The Measures for the Administration of Safety Licenses for Radioisotopes and Radiation Devices was promulgated in 2008.
Application and Issuance of License
Article 7: Before applying for a license, a radiation work unit shall organize the preparation or filing of an environmental impact assessment document and submit it to the competent department of environmental protection for approval in accordance with state regulations.
The environmental impact assessment documents in the environmental impact report or environmental impact report form shall be prepared by an organization with the appropriate environmental impact assessment qualifications.
Article 8 According to the safety and protection requirements of radioisotopes and radiation devices and their degree of impact on the environment, the environmental impact assessment documents shall be categorized and managed.
The activities of transferring radioisotopes and radiation devices are not required to prepare environmental impact assessment documents.
Article 9 The radiation work unit applying for a license to engage in the following activities shall organize the preparation of an environmental impact report:
(1) production of radioisotopes (except for the preparation of radiopharmaceuticals for PET);
(2) use of radioactive sources of Class I (except for medical use);
(3) sale (including the construction of) and use of Class Ⅰ radiation device.
Article 10 If a radiation work unit applying for a license engages in the following activities, it shall organize the preparation of an environmental impact report form:
(1) Preparation of radiopharmaceuticals for PET;
(2) Sale of radioactive sources of Class I, Class II, and Class III;
(3) Medical use of Class I radioactive sources;
(4) Use of Class II, Class III radioactive sources;
(e) the production, sale and use of Class II radiation device.
Article XI of the radiation work unit to apply for a license to engage in the following activities, shall fill in the Environmental Impact Registration Form:
(a) the sale and use of Class Ⅳ, Class V radioactive sources;
(b) the production, sale and use of Class Ⅲ radiation device.
Article XII of the radiation work unit organization to prepare or fill in the environmental impact assessment documents, should be in accordance with its planning and design of radioisotopes and radiation devices, production, sales and use of scale evaluation.
The environmental impact assessment documents referred to in the preceding paragraph shall, in addition to being prepared or filled out in accordance with the requirements of the state on environmental impact assessment, also include an evaluation of the technical capacity of the radiation work unit to engage in the corresponding radiation activities, radiation safety and protection measures.
Article 13 A unit that produces radioisotopes and applies for a license shall have the following conditions:
(1) A special radiation safety and environmental protection management organization.
(ii) no fewer than five nuclear physics, radiochemistry, nuclear medicine and radiation protection and other related professional and technical personnel, of which no fewer than one has a senior title.
Units producing radioisotopes with a half-life of more than 60 days shall have not less than 30 professional and technical personnel referred to in the preceding subparagraph, of whom not less than 6 shall have senior titles.
(C) personnel engaged in radiation work must pass the training and examination of specialized knowledge of radiation safety and protection as well as relevant laws and regulations, of which key positions in radiation safety should be held by registered nuclear safety engineers.
(4) There are radioisotope production sites, production facilities, temporary storage or temporary storage equipment that are compatible with the designed scale of production and meet the requirements of radiation safety and protection and physical defense, and have the ownership of the production sites and production facilities.
(v) has the transportation and storage of radioisotopes packaging containers that meet the requirements of the relevant state regulations.
(F) has a means of transportation that meets the national requirements for the transportation of radioisotopes, and is equipped with a full-time driver with more than five years of driving experience.
(vii) Equipped with protective gear and monitoring instruments appropriate to the type and level of radiation, including personal dosimetry alarms, fixed and portable radiation monitoring, surface contamination monitoring, effluent monitoring and other equipment.
(viii) the establishment of sound operating procedures, job responsibilities, radiation protection system, safety and security system, equipment repair and maintenance system, personnel training system, ledger management system and monitoring program.
(ix) the establishment of emergency response agencies, the development of emergency response plan and emergency personnel training exercise system, the necessary emergency equipment and materials preparedness, and the design and production scale of the accident emergency response capabilities.
