KYB CHINA(2005年9月14日中华人民共和国国务院令第449号公布 根据2014年7月29日《国务院关于修改部分行政法规的决定》第一次修订 根据2019年3月2日《国务院关于修改部分行政法规的决定》第二次修订)
(Promulgated by Decree No. 449 of the State Council of the People's Republic of China on September 14, 2005; first revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on July 29, 2014; second revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on March 2, 2019)
总则
General Provisions
为了加强对放射性同位素、射线装置安全和防护的监督管理，促进放射性同位素、射线装置的安全应用，保障人体健康，保护环境，制定本条例。
These Regulations are formulated to strengthen the supervision and management of the safety and protection of radioactive isotopes and radiation-emitting devices, promote the safe application of radioactive isotopes and radiation-emitting devices, protect human health, and protect the environment.
在中华人民共和国境内生产、销售、使用放射性同位素和射线装置，以及转让、进出口放射性同位素的，应当遵守本条例。
The production, sale, use of radioactive isotopes and radiation-emitting devices, as well as the transfer, import, and export of radioactive isotopes within the territory of the People's Republic of China, shall comply with these Regulations.
本条例所称放射性同位素包括放射源和非密封放射性物质。
For the purposes of these Regulations, radioactive isotopes include radiation sources and unsealed radioactive substances.
国务院生态环境主管部门对全国放射性同位素、射线装置的安全和防护工作实施统一监督管理。
The competent department of ecological environment under the State Council shall implement unified supervision and management of the safety and protection of radioactive isotopes and radiation-emitting devices nationwide.
国务院公安、卫生等部门按照职责分工和本条例的规定，对有关放射性同位素、射线装置的安全和防护工作实施监督管理。
The public security, health, and other departments under the State Council shall, in accordance with their respective functions and duties and the provisions of these Regulations, implement supervision and management of the safety and protection of relevant radioactive isotopes and radiation-emitting devices.
县级以上地方人民政府生态环境主管部门和其他有关部门，按照职责分工和本条例的规定，对本行政区域内放射性同位素、射线装置的安全和防护工作实施监督管理。
The competent departments of ecological environment and other relevant departments of local people's governments at or above the county level shall, in accordance with their respective functions and duties and the provisions of these Regulations, implement supervision and management of the safety and protection of radioactive isotopes and radiation-emitting devices within their respective administrative regions.
国家对放射源和射线装置实行分类管理。根据放射源、射线装置对人体健康和环境的潜在危害程度，从高到低将放射源分为Ⅰ类、Ⅱ类、Ⅲ类、Ⅳ类、Ⅴ类，具体分类办法由国务院生态环境主管部门制定；将射线装置分为Ⅰ类、Ⅱ类、Ⅲ类，具体分类办法由国务院生态环境主管部门商国务院卫生主管部门制定。
The state implements classified management of radiation sources and radiation-emitting devices. According to the degree of potential harm to human health and the environment, radiation sources are classified from high to low into Class I, Class II, Class III, Class IV, and Class V, with specific classification measures formulated by the competent department of ecological environment under the State Council; radiation-emitting devices are classified into Class I, Class II, and Class III, with specific classification measures formulated by the competent department of ecological environment under the State Council in consultation with the competent health department under the State Council.
许可和备案
Licensing and Filing
生产、销售、使用放射性同位素和射线装置的单位，应当依照本章规定取得许可证。
Entities that produce, sell, or use radioactive isotopes and radiation-emitting devices shall obtain a license in accordance with the provisions of this chapter.
除医疗使用Ⅰ类放射源、制备正电子发射计算机断层扫描用放射性药物自用的单位外，生产放射性同位素、销售和使用Ⅰ类放射源、销售和使用Ⅰ类射线装置的单位的许可证，由国务院生态环境主管部门审批颁发。
Except for entities that use Class I radiation sources for medical purposes or prepare radiopharmaceuticals for self-use in positron emission tomography, the licenses for entities that produce radioactive isotopes, sell and use Class I radiation sources, and sell and use Class I radiation-emitting devices shall be examined, approved, and issued by the competent department of ecological environment of the State Council.
除国务院生态环境主管部门审批颁发的许可证外，其他单位的许可证，由省、自治区、直辖市人民政府生态环境主管部门审批颁发。
Except for licenses examined, approved, and issued by the competent department of ecological environment of the State Council, licenses for other entities shall be examined, approved, and issued by the competent department of ecological environment of the people's government of the province, autonomous region, or municipality directly under the Central Government.
国务院生态环境主管部门向生产放射性同位素的单位颁发许可证前，应当将申请材料印送其行业主管部门征求意见。
Before issuing a license to an entity that produces radioactive isotopes, the competent department of ecological environment of the State Council shall send the application materials to its industrycompetent authority for comments.
生态环境主管部门应当将审批颁发许可证的情况通报同级公安部门、卫生主管部门。
The competent department of ecological environment shall notify the public security department and the health department at the same level of the approval and issuance of the license.
生产、销售、使用放射性同位素和射线装置的单位申请领取许可证，应当具备下列条件：
An entity applying for a license to produce, sell, or use radioactive isotopes and radiation-emitting devices shall meet the following conditions:
(一)有与所从事的生产、销售、使用活动规模相适应的，具备相应专业知识和防护知识及健康条件的专业技术人员；
(1) Having professional and technical personnel with corresponding professional knowledge, protection knowledge, and health conditions suitable for the scale of the production, sale, or use activities engaged in;
(二)有符合国家环境保护标准、职业卫生标准和安全防护要求的场所、设施和设备；
(2) Having premises, facilities, and equipment that meet national environmental protection standards, occupational health standards, and safety protection requirements;
(三)有专门的安全和防护管理机构或者专职、兼职安全和防护管理人员，并配备必要的防护用品和监测仪器；
(3) Having a dedicated safety and protection management organization or full-time or part-time safety and protection management personnel, and being equipped with necessary protective equipment and monitoring instruments;
(四)有健全的安全和防护管理规章制度、辐射事故应急措施；
(4) Having sound safety and protection management rules and regulations, and radiation accident emergency measures.
(五)产生放射性废气、废液、固体废物的，具有确保放射性废气、废液、固体废物达标排放的处理能力或者可行的处理方案。
(5) If radioactive waste gas, waste liquid, or solid waste is generated, there shall be treatment capacity or a feasible treatment plan to ensure that the discharge of radioactive waste gas, waste liquid, and solid waste meets the standards.
生产、销售、使用放射性同位素和射线装置的单位，应当事先向有审批权的生态环境主管部门提出许可申请，并提交符合本条例第七条规定条件的证明材料。
Units that produce, sell, or use radioactive isotopes and radiation-emitting devices shall submit a license application to the competent ecological environment authority with approval authority in advance, and submit evidentiary materials that meet the conditions specified in Article 7 of these Regulations.
使用放射性同位素和射线装置进行放射诊疗的医疗卫生机构，还应当获得放射源诊疗技术和医用辐射机构许可。
Medical and health institutions that use radioactive isotopes and radiation-emitting devices for radiological diagnosis and therapy shall also obtain a license for radiological source diagnosis and therapy technology and medical radiation.
