations prior to their health, their age, their special abilities and their economic and social responsibilities, and, if necessary, to proceed in accordance with the Federal Labor Law.

TITLE FOURTH

OF IONIZING RADIATION SOURCES

CHAPTER I

GENERAL PROVISIONS

Article 56.- ionising radiation generating devices and equipment containing sources of ionizing radiation must be provided with the appropriate security systems that prevent their use by unauthorized personnel.

Article 57.- The permit may only modify the design, operating conditions and use of the equipment mentioned in the previous Article or its components if it has the prior authorisation of the Commission.

Article 58.- For the purposes of this Regulation, radioactive materials are classified into sealed sources and open sources. No source of radiation subject to a licence may be transferred to third parties unless the recipient has the respective licence and the Commission authorises the transfer.

CHAPTER II

OF SEALED SOURCES

Article 59.- All sealed sources of radioactive materials shall have a certificate issued by the manufacturer indicating the activity of the same and the corresponding leakage tests.

Article 60.- The certificates referred to in the previous Article shall include at least the information relating to: radioisotope, the activity and date on which it is valid, physical and chemical forms, material and type of encapsulation, mark, model and serial number of the source, and where appropriate the procedure and result of leakage test.

Article 61.- To transfer sealed sources of radioactive material, tests and measurements shall be carried out to ensure integrity of the source and the container, as provided for in Articles 67 and 69 of this Regulation.

Article 62.- Sealed sources may only be handled by the use of manual or automatic distance handling devices appropriate.

Article 63.- Sealed sources must be properly stored in appropriate containers when they are not in use.

Article 64.- The sealed sources must be tested for leakage at the time of receipt and then periodically, according to the conditions laid down in the licence issued by the Commission, taking into account the characteristics and use of these sources.

Article 65.- A record of the leakage tests shall be carried out on each of the sealed sources. This record shall record the data relating to the method used, the equipment used, the result of the test and the date on which it was carried out and the name and signature of the person who made it.

Article 66.- The result of the leak test shall be sent to the Commission within five working days of the date on which it was count on the results. If leakage is detected, the Commission shall be notified immediately.

Article 67.- A sealed source shall be deemed to be hermetic when the result of the leak test is less than 185 Bq (5 nCi) of material Removable radioactive for different sources from Radio-226. For Radio-226 sources the Radon-222 leak in 24 hours must not be greater than or equal to 37 Bq (1 nCi).

Article 68.- In case the source is not airtight as set out in the previous Article, the source will be entered into a container appropriate and may not be used until the necessary repairs have been made to it and have satisfied the airtight requirements.

Article 69.- The permissioner shall be responsible for the time of its receipt and thereafter on a periodic basis at least every six months, measurements of the radiation levels around the transport, storage or use containers that are housed in sealed sources. These levels will be measured on the surface of the container and a meter of the container in different directions.

Article 70.- Based on the measured radiation levels, the permissioner will limit the length of time for the staff to be permanently exposed in the area where the container is located, so that the equivalent of the dose received by the staff is as low as reasonably achievable, without exceeding the limits laid down in this Regulation.

Article 71.- The areas where the containers are located that house sealed sources must be considered in the the physical and radiological security procedures of the installation, contained in the Radiological Safety Manual.

Article 72.- The equipment that operates with sealed sources and calibration shall be regularly tested for good performance. so require.

Article 73.- A record of the good performance tests and calibrations shall be kept, in which the date, type of tests performed, equipment used in your case, as well as the name, position and signature of the person who executed them.

Article 74.- Equipment containing sealed sources shall be used with the accessories or components previously authorised by the Commission.

Article 75.- Containers used to transport, use or store sealed sources and equipment containing them, shall bear signs fixed with the international symbol indicating the presence of radiation, the information in Spanish relating to the radioisotope, activity and date on which it is valid, model, mark and number of the source series, as well as the transport index, the names and telephones of the permissioner and the radiation safety officer when applicable.

Article 76.- Each time the source hosting the container is changed, the label information is modified.

Article 77.- The labels will always be preserved in good condition and in case of deterioration they will be replaced immediately.

Article 78.- The rapidity of exposure on the surface of sealed source containers shall not exceed 5.2 X 10 (-5) Coul/kgh (200 mR h (-1)), nor 5.2 x 10 (-7) Coul/Kgh (2 mR h (-1)) to one meter of the same.

Article 79.- The same container may be used for storage, use and transport of sealed sources, if the Commission considers that the required security requirements.

Article 80.- Containers for the transport of sealed sources are further subject to the requirements set out in the regulations corresponding.

Article 81.- Any permissioner possessing sealed sources of radioactive material shall bear an inventory of the same in which it is stipulated: date of receipt, mark, model and serial number of the source, radioisotope, activity and date on which it is valid, source container, mark, model and number and series of the source, and its location. The date and cause of the withdrawal of the source of the routine work as well as the final destination of the work should also be noted.

CHAPTER III

OPEN SOURCES

Article 82.- For the reception and opening of packages containing open sources, a procedure previously established by the the permit, specifying at least the place and conditions of reception and opening, the review of the integrity of the packaging and the measurement of the levels of radiation.

Article 83.- Open radioactive sources must be stored in closed containers that prevent their dispersion. The mechanical design of the containers shall consider the pressures which may be caused by the chemical nature of the source. These containers shall facilitate the handling of the sources.

Article 84.- Any container containing open sources, when not in use, must be in an appropriate container and in an area dedicated to the storage of open sources, which shall be appropriate from the point of view of radiological and physical security.

Article 85.- Containers and containers that host open sources must have a Spanish-language label in which they appear:

I).- The international symbol indicating the presence of radiation;

II).- The radioisotope it contains;

III).- The activity and date it is valid, and

IV).- The chemical and physical form of the source.

Article 86.- The labels must always be kept in good condition, and in case of deterioration they will be replaced immediately.

Article 87.- At the end of the working day, the levels of radiation and pollution on the working surfaces, equipment, and equipment must be reviewed. and, in case of incident or radiological accident, this review will be carried out in all places where contamination is presumed. Where the readings obtained are greater than those laid down by the Commission in the relevant technical standard, the necessary corrective measures shall apply.

Article 88.- The equipment used to perform these radiation and pollution levels, will be calibrated and in good State of operation shall be adequate to detect the type of radiation involved and shall have sufficient sensitivity to accurately measure 50% of the applicable limit for removable contamination indicated in the relevant technical standard.

Article 89.- When open sources are used, equipment and accessories that provide due radiation protection shall be used.

Article 90.- All of the permissioner that has open sources must keep a record, in which it will settle: type of radioisotope, activity to the date on which the source is received, activities employed and their use, discarded residual activities as well as the date and manner of disposal.

CHAPTER IV

OF THE IONISING RADIATION GENERATORS

Article 91.- For the case of X-ray devices for medical diagnostic purposes, it must be complied with in accordance with the technical standards (a) to be issued by the Secretariat through the Commission.

Article 92.- Before the operation of an ionizing radiation generating device for authorized activities is initiated, it must Check the proper functioning of all systems of the device, including alarm systems, indicator lights, control board, radiation beam collimation, exposure time, and others. This review shall be carried out every six months from the start of operations and records of these revisions shall be kept as well as the preventive and corrective maintenance to be carried out.

Article 93.- Before the operation of the ionising radiation generating device is first initiated for the authorized activities, The radiation beam shall be calibrated in order to know the intensity of radiation with different voltages, electric currents, filters, collimation areas and distances. This calibration shall be carried out in accordance with the use of the device. Subsequently, the calibration must be carried out every six months, from which it will be recorded, indicating the date, procedure and signature of the person who made it.

Article 94.- The permissioner must verify by means of tests that the existing radiation levels in the areas adjacent to the installation, when the device is in a power-on position, are internal or equal to those indicated in the Radiological Safety Report accepted by the Commission. In case the radiation levels are greater than the accepted values, the necessary corrections must be made.

Article 95.- Signs of "DANGER" and "CAUTION" must be installed, as well as the international symbol indicating the presence of radiation in the access to the controlled areas. These signs must be changed immediately in the event of deterioration.

Article 96.- The alarms associated with ionizing radiation generating devices must always be calibrated and in conditions of operation.

Article 97.- In order to apply the radiation safety measures, during the operation of particle accelerators, they must be considered and evaluate the following aspects:

I).- The energy distribution and intensity of the radiation field;

II).- The activation of materials belonging to the accelerator, shields, or installation;

III).- The production of radiation derived from the interaction of the primary radiation with the materials of the installation;

IV).- Air-induced radioactivity and the production of harmful gases;

V).- The alteration due to the radiation of the electronic components, and

VI).- The effects of warming and possible fire or explosion risks.