(J) has to ensure that radioactive waste gas, waste liquid, solid waste discharge capacity or feasible treatment programs.
Article 14 Sale of radioisotopes unit to apply for a license, shall have the following conditions:
(a) a special radiation safety and environmental protection management organization, or at least one with a bachelor's degree or higher degree of technical personnel dedicated to radiation safety and environmental protection management.
(ii) personnel engaged in radiation work must pass the training and examination of specialized knowledge of radiation safety and protection as well as relevant laws and regulations.
(C) the need for temporary storage of radioisotopes, there are to meet the requirements of radiation safety and protection, physical security of the temporary storage library or equipment.
(D) need to install and debug radioisotopes, there are installation and debugging sites to meet the requirements of preventing misuse and preventing accidental exposure of staff and the public.
(E) with the requirements of the relevant state regulations for the storage and transportation of radioisotopes, packaging containers.
(F) transportation of radioisotopes can be used in accordance with national requirements for the transportation of radioisotopes means of transport.
(vii) Equipped with protective equipment and monitoring instruments appropriate to the type and level of radiation, including personal dosimetry alarms, portable radiation monitoring, surface contamination monitoring and other instruments.
(viii) There are sound operating procedures, job responsibilities, safety and security systems, radiation protection measures, account management system, personnel training programs and monitoring programs.
(ix) has a perfect emergency response to radiation accidents.
Article 15 Production and sale of radiation devices to apply for a license, shall have the following conditions:
(a) a special radiation safety and environmental protection management organization, or at least one with a bachelor's degree or higher technical personnel dedicated to radiation safety and environmental protection management.
(ii) personnel engaged in radiation work must pass the training and examination of specialized knowledge of radiation safety and protection as well as relevant laws and regulations.
(C) ray device production, commissioning sites to meet the safety requirements to prevent misuse, to prevent accidental exposure of staff and the public.
(d) equipped with the necessary protective equipment and monitoring instruments.
(E) have sound operating procedures, job responsibilities, radiation protection measures, account management system, training programs and monitoring programs.
(F) have emergency measures for radiation accidents.
Article 16 Use of radioisotopes, radiation devices, units applying for a license, shall have the following conditions:
(a) the use of Class Ⅰ, Ⅱ, Ⅲ radioactive sources, the use of Class Ⅰ, Ⅱ type of radiation device, there should be a special radiation safety and environmental protection management organization, or at least one with a bachelor's degree or higher degree of technical personnel full-time responsible for the radiation accident. More than a bachelor's degree in technical personnel responsible for radiation safety and environmental protection management; other radiation work units should have a college degree or above, full-time or part-time technical personnel responsible for radiation safety and environmental protection management; based on the list of key positions in radiation safety should be established key positions in radiation safety, the position should be a registered nuclear safety engineer.
(2) personnel engaged in radiation work must pass the radiation safety and protection of professional knowledge and relevant laws and regulations of training and assessment.
(3) Units using radioisotopes shall have temporary storage of radioactive sources or equipment that meets the requirements of radiation protection and physical defense.
(d) radioisotopes and radiation devices use sites have to prevent misuse, to prevent staff and the public from accidental exposure to safety measures.
(v) equipped with protective equipment and monitoring instruments appropriate to the type and level of radiation, including personal dosimetry alarms, radiation monitoring and other instruments. Units using unsealed radioactive material should also have a surface contamination monitor.
(f) have sound operating procedures, job responsibilities, radiation protection and safety and security systems, equipment maintenance system, equipment maintenance system, radioisotope use registration system, personnel training programs, monitoring programs.
(vii) There are comprehensive emergency response measures for radiation accidents.
(viii) the generation of radioactive waste gas, waste liquids, solid waste, should also have to ensure that radioactive waste gas, waste liquids, solid waste discharge capacity or feasible treatment programs.