生态环境主管部门应当自受理申请之日起20个工作日内完成审查，符合条件的，颁发许可证，并予以公告；不符合条件的，书面通知申请单位并说明理由。
The competent ecological environment authority shall complete the review within 20 working days from the date of accepting the application. If the conditions are met, it shall issue a license and make an announcement; if the conditions are not met, it shall notify the applicant unit in writing and state the reasons.
许可证包括下列主要内容：
The license shall include the following main contents:
(一)单位的名称、地址、法定代表人；
(1) The name, address, and legal representative of the unit;
(二)所从事活动的种类和范围；
(2) The type and scope of activities engaged in;
(三)有效期限；
(3) The validity period;
(四)发证日期和证书编号。
(4) The date of issuance and the certificate number.
持证单位变更单位名称、地址、法定代表人的，应当自变更登记之日起20日内，向原发证机关申请办理许可证变更手续。
If a licensed unit changes its name, address, or legal representative, it shall apply to the original issuing authority for license change procedures within 20 days from the date of the change registration.
有下列情形之一的，持证单位应当按照原申请程序，重新申请领取许可证：
Under any of the following circumstances, the license holder shall re-apply for a license in accordance with the original application procedures:
(一)改变所从事活动的种类或者范围的；
(1) Changing the type or scope of activities engaged in;
(二)新建或者改建、扩建生产、销售、使用设施或者场所的。
(2) Constructing new or renovating, expanding production, sales, or use facilities or sites.
许可证有效期为5年。有效期届满，需要延续的，持证单位应当于许可证有效期届满30日前，向原发证机关提出延续申请。原发证机关应当自受理延续申请之日起，在许可证有效期届满前完成审查，符合条件的，予以延续；不符合条件的，书面通知申请单位并说明理由。
The license is valid for 5 years. If renewal is needed upon expiration, the license holder shall submit a renewal application to the original issuing authority 30 days before the license expires. The original issuing authority shall complete the review before the license expires from the date of accepting the renewal application. If conditions are met, renewal shall be granted; if not, a written notice shall be given to the applicant with reasons.
持证单位部分终止或者全部终止生产、销售、使用放射性同位素和射线装置活动的，应当向原发证机关提出部分变更或者注销许可证申请，由原发证机关核查合格后，予以变更或者注销许可证。
If a license holder partially or completely terminates activities involving the production, sale, or use of radioactive isotopes and radiation-emitting devices, it shall apply to the original issuing authority for partial modification or cancellation of the license. After verification by the original issuing authority, the license shall be modified or cancelled.
禁止无许可证或者不按照许可证规定的种类和范围从事放射性同位素和射线装置的生产、销售、使用活动。
It is prohibited to engage in the production, sale, or use of radioactive isotopes and radiation-emitting devices without a license or not in accordance with the type and scope specified in the license.
禁止伪造、变造、转让许可证。
It is prohibited to forge, alter, or transfer licenses.
国务院对外贸易主管部门会同国务院生态环境主管部门、海关总署和生产放射性同位素的单位的行业主管部门制定并公布限制进出口放射性同位素目录和禁止进出口放射性同位素目录。
The competent department of foreign trade under the State Council, together with the competent department of ecological environment under the State Council, the General Administration of Customs, and the competent department of the industry of units producing radioactive isotopes, shall formulate and publish a list of restricted import and export radioactive isotopes and a list of prohibited import and export radioactive isotopes.
进口列入限制进出口目录的放射性同位素，应当在国务院生态环境主管部门审查批准后，由国务院对外贸易主管部门依据国家对外贸易的有关规定签发进口许可证。进口限制进出口目录和禁止进出口目录之外的放射性同位素，依据国家对外贸易的有关规定办理进口手续。
For importing radioactive isotopes included in the restricted import and export list, after review and approval by the competent department of ecological environment under the State Council, the competent department of foreign trade shall issue an import license in accordance with the relevant provisions of the state on foreign trade. For importing radioactive isotopes not included in the restricted import and export list or the prohibited import and export list, import procedures shall be handled in accordance with the relevant provisions of the state on foreign trade.
申请进口列入限制进出口目录的放射性同位素，应当符合下列要求：
To apply for importing radioactive isotopes included in the restricted import and export list, the following requirements shall be met:
(一)进口单位已经取得与所从事活动相符的许可证；
(1) The importing entity has obtained a license compatible with the activities it engages in;
(二)进口单位具有进口放射性同位素使用期满后的处理方案，其中，进口Ⅰ类、Ⅱ类、Ⅲ类放射源的，应当具有原出口方负责回收的承诺文件；
(2) The importing entity has a plan for the disposal of the imported radioactive isotopes after their use period expires; where Class I, II, or III radiation sources are imported, a commitment document from the original exporter to take back the sources shall be provided;
(三)进口的放射源应当有明确标号和必要说明文件，其中，Ⅰ类、Ⅱ类、Ⅲ类放射源的标号应当刻制在放射源本体或者密封包壳体上，Ⅳ类、Ⅴ类放射源的标号应当记录在相应说明文件中；
(3) The imported radiation sources shall have clear markings and necessary documentation; for Class I, II, and III radiation sources, the markings shall be engraved on the source body or sealed capsule; for Class IV and V radiation sources, the markings shall be recorded in the corresponding documentation;
(四)将进口的放射性同位素销售给其他单位使用的，还应当具有与使用单位签订的书面协议以及使用单位取得的许可证复印件。
(4) If the imported radioactive isotopes are to be sold to other entities for use, a written agreement with the using entity and a copy of the using entity's license shall also be provided.
进口列入限制进出口目录的放射性同位素的单位，应当向国务院生态环境主管部门提出进口申请，并提交符合本条例第十七条规定要求的证明材料。
Entities importing radioactive isotopes listed in the restricted import/export catalog shall submit an import application to the competent department of ecological environment of the State Council, along with supporting documents that meet the requirements of Article 17 of these Regulations.
国务院生态环境主管部门应当自受理申请之日起10个工作日内完成审查，符合条件的，予以批准；不符合条件的，书面通知申请单位并说明理由。
The competent department of ecological environment of the State Council shall complete the review within 10 working days from the date of accepting the application; if the conditions are met, approval shall be granted; if not, a written notice shall be given to the applicant with reasons.
海关验凭放射性同位素进口许可证办理有关进口手续。进口放射性同位素的包装材料依法需要实施检疫的，依照国家有关检疫法律、法规的规定执行。
Customs shall handle the relevant import procedures upon verification of the radioactive isotope import license. If the packaging materials of imported radioactive isotopes require quarantine according to law, the relevant national quarantine laws and regulations shall apply.
对进口的放射源，国务院生态环境主管部门还应当同时确定与其标号相对应的放射源编码。
For imported radiation sources, the competent department of ecological environment of the State Council shall also determine a radiation source code corresponding to its marking.
申请转让放射性同位素，应当符合下列要求：
An application for the transfer of radioactive isotopes shall meet the following requirements:
(一)转出、转入单位持有与所从事活动相符的许可证；
(1) The transferring and receiving entities hold licenses compatible with the activities they engage in;
(二)转入单位具有放射性同位素使用期满后的处理方案；
(2) The receiving unit has a plan for the disposal of the radioactive isotope after its use period expires;
(三)转让双方已经签订书面转让协议。
(3) The transferring and receiving parties have signed a written transfer agreement.