TITLE FIFTH

RADIOACTIVE INSTALLATIONS

CHAPTER I

CLASSIFICATION

Article 98.- For the purposes of this Regulation, radioactive installations are classified as:

Type I.- Those in which sealed sources or devices are produced, manufactured, stored or used, or devices that generate ionizing radiation; radioactive mineral is extracted or processed, or in which radioactive waste of low and intermediate levels is treated, conditioned or stored.

Type II.- Those where open sources are produced, manufactured, stored, or used.

Article 99.- Attended to the magnitude of the risk related to operations involving radiation sources, the facilities to which refers to the Type I of the previous Article, they are classified in turn in three groups: A, B and C.

Article 100.- They are considered to be Type I-A facilities that have irradiators installed in which the sources exit the shield. during their operation or particle accelerators with energies equal to or greater than 10 MeV; mines and plants for the treatment of radioactive minerals, their jales dams and the work areas associated with them and the temporary or permanent warehouses of radioactive waste of low or intermediate levels. In this type of facility, the places where industrial radiography work with portable equipment, whether based on radioactive or X-ray material, are included. Also, the places are included in this classification. where geophysical well studies are performed in which the source of radiation comes out of its container, and the places of permanence of patients with brachytherapy applications.

Article 101.- They are considered to be Type I-B facilities, those that house teletherapy units, brachytherapy units, X-ray units for purposes therapeutic, irradiators in which sources do not emerge from shielding during operation or particle accelerators with energies less than 10 McV. They belong to this type, the fixed installations in which industrial radiography works are carried out, either with radioactive material or with X-Ray.

Article 102.- They are considered to be Type I-C facilities, those in which the use of ophthalmic applicators, thickness meters, density or level, or static electricity removers and meters.

Article 103.- Attended to the activity and radiotoxicity of the radiation sources used, the Type II installations are classified in three groups: A, B, and C.

Article 104.- For the purposes of this Regulation, the radionuclides according to their toxicity per unit of activity, may be very high, high, moderate or low radiotoxicity, in accordance with the relevant technical standard.

Article 105.- They are Type II-A facilities, those in which they may be present, at any given time, more than 370 MBq (10 mCi) of radionuclides of very high radiotoxicity, more than 3.7 GBq (100 mCi) of high radiotoxicity radionuclides, more than 37 GBq (1 Ci) of moderate radiotoxicity radionuclides or more than 370 GBq (10 Ci) of low radiotoxicity radionuclides.

Article 106.- They are Type II-B installations, those in which they can be present, at any given time, up to 370 MBq (10 mCi) of radionuclides of very high radiotoxicity, up to 3.7 GBq (100 mCi) of high radiotoxicity radionuclides, up to 3.7 GBq (1 Ci) of moderate radiotoxicity radionuclides or up to 370 GBq (10 Ci) of low-radiotoxicity radionuclides.

Article 107.- They are Type II-C facilities, those in which they may be present, at any given time, up to 370 KBq (10 uCi) of radionuclides of very high radiotoxicity, up to 3.7 MBq (100 uCi) of high radiotoxicity radionuclides, up to 37 MBq (1 mCi) of moderate radiotoxicity radionuclides or up to 370 MBq (10 mCi) of low-radiotoxicity radionuclides.

Article 108.- The limits set out in the above Articles for the classification of Type II installations must be modified in reason for the complexity of the operations carried out with the sources according to the relevant technical standard.

Article 109.- Those radioactive installations which are not covered by the foregoing Articles shall be assessed and classified in each case

(a) the Commission.

CHAPTER II

OF THE CONDITIONS OF RADIOACTIVE INSTALLATIONS

Article 110.- In the design of the radioactive installations, the following shall be taken into consideration among other aspects: classification and use of the source; workload, factors of use, and building materials of primary and secondary barriers; distance from the source to the areas occupied by individuals; occupation factors of the areas adjacent to the facility and levels of radiation and derived concentrations in air, at the end of the applicable provisions of Title III of this Regulation are complied with.

Article 111.- In the design of the facilities that will house devices that generate ionising radiation, they must be taken into account Electromechanical specifications of the equipment manufacturer to be installed, as well as the shields of the myriad, ducts and access doors.

Article 112.- During the construction of the facilities, the permissioner must ensure that the barriers and shields of the myriad, ducts and access doors comply with the specifications and commitments set out in the Radiological Safety Report presented to the Commission.

Article 113.- Any radioactive installation shall establish controlled areas in which the permit shall exercise supervision and control with the the purpose of providing adequate radiation protection.

Article 114.- According to the expected radiation levels and for better radiological control, within the controlled zone they will be defined, according to the case, the following:

I).- Radiation zone: that accessible only to the occupational staff exposed, in which the equivalent of the dose to the whole body, may be greater than 0.05 mSv (5 mrem) in one hour or 1 mSv (100 mrem) for any consecutive five-day period,

II).- High-radiation zone: that accessible only to the occupational staff exposed, in which the equivalent of the dose to the entire body within one hour, it may be greater than 1 mSv (100 mrem).

III).- Radioactive material zone suspended in air:

a) Aquella that is not normally occupied by people and where the concentration of existing radioactive material is higher than the indicated in the relevant technical standard, and

b) Aquella which may be occupied by occupational personnel exposed and in which the concentration of existing radioactive material, averaged with the weekly stay of staff in the area, be more than 25% of the concentration indicated in the technical standard referred to in the preceding paragraph.

Article 115.- In controlled areas, radiation, high radiation and radioactive material suspended in air, must exist signalling, appropriate access controls, emergency instructions and evacuation routes.

Article 116.- Regardless of the different control requirements in each of the areas referred to in the previous Article, specify the maximum permitted length of stay and the special radiation protection equipment required by clearly visible signs at the access points.

Article 117.- The Permissioner shall periodically review all areas referred to in Article 115, as set out in the Report Radiation Safety in order to check the levels of radiation and pollution and, where appropriate, to further delimit the extent of radiation.

Article 118.- The premises of the application of radioactive material and the permanence of the patient who is being treated with radioactive material, be duly marked with signs indicating the presence of radiation and the speed of exposure to one metre of the geometric centre of the organ with the highest amount of radioisotope or implant and in contact with the patient.

Article 119.- The radiation, high radiation and radioactive material suspended in air must be provided with the adequate and properly placed radiation, with which radiation levels, concentrations of suspended radioactive material in air and concentrations of radioactive material in the effluents as appropriate in each case may be determined.

Article 120.- When the Commission determines it must be installed at the entrance and exit of the areas where there is a risk of contamination radioactive, dressing rooms for staff to make necessary clothing changes, as well as specific areas for the decontamination of staff and components, tools and equipment.

Article 121.- When radioactive contamination of any equipment or surface is greater than the levels established in the technical standard appropriate, to be decontaminated or disposed of.

Article 122.- Stores and workshops where radioactive material is handled, as well as laundry laundry, will be located within a controlled zone.

Article 123.- No equipment, components, objects, or persons that are contaminated to uncontrolled zones will be moved, unless it is strictly necessary for which the relevant radiation safety measures are to be taken.

Article 124.- Prior to the start of operations, any radioactive installation must have an Emergency Plan in line with the guidelines of the National Civil Protection System and based on the study of the radiological consequences of accidents that may occur in the facility.

Article 125.- The Emergency Plan referred to in the previous article will have the purposes of: restricting exposure to radiation by keeping it as low as reasonably achievable, to ensure that the dose equivalents are kept below the limits laid down in this Regulation, to monitor the accident to be presented, and to obtain the necessary information for determine the causes and consequences of such an accident. The Emergency Plan shall contain at least:

I).- The procedures and equipment for the radiological measurements necessary to assess and determine the situation created by the accidents;

II).- The protective measures necessary to reduce exposures to ionizing radiation;

III).- The means and resources available to perform the protective measures referred to in the previous fraction;

IV).- The levels of intervention that will serve as a guide for implementing the measures referred to in the previous fraction II, and

V).- Establish protection measures for the surrounding population, consistent with the guidelines of the National Civil Protection System.

Article 126.- The storage sites of radioactive material shall be dedicated exclusively for that purpose and must comply with the physical and radiological security requirements, which according to the characteristics of the sources stored therein are applicable.

Article 127.- All places of use or storage of radioactive materials must be properly signposted, in addition to appropriate security systems to prevent unauthorised access by unauthorised persons. This should also be observed in those premises where ionising radiation generating devices are installed.

Article 128.- Places intended for reception, storage and use of radioactive material shall have a relative location such that during the internal transport of the sources the risks of contamination and the irradiation of the individuals are reduced.

