Nuclear technology utilization unit "Radiation Safety License" issued operation specifications

I. Name and nature of the administrative approval project
1. Name: Nuclear technology utilization unit "Radiation Safety License" issued
2. Nature: Administrative license

II. Basis for setting up (1) Law of the People's Republic of China on Prevention and Control of Radioactive Pollution (Promulgated by the President of the People's Republic of China (No. 6), implemented on October 1, 2003)
Article 28 Units that produce, sell or use radioisotopes and radiation devices shall apply for registration procedures in accordance with the provisions of the State Council on radiological isotope and radiation devices for radiation protection.
(2) Regulations on the Safety and Protection of Radioisotopes and Radiation Devices (Order No. 449 of the State Council of the People's Republic of China, implemented on December 1, 2005)
Article 5 Units that produce, sell or use radioisotopes and radiation devices shall obtain a permit in accordance with the provisions of this Chapter.
Article 6 The licenses for the production of radioisotopes, the sale and use of Class I radioactive sources, and the sale and use of Class I radiation devices shall be examined and approved by the competent department of environmental protection under the State Council. The licenses of units other than those specified in the preceding paragraph shall be examined and approved by the environmental protection department of the people's government of the province, autonomous region or municipality directly under the Central Government.
Article 7 Units that produce, sell or use radioisotopes and radiation devices shall apply for the following conditions:
1. Professional and technical personnel with corresponding professional knowledge and protective knowledge and health conditions that are compatible with the scale of production, sales and use activities;
2. There are places, facilities and equipment that meet the national environmental protection standards, occupational health standards and safety protection requirements;
3. Have a special safety and protection management agency or full-time, part-time safety and protection management personnel, and equipped with necessary protective equipment and monitoring equipment;
4. There are sound safety and protection management rules and regulations and radiation accident emergency measures;
5. Produce radioactive waste gas, waste liquid, solid waste, and have the processing capacity or feasible treatment plan to ensure the discharge of radioactive waste gas, waste liquid and solid waste.
Article 8 Units that produce, sell or use radioisotopes and radiation devices shall, in advance, submit a permit application to the competent department of environmental protection with the power of examination and approval, and submit the certification materials in accordance with the conditions stipulated in Article 7 of these Regulations.
Medical and health institutions that use radioisotopes and radiation devices for radiotherapy should also obtain radio source diagnostic technology and medical radiation agency licenses.
Article 9 The competent department of environmental protection shall complete the examination within 20 working days from the date of accepting the application. If the conditions are met, the permit shall be issued and announced; if the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained.
Article 12 In any of the following circumstances, the license-issuing unit shall apply for a permit again in accordance with the original application procedure:
1. Change the type or scope of activities undertaken;
2. Newly built or rebuilt or expanded production, sales, use facilities or places.
(3) Measures for the Administration of Safety Permits for Radioisotopes and Radiation Devices (promulgated by Order No. 31 of the State Environmental Protection Administration on January 18, 2006, according to the 2nd Ministerial Meeting of the Ministry of Environmental Protection of China on November 21, 2008 Amendment to the decision to amend the "Administrative Measures for the Safety of Radioisotopes and Radiation Devices"
Article 2 Units that produce, sell or use radioisotopes and radiation devices within the territory of the People's Republic of China (hereinafter referred to as "radiation work units") shall obtain radiation safety licenses (hereinafter referred to as "licenses") in accordance with the provisions of these Measures. .
III. Implementation authority and main body basis “Administrative Measures for Safety Licensing of Radioisotopes and Radiation Devices” and “Regulations on Safety License for Radioisotopes and Radiation Devices in Guangxi Zhuang Autonomous Region (Trial)” (Guihuafa [2009] No.13, March 2009 The relevant regulations for the implementation of the 1st, the classification approval authority is as follows:
(1) Licenses for the production of radioisotopes, sales and use of Class I radioactive sources (except for medical use of Class I radioactive sources), units for the sale and use of Class I radiation devices, and approval by the Ministry of Environmental Protection.