转让放射性同位素，由转入单位向其所在地省、自治区、直辖市人民政府生态环境主管部门提出申请，并提交符合本条例第十九条规定要求的证明材料。
For the transfer of radioactive isotopes, the receiving unit shall submit an application to the competent department of ecological environment of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located, and provide evidentiary materials that meet the requirements of Article 19 of these Regulations.
省、自治区、直辖市人民政府生态环境主管部门应当自受理申请之日起15个工作日内完成审查，符合条件的，予以批准；不符合条件的，书面通知申请单位并说明理由。
The competent department of ecological environment of the people's government of the province, autonomous region, or municipality directly under the Central Government shall complete the review within 15 working days from the date of accepting the application. If the conditions are met, approval shall be granted; if not, a written notice shall be given to the applicant unit with reasons explained.
放射性同位素的转出、转入单位应当在转让活动完成之日起20日内，分别向其所在地省、自治区、直辖市人民政府生态环境主管部门备案。
The transferring and receiving units of radioactive isotopes shall, within 20 days from the completion of the transfer activity, respectively file records with the competent department of ecological environment of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located.
生产放射性同位素的单位，应当建立放射性同位素产品台账，并按照国务院生态环境主管部门制定的编码规则，对生产的放射源统一编码。放射性同位素产品台账和放射源编码清单应当报国务院生态环境主管部门备案。
Units that produce radioactive isotopes shall establish a product ledger for radioactive isotopes and uniformly code the produced radioactive sources in accordance with the coding rules formulated by the competent department of ecological environment of the State Council. The product ledger of radioactive isotopes and the list of radioactive source codes shall be reported to the competent department of ecological environment of the State Council for record.
生产的放射源应当有明确标号和必要说明文件。其中，Ⅰ类、Ⅱ类、Ⅲ类放射源的标号应当刻制在放射源本体或者密封包壳体上，Ⅳ类、Ⅴ类放射源的标号应当记录在相应说明文件中。
The produced radioactive sources shall have clear labels and necessary explanatory documents. Among them, the labels of Class I, II, and III radioactive sources shall be engraved on the source body or sealed capsule shell, while the labels of Class IV and V radioactive sources shall be recorded in the corresponding explanatory documents.
国务院生态环境主管部门负责建立放射性同位素备案信息管理系统，与有关部门实行信息共享。
The competent department of ecological environment of the State Council is responsible for establishing a radioactive isotope record information management system and sharing information with relevant departments.
未列入产品台账的放射性同位素和未编码的放射源，不得出厂和销售。
Radioactive isotopes not listed in the product ledger and radioactive sources not coded shall not be delivered from the factory or sold.
持有放射源的单位将废旧放射源交回生产单位、返回原出口方或者送交放射性废物集中贮存单位贮存的，应当在该活动完成之日起20日内向其所在地省、自治区、直辖市人民政府生态环境主管部门备案。
Units holding radioactive sources that return spent radioactive sources to the production unit, return them to the original exporter, or deliver them to a centralized radioactive waste storage unit for storage shall, within 20 days from the completion of such activity, file records with the competent department of ecological environment of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located.
本条例施行前生产和进口的放射性同位素，由放射性同位素持有单位在本条例施行之日起6个月内，到其所在地省、自治区、直辖市人民政府生态环境主管部门办理备案手续，省、自治区、直辖市人民政府生态环境主管部门应当对放射源进行统一编码。
For radioactive isotopes produced and imported before the implementation of these Regulations, the holding unit shall, within 6 months from the date of implementation of these Regulations, go through the filing procedures with the competent department of ecological environment of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. The competent department of ecological environment of the province, autonomous region, or municipality directly under the Central Government shall uniformly code the radiation sources.
使用放射性同位素的单位需要将放射性同位素转移到外省、自治区、直辖市使用的，应当持许可证复印件向使用地省、自治区、直辖市人民政府生态环境主管部门备案，并接受当地生态环境主管部门的监督管理。
A unit using radioactive isotopes that needs to transfer radioactive isotopes to another province, autonomous region, or municipality directly under the Central Government for use shall file a copy of the license with the competent department of ecological environment of the people's government of the province, autonomous region, or municipality directly under the Central Government where the isotopes will be used, and shall accept the supervision and management of the local competent department of ecological environment.
出口列入限制进出口目录的放射性同位素，应当提供进口方可以合法持有放射性同位素的证明材料，并由国务院生态环境主管部门依照有关法律和我国缔结或者参加的国际条约、协定的规定，办理有关手续。
For the export of radioactive isotopes listed in the restricted import and export catalogue, the exporter shall provide evidence that the importer can legally hold the radioactive isotopes, and the competent department of ecological environment of the State Council shall handle the relevant procedures in accordance with relevant laws and the provisions of international treaties or agreements concluded or acceded to by China.
出口放射性同位素应当遵守国家对外贸易的有关规定。
The export of radioactive isotopes shall comply with the relevant provisions of the state on foreign trade.
安全和防护
Safety and Protection
生产、销售、使用放射性同位素和射线装置的单位，应当对本单位的放射性同位素、射线装置的安全和防护工作负责，并依法对其造成的放射性危害承担责任。
Units that produce, sell, or use radioactive isotopes and radiation-emitting devices shall be responsible for the safety and protection of their radioactive isotopes and radiation-emitting devices, and shall bear liability for the radioactive hazards caused thereby in accordance with the law.
生产放射性同位素的单位的行业主管部门，应当加强对生产单位安全和防护工作的管理，并定期对其执行法律、法规和国家标准的情况进行监督检查。
The competent industry department of units producing radioactive isotopes shall strengthen the management of the safety and protection work of the production units, and shall regularly conduct supervision and inspection of their compliance with laws, regulations, and national standards.
生产、销售、使用放射性同位素和射线装置的单位，应当对直接从事生产、销售、使用活动的工作人员进行安全和防护知识教育培训，并进行考核；考核不合格的，不得上岗。
Units that produce, sell, or use radioactive isotopes and radiation-emitting devices shall conduct education and training on safety and protection knowledge for workers directly engaged in production, sales, or use activities, and shall assess them; those who fail the assessment shall not take up their posts.
辐射安全关键岗位应当由注册核安全工程师担任。辐射安全关键岗位名录由国务院生态环境主管部门商国务院有关部门制定并公布。
Key positions in radiation safety shall be held by registered nuclear safety engineers. The catalogue of key positions in radiation safety shall be formulated and published by the competent department of ecological environment of the State Council in consultation with the relevant departments of the State Council.
生产、销售、使用放射性同位素和射线装置的单位，应当严格按照国家关于个人剂量监测和健康管理的规定，对直接从事生产、销售、使用活动的工作人员进行个人剂量监测和职业健康检查，建立个人剂量档案和职业健康监护档案。
Units that produce, sell, or use radioactive isotopes and radiation-emitting devices shall, in strict accordance with the state provisions on personal dose monitoring and health management, conduct personal dose monitoring and occupational health examinations for workers directly engaged in production, sales, or use activities, and establish personal dose files and occupational health surveillance files.