Article 129.- Facilities where sources of ionizing radiation that can release gases are manufactured, used, manipulated or stored, Radioactive vapours or dusts shall have adequate ventilation systems in order to ensure that the concentration of radioactive material suspended in air in the work area is kept as low as reasonably achievable, without exceeding limits set out in the relevant technical standard.

Article 130.- The permissioner shall calculate the derived limits for concentrations of radioactive isotopes in the effluents, in the border with the uncontrolled area, so as to demonstrate that the limits authorised in each case by the Commission will not be exceeded, and shall describe in detail the model used for this purpose, in order to be assessed and approved.

Article 131.- In the controlled areas, the permissioner must establish measures to prevent the occupational personnel from inhaling in one year a quantity of radioactive material higher than that resulting from the constant inhalation of the same radionuclide to the air-derived concentrations established in the relevant technical standard.

Article 132.- When work with ionising radiation sources is carried out outside fixed installations, barriers and barriers must be installed. points on a perimeter such that access to the controlled area is restricted.

Article 133.- It is forbidden to introduce and ingest beverages and food, as well as smoking and makeup in the areas of the facilities where it exists risk of radioactive contamination.

Article 134.- During the operation of ionizing radiation sources the presence of unauthorized personnel within the zones will not be permitted. controlled of the radioactive installations.

TITLE SIXTH

OF THE TEAM

ONLY CHAPTER

GENERAL PROVISIONS

Article 135.- The equipment required to comply with the Radiological Protection Program is for:

I).- The detection and measurement of ionizing radiation;

II).- Personal dosimetry;

III).- The use of ionizing radiation sources;

IV).- Individual protection, and

V).- Decontamination.

Article 136.- The equipment used must be designed so that its operation is not affected by environmental conditions and mechanical effects on which their operation is foreseen, such as temperature, humidity, pressure, fumes, vapours, chemical pollutants in the atmosphere, blows and vibrations.

Article 137.- The equipment referred to in Article 135 fractions I and II and those of the fraction III that require it shall be calibrated periodically in accordance with the terms of the licence, permit or authorisation issued by the Commission.

Article 138.- The permissioner must carry a calibration record in which it settles at least:

I).- Employee procedure;

II).- Brand, model, and serial number of calibrated equipment;

III).- Mark, model, serial number, radioisotope, activity and date of calibration of the radiation source used as reference;

IV).- Calibration factors or calibration curves obtained;

V).- Lineality and directional response of the instrument, and

VI).- The date, name, and signature of the person who performed the calibration.

Article 139.- The accuracy of ionizing radiation detection and measurement equipment shall meet the requirements set out in the corresponding technical standard.

Article 140.- The equipment must be labeled with the date and calibration factors for each scale and, if applicable, the calibration.

Article 141.- The calibration of the detection and measurement equipment of ionizing radiation must be carried out using approved standards and methods by the Commission.

Article 142.- The detection and measurement equipment of ionizing radiation and those that allow the use of sealed sources will be subject to a well functioning test programme approved by the Commission. From these tests, the type of test to which the equipment was submitted will be recorded and the date, name and signature of the person who performed them.

Article 143.- Physical or moral persons using radiation sources to provide calibration services to the equipment identified in the Article 135 fractions I, II and III shall be authorised by the Commission.

Article 144.- Natural persons providing maintenance services to the equipment referred to in Article 135 fractions I, II and III shall be required to prove to have carried and approved a course of technical training in the field, recognised by the Commission.

TITLE SEVENTH

OF THE PERMIT, RESPONSIBLE FOR RADIOLOGICAL SECURITY AND OCCUPATIONAL PERSONNEL EXPOSED

CHAPTER I

GENERAL PROVISIONS

Article 145.- The internal organization of the permit must have a Radiological Security Group that will have under its management and monitoring of all aspects of radiation protection in the workplace. This group will depend directly on the license holder, permission, or authorization.

Article 146.- The Radiological Security Group should be supported by the permissioner in all aspects related to the elaboration, implementation, monitoring and modification of the Radiological Safety Programme. The Head of this Group shall be appointed as a radiological security officer.

CHAPTER II

OF THE OBLIGATIONS OF THE PERMIT

Article 147.- The permissioner shall be directly responsible for the radiological security of the institution or undertaking to the Commission.

Article 148.- They are the obligations of the permissioner:

I).- Register with the Commission the occupational staff exposed and the members of the Radiological Safety Group, documenting their level of studies and training, which shall be consistent with the work and functions assigned to them in the installation;

II).- Support the radiation security officer in all aspects related to the elaboration, execution, supervision and modification of the Radiation Safety Program;

III).- Provide all of the staff with occupational exposure, training, information, costumes, equipment, accessories, and devices radiation protection appropriate to the work they perform and the necessary medical care in the case of radiological accidents;

IV).- Meet the commitments contained in the Radiological Safety Report approved by the Commission and with the conditions of the license, permission or authorization;

V).- Give notice and deliver the reports to the Commission in case of radiological accidents, regardless of the warnings to be given to others Dependencies;

VI).- Notify the Commission immediately of any theft or loss of sources of ionizing radiation;

VII).- Watch that the radiation security officer performs his duties, analyzing and evaluating the reports together with the reports, reports and records that are presented to you on radiological security;

VIII).- To monitor regular reviews and analyses of the work procedures, the equipment used and the facilities of the agreement as outlined in the radiological safety report;

IX).- Develop and maintain in operational conditions the Emergency Plan;

X).- Elaborate and make known to all staff occupational exposure to the Radiological Safety Manual;

XI).- Exorder the occupational staff, the annual certificates and the constances at the end of the employment relationship, from the equivalent of individual doses received in the previous 52 weeks and the total cumulative dose to date. Copies of these documents shall be sent to the Commission with the signature of the individual received;

XII).- Take record of the medical examinations performed on the occupational staff, which will be carried out on the terms and the conditions referred to in the relevant technical standard;

XIII).- Take record of all release, vertigo and destination or final disposal of radioactive materials;

XIV).- Monitor that records of input and output of the material are kept in the storage of radioactive material;

XV).- periodically verify the inventory of radioactive material as outlined in the Radiological Safety Report;

XVI).- Grant the facilities required during inspections, audits, verifications and acknowledgements to be carried out by the Commission;

XVII).- Provide the information required during the proceedings referred to in the previous fraction;

XVIII).- Submit to the inspectors the manuals, records or documents related to the radiological security, when requested;

XIX).- Perform the tests and operations that are required during inspection, audit, verification, or recognition;

XX).- Allow Commission inspectors to take sufficient samples to perform relevant analyses and checks;

XXI).- Correct the deficiencies and anomalies detected in the inspections, audits, verifications and acknowledgments, and forward to the Commission, on your opportunity, the corresponding correction report;

XXII).- Provide the information and documentation required by the Commission, within the time limits set by the Commission;

XXIII).- Sign and sign all documentation that is submitted to or submitted to the Commission;

XXIV).- Where appropriate, cover all expenses arising from radiological accidents, including indemnities to third parties;

XXV).- Notify the Commission, for authorization, of the sale, loan, lease, donation, cession or any other act involving the transmission of ownership and deposit of sources of ionizing radiation;

XXVI).- Immediately warn the Commission when it stops using or definitively possessing the authorized radioactive material;

XXVII).- Take all radiological and physical security measures that are required to safeguard the integrity of radiation sources in Case of strike or strike;

XXVIII).- To warn the Commission of the outbreak and termination of the strike or strike that occurs at the facility, and

XXIX).- Fulfill those other obligations imposed on you by this Regulation.

CHAPTER III

OF THE REQUIREMENTS, CLASSIFICATION, AND OBLIGATIONS OF THE RADIOLOGICAL AND ANCILLARY SECURITY OFFICER

Article 149.- The radiation security officer will be classified into A, B, or C, depending on the type of radioactive installation he/she has in charge of.

Article 150.- To be in charge of class A radiological security is required:

I).- Professional title in the areas of duly registered physico-mathematical or chemical-biological and professional cedula issued by the authority corresponding.

II).- Certificate or record of approval of an advanced radiation safety course recognized by the Commission;

III).- Constances demonstrating three-year experience in radiation safety:

IV).- Constances that accredit a year's experience in the aspects of radiation protection, related to the use of the sources of radiation;

v).- Reside in the location where the installation is located, and

VI).- Contar with authorization from the Commission regarding their training and training.

Article 151.- To be in charge of class B radiological security is required:

I).- Professional title and cedula in the terms of section I of the previous Article;

II).- Certificate or record of approval of an advanced radiation safety course recognized by the Commission;

III).- Constances demonstrating a year's experience in radiation security;

IV).- Constances that accredit six-month experience in the aspects of radiation protection related to the use of the sources of ionizing radiation;

v).- Reside in the location where the installation is located, and

VI).- Contar with authorization from the Commission regarding their training and training.