The use of radioisotopes and radiation devices to carry out diagnostic and therapeutic units, should also be equipped with quality control testing equipment, develop the appropriate quality assurance program and quality control testing, at least one medical physicist responsible for quality assurance and quality control testing.
Article XVII will be purchased radioactive sources assembled in equipment for sale of radiation work units, in accordance with the sale and use of radioisotopes to apply for a license.
Article XVIII of the application for a license to receive the radiation work unit shall submit the following materials to the competent authority for environmental protection with the right to approve:
(a) radiation safety license application form (see Annex 1);
(b) the original and copy of the business license of the enterprise legal person, or legal person certificate of an institution, the original and copy of the certificate of a legal entity, and the original identity card of the legal representative and its photocopy, and the copy to be retained after the verification;
Article 18 Retain a copy after examination;
(3) approved environmental impact assessment documents;
(4) to meet the corresponding provisions of Articles 13 to 16 of these Measures to prove the material;
(5) units of the existing and proposed new sources of radiation and radiation devices detailed list.
Article 19 When accepting the application, the competent department for environmental protection shall inform the applicant unit to apply for the license in accordance with the scale of planning and design for the production, sale and use of radioisotopes and radiation devices described in the environmental impact assessment document.
The competent department for environmental protection shall complete the review within 20 working days from the date of acceptance of the application, and if it meets the conditions, issue a license and make a public announcement; if it does not meet the conditions, notify the applicant unit in writing and explain the reasons.
Article 20 The license includes the following main contents:
(1) the name, address and legal representative of the unit;
(2) the type and scope of the activities engaged in;
(3) the validity period;
(4) the date of issuance of the certificate and certificate number.
The type of activity in the license is divided into three categories: production, sale and use; the scope of the activity refers to the type and total activity of all radioisotopes and the type and number of radiation devices produced, sold and used by the radiation work unit.
The licenses are divided into original and duplicate (see Annex 2 for specific format and content), which are of equal validity.
Article 21 A radiation work unit that has obtained a license for the production, sale and use of radioisotopes and radiation devices of a higher category, and engages in the production, sale and use of radioisotopes and radiation devices of a lower category, does not need to apply separately for a license for radioisotopes and radiation devices of a lower category.
Article 22 If a radiation work unit changes its name, address and legal representative, it shall, within 20 days from the date of registration of the change, apply to the original licensing authority to apply for a change of license and provide the following relevant materials:
(1) a report on the application for a change of license;
(2) a copy of the business license of the enterprise legal person or the certificate of the legal person of the enterprise after the change;
(3) a copy of the business license of the enterprise legal person, or the certificate of the legal person of the establishment;
(c) the original and copy of the license.
The original licensing authority review and approval, the replacement license.
Article 23 of the following circumstances, the licensee shall, in accordance with the provisions of the license application procedures, re-apply for a license:
(a) change the type or scope of the activities specified in the license;
(b) new construction or alteration, expansion of the production, sales, use of facilities or premises.
Article 24 The license is valid for five years. The expiration of the validity period, the need for continuation, the license shall be valid for 30 days before the expiration of the renewal application to the original licensing authority, and provide the following materials:
(A) the license renewal application report;
(B) the monitoring report;
(C) the license validity of the work of radiation safety and protection of a summary;
(D) the license is, a copy.
The original licensing authority shall accept the continuation of the application from the date of expiration of the license to complete the review, meet the conditions for continuation, reissue of the license, and use the original license number; does not meet the conditions, notify the applicant in writing and explain the reasons.
Article 25 of the radiation work unit part of the termination or total termination of the production, sale, use of radioisotopes and radiation device activities, shall be part of the original licensing authority to apply for change or cancellation of the license by the original licensing authority to verify the eligibility of the license shall be changed or canceled.
Article 26 of the radiation work unit for reasons of loss of license shall be promptly to the location of the provincial newspaper published a notice of loss, and the announcement of 30 days after the announcement of a month to the original licensing authority to apply for reissuance with the announcement.