The radiological work unit shall establish a radiological protection responsibility system and take the following management measures:
(1) set up a radiological protection management agency or organization, equip with a full-time (part-time) radiological protection management personnel, and set up a radiological work management file;
(2) formulate and implement the rules and regulations on the management of radiological protection;
(3) regularly conduct radiological protection tests and inspections on the radiological work (C) regular radiation protection of the workplace and its surrounding environment for radiation protection testing and inspection;
(D) organization of the unit of radiation workers to receive radiation protection regulations, professional and technical knowledge training;
(E) the development and implementation of preventive measures and emergency response to radiological accidents, radiological accidents should be reported in accordance with the relevant provisions of the report. Radiation work unit shall set up the following equipment and places to provide warning signs:
(a) radioisotopes and radioisotopes containing instruments, containers, should be affixed with the sign of ionizing radiation;
(b) radioisotopes of the storage place of conspicuous places, should be set up to provide warning signs of ionizing radiation;
(c) the entrance and exit of the radiation workplace, should be set up ionizing radiation warning signs. Sealed radioisotope devices and instruments, as well as the use of radiation devices and debugging and maintenance sites, the necessary warning devices should be set up;
(d) outdoor, field radiation work and field operation of radioisotopes in temporary storage sites should be set aside for safety protection areas, set up ionizing radiation warning signs, and, if necessary, set up a special person to keep watch;
(e) open-type radioactive workplaces are divided into controlled areas in accordance with the relevant standards. When the workplace is divided into control area and supervision area according to the relevant standards, the international common color (red and yellow) can be used as the sign of the work area; in the control area, the import and export, as well as other appropriate locations, ionizing radiation warning signs should be set up. The storage place of radioisotopes shall meet the following requirements:
(1) the storage of radioisotopes must meet the requirements of radiation protection, and shall not exceed the maximum storage capacity of the protection design of the storage place;
(2) the radioisotopes shall not be stored in the same warehouse with flammable, explosive and corrosive articles, and the storage place shall take effective protection measures and install corresponding alarm devices
(3) Radioactive isotopes should be stored in a place with a person in charge, with a perfect system of deposit, collection, return registration and inspection, so as to achieve a strict handover, timely inspection, a clear account, the account matches the goods, complete record information.
Railway, civil aviation, transportation and other transport sector freight warehouses, dangerous goods storage sites or may store radioisotopes, should meet the above requirements. Places of use of radioisotopes and radiation devices shall comply with national radiation health standards and the following health requirements:
(1) equipped with protective facilities, equipment and personal protective equipment appropriate to the place of use;
(2) regular radiation level testing;
(3) open radioisotopes workplace staff should be good personal protection. When leaving each operation, the personal body surface and protective equipment should be tested for contamination, and any contamination found should be dealt with immediately, and records should be made and filed;
(4) Irradiation processing devices, gas pedals, industrial flaw detectors, and cobalt-60 treatment devices and other radiation sources in the workplace should be equipped with a variety of interlocking devices and emergency response devices, and should be such that in case of failure of a single interlocking device, the rest of the interlocking devices are still able to
(e) radiation workplace dose monitoring instruments, personal protective equipment should be frequently overhauled to ensure normal use. Production of radioisotopes and their products production sites, ray device startup and commissioning of the workplace, should be set up to protect facilities, and in line with the relevant national radiation health standards and the provisions of Article 22 of these Measures and other health requirements.
The production of radioisotopes and their products, products and radiation devices should meet the radiation protection requirements, unqualified shall not leave the factory. The use of equipment containing radioactive isotopes or radiation devices shall comply with the following requirements:
(1) After installation, repair or replacement of the equipment with components related to the radiation source, the equipment shall be tested and accepted by the testing organization, and shall be confirmed to be qualified before it is activated;
(2) The use of the unit shall be equipped with the necessary quality control and testing instruments, and shall carry out the quality assurance management in accordance with the regulations;
(c) the development and strict compliance with operating procedures, regular stability testing and calibration, should be a comprehensive annual maintenance and acceptance of the testing organization in accordance with the relevant provisions of the status of the test;
(d) prohibit the acquisition, transfer, rental or use of unqualified products and the relevant state departments of the elimination of the products, products and equipment. Engaged in radiological diagnosis, treatment units, should be developed and the unit engaged in the diagnosis, treatment program compatible with the implementation of quality control, compliance with quality control and monitoring specifications. Radiological diagnosis, treatment device protection performance and technical indicators related to the quality of irradiation, should be in line with the relevant standard requirements.