Article 152.- To be in charge of C-class radiation security is required:

I).- Professional title and cedula in the terms of section I of Article 150 or letter of intern in the areas of physio-mathematics or chemical-biological, and

II).- Constancy of training on radiation safety in the use that the permissioner of to the sources of ionizing radiation recognized by the Commission.

Article 153.- The class A radiological security officer may be one of only one type of radioactive installation Type I-A or II-A; in charge class B may serve up to two Type I-B or II-B; installations and the Class C in charge up to three Type I-C or II-C installations.

Article 154.- They are obligations of the radiological security officers:

I).- Establish the radiological and physical security procedures applicable to the acquisition, import, export, production, possession, use, transfer, transport, storage and destination or final disposal of radioactive materials and ionising radiation generating devices; for review and approval in their case of the Commission;

II).- Adistrate and qualify the staff employed in the correct application of the radiation safety standards and procedures physical, as well as monitoring compliance during operations with the sources of ionizing radiation;

III).- Establish the radiological surveillance program for the determination, recording, analysis and evaluation of the dose equivalents received by the occupational staff exposed;

IV).- Monitor that the staff are provided with the dressing room, equipment, accessories and devices for radiation protection. appropriate and ensure that you use them properly;

V).- Identify zones, locations, operations, and conditions that potentially cause exposure to radiation;

VI).- Immediately communicate to the permissioner any fact that in his judgment may imply an increase in the risk of exposure to radiation during the management of the sources of ionizing radiation in order to implement the relevant corrective measures;

VII).- Notify the Commission immediately of any theft or loss of sources of ionizing radiation;

VIII).- Develop projects, procedures and methods to maintain exposure to radiation from occupational and occupational personnel public, as low as reasonably achievable, but less than the dose equivalent limits set out in this Regulation;

IX).- Develop and monitor the test program for good performance and calibration of all the detector equipment and radiation meter ionising;

X).- Develop, monitor, and participate in the training programs of the occupational personnel exposed;

XI).- Taking record of the dose equivalents received by the occupational staff exposed, annexing the dose equivalent received at previous jobs when the respective constances have been submitted;

XII).- Monitor that the handling and disposal of radioactive waste is carried out in accordance with applicable radiation safety standards;

XIII).- Carry out leakage tests on sources of ionizing radiation at the time of their reception and at periods established under the conditions of the licence, authorisation or permit, as well as after any radiological accident;

XIV).- Keep track of leakage tests, calibration and smooth operation of ionizing radiation sources and detector and detection equipment meters of such radiation, in the terms of this Regulation;

XV).- Be present during the development of inspections, audits, verifications and acknowledgments to be carried out by the Commission permissioner;

XVI).- Provide the information requested by the inspectors in the course of the proceedings outlined in the previous section;

XVII).- Correct deficiencies and anomalies detected in inspections, audits, verifications, and acknowledgments;

XVIII).- Develop and collect the necessary documentation for the timely procurement and renewal of licenses, permits, and authorizations;

XIX).- Develop, update, control, and archive the plans, reports, records, and writings related to the Radiological Security Report and with the inspections, audits, verifications or examinations carried out by the Commission;

XX).- Participate in the elaboration, updating, and application of the Installation Emergency Plan and Radiological Security Manual;

XXI).- Immediately charge the installation in case of a radiological accident to coordinate and supervise the operations to be carried out, notifying the Commission, in accordance with the provisions of Title Ninth, Chapter I of this Regulation;

XXII).- Develop a training program for emergency cases, which includes both potential radiological accidents during routine operations, such as those that may occur as a result of a fire, explosion, flood, collapse or other claims, including periodic drills with the staff involved;

XXIII).- Provide the information or documentation required by the Commission, within the time limits set by the Commission, and

XXIV).- Meet the other obligations of this Regulation.

Article 155.- The number of auxiliaries to be given by the radiation security officer is determined by the type and installation group that you are treat, activity, characteristics, number and specific use of the sources of ionizing radiation. Auxiliaries may be Class A or B.

Article 156.- To be auxiliary to the radiation security officer, class A, it is required:

I).- Poseer professional title and cedula in the terms of section I of Article 150;

II).- Credit a year of experience in radiation security;

III).- Acredit six months of experience in the aspects of radiation protection related to the use of the permit from the sources of ionising radiation;

IV).- Demonstrate that a radiation safety course, recognized by the Commission, has been carried and approved, and

V).- Contar with authorization from the Commission regarding their training and training.

Article 157.- To be auxiliary to the radiation security officer, class B, it is required:

I).- Poseer professional title and cedula in the terms of section I of Article 150, or letter of intern in the areas of physio-mathematics or chemic-biologics;

II).- Credit the approval of a radiation safety course recognized by the Commission or demonstrate six months of experience in the use specified that the permissioner of the sources of ionizing radiation, and

III).- Contar with authorization from the Commission regarding their training and training.

Article 158.- It is the duty of the auxiliary of the radiation security officer to refer to the permit all documentation relating to the inspections, audits, verifications and surveys to be carried out by the Commission, and in which they are involved in replacement of the radiation safety officer.

CHAPTER IV

OF THE REQUIREMENTS AND OBLIGATIONS OF OCCUPATIONAL STAFF EXPOSED

Article 159.- The occupational staff exposed must:

I).- Be registered with the Commission;

II).- Being over 18 years;

III).- Poseer certificate of studies, as stipulated by the corresponding technical standard. This certificate must be issued by the appropriate authority, and

IV).- Contar with authorization from the Commission regarding their training and training.

Article 160.- They are obligations of the occupational staff exposed:

I).- Know and apply the basic principles of radiation security correctly;

II).- Avoid any unnecessary exposure to the radiation of your person and the public;

III).- Care and monitor that when the sources of ionizing radiation are no longer used, they are in adequate safety conditions. radiological and physical; the radioactive material in its containers and the equipment containing the sources or the ionising radiation generating device in the off position;

IV).- Check when you leave an area where there is a risk of radioactive contamination, that your person and locker room are not contaminated;

V).- Know and apply correctly the standards, instructions and procedures contained in the Radiological Safety Manual and the Plan of Installation Emergency;

VI).- Know the correct handling and use of the sources of ionizing radiation, the detector equipment and radiation meter, the accessories and radiation safety devices and, of the shielding, distance and time factors, to the extent required by their functions and responsibilities;

VII).- Portar during the working day the personal dosimeters that are required according to the provisions of the Security Manual Radiological;

VIII).- Seek to develop the least amount of radioactive waste in the development of its activities;

IX).- Know and apply correctly the procedures authorized by the radiation safety officer for the disposal of waste radioactive;

X).- Learn about the dose equivalents that you have received in performing your tasks with the periodicity with which they are recorded in the log corresponding;

XI).- Submit to the taking of biological samples that are required for medical surveillance and for bioassay testing;

XII).- Provide truthfully with the data required during the inspections, audits, verifications and acknowledgments that you perform the Commission;

XIII).- Know the behavior to follow in case of radiological accident;

XIV).- Staff who provide services at various facilities and are professionally exposed must inform the security officer radiological, of each of them, so that they all have the full dosimetric history, and

XV).- Report to the radiation security officer, on any situation of high risk, incident and radiological accident.

Article 161.- The Commission may impose additional requirements on the radiological, auxiliary and personnel responsible for the use of radiation, in cases where the radiation safety so requires.

TITLE EIGHTH

OF MEDICAL APPLICATIONS

ONLY CHAPTER

OF ADMINISTRATION, APPLICATION, AND IMPLANT OF RADIOACTIVE MATERIAL

Article 162.- All administration, application or implantation of radioactive material shall be established in the patient's clinical file, indicating the date and time of the withdrawal in case of application or temporary implant, radioisotope and activity used, route of administration and name and signature of the responsible physician.

Article 163.- In cases of administration of radioactive material for therapeutic purposes, in which it is expected that there will be an important dissemination of the radionuclide in the patient or an important excretion of the patient, the speed of exposure to one metre of the centre of the organ with the highest amount of the radioisotope shall be measured every 12 hours until completion of 96 hours after administration. These readings will be based on the patient's clinical record.

" The radiation safety officer shall establish appropriate procedures for the handling, treatment and disposal of contaminated excreta, know the doctor, nurses and affanadors of the area, who in turn will instruct the patient about it. "

Article 164.- In any administration, application or implant of radioactive material, for therapeutic purposes, the radioisotope and the activity to be used, and the identification of the patient in question shall be verified. The patient's clinical record shall establish the speed of exposure to one metre of the implant or organ with the highest amount of radioisotope immediately after and within 12 hours of being applied, administered or implanted.