生产、销售、使用放射性同位素和射线装置的单位，应当对本单位的放射性同位素、射线装置的安全和防护状况进行年度评估。发现安全隐患的，应当立即进行整改。
Units that produce, sell, or use radioactive isotopes and radiation-emitting devices shall conduct an annual assessment of the safety and protection status of their radioactive isotopes and radiation-emitting devices. If safety hazards are discovered, they shall immediately carry out rectification.
生产、销售、使用放射性同位素和射线装置的单位需要终止的，应当事先对本单位的放射性同位素和放射性废物进行清理登记，作出妥善处理，不得留有安全隐患。生产、销售、使用放射性同位素和射线装置的单位发生变更的，由变更后的单位承担处理责任。变更前当事人对此另有约定的，从其约定；但是，约定中不得免除当事人的处理义务。
Units that produce, sell, or use radioactive isotopes and radiation-emitting devices that need to terminate operations shall, in advance, clean up and register their radioactive isotopes and radioactive waste, and handle them properly, leaving no safety hazards. If such a unit undergoes a change, the unit after the change shall assume the responsibility for handling. If the parties before the change have agreed otherwise, that agreement shall prevail; however, the agreement shall not exempt the parties from their handling obligations.
在本条例施行前已经终止的生产、销售、使用放射性同位素和射线装置的单位，其未安全处理的废旧放射源和放射性废物，由所在地省、自治区、直辖市人民政府生态环境主管部门提出处理方案，及时进行处理。所需经费由省级以上人民政府承担。
For units that had already terminated production, sale, or use of radioactive isotopes and radiation-emitting devices before the implementation of these Regulations, the ecological environmentcompetent authority of the province, autonomous region, or municipality directly under the Central Government where the unit is located shall propose a handling plan for the untreated spent radioactive sources and radioactive waste and carry out timely treatment. The necessary funds shall be borne by the provincial-level or higher government.
生产、进口放射源的单位销售Ⅰ类、Ⅱ类、Ⅲ类放射源给其他单位使用的，应当与使用放射源的单位签订废旧放射源返回协议；使用放射源的单位应当按照废旧放射源返回协议规定将废旧放射源交回生产单位或者返回原出口方。确实无法交回生产单位或者返回原出口方的，送交有相应资质的放射性废物集中贮存单位贮存。
Units that produce or import radioactive sources and sell Class I, II, or III radioactive sources to other units for use shall sign a spent radioactive source return agreement with the units using the radioactive sources; the units using the radioactive sources shall return the spent radioactive sources to the production unit or the original exporter according to the spent radioactive source return agreement. If it is truly impossible to return them to the production unit or the original exporter, they shall be delivered to a qualified centralized radioactive waste storage unit for storage.
使用放射源的单位应当按照国务院生态环境主管部门的规定，将Ⅳ类、Ⅴ类废旧放射源进行包装整备后送交有相应资质的放射性废物集中贮存单位贮存。
Units using radioactive sources shall, in accordance with the regulations of the ecological environment department of the State Council, package and prepare Class IV and V spent radioactive sources and then deliver them to a qualified centralized radioactive waste storage unit for storage.
使用Ⅰ类、Ⅱ类、Ⅲ类放射源的场所和生产放射性同位素的场所，以及终结运行后产生放射性污染的射线装置，应当依法实施退役。
Places where Class I, II, or III radioactive sources are used and places where radioactive isotopes are produced, as well as radiation-emitting devices that generate radioactive contamination after termination of operation, shall undergo decommissioning in accordance with the law.
生产、销售、使用、贮存放射性同位素和射线装置的场所，应当按照国家有关规定设置明显的放射性标志，其入口处应当按照国家有关安全和防护标准的要求，设置安全和防护设施以及必要的防护安全联锁、报警装置或者工作信号。射线装置的生产调试和使用场所，应当具有防止误操作、防止工作人员和公众受到意外照射的安全措施。
Places where radioactive isotopes and radiation-emitting devices are produced, sold, used, or stored shall be equipped with obvious radioactive signs in accordance with relevant state regulations, and at their entrances, safety and protection facilities as well as necessary protective safety interlocks, alarm devices, or work signals shall be installed in accordance with relevant national safety and protection standards. Places where radiation-emitting devices are produced, debugged, and used shall have safety measures to prevent misoperation and accidental exposure of workers and the public.
放射性同位素的包装容器、含放射性同位素的设备和射线装置，应当设置明显的放射性标识和中文警示说明；放射源上能够设置放射性标识的，应当一并设置。运输放射性同位素和含放射源的射线装置的工具，应当按照国家有关规定设置明显的放射性标志或者显示危险信号。
Packaging containers for radioactive isotopes, equipment containing radioactive isotopes, and radiation-emitting devices shall be provided with obvious radioactive identification and warning instructions in Chinese; if radioactive identification can be set on the radioactive source itself, it shall also be set. Tools for transporting radioactive isotopes and radiation-emitting devices containing radioactive sources shall be equipped with obvious radioactive signs or danger signals in accordance with relevant state regulations.
放射性同位素应当单独存放，不得与易燃、易爆、腐蚀性物品等一起存放，并指定专人负责保管。贮存、领取、使用、归还放射性同位素时，应当进行登记、检查，做到账物相符。对放射性同位素贮存场所应当采取防火、防水、防盗、防丢失、防破坏、防射线泄漏的安全措施。
Radioactive isotopes shall be stored separately, not together with flammable, explosive, corrosive items, etc., and a designated person shall be responsible for their custody. When storing, receiving, using, and returning radioactive isotopes, registration and inspection shall be carried out to ensure that accounts match physical items. Safety measures such as fire prevention, waterproofing, theft prevention, loss prevention, vandalism prevention, and radiation leakage prevention shall be taken for radioactive isotope storage places.
对放射源还应当根据其潜在危害的大小，建立相应的多层防护和安全措施，并对可移动的放射源定期进行盘存，确保其处于指定位置，具有可靠的安全保障。
For radioactive sources, corresponding multi-layer protection and safety measures shall also be established based on their potential hazard level, and movable radioactive sources shall be regularly inventoried to ensure they are in designated positions with reliable safety guarantees.
在室外、野外使用放射性同位素和射线装置的，应当按照国家安全和防护标准的要求划出安全防护区域，设置明显的放射性标志，必要时设专人警戒。
When using radioactive isotopes and radiation-emitting devices outdoors or in the field, a safety protection area shall be demarcated in accordance with national safety and protection standards, conspicuous radioactive signs shall be set up, and if necessary, special personnel shall be assigned foralert.
在野外进行放射性同位素示踪试验的，应当经省级以上人民政府生态环境主管部门商同级有关部门批准方可进行。
When conducting radioactive isotope tracer experiments in the field, approval from the competent department of ecological environment of the people's government at or above the provincial level, after consultation with the relevant departments at the same level, shall be obtained before proceeding.