Diagnosis and treatment of patients and examinees, should be in accordance with operating procedures, strict control of the irradiated dose, adjacent to the irradiation field of sensitive organs and tissues should be shielded protection; medical irradiation of pregnant women and young children should be informed in advance of the impact on health. When units and individuals purchase radioisotopes and radioisotope-containing equipment, they shall apply for approval for purchase in advance at the health administrative department of the local people's government at the provincial level, and after approval is granted, they shall go through the procedures of ordering, purchasing and transportation of the radioisotopes with the approval for purchase.
It is prohibited to transfer, assign or lease radioisotopes, radioisotope-containing equipments or ray devices to units and individuals without health license. Sales of radioisotopes, equipment containing radioisotopes and radiation devices should be detailed records of sales, registration, and reported to the provincial people's government health administrative department for the record.
It is prohibited to sell radioisotopes and their products or equipment containing radioisotopes to units and individuals who do not have a permit to purchase. The consignor, carrier and self-transporter of radioisotopes shall comply with the following requirements:
(1) pack the transported items in accordance with the relevant transport regulations, and affix the radioactive package grade mark on the outer package, which includes: ionizing radiation mark, package grade, nuclide name, activity, and transport index;
(2) carry out dosage testing of the packages, and have the testing agency issue the "Certificate of Dosage Inspection of Radioactive Substances". Certificate of Dose Inspection of Radioactive Substances" by the testing agency, by the local people's government at or above the county level of the administrative department of health verification before transportation;
(c) the carrier shall check the "Certificate of Dose Inspection of Radioactive Substances" is correct, before going through the transportation formalities and to ensure that the package in the process of loading and unloading, storage, transit and other transportation of radiological protection and safety.
Empty containers filled with radioisotopes shall be packaged and dosimetrically tested in accordance with the regulations, and the transportation of empty containers contaminated with radioisotopes shall also comply with the above requirements. Engaged in radiation protection evaluation, testing and personal dose monitoring testing organizations, should have the appropriate conditions and obtain the qualification certification of the health administrative department at or above the provincial level.
Testing organizations to obtain accreditation should be certified within the scope of work. Health administrative departments of the people's governments at or above the county level of radiation work units should be established on file for supervision and inspection not less than once a year, γ irradiation devices, radiation therapy devices and γ flaw detection inspection, not less than two times a year, and detailed records of the results of supervision and inspection, and found that it does not have the conditions of radiation protection, by the original licensing authority to revoke its health license, and in accordance with the provisions of these measures to give administrative penalties.
The health administrative department of the people's government at the provincial level shall organize regular radiation health supervision and inspection and technical guidance. The health administrative department of the people's government at or above the county level to perform supervision and inspection duties, has the right to take the following measures:
(a) enter the radiation work unit, testing institutions and medical and health institutions, to understand the situation, investigation and evidence collection;
(b) access to relevant information, and if necessary, can copy the relevant information;
(c) order the radiation work unit, testing institutions, medical and health institutions to immediately stop illegal activities. When a radiation accident occurs or there is evidence that the hazardous state may lead to a radiation accident, the administrative department of health may take the following temporary control measures, and after the accident or hazardous state has been effectively controlled, the control measures shall be lifted in a timely manner:
(1) ordering the suspension of the practice of activities that produce radiation hazards;
(2) sealing up radioactive isotopes and radiographic devices that have caused the radiation accident or may lead to the accident; and (3) ordering the radiation work unit, testing organization or medical and health institution to immediately stop illegal activities. (ii) sealing the radioisotopes and radiation devices that caused the radiation accident or may lead to the radiation accident;
(iii) controlling the scene of the hazard in conjunction with the relevant departments. In case of violation of the Regulations and these Measures, the construction unit shall be ordered by the health administrative department of the people's government at or above the county level to make corrections within a certain period of time, and shall be given a warning, or shall be imposed a fine of not less than 5,000 yuan and not more than 30,000 yuan; and in case of serious cases, it shall be ordered to suspend production and business:
(1) unauthorized construction without carrying out a design review of radiation protection facilities or a review of the facilities which fails to qualify;
(2) failure to carry out a completion acceptance of radiation protection facilities; and Radiation protection facilities completion inspection or acceptance or unqualified acceptance, unauthorized operation or use;
(C) radiation protection facilities and the main project is not the same time operation or use. Violation of the "Regulations" and the provisions of these measures, did not obtain a health license or health license is invalid still engaged in radiological work, by the people's governments at or above the county level health administrative department shall be banned, confiscate the illegal income, and impose a fine of five thousand yuan or more than 30,000 yuan.