Article 165.- In cases where it is necessary to transfer, within the same institution, patients who are being treated with Incorporated radioactive material, the transfer shall be carried out on pre-fixed routes, chosen in such a way as to avoid unnecessary exposure of non-occupationally exposed persons or the public.

Article 166.- Treatments with teletherapy, deep therapy, or surface therapy will settle in the clinical case of the patient, indicating the administered dose.

Article 167.- The patient area to be irradiated with teletherapy, deep therapy, or surface therapy equipment will be identified. clearly and their location will be verified by the responsible physician in the course of the treatments; while the areas that do not wish to be irradiated, must be protected with the appropriate devices.

Article 168.- In therapy equipment with ionizing radiation sources, diaphragms and adjustable collimers that delimit the beam will be used. useful for radiation.

Article 169.- When the conditions of the patient merit it, in the treatment of teletherapy, deep or superficial therapy, they will be used fasteners that prevent the mobility of the same.

Article 170.- The patient's hospitalization will be required from the radiation safety point of view when the activity is administered or The invention relates to a method for the use of said method, which can be used to provide a permanent implant or the speed of exposure to one metre of the implant centre or the organ with the highest amount of radioisotope. This standard will establish the radiation safety conditions to be taken into account when discharged to these patients.

Article 171.- The patient who is subjected to temporary applications or implants with sealed sources of radioactive material of a half-life You must be hospitalized during treatment for more than 125 days. Radiation sources must be removed before the patient is discharged.

Article 172.- When it is necessary to surgically intervene in patients who have been administered, applied or implanted material radioactive, shall be made from the knowledge of the radiation safety officer, to determine the relevant measures.

Article 173.- In cases of embalming, autopsy, inhumation or cremation of corpses containing therapeutic doses of radioactive material, shall be consulted in advance with the radiation safety officer, who shall assess the situation and determine the precautions to be followed on radiation safety, notifying the Commission thereof.

Article 174.- To bodies containing sealed sources used for temporary implants, they will be removed before being cremated or inhumed.

TITLE NINTH

RADIOLOGICAL ACCIDENTS AND PREVENTIVE OR SAFETY MEASURES

CHAPTER I

OF WARNINGS AND REPORTS

Article 175.- The permissioner, the radiological security officer, or the occupational personnel exposed, must immediately put in knowledge of the Commission any radiological accident, regardless of the warnings to be given to other Dependencies.

Article 176.- The permit must be delivered to the Commission within 24 hours by a written report of the radiological accident.

Article 177.- The report referred to in the previous article will contain:

I).- Description of the accident occurred;

II).- Likely causes of the same;

III).- Sources of radiation involved and in their case, quantity and physical and chemical form of the radioactive material released to the environment;

IV).- Immediate actions taken and people intervening in them;

V).- Estimate of the dose equivalent received by the occupational staff exposed;

VI).- Estimate of the dose equivalent received by members of the public who were exposed;

VII).- Data of persons involved in the accident, such as: Name, address, telephone, sex, date of birth, occupation, number of membership of the IMSS or ISSSTE and, relationship to the permit, and

VIII).- The signature of the permissioner and the radiation security officer on the sidelines of each of its leaves and the calce of the latter.

Article 178.- The permit within 15 working days after delivery of the report referred to in Article 176 shall be delivered in writing to the Commission a report containing:

I).- Description of the accident, magnitude of the accident, and specific causes that motivated it;

II).- Description, brand, model, serial number, and physical and chemical form of the radiation sources involved and, if applicable, the amount released to the radioactive material environment;

III).- Actions taken for the management of the accident, persons who carried out the accident and the calculation of the dose equivalent received by the same;

IV).- Measures taken to prevent the accident from recurring;

V).- Calculation of the effective dose equivalent received by the staff employed in the event due to the accident;

VI).- Calculation of the effective dose equivalent received by members of the public who were exposed due to the accident;

VII).- The data referred to in section VII of the previous Article;

VIII).- The signature of the permit and the radiation security officer in the terms of section VIII of the previous Article, and

IX.- Anexar, if any, copy of the minutes raised before the Public Ministry on the occasion of the accident.

Article 179.- The permit will provide the Commission with the additional information it requires in connection with the accident.

Article 180.- Cases of radiological incidents or accidents are the direct responsibility of the permit.

CHAPTER II

PREVENTIVE OR SECURITY MEASURES

Article 181.- For the purposes of this Regulation, it is considered that there is imminent danger or risks to the staff of an installation radioactive or for society in general, when:

I).- Be deprived of the authorization, permission or license required by the Law;

II).- Sealed sources lose their tightness;

III).- The systems or equipment for the control of the source of radiation or equipment containing it are in conditions that contravene the provisions of this Regulation;

IV).- Do not have the required ionising radiation measurement equipment or is not in suitable operating conditions;

V).- The use of radiation sources or equipment containing them is in contravention of the provisions of this Regulation;

VI).- Physical and radiological protection engineering barriers do not meet the specifications required by the Commission;

VII).- The staff responsible for the use of the radiation sources or equipment containing them shall not be authorised by the Commission. with respect to their training and training;

VIII).- The release of radioactive material outside the facility exceeds the limits set on the respective permit or license;

IX).- The systems of control of radiation sources or equipment that contain them, operate in a deficient manner or are close to suffering fails;

X).- The hermeticity of sealed sources is lost and the surface contamination above the set limits is caused in the relevant technical standard;

XI).- The amount of radioactive material suspended in the air exceeds the limits laid down in the relevant technical standard;

XII).- The surface contamination levels of movable or immovable property exceed the limits laid down in the relevant technical standard, and decontamination is not possible, and

XIII).- The conditions of the installations housing the sources of radiation or equipment containing them, may affect the safety of these.

Article 182.- The Commission may order and implement as preventive or safety measures, the following:

I).- Retention, securing or depositing the sources of ionizing radiation or equipment containing them, as well as any contaminated goods;

II).- Temporary, partial or total closure of radioactive installations or contaminated real estate;

III).- Definitive closure of radioactive installations or contaminated real estate, and

IV).- Temporarily occupy nuclear and radioactive facilities under the terms of Article 34 of the Act.

Article 183.- The retention, securing or deposit of the sources of ionizing radiation or equipment containing them shall be carried out in cases where Parts I, II, III, IV, V, VI and VII of Article 181, as well as in the case of fraction VIII of the same precept, are referred to when the release does not exceed twice the above limits.

Article 184.- The retention, securing or deposit of any contaminated furniture in the case of Article XII of the Article shall proceed. 181.

Article 185.- The temporary closure, partial or total, of radioactive installations in the cases referred to in fractions VIII, shall proceed. where the release of radioactive material is greater than twice the limits indicated, IX, X, XI, XII and XIII of Article 181.

Article 186.- The temporary, partial or total closure of contaminated real estate in the case of Article 181 (XII) shall proceed.

Article 187.- Executing the temporary closure referred to in Articles 185 and 186, the Commission shall fix the time limit for correcting the deficiencies or found failures.

Article 188.- Prior to the corresponding technical opinion, the Commission shall proceed to the final closure of radioactive installations or goods contaminated buildings, where the time limit set for this purpose is not remedied, the deficiencies or anomalies which led to the temporary closure.

TITLE TENTH

OF AUTHORIZATIONS, PERMISSIONS, AND LICENSES

CHAPTER I

OF AUTHORIZATIONS

Article 189.- Any activity with sources of ionizing radiation shall be prohibited when the authorization, permit or license is lacking respective.

Article 190.- To request an authorization for acquisition, import, export, possession, use, transfer, transport, storage, and the final disposal or disposal of radioactive material and ionising radiation generating devices, the data subject shall submit to the Commission the documentation and information to be provided for each case in this Regulation, on paper the undertaking or institution requesting and duly signed by the legal representative and the proposed candidate for the radiological security officer of that undertaking or institution.

Article 191.- To request authorizations for the acquisition and transfer of sources of ionizing radiation, the interested parties must comply with the Following requirements:

I).- Present:

a).- Request in the appropriate official form;

b).- The constitutive act of the applicant company, duly registered in the Public Registry of the Property. In the case of which the acquisition and transfer of radioactive material must be included, and

c).- Fianza or institution or company legally authorized to guarantee damages caused by ionising radiation to third parties.