辐射防护器材、含放射性同位素的设备和射线装置，以及含有放射性物质的产品和伴有产生X射线的电器产品，应当符合辐射防护要求。不合格的产品不得出厂和销售。
Radiation protection equipment, equipment containing radioactive isotopes and radiation-emitting devices, as well as products containing radioactive substances and electrical products that produce X-rays, shall meet radiation protection requirements. Non-conforming products shall not be shipped from the factory or sold.
使用放射性同位素和射线装置进行放射诊疗的医疗卫生机构，应当依据国务院卫生主管部门有关规定和国家标准，制定与本单位从事的诊疗项目相适应的质量保证方案，遵守质量保证监测规范，按照医疗照射正当化和辐射防护最优化的原则，避免一切不必要的照射，并事先告知患者和受检者辐射对健康的潜在影响。
Medical and health institutions using radioactive isotopes and radiation-emitting devices for radiological diagnosis and treatment shall, in accordance with the relevant regulations of the competent health department of the State Council and national standards, formulate a quality assurance plan suitable for the diagnosis and treatment items undertaken by the unit, comply with quality assurance monitoring specifications, adhere to the principles of justification of medical exposure and optimization of radiation protection, avoid all unnecessary exposure, and inform patients and examinees in advance of the potential health effects of radiation.
金属冶炼厂回收冶炼废旧金属时，应当采取必要的监测措施，防止放射性物质熔入产品中。监测中发现问题的，应当及时通知所在地设区的市级以上人民政府生态环境主管部门。
When metal smelting plants recycle and smelt scrap metal, they shall take necessary monitoring measures to prevent radioactive substances from melting into the products. If problems are found during monitoring, they shall promptly notify the competent department of ecological environment of the people's government at or above the city divided into districts level.
辐射事故应急处理
Emergency Handling of Radiation Accidents
根据辐射事故的性质、严重程度、可控性和影响范围等因素，从重到轻将辐射事故分为特别重大辐射事故、重大辐射事故、较大辐射事故和一般辐射事故四个等级。
Based on factors such as the nature, severity, controllability, and scope of impact of the radiation accident, radiation accidents are classified into four levels from most severe to least severe: particularly major radiation accident, major radiation accident, relatively major radiation accident, and general radiation accident.
特别重大辐射事故，是指Ⅰ类、Ⅱ类放射源丢失、被盗、失控造成大范围严重辐射污染后果，或者放射性同位素和射线装置失控导致3人以上(含3人)急性死亡。
A particularly major radiation accident refers to the loss, theft, or loss of control of Class I or Class II radioactive sources causing large-scale severe radiation contamination, or the loss of control of radioactive isotopes and radiation-emitting devices resulting in acute death of 3 or more persons (including 3 persons).
重大辐射事故，是指Ⅰ类、Ⅱ类放射源丢失、被盗、失控，或者放射性同位素和射线装置失控导致2人以下(含2人)急性死亡或者10人以上(含10人)急性重度放射病、局部器官残疾。
A major radiation accident refers to the loss, theft, or loss of control of Class I or Class II radioactive sources, or the loss of control of radioactive isotopes and radiation-emitting devices resulting in acute death of 2 or fewer persons (including 2 persons) or acute severe radiation sickness or local organ disability in 10 or more persons (including 10 persons).
较大辐射事故，是指Ⅲ类放射源丢失、被盗、失控，或者放射性同位素和射线装置失控导致9人以下(含9人)急性重度放射病、局部器官残疾。
A relatively major radiation accident refers to the loss, theft, or loss of control of Class III radioactive sources, or the loss of control of radioactive isotopes and radiation-emitting devices resulting in acute severe radiation sickness or local organ disability in 9 or fewer persons (including 9 persons).
一般辐射事故，是指Ⅳ类、Ⅴ类放射源丢失、被盗、失控，或者放射性同位素和射线装置失控导致人员受到超过年剂量限值的照射。
A general radiation accident refers to the loss, theft, or loss of control of Class IV or Class V radioactive sources, or the loss of control of radioactive isotopes and radiation-emitting devices resulting in personnel exposure exceeding the annual dose limit.
县级以上人民政府生态环境主管部门应当会同同级公安、卫生、财政等部门编制辐射事故应急预案，报本级人民政府批准。辐射事故应急预案应当包括下列内容：
The competent department of ecological environment of the people's government at or above the county level shall, together with the public security, health, and finance departments at the same level, formulate a radiation accident emergency response plan, which shall be submitted to the people's government at the same level for approval. The radiation accident emergency response plan shall include the following contents:
(一)应急机构和职责分工；
(1) Emergency organization and division of responsibilities;
(二)应急人员的组织、培训以及应急和救助的装备、资金、物资准备；
(2) Organization and training of emergency personnel, and preparation of equipment, funds, and materials for emergency and rescue;
(三)辐射事故分级与应急响应措施；
(3) Classification of radiation accidents and emergency response measures;
(四)辐射事故调查、报告和处理程序。
(4) Procedures for investigation, reporting, and handling of radiation accidents.
生产、销售、使用放射性同位素和射线装置的单位，应当根据可能发生的辐射事故的风险，制定本单位的应急方案，做好应急准备。
Entities that produce, sell, or use radioactive isotopes and radiation-emitting devices shall, based on the risks of possible radiation accidents, formulate their own emergency plans and make emergency preparations.
发生辐射事故时，生产、销售、使用放射性同位素和射线装置的单位应当立即启动本单位的应急方案，采取应急措施，并立即向当地生态环境主管部门、公安部门、卫生主管部门报告。
When a radiation accident occurs, the entity that produces, sells, or uses radioactive isotopes and radiation-emitting devices shall immediately activate its own emergency plan, take emergency measures, and immediately report to the local competent department of ecological environment, public security department, and health department.
生态环境主管部门、公安部门、卫生主管部门接到辐射事故报告后，应当立即派人赶赴现场，进行现场调查，采取有效措施，控制并消除事故影响，同时将辐射事故信息报告本级人民政府和上级人民政府生态环境主管部门、公安部门、卫生主管部门。
Upon receiving a report of a radiation accident, the competent department of ecological environment, public security department, and health department shall immediately dispatch personnel to the scene, conduct on-site investigation, take effective measures to control and eliminate the impact of the accident, and simultaneously report the radiation accident information to the people's government at the same level and to the higher-level competent departments of ecological environment, public security, and health.
县级以上地方人民政府及其有关部门接到辐射事故报告后，应当按照事故分级报告的规定及时将辐射事故信息报告上级人民政府及其有关部门。发生特别重大辐射事故和重大辐射事故后，事故发生地省、自治区、直辖市人民政府和国务院有关部门应当在4小时内报告国务院；特殊情况下，事故发生地人民政府及其有关部门可以直接向国务院报告，并同时报告上级人民政府及其有关部门。
The local people's government at or above the county level and its relevant departments, upon receiving a report of a radiation accident, shall promptly report the radiation accident information to the higher-level people's government and its relevant departments in accordance with the provisions on graded reporting of accidents. After the occurrence of a particularly major radiation accident or a major radiation accident, the people's government of the province, autonomous region, or municipality directly under the Central Government where the accident occurred and the relevant departments of the State Council shall report to the State Council within 4 hours; under special circumstances, the local people's government and its relevant departments may directly report to the State Council, and simultaneously report to the higher-level people's government and its relevant departments.