(2) The environmental protection department of the people's government of the autonomous region shall be responsible for the issuance of radiation safety licenses for radiation working units of radioactive isotope and radiation devices below the district:
1. Medical use of Class I sealed radioactive sources;
2. Selling and using Class II, III, IV, and V radioactive sources;
3. Production and sale of Class II and III radiation devices, using Class II radiation devices;
4. Class A, B, and C non-sealed radioactive materials.
(3) The competent department of environmental protection of the people's government of the district and city shall be responsible for the issuance of radiation safety licenses for the radiation working units of Class III radiation devices.
IV. Administrative examination and approval conditions The application for the application for a permit shall comply with the provisions of Article 29 of the Law of the People's Republic of China on the Prevention and Control of Radioactive Pollution and Articles 13 to 16 of the Measures for the Administration of Safety Regulations for Radioisotopes and Radiation Devices. The required conditions and Article 9 of the Measures for the Administration of Safety Regulations for Radioisotopes and Radiation Devices,
The provisions of Articles 10 and 11.
(1) The applicant unit has prepared an environmental impact assessment document for the nuclear technology utilization project and submitted it to the environmental protection administrative department for approval.
(2) Units selling radioisotopes shall meet the following conditions:
1. There is a special radiation safety and environmental protection management organization, or at least one technician with bachelor degree or above is responsible for radiation safety and environmental protection management;
2. Personnel who work on radiation must pass the training and assessment of radiation safety and protection expertise and relevant laws and regulations;
3. Temporary storage of equipment or equipment to meet the requirements of radiation safety and protection and physical protection;
4. Installation and commissioning of radioisotopes shall be provided with installation and commissioning sites that prevent accidental operation and prevent accidental exposure of workers and the public;
5. Storage and transportation of radioisotope packaging containers in accordance with relevant national regulations;
6. The transportation of radioisotopes should use transportation means that meet the relevant requirements for national radioisotope transportation;
7. Equipped with protective equipment and monitoring equipment suitable for radiation type and radiation level, including personal dose alarm, portable radiation monitor, surface pollution monitor, etc.
8. Have sound operating procedures, job responsibilities, safety and security systems, radiation protection measures, account management systems, personnel training plans and monitoring programs;
9. There are perfect emergency measures for radiation accidents.
(3) The units that produce and sell the radiation equipment shall meet the following conditions:
1. There is a special radiation safety and environmental protection management organization, or at least one technician with bachelor degree or above is responsible for radiation safety and environmental protection management;
2. Personnel engaged in radiation work must pass the training and assessment of radiation safety and protection expertise and relevant laws and regulations;
3. The production and debugging places of the radiation equipment meet the safety requirements for preventing accidental operation and preventing accidental exposure of workers and the public;
4. Equipped with necessary protective equipment and monitoring equipment;
5. Have sound operating procedures, job responsibilities, radiation protection measures, account management system, training plan and monitoring plan;
6. There are emergency measures for radiation accidents.
(4) Units using radioisotopes and radiation devices shall meet the following conditions:
1. Class I, Class II, Class III radioactive sources, and Class I and Class II radiation devices shall be provided with special radiation safety and environmental protection management agencies, or at least one technician with bachelor degree or above. Responsible for radiation safety and environmental protection management; other radiation work units shall have one technician with college education or above to be responsible for radiation safety and environmental protection management at full or part-time; according to the list of key posts for radiation safety, radiation safety key positions shall be established. This position should be performed by a registered nuclear safety engineer.