II).- By writing the information regarding:

a).- Activity and radioisotopes by product and physical and chemical form;

b).- Category of packages and type of packaging used during transport and storage in transit of sources of ionizing radiation, as well as a transport index;

c).- Procedure for transferring the sources of ionizing radiation to the permissioners;

d).- Program of training in radiation protection to permissionaries, for the use of ionizing radiation sources;

e).- Technical and administrative advisory plan to be provided by the applicant to the permissionaries of ionizing radiation sources, the procedures before the Commission and the different activities with these sources;

f).- The delivery program for ionizing radiation sources, and

g).- Physical and radiological security conditions to be applied by the applicant during transit storage of radiation sources ionising.

Article 192.- To apply for import authorizations for ionising radiation sources, interested parties must submit in writing to the Commission the following information:

I).- The number of the recipient's authorization, permission, or operating license;

II).- Radioisotopes; activity; physical and chemical form; and specifications of the equipment containing the radioactive material or the specifications of the device for generating ionizing radiation;

III).- Customs where the import is intended to be performed;

IV).- Type of packages, packaging, or containers to be used in the transport;

V).- Copy of the import request, and

VI).- Physical and radiological security plan.

Article 193.- The Commission shall suspend the processing of an application for authorization to import sources of ionizing radiation, where the information referred to in the previous Article is incomplete, or the addressee or applicant is in any of the following cases:

I).- Carage of authorization, permission, or license, or these are suspended or canceled, and

II).- The activity of radioactive material or the capacity of the ionising radiation generating device, which is intended to be imported, exceeds the authorised by the Commission.

Article 194.- Once the import of sources of ionizing radiation by the holders of the respective authorization has been carried out, they must forward to the Commission within five working days from the date of delivery of the same, the acknowledgement of receipt of the sources by the consignee indicated in the application submitted in accordance with Article 192 of this Regulation. Regulation, and the transport certificates of those sources issued by the competent authority in the field of radiological security in the country of origin.

Article 195.- To process the authorization of the export of ionizing radiation sources, the applicant shall submit in writing to the Commission the following information and documentation:

I).- The authorization number, permission, or operation license of the permit;

II).- Radioisotopes, activity, physical and chemical form, and specifications of the equipment containing the radioactive material;

III).- Customs where export is intended to be performed;

IV).- Name, address, and phone or telex number of the recipient;

V).- Physical and radiological security plan;

VI).- Original radioactive material transport authorization, and

VII).- Copy of the export request.

Article 196.- The requirements for processing authorization for the acquisition, possession and use of sources of ionizing radiation shall be as established In Articles 219, 220 and 221 of this Regulation.

Article 197.- The possession and use of radioactive material in buildings intended for room shall not be permitted.

Article 198.- To request transport authorizations for radioactive material, stakeholders must:

I).- Submit a request in the appropriate official form;

II).- Exhibit constitutive acta of the company, duly registered in the Public Registry of the Property, in whose social object it must be including the transport of radioactive material;

III).- Propose a person to be in charge of radiation security;

IV).- Propose people who might serve as occupational personnel exposed;

V).- Describe the radioactive material that is intended to be transported, as well as the shipping containers and packaging;

VI).- Detailed the physical and radiological security plan;

VII).- Describe security equipment and devices;

VIII).- Present risk analysis and emergency plan for the case of accidents with radioactive material during transport and storage in transit;

IX).- Drill down the route that the vehicle will follow that will transport the radioactive material;

X).- Describe the procedures for receiving and delivering the radioactive material, and

XI).- Fiance or course of institution or company legally authorized to guarantee damages caused by ionising radiation to third parties.

Article 199.- The radiation safety standards applicable to the transport of radioactive materials shall be those contained in the Respective transport.

Article 200.- Ionizing radiation generating devices will not require authorization for their transportation.

Article 201.- To process the authorization of a temporary storage of radioactive material, the applicant shall:

I).- Present:

a).- Request in the appropriate official form;

b).- Constitutive Act of the company, duly registered in the Public Registry of the Property and of Commerce, in whose social object it must be including the storage of radioactive material;

c).- Installation analytic memory;

d).- The installation's architectural planos, indicating the areas adjacent to it and the type of use to which they are intended areas;

e).- Radiological Security Manual;

f).- Risk Analysis and Emergency Plan;

g).- A person's proposal for radiation security, and

h).- Proposal of persons who could serve as occupational personnel exposed.

II).- By writing the information regarding:

a).- Maximum activities of radioisotopes;

b).- Procedure and registration of receipt and delivery of radioactive materials, and

c).- Characteristics of the ionizing radiation detector equipment.

Article 202.- The requirements for processing the authorization of a final radioactive material store shall be as set out in the Articles 219, 220 and 221 of this Regulation. In addition, a programme for the final closure of the installation and the maintenance to be provided after the active use of the installation is completed. This programme shall include plans for the immobilisation of radioactive materials, and their isolation from the environment as effectively as reasonably achievable, as well as for the monitoring of the retention of radioactive pollutants and of the stability of the installation.

Article 203.- The holder of the authorization of a definitive radioactive material store shall take the appropriate corrective actions to maintain the stability and integrity of the facility for the duration of its responsibility.

Article 204.- The permanent storage of flammable, pyrophoric, liquid radioactive waste in liquid state is prohibited in the form of compressed gases or unknown compounds.

Article 205.- The disposal of radioactive waste at sea is prohibited.

Article 206.- The information necessary for processing authorization for processing, conditioning, discharge and final disposal for low and intermediate level radioactive waste, shall be as laid down in Articles 219, 220 and 221 of this Regulation.

Article 207.- For the purposes of the previous Article, the Commission shall classify radioactive waste according to its specific activity, exposure on the surface of the container or packaging, half-life, radiotoxicity, chemical and physical form and taking into account the origin, properties of the radionuclide, risk of external irradiation, characteristics of the container, packaging or bulk, mechanism of ecological dispersion and form of release to environment.

Article 208.- Not allowed to mix radioactive waste with other materials except as part of a procedure or conditioning approved by the Commission.

Article 209.- The Commission shall authorise the incineration of radioactive waste provided that the permit demonstrates to the Commission that the radioactive releases involved in such a process shall not result in the exposure of the general public to equivalent doses exceeding the permitted limits.

Article 210.- The burial of radioactive waste can only be carried out in facilities authorized by the Commission provided that the same have the respective operating license.

Article 211.- The holder of an operating licence for a radioactive installation in which radioactive waste is produced from low and low levels intermediate with open sources will be authorised by the Commission to see them in the system of drainage of the installation as long as it is found that:

I).- The liquids are completely soluble or dispersible in water;

II).- The average daily concentrations of discharge of radioactive liquids shall not exceed the values indicated by the Commission in the corresponding technical rule;

III).- The average monthly concentration of radioactive liquids, diluted in the average monthly amount of water discharge from the installation, shall not exceed the values indicated by the Commission in the relevant technical standard, and

IV).- The maximum total allowable activity of discharging radioactive liquids to the drain shall not exceed 37,0 GBq (1 Ci) per year.

Article 212.- The Commission may allow decommitments exceeding the limits authorised in each case where, in the case of such a case, there are reasons to justify it, upon request in writing by the permissioner attaching the information required to it.

Article 213.- The Commission may limit the quantity of radioactive material to be discharged into areas not controlled by discharges of liquids or gases from an installation, where it is considered that the authorised limits may be exceeded for the critical group corresponding.

Article 214.- The procedure, conditioning and final disposal of radioactive waste with open sources and high level sealed sources subject to the provisions of the Nuclear Facility Security Regulation.

Article 215.- Sources sealed with activities exceeding those indicated by the corresponding technical standard may only be disposed of in two forms:

I).- Sending them to a definitive radioactive waste warehouse, or

II).- Sending them abroad upon export authorization in the terms of the Law and this Regulation.

Article 216.- For the final destination or disposition of sealed sources, the permissioner must first ask the Commission for authorization corresponding, providing the following information in writing:

I).- Radioisotope, activity and date on which it is valid, mark, model, and serial number of the source;

II).- Number and date of issue of the authorization, permit or license, in which the source is covered;

III).- Reason for the source removal;

IV).- The type, brand, and model of the container with which the source is intended to be transported, and

V).- Proposed target or final disposition.

Article 217.- For authorization to install or service sources of ionizing radiation and equipment containing them, as well as for calibrating detection equipment and ionizing radiation meters, the applicant shall submit to the Commission:

I).- Request in the appropriate official form;

II).- Copy of the Constitutive Act of the company concerned, duly registered in the Public Registry of the Property, in whose social object the installation or provision of services to ionising radiation sources and equipment containing them shall be included;

III).- Radiological Security Report;

IV).- A person's proposal for radiation security, and

V).- Propose people who might be able to serve as occupational personnel exposed.