禁止缓报、瞒报、谎报或者漏报辐射事故。
It is prohibited to delay reporting, conceal, falsely report, or omit reporting a radiation accident.
在发生辐射事故或者有证据证明辐射事故可能发生时，县级以上人民政府生态环境主管部门有权采取下列临时控制措施：
When a radiation accident occurs or there is evidence that a radiation accident may occur, the competent department of ecological environment of the people's government at or above the county level has the authority to take the following temporary control measures:
(一)责令停止导致或者可能导致辐射事故的作业；
(1) Order the cessation of operations that cause or may cause a radiation accident;
(二)组织控制事故现场。
(2) Organize the control of the accident site.
辐射事故发生后，有关县级以上人民政府应当按照辐射事故的等级，启动并组织实施相应的应急预案。
After a radiation accident occurs, the relevant people's government at or above the county level shall, in accordance with the level of the radiation accident, activate and organize the implementation of the corresponding emergency plan.
县级以上人民政府生态环境主管部门、公安部门、卫生主管部门，按照职责分工做好相应的辐射事故应急工作：
The competent department of ecological environment, the public security department, and the health department of the people's government at or above the county level shall, in accordance with their respective responsibilities, carry out the corresponding radiation accident emergency work:
(一)生态环境主管部门负责辐射事故的应急响应、调查处理和定性定级工作，协助公安部门监控追缴丢失、被盗的放射源；
(1) The competent department of ecological environment is responsible for emergency response, investigation and handling, and determination of nature and level of radiation accidents, and assists the public security department in monitoring and recovering lost or stolen radioactive sources;
(二)公安部门负责丢失、被盗放射源的立案侦查和追缴；
(2) The public security department is responsible for filing and investigating cases of lost or stolen radioactive sources and recovering them;
(三)卫生主管部门负责辐射事故的医疗应急。
(3) The health department is responsible for medical emergency response to radiation accidents.
生态环境主管部门、公安部门、卫生主管部门应当及时相互通报辐射事故应急响应、调查处理、定性定级、立案侦查和医疗应急情况。国务院指定的部门根据生态环境主管部门确定的辐射事故的性质和级别，负责有关国际信息通报工作。
The competent department of ecological environment, the public security department, and the health department shall promptly inform each other of the emergency response, investigation and handling, determination of nature and level, case filing and investigation, and medical emergency response of radiation accidents. The department designated by the State Council shall be responsible for relevant international information notification based on the nature and level of the radiation accident determined by the competent department of ecological environment.
发生辐射事故的单位应当立即将可能受到辐射伤害的人员送至当地卫生主管部门指定的医院或者有条件救治辐射损伤病人的医院，进行检查和治疗，或者请求医院立即派人赶赴事故现场，采取救治措施。
The unit that has caused a radiation accident shall immediately send persons who may have been exposed to radiation to a hospital designated by the local competent health department or a hospital capable of treating radiation injuries for examination and treatment, or request the hospital to immediately send personnel to the accident site to take treatment measures.
监督检查
Supervision and Inspection
县级以上人民政府生态环境主管部门和其他有关部门应当按照各自职责对生产、销售、使用放射性同位素和射线装置的单位进行监督检查。
The competent ecological environment departments of the people's governments at or above the county level and other relevant departments shall, in accordance with their respective duties, conduct supervision and inspection of units that produce, sell, or use radioactive isotopes and radiation-emitting devices.
被检查单位应当予以配合，如实反映情况，提供必要的资料，不得拒绝和阻碍。
The unit being inspected shall cooperate, truthfully reflect the situation, provide necessary materials, and shall not refuse or obstruct the inspection.
县级以上人民政府生态环境主管部门应当配备辐射防护安全监督员。辐射防护安全监督员由从事辐射防护工作，具有辐射防护安全知识并经省级以上人民政府生态环境主管部门认可的专业人员担任。辐射防护安全监督员应当定期接受专业知识培训和考核。
The competent ecological environment departments of the people's governments at or above the county level shall be equipped with radiation protection safety supervisors. Radiation protection safety supervisors shall be professionals engaged in radiation protection work, possessing radiation protection safety knowledge, and recognized by the competent ecological environment departments of the people's governments at or above the provincial level. Radiation protection safety supervisors shall regularly receive professional knowledge training and assessment.
县级以上人民政府生态环境主管部门在监督检查中发现生产、销售、使用放射性同位素和射线装置的单位有不符合原发证条件的情形的，应当责令其限期整改。
If, during supervision and inspection, the competent ecological environment department of the people's government at or above the county level discovers that a unit producing, selling, or using radioactive isotopes and radiation-emitting devices no longer meets the conditions for the original license, it shall order the unit to rectify within a specified period.
监督检查人员依法进行监督检查时，应当出示证件，并为被检查单位保守技术秘密和业务秘密。
When conducting supervision and inspection according to law, inspectors shall present their credentials and keep confidential the technical and business secrets of the unit being inspected.
任何单位和个人对违反本条例的行为，有权向生态环境主管部门和其他有关部门检举；对生态环境主管部门和其他有关部门未依法履行监督管理职责的行为，有权向本级人民政府、上级人民政府有关部门检举。接到举报的有关人民政府、生态环境主管部门和其他有关部门对有关举报应当及时核实、处理。
Any unit or individual has the right to report to the competent ecological environment department or other relevant departments any violation of these Regulations; and has the right to report to the people's government at the same level or the relevant department of the people's government at a higher level any failure of the competent ecological environment department or other relevant departments to perform their supervision and management duties according to law. The relevant people's government, competent ecological environment department, or other relevant department that receives the report shall promptly verify and handle the report.
法律责任
Legal Liability
违反本条例规定，县级以上人民政府生态环境主管部门有下列行为之一的，对直接负责的主管人员和其他直接责任人员，依法给予行政处分；构成犯罪的，依法追究刑事责任：
If, in violation of these Regulations, the competent ecological environment department of the people's government at or above the county level commits any of the following acts, the directly responsible supervisor and other directly responsible personnel shall be given administrative sanctions according to law; if a crime is constituted, criminal liability shall be pursued according to law:
(一)向不符合本条例规定条件的单位颁发许可证或者批准不符合本条例规定条件的单位进口、转让放射性同位素的；
(1) Issuing a license to a unit that does not meet the conditions prescribed in these Regulations, or approving the import or transfer of radioactive isotopes by a unit that does not meet the conditions prescribed in these Regulations;
(二)发现未依法取得许可证的单位擅自生产、销售、使用放射性同位素和射线装置，不予查处或者接到举报后不依法处理的；
(2) Failing to investigate and punish a unit that produces, sells, or uses radioactive isotopes and radiation devices without a license as legally required, or failing to handle the matter according to law after receiving a report;
(三)发现未经依法批准擅自进口、转让放射性同位素，不予查处或者接到举报后不依法处理的；
(3) Failing to investigate and punish the unauthorized import or transfer of radioactive isotopes without legal approval, or failing to handle the matter according to law after receiving a report;
(四)对依法取得许可证的单位不履行监督管理职责或者发现违反本条例规定的行为不予查处的；
(4) Failing to perform supervision and management duties for units that have legally obtained licenses, or failing to investigate and punish acts that violate the provisions of these Regulations;
(五)在放射性同位素、射线装置安全和防护监督管理工作中有其他渎职行为的。
(5) Other acts of dereliction of duty in the supervision and management of the safety and protection of radioactive isotopes and radiation devices.