Forgery, alteration, transfer, rental health license, in addition to the provisions of the preceding paragraph confiscate the illegal income and a fine, seize the health license. Violation of the "Regulations" and the provisions of these Measures, the radiation work unit of one of the following acts, by the people's government at or above the county level, the health administrative department shall give a warning and order to stop the radiation hazardous activities, or impose a fine of more than 1,000 yuan to less than 20,000 yuan:
(a) failure to establish the responsibility system of radiological protection or implementation of the management measures in accordance with the provisions of the system;
(b) the radiation workplace Does not meet the national radiation health standards or health requirements;
(C) not set up in accordance with the provisions of the sign of ionizing radiation or ionizing radiation warning signs;
(D) without the record, the radioisotope tracer test;
(E) storage sites are not in accordance with the provisions of the storage of radioisotopes;
(F) the use of radioisotopes containing (F) the use of equipment containing radioactive isotopes or radiation devices, does not meet the health protection requirements;
(G) not in accordance with the provisions of the development of radiation diagnosis, treatment of quality control program, or not in accordance with the norms of radiation protection, technical standards and health requirements for diagnosis, treatment;
(H) not in accordance with the provisions of the radioisotope-containing equipment and radiation devices, radiation workplaces and their surrounding environment, radiation protection facilities Performance testing;
(ix) the sale of radioisotopes, radioisotope-containing equipment or radiation devices are not registered in accordance with the provisions of the provincial administrative department of health for the record;
(x) consignment, transportation and self-transportation of radioisotopes, without dose verification or verified does not meet the requirements of health care;
(xi) on the abandoned Radioisotopes, not in accordance with the provisions of the disposal or cancellation procedures;
(xii) not in accordance with the provisions of the individual dose monitoring of radiation workers, health check-ups or failure to establish health records;
(xiii) beyond the scope of the health license or change the project is not in accordance with the provisions of the review and consent. Violation of the "Regulations" and the provisions of this approach, the radiation work unit has one of the following acts, by the people's government at or above the county level, the health administrative department shall give a warning, ordered to stop the radiation hazardous activities, or impose a fine of more than 5,000 yuan of 30,000 yuan and confiscate the illegal income; the circumstances are serious, ordered to stop production and shut down the business:
(a) the production and sale of substandard radioisotopes and their products, products or radiation devices;
(2) the purchase, transfer or lease of radioisotopes and products that do not meet the protection requirements and products that have been eliminated by the state;
(3) the sale of radioisotopes and their products, or radioisotope-containing equipment, to units and individuals that do not have authorization to purchase;
(4) the transfer or lease of radioisotopes, radioisotope-containing equipment, or radiation devices equipment or radiation device to transfer, lease to units without a health license. Violation of the "Regulations" and the provisions of this approach, radiation accidents, resulting in damage to human health, the health administrative department shall order the suspension of production and business, according to the level of the accident shall be fined not less than one thousand yuan and not more than 30,000 yuan; the circumstances are serious, the revocation of health permits; constitutes a crime, shall be investigated for criminal responsibility. Cause damage to others, shall bear civil liability according to law.
Radiation work unit by the health administrative department cancellation, revocation or revocation of health permits, not in accordance with the provisions of the radioisotopes will be sent to the radioactive waste management agencies for disposal or sent to the original supply unit recovery, resulting in radiation accidents, by the administrative department of health, a fine of 10,000 yuan or more than 30,000 yuan; constitutes a crime, shall be investigated for criminal responsibility. To others causing damage, shall bear civil liability according to law. Engaged in radiation hygiene testing and evaluation of testing organizations in violation of the Regulations and the provisions of this method, one of the following acts, by the people's governments at or above the county level of the health administrative department shall order the immediate cessation of illegal acts, give a warning, or impose a fine of one thousand yuan or more than 10,000 yuan or less; the circumstances are serious, by the original accreditation authority to disqualify:
(a) beyond the scope of qualification and certification to engage in the evaluation or testing work
(ii) the issuance of false documents. Violation of the "Regulations" and the provisions of these Measures, the health administrative department and its health supervision and law enforcement personnel of one of the following acts, resulting in radiation accidents, constituting a crime, shall be investigated for criminal responsibility; does not constitute a crime, the directly responsible supervisory personnel and other personnel directly responsible for the administrative sanctions in accordance with the law shall be given to the demotion or dismissal of:
(a) do not meet the statutory conditions of the radiation work unit Issuance of health permits or other health permit approvals;
(B) has obtained a health permit for the unit does not perform supervision and inspection duties;
(C) found that the accident potential hazards, and did not take timely measures in accordance with the law resulting in radiological accidents;
(D) there are other violations of these measures.