Article 218.- The Radiological Safety Report referred to in section III of the previous Article shall contain:

I).- The detailed procedures for each of the activities to be carried out to grant the services or calibrations involved, indicating the applicable national or international standards, and

II).- The relationship and characteristics of the equipment and the sources of ionizing radiation used to perform the described procedures.

CHAPTER II

OF PERMISSIONS AND LICENSES

Article 219.- To request building permits and operating licenses, modification, cessation of operations, dismantling or closing The following documentation shall be submitted to the Commission by the interested parties:

I).- Request in the appropriate official form;

II).- Copy of the constitutive act of the company duly registered in the Public Registry of Property and Commerce;

III).- Radiological Security Report;

IV).- Manual of Radiological Security, and

V).- Fiance or course of institution or company legally authorized to guarantee damages to third parties.

Article 220.- In the case of the application for the building permit of a radioactive installation, the Radiological Safety Report has the purpose of describing the radiological safety features to be applied in the design, design, calculation methods and controls for procedures and materials used. The above information shall be submitted to the Commission in accordance with the following points

I).- Proposed installations and activities;

II).- Options evaluation;

III).- Placement;

IV).- Installation design, and

V).- Quality Assurance Program.

The scope and content of this Report is established for each case in the corresponding technical standard.

Article 221.- When it comes to the application for a radioactive installation operation license, the Radiological Safety Report contain the information regarding:

I).- General installation specifications;

II).- Organization of the requester;

III).- Radiological security policy;

IV).- Quality Assurance Program;

V).- Radiological Security Group;

VI).- Radiation sources;

VII).- Design features as regards radiation security;

VIII).- Estimation of dose equivalents;

IX).- Radiological security program;

X).- Risk analysis and emergency plan;

XI).- Environmental impact, and

XII).- Cese of operations, decommissioning, and final closure.

The scope and content of this Report is established for each case in the corresponding technical standard.

Article 222.- When it comes to the request for a license to modify a radioactive installation, the Radiological Safety Report contain the information regarding:

I).- The reason for the modification;

II).- The radiation security implications, and

III).- The estimate of the dose equivalent.

The scope and content of this Report is established for each case in the corresponding technical standard.

Article 223.- The Radiological Safety Report, in the case of the application for a cessation of operations or the dismantling of a radioactive installation, shall contain:

I).- Where appropriate, the report of amendments to the "programme of activities for the cessation of operations or decommissioning", contained in the Radiation safety which was submitted to the Commission on the occasion of the application for a licence to operate the same installation. In this programme of activities the radioactive installation shall be deemed to be free from removable surface contamination;

II).- A detailed relationship of the procedures to be followed to comply with the "program of activities for the cessation of operations or dismantling" mentioned in the previous fraction, and

III).- For the case of radioactive waste generation and the control of residual radiation sources, the procedures for the processing, conditioning, discharge and final disposal.

Article 224.- The Radiological Safety Report in the case of the application for a definitive closure license for a radioactive installation, it shall contain the documents verifying that the conditions laid down in the Radiological Safety Report presented together with the application for the operating licence have been met.

CHAPTER III

OF THE REQUIREMENTS FOR RENEWAL OF AUTHORIZATIONS, PERMISSIONS, OR LICENSES

Article 225.- The application for renewal of the authorizations, permits and licenses must be submitted 30 calendar days before the date of their expiration.

Article 226.- Requests for renewal of authorizations, permissions, or licenses, provided they do not change the conditions under which they are They shall be accompanied by a detailed report of the experience of radiation protection acquired.

CHAPTER IV

OF THE ASSESSMENT OF THE REQUEST FOR AUTHORIZATIONS, PERMISSIONS, AND LICENSES, AND THEIR RENEWAL

Article 227.- No authorization, permission, license, or renewal request will be made when:

I).- The data contained in it are incomplete or missing the signatures or do not correspond to the applicant, his legal representative and the person in charge of Radiation security, or these are deleted, amended or crossed out;

II).- The installation or equipment is not suitable for the specific use that will be given to the sources of ionizing radiation;

III).- The person proposed for the radiation security officer does not meet the relevant requirements.

IV).- The information provided in the Radiolic Security Report is not truthful;

V).- The authorization, permission or license previously conceived, has been suspended or cancelled and the causes or reasons for that suspension or cancellation subsist or impact on the conditions of the new application;

VI).- The person proposed to be in charge of radiation security, has previously held the position and his appointment has been cancelled by the Commission;

VII).- The sanction or any fine or damage to third parties and expenses arising from any radiological accident has not been complied with;

VIII).- The documentation submitted by the applicant is not clear, incomplete or contradictory, or

IX).- The deficiencies or anomalies detected in inspections, audits, verifications, and acknowledgments have not been corrected.

Article 228.- The processing of the application may be continued, when it is shown that the cause that interrupted it has disappeared.

Article 229.- When the Commission considers that the documentation submitted for the processing of an authorization, permit or license or its renewal is incomplete or insufficient content to carry out its assessment, it will require the applicant to complete, clarify, correct or extend it.

Article 230.- The Commission reserves the right not to receive documentation submitted for the processing of an authorisation, permit, licence or renewal, where it considers that it is incomplete or that its content is insufficient to carry out its assessment, in accordance with the requirements set out in the Regulation.

Article 231.- The Commission shall verify the information and documentation provided by the applicant.

CHAPTER V

GRANTING AUTHORIZATIONS, PERMISSIONS, LICENSES, OR THEIR REFRESH

Article 232.- When the documentation is deemed sufficient and the deficiencies found are remedied, the Commission shall grant the authorization, permission, license or renewal, corresponding.

Article 233.- The authorizations, permits or licenses or their renewals shall only be valid for the permit whose name, address and classification is expressed and under the specific conditions for which they were issued, the validity of which will be included in the document itself. The original of the permit, licence or authorisation must be kept at the legal domicile of the permit and, copy of these documents must accompany the sources of ionizing radiation, in order to be able to appear during the audits, inspections, verifications and surveys to be carried out by the Commission.

Article 234.- When the permissioner stops using or definitively possessing sources of ionizing radiation, authorization, permission, or license or its renewal that has been granted.

TITLE TENTH FIRST

ADMINISTRATIVE PROCEDURES

CHAPTER I

OF INSPECTIONS, AUDITS, VERIFICATIONS AND ACKNOWLEDGMENTS

Article 235.- The Commission's authorized personnel for the practice of inspections, audits, verifications and surveys shall have the following: Inherent powers and access to the places, establishments and equipment subject to such measures.

Article 236.- Inspections, audits, verifications and examinations shall be carried out by the Commission at the request of an interested party or trade with the frequency that the person determines in each case.

Article 237.- Inspection, audit, verification and recognition visits shall be conducted in business days and hours by authorized personnel of the Commission. The Commission may authorise such visits in days and indeft hours in order to avoid interruptions, where such authorisation shall be expressed in the relevant order.

Article 238.- Commission inspectors, for the practice of inspections, audits, verifications and recognitions shall be identified duly and be provided with the respective orders.

Article 239.- The orders referred to in the previous Article must meet the following requirements:

I).- Constar in writing;

II).- Point out authority that issues it;

III).- Be grounded and motivated, and express resolution, object, or purpose;

IV).- Ostend the signature of the competent official and, if appropriate, the name or names of the persons to whom it is addressed, the data shall be indicated sufficient to permit identification;

V).- Point the place or places to be performed;

VI).- Contain the name of the person (s) to be made, which may at any time be replaced, increased or reduced in number by the Commission. These changes shall be notified to the interested party in a timely manner. Designated persons who are required to carry out the above measures may do so jointly or separately, and

VII).- To mention the date or dates when the due diligence will be performed.

Article 240.- During the practice of inspections, audits, verifications and acknowledgments, all natural and moral persons as requires them to provide facilities, provide information, present documentation, carry out tests and operations, and allow sufficient samples to be taken to carry out the relevant analyses and checks. The above provisions shall apply both to proceedings in the legal domicile of the permit or in the field.

Article 241.- Once the diligence in question has been initiated, it may not be interrupted or suspended without express order or authorization of the Commission. In cases where staff are prevented from carrying out their duties, the Commission shall take the measures they have taken, including by requesting the support of the public force, in order to enable it to be implemented.

Article 242.- In cases where due to any cause is prevented, obstructed or difficult due diligence, the inspector shall lift the act by pointing out these facts to ensure that the appropriate penalties are applied.

Article 243.- Any inspection, audit, verification or recognition shall be documented in the presence of two witnesses.