违反本条例规定，县级以上人民政府生态环境主管部门和其他有关部门有下列行为之一的，对直接负责的主管人员和其他直接责任人员，依法给予行政处分；构成犯罪的，依法追究刑事责任：
Where, in violation of these Regulations, the competent department of ecological environment of the people's government at or above the county level and other relevant departments commit any of the following acts, the directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law; if a crime is constituted, criminal liability shall be pursued according to law:
(一)缓报、瞒报、谎报或者漏报辐射事故的；
(1) Delaying, concealing, falsifying, or omitting the reporting of a radiation accident;
(二)未按照规定编制辐射事故应急预案或者不依法履行辐射事故应急职责的。
(2) Failing to prepare a radiation accident emergency plan as required, or failing to perform radiation accident emergency duties according to law.
违反本条例规定，生产、销售、使用放射性同位素和射线装置的单位有下列行为之一的，由县级以上人民政府生态环境主管部门责令停止违法行为，限期改正；逾期不改正的，责令停产停业或者由原发证机关吊销许可证；有违法所得的，没收违法所得；违法所得10万元以上的，并处违法所得1倍以上5倍以下的罚款；没有违法所得或者违法所得不足10万元的，并处1万元以上10万元以下的罚款：
Where, in violation of these Regulations, a unit that produces, sells, or uses radioactive isotopes and radiation devices commits any of the following acts, the competent department of ecological environment of the people's government at or above the county level shall order it to cease the illegal act and rectify within a time limit; if it fails to rectify within the time limit, it shall be ordered to suspend production or business, or the license shall be revoked by the original issuing authority; if there is illegal income, the illegal income shall be confiscated; if the illegal income is 100,000 yuan or more, a fine of not less than one time but not more than five times the illegal income shall be imposed; if there is no illegal income or the illegal income is less than 100,000 yuan, a fine of not less than 10,000 yuan but not more than 100,000 yuan shall be imposed:
(一)无许可证从事放射性同位素和射线装置生产、销售、使用活动的；
(1) Engaging in the production, sale, or use of radioactive isotopes and radiation devices without a license;
(二)未按照许可证的规定从事放射性同位素和射线装置生产、销售、使用活动的；
(2) Engaging in the production, sale, or use of radioactive isotopes and radiation-emitting devices not in accordance with the provisions of the license;
(三)改变所从事活动的种类或者范围以及新建、改建或者扩建生产、销售、使用设施或者场所，未按照规定重新申请领取许可证的；
(3) Changing the type or scope of activities, or constructing, rebuilding, or expanding facilities or sites for production, sale, or use without reapplying for a license as required;
(四)许可证有效期届满，需要延续而未按照规定办理延续手续的；
(4) Failing to go through the renewal procedures as required when the license expires and needs to be renewed;
(五)未经批准，擅自进口或者转让放射性同位素的。
(5) Importing or transferring radioactive isotopes without authorization.
违反本条例规定，生产、销售、使用放射性同位素和射线装置的单位变更单位名称、地址、法定代表人，未依法办理许可证变更手续的，由县级以上人民政府生态环境主管部门责令限期改正，给予警告；逾期不改正的，由原发证机关暂扣或者吊销许可证。
Where a unit that produces, sells, or uses radioactive isotopes and radiation-emitting devices changes its name, address, or legal representative without going through the license change procedures as required by law, the competent department of ecological environment of the people's government at or above the county level shall order it to make corrections within a specified period and give a warning; if it fails to make corrections within the specified period, the original issuing authority shall temporarily suspend or revoke the license.
违反本条例规定，生产、销售、使用放射性同位素和射线装置的单位部分终止或者全部终止生产、销售、使用活动，未按照规定办理许可证变更或者注销手续的，由县级以上人民政府生态环境主管部门责令停止违法行为，限期改正；逾期不改正的，处1万元以上10万元以下的罚款；造成辐射事故，构成犯罪的，依法追究刑事责任。
Where a unit that produces, sells, or uses radioactive isotopes and radiation-emitting devices partially or completely terminates its production, sale, or use activities without going through the license change or cancellation procedures as required, the competent department of ecological environment of the people's government at or above the county level shall order it to cease the illegal act and make corrections within a specified period; if it fails to make corrections within the specified period, a fine of not less than 10,000 yuan but not more than 100,000 yuan shall be imposed; if a radiation accident is caused and constitutes a crime, criminal liability shall be pursued according to law.
违反本条例规定，伪造、变造、转让许可证的，由县级以上人民政府生态环境主管部门收缴伪造、变造的许可证或者由原发证机关吊销许可证，并处5万元以上10万元以下的罚款；构成犯罪的，依法追究刑事责任。
Where a unit forges, alters, or transfers a license in violation of these regulations, the competent department of ecological environment of the people's government at or above the county level shall confiscate the forged or altered license, or the original issuing authority shall revoke the license, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if a crime is constituted, criminal liability shall be pursued according to law.
违反本条例规定，伪造、变造、转让放射性同位素进口和转让批准文件的，由县级以上人民政府生态环境主管部门收缴伪造、变造的批准文件或者由原批准机关撤销批准文件，并处5万元以上10万元以下的罚款；情节严重的，可以由原发证机关吊销许可证；构成犯罪的，依法追究刑事责任。
Where a unit forges, alters, or transfers an approval document for the import or transfer of radioactive isotopes in violation of these regulations, the competent department of ecological environment of the people's government at or above the county level shall confiscate the forged or altered approval document, or the original approving authority shall revoke the approval document, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if the circumstances are serious, the original issuing authority may revoke the license; if a crime is constituted, criminal liability shall be pursued according to law.
违反本条例规定，生产、销售、使用放射性同位素的单位有下列行为之一的，由县级以上人民政府生态环境主管部门责令限期改正，给予警告；逾期不改正的，由原发证机关暂扣或者吊销许可证：
Where a unit that produces, sells, or uses radioactive isotopes commits any of the following acts in violation of these regulations, the competent department of ecological environment of the people's government at or above the county level shall order it to make corrections within a specified period and give a warning; if it fails to make corrections within the specified period, the original issuing authority shall temporarily suspend or revoke the license:
(一)转入、转出放射性同位素未按照规定备案的；
(1) Failing to file a record as required when transferring in or out radioactive isotopes;
(二)将放射性同位素转移到外省、自治区、直辖市使用，未按照规定备案的；
(2) Transferring radioactive isotopes to another province, autonomous region, or municipality for use without registering as required;
(三)将废旧放射源交回生产单位、返回原出口方或者送交放射性废物集中贮存单位贮存，未按照规定备案的。
(3) Returning waste radioactive sources to the production unit, returning them to the original exporter, or delivering them to a centralized radioactive waste storage unit for storage without registering as required.