2. Personnel engaged in radiation work must be trained and assessed by radiation safety and protection expertise and relevant laws and regulations;
3. Units using radioisotopes should have radioactive storage bases or equipment that meet the requirements for radiation protection and physical protection;
4. Radioactive isotope and radiation device use all safety measures to prevent accidental operation and prevent accidental exposure of workers and the public;
5. Equipped with protective equipment and monitoring instruments that are compatible with radiation type and radiation level, including personal dose alarms, radiation monitoring and other instruments. Units using unsealed radioactive materials should also have surface contamination monitors;
6. Have sound operating procedures, job responsibilities, radiation protection and safety and security systems, equipment maintenance and repair systems, radioisotope use registration system, personnel training plans, monitoring programs, etc.;
7. There are perfect emergency measures for radiation accidents;
8. The production of radioactive waste gas, waste liquid and solid waste shall also have the processing capacity to ensure the discharge of radioactive waste gas, waste liquid and solid waste, or a feasible treatment plan.
Units that use radioisotopes and radiation devices for diagnosis and treatment should also be equipped with quality control testing equipment, develop appropriate quality assurance programs and quality control testing plans, and at least one medical physicist is responsible for quality assurance and quality control testing.
V. Implementation object and scope: The units engaged in the following radiation work in the autonomous region.
(1) Medical use of Class I sealed radioactive sources;
(2) Sales, Class II, Class III, Class IV, Class V radioactive sources;
(3) Producing and selling Class II and Class III radiation devices, using Class II and Class III radiation devices;
(4) Selling and using unsealed radioactive materials.
Object:
(1) Applying for a new permit (2) Changing the license (3) Re-applying for a permit (4) Continuation of the license 6. Application materials (1) Application report (unit document) for handling the Radiation Safety Permit.
(2) The application form for the "Radiation Safety Permit" is in triplicate. It must be filled in carefully according to the requirements of the “Filling Safety Permit” “filling in the form” and must not be altered.
The Radiation Safety License can be downloaded from the "http:// Safety and Radiation Environment - Service Guide".
(3) The following materials shall be in triplicate and stamped with the official seal of the unit:
1. A copy of the business license of the enterprise legal person, the legal person certificate of the institution or the practice license of the medical institution.
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2. A copy of the legal representative's ID card.
3. Approval documents for environmental impact assessment of radiation projects.
4. A list of existing and proposed new radioisotopes and radiation devices. Should contain the following contents: radioactive source details: nuclide name, date of manufacture, factory activity, label, code, source, etc.;
Details of unsealed radioactive materials: name of the nuclide, date of manufacture, factory activity, use, source, etc.;
Ray device details: device name, specification model, type of radiation, use, source, etc.
5. The person in charge of radiation safety participates in the “General Certificate of Radiation Safety and Protection Training Certificate” obtained by the radiation safety and protection professional knowledge training organized by the environmental protection department, or the “radiation safety training assessment certificate” Guangxi Radiation Environmental Supervision and Management Station, photocopying Piece
6. A copy of the person in charge of the workplace, "Radiation Safety Training Assessment Certificate"
7. A copy of the radiation safety management professional technicians and the operator who is directly engaged in radiation work, "radiation safety training assessment certificate";
8. A diploma of professional technicians in radiation safety management and a copy of ID card. Among them: sales, use of Class II sealed radioactive sources, sales and use of Class II radiation devices, professional and technical personnel qualifications for college or above, the rest for college or above.
9. The unit is uniformly formulated to comply with the current laws, regulations and management system, and also meets the actual management of the unit, and is promulgated by the unit: 1 safety operation procedures, 2 radiation job duties, 3 radiation protection and safety protection system, 4 personnel training Management regulations for plans, 5 radiation accident emergency measures or plans, 6 radioactive waste and radioactive source decommissioning disposal plans, 7 radiation environment and personal dose monitoring programs. Production and sales units must also submit a ledger management system.
(4) The above materials shall be arranged in the above order, and the page numbers shall be prepared and bound into a book.
(5) The application form shall be stamped with the application unit's riding seal, and each page of the attached materials shall be stamped with the official seal of the unit.
VII. Time limit for statutory time limit: 20 working days commitment time limit: 10 working days 8. There is no limit on the number of administrative approvals.
9. There is no charge for fees, standards and basis.
X. Consultation and complaints (0771) 5303092.

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