Article 244.- In the inspection, audit, verification or recognition act, it shall be stated:

I).- Time, day, month, and year in which diligence is practiced;

II).- Street, number, population and federal entity in which the place where the diligence or full identification of the person is located is located site;

III).- The number and date of the order that the reason;

IV).- The name and character of the person with whom the diligence is understood;

V).- Name and address of the people who serve as witnesses;

VI).- What was disclosed to the person with whom the diligence was understood, their right to make observations to the inspector during the practice of the same;

VII).- Data relating to the performance;

VIII).- Declaration of the person referred to in the previous section VI, if you would like to do so;

IX).- That the person with whom the due diligence was understood was given the right to write observations to the minutes, having to do so a period of 10 working days from the date on which the due diligence was carried out, and

X).- Name and signature of those who intervened in the diligence.

Article 245.- The facts to be recorded by the inspector in the documents to be drawn up in the exercise of their duties shall be taken for certain purposes. as long as the contrary is not proven.

Article 246.- The person with whom the diligence was understood will be copied from the record even if it has been refused to sign it, which will not affect their validity, this circumstance being recorded in the respective minutes.

Article 247.- The Commission shall forward to the parties concerned within 20 working days of the diligence, the respective opinion, where appropriate, the anomalies and deficiencies found and the time-limits for the correction of such deficiencies.

Article 248.- The interested party must inform the Commission, within the time limits set, of the measures taken to correct the anomalies and shortcomings identified in the opinion mentioned. The Commission may verify compliance with these measures.

Article 249.- The Commission may extend the time limits fixed upon application by the person concerned, stating the reasons for the request.

Article 250.- Where the Commission's satisfaction is not corrected, the deficiencies or anomalies detected within the time limits are granted, the appropriate penalties shall apply.

Article 251.- If deficiencies or anomalies involving an imminent danger or risk to staff are found during the due diligence The inspector shall be entitled to apply the preventive or safety measures referred to in Article 182 of this Regulation, subject to the order of the Commission, in which case it shall lift the provisions of Article 182 of this Regulation. act in the terms of the previous Article 244.

Article 252.- When the contents of the act result in the possible commission of a crime, the Commission shall do so with the knowledge of the authority competent.

CHAPTER II

OF THE SANTIONS

Article 253.- The violation or non-compliance with the precepts of the Law, this Regulation and other provisions derived therefrom, independently where appropriate under other laws or regulations, shall be administered by the Commission administratively as follows:

I).- Multa from five to five thousand times the general minimum wage in force at the place and time the violation is committed. If the infringement persists and the time limit granted for its correction persists, the Commission may impose fines for each day that elapses without the respective mandate being obeyed, provided that it does not exceed the limit set, and regardless of the other penalties provided for in this Regulation;

II).- Suspension of authorization, permission, or license, and

III).- Cancellation of authorization, permission, or license.

Article 254.- Sanctions shall be imposed based on the outcome of the inspection, audit, verification or recognition minutes, and Decisions arising from them, in accordance with the provisions of this Regulation and other provisions arising therefrom, taking into account the evidence and arguments of the person concerned. In any event, the resolutions issued in the field of sanctions must be based and reasoned on the basis of the right and taking into account the criteria laid down in Article 256 of this Regulation.

Article 255.- The penalty should be paid to those who are liable in cases of violation of Articles 16, 18, 27, 28, 29, 32, 34, 35, 38, 41, 42, 44, 45, 49 fractions I, II, III, IV and V, 50, 52, 53, 54, 56, 57, 59, 60, 61, 62, 63, 64, 65, 66, 68, 69, 70, 72, 73, 74, 75, 76, 77, 78, 81, 83, 84, 85, 86, 87, 88, 89, 90, 92, 93, 94, 95, 96, 97, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 137, 138, 139, 140, 141, 142, 143, 144, 148, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 189, 194, 203, 204, 205, 208, 210, 225, 240 and 248.

Article 256.- For the quantification and imposition of sanctions, the following shall be taken into consideration:

I).- The severity of the violation committed,

II).- The economic conditions of the offender, and

III).- The recidivism, if any.

Article 257.- In the event of recidivism the originally imposed fine shall be doubled, without the amount exceeding twice the maximum fixed in the Article 253 (I) of this Regulation.

A recidivism is understood for the purposes of this Regulation and other provisions arising therefrom, each subsequent infringement to the the same provision as is not continuous, committed within two years of the date of the judgment in which the previous infringement was recorded, provided that the previous infringement was not distorted.

Article 258.- The suspension is applicable when:

I).- Of the inspection, audit, verification or recognition practiced, it appears that the conditions of the authorization have not been met, permission or license;

II).- In the inspection, audit, verification or recognition shall consist of the non-compliance with the physical and radiological safety standards applicable;

III).- For inspection, audit, verification or recognition it is detached that the equipment, instruments or installation do not meet the conditions for safe and appropriate use;

IV).- I will note that the permissioner has provided false information or documentation to the Commission, and

V).- The lack of Radiological Security Charge.

Article 259.- Cancellation is appropriate when:

I).- Inspection, audit, verification or recognition practiced at the permit, demonstrate negligence in employment, transportation, storage and other activities related to sources of ionizing radiation, and

II).- Due to the time limits granted to correct the anomalies or deficiencies found in the inspections, audits, Verifications or acknowledgements performed, these have not been properly corrected.

Article 260.- The suspension or cancellation of licenses, authorizations and permits granted will involve the Commission ordering and executing the security measures referred to in Article 182 (I) of this Regulation as regards the sources or equipment, in which case the minutes shall be established in the terms of Article 244 above.

Article 261.- Cancellation or suspension may be enacted in addition to or without the fines.

Article 262.- As long as an authorization, permission or license is suspended or cancelled, none of the activities covered by such documents.

Article 263.- The suspension of the authorization, permit or license shall be lifted when the Commission is satisfied that they have been corrected the causes that motivated her.

Article 264.- The application of the sanctions referred to in this Chapter shall be without prejudice to civil, criminal and labor liability in respect of that the permissioner incurs if damage to people or property is caused.

CHAPTER III

OF THE REVIEW RESOURCE

Article 265.- Resolutions that are based on this Regulation may be appealed within 15 working days. following the date of their notification.

Article 266.- The appeal shall be directed and submitted in writing to the Registrar of the Secretariat, in which the related evidence shall be provided with the contested administrative act. If the tests are exhausted and the procedures are exhausted, within the next 30 working days, the appropriate resolution shall be issued.

Article 267.- The interposition of the resource will only suspend the execution of the contested decision, when this involves payment for fines and the This is guaranteed under the Federation's Fiscal Code.

Item 268.- The resource will be unfiled:

I).- When presented outside the term referred to in Article 265 of this Regulation;

II).- When the documentation relating to the personality of the person who subscribes or is not legally accredited has not been filed, and

III).- When you do not appear subscribed, unless you sign up before the expiration of the term to interpose it.

Article 269.- Non-appealed resolutions within the term set forth in Article 265 prior to and those rendered when the resource is resolved or have the character of the final, as they are not interposed.

Article 270.- With respect to other resolutions the suspension of enforcement of the resolution shall only proceed if the following requirements are met:

I).- That is requested by the appellant;

II).- That the resource is sourced;

III).- That it does not bring with it the consummation or continuation of acts or omissions that imply non-observance or violation of the provisions of this Regulation and other provisions deriving from it;

IV).- That no damages or damages are caused to third parties, unless these are guaranteed for the failure to obtain favorable resolution, and

V).- That the execution of the recursion resolution will cause damage or damage that is difficult to repair.

TRANSIENT

FIRST.- This Regulation shall enter into force on the day following its publication in the Official Journal of the Federation.

SECOND.- The Commission shall issue the radiation safety standards applicable to the transport of radioactive materials until the time of issue. Respective Transport Regulations.

THIRD.- All provisions that are opposed to this Regulation are repealed.

Given at the Federal Executive Branch, in Mexico City, Federal District, eight days in the month of November of a thousand nine hundred and eighty and eight.- Miguel de la Madrid H.-Rubrica.-The Secretary of the Interior, Manuel Bartlett Díaz.-Heading.-The Secretary of Foreign Relations, Bernardo Sepulveda Amor.-Heading.-The Secretary of Programming and Budget, Pedro Aspe Armella.-Heading.-The Secretary of Energy, Mines and Parastatal Industry, Fernando Hiriart Balderrama.-Heading.-The Secretary of Communications and Transport, Daniel Díaz Díaz.-Rubrias.-The Secretary of Urban Development and Ecology, Gabino Fraga Mouret.-Heading.-The Secretary Health, Guillermo Soberon Acevedo.-Heading.-The Secretary of Labor and Social Welfare, Arsenio Farell Cubillas.-Heading.