违反本条例规定，生产、销售、使用放射性同位素和射线装置的单位有下列行为之一的，由县级以上人民政府生态环境主管部门责令停止违法行为，限期改正；逾期不改正的，处1万元以上10万元以下的罚款：
Where an entity producing, selling, or using radioactive isotopes and radiation-emitting devices violates these Regulations by committing any of the following acts, the competent department of ecological environment of the people's government at or above the county level shall order it to cease the illegal act and rectify within a specified period; if it fails to rectify within the specified period, a fine of not less than 10,000 yuan but not more than 100,000 yuan shall be imposed:
(一)在室外、野外使用放射性同位素和射线装置，未按照国家有关安全和防护标准的要求划出安全防护区域和设置明显的放射性标志的；
(1) Using radioactive isotopes and radiation-emitting devices outdoors or in the field without delineating a safety protection zone and setting up obvious radioactive signs in accordance with national safety and protection standards;
(二)未经批准擅自在野外进行放射性同位素示踪试验的。
(2) Conducting radioactive isotope tracer tests in the field without approval.
违反本条例规定，生产放射性同位素的单位有下列行为之一的，由县级以上人民政府生态环境主管部门责令限期改正，给予警告；逾期不改正的，依法收缴其未备案的放射性同位素和未编码的放射源，处5万元以上10万元以下的罚款，并可以由原发证机关暂扣或者吊销许可证：
Where an entity producing radioactive isotopes violates these Regulations by committing any of the following acts, the competent department of ecological environment of the people's government at or above the county level shall order it to rectify within a specified period and give a warning; if it fails to rectify within the specified period, the unregistered radioactive isotopes and uncoded radiation sources shall be confiscated according to law, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed, and the original licensing authority may suspend or revoke the license:
(一)未建立放射性同位素产品台账的；
(1) Failing to establish a product inventory of radioactive isotopes;
(二)未按照国务院生态环境主管部门制定的编码规则，对生产的放射源进行统一编码的；
(2) Failing to uniformly code the radiation sources produced in accordance with the coding rules formulated by the competent department of ecological environment of the State Council;
(三)未将放射性同位素产品台账和放射源编码清单报国务院生态环境主管部门备案的；
(3) Failing to report the product inventory of radioactive isotopes and the list of radiation source codes to the competent department of ecological environment of the State Council for registration;
(四)出厂或者销售未列入产品台账的放射性同位素和未编码的放射源的。
(4) Delivering or selling radioactive isotopes not included in the product inventory and uncoded radiation sources.
违反本条例规定，生产、销售、使用放射性同位素和射线装置的单位有下列行为之一的，由县级以上人民政府生态环境主管部门责令停止违法行为，限期改正；逾期不改正的，由原发证机关指定有处理能力的单位代为处理或者实施退役，费用由生产、销售、使用放射性同位素和射线装置的单位承担，并处1万元以上10万元以下的罚款：
In violation of these Regulations, if an entity producing, selling, or using radioactive isotopes and radiation-emitting devices commits any of the following acts, the competent department of ecological environment under the people's government at or above the county level shall order cessation of the illegal act and rectification within a specified period; if rectification is not made within the period, the original licensing authority shall designate a capable entity to handle the matter or carry out decommissioning, with the costs borne by the entity producing, selling, or using radioactive isotopes and radiation-emitting devices, and a fine of not less than 10,000 yuan but not more than 100,000 yuan shall be imposed:
(一)未按照规定对废旧放射源进行处理的；
(1) Failing to dispose of spent radioactive sources in accordance with regulations;
(二)未按照规定对使用Ⅰ类、Ⅱ类、Ⅲ类放射源的场所和生产放射性同位素的场所，以及终结运行后产生放射性污染的射线装置实施退役的。
(2) Failing to carry out decommissioning of premises where Class I, II, and III radioactive sources are used and premises where radioactive isotopes are produced, as well as radiation-emitting devices that generate radioactive contamination after termination of operation, in accordance with regulations.
违反本条例规定，生产、销售、使用放射性同位素和射线装置的单位有下列行为之一的，由县级以上人民政府生态环境主管部门责令停止违法行为，限期改正；逾期不改正的，责令停产停业，并处2万元以上20万元以下的罚款；构成犯罪的，依法追究刑事责任：
In violation of these Regulations, if an entity producing, selling, or using radioactive isotopes and radiation-emitting devices commits any of the following acts, the competent department of ecological environment under the people's government at or above the county level shall order cessation of the illegal act and rectification within a specified period; if rectification is not made within the period, it shall order suspension of production and business, and impose a fine of not less than 20,000 yuan but not more than 200,000 yuan; if a crime is constituted, criminal liability shall be pursued according to law:
(一)未按照规定对本单位的放射性同位素、射线装置安全和防护状况进行评估或者发现安全隐患不及时整改的；
(1) Failing to assess the safety and protection status of the entity's radioactive isotopes and radiation-emitting devices in accordance with regulations, or failing to rectify safety hazards in a timely manner after discovery;
(二)生产、销售、使用、贮存放射性同位素和射线装置的场所未按照规定设置安全和防护设施以及放射性标志的。
(2) Failing to set up safety and protection facilities and radiation signs in accordance with regulations at premises where radioactive isotopes and radiation-emitting devices are produced, sold, used, or stored.
违反本条例规定，造成辐射事故的，由原发证机关责令限期改正，并处5万元以上20万元以下的罚款；情节严重的，由原发证机关吊销许可证；构成违反治安管理行为的，由公安机关依法予以治安处罚；构成犯罪的，依法追究刑事责任。
In violation of these Regulations, if a radiation accident is caused, the original licensing authority shall order rectification within a specified period and impose a fine of not less than 50,000 yuan but not more than 200,000 yuan; if the circumstances are serious, the original licensing authority shall revoke the license; if the act constitutes a violation of public security administration, the public security organ shall impose a public security penalty according to law; if a crime is constituted, criminal liability shall be pursued according to law.
因辐射事故造成他人损害的，依法承担民事责任。
If a radiation accident causes damage to others, civil liability shall be borne according to law.
生产、销售、使用放射性同位素和射线装置的单位被责令限期整改，逾期不整改或者经整改仍不符合原发证条件的，由原发证机关暂扣或者吊销许可证。
If an entity producing, selling, or using radioactive isotopes and radiation-emitting devices is ordered to rectify within a specified period but fails to do so or still does not meet the original licensing conditions after rectification, the original licensing authority shall suspend or revoke the license.
违反本条例规定，被依法吊销许可证的单位或者伪造、变造许可证的单位，5年内不得申请领取许可证。
In violation of these Regulations, an entity whose license has been revoked according to law or an entity that has forged or altered a license shall not apply for a license within five years.
县级以上地方人民政府生态环境主管部门的行政处罚权限的划分，由省、自治区、直辖市人民政府确定。
The division of administrative penalty authority of the competent department of ecological environment of the local people's government at or above the county level shall be determined by the people's government of the province, autonomous region, or municipality directly under the Central Government.
附则
Supplementary Provisions
军用放射性同位素、射线装置安全和防护的监督管理，依照《中华人民共和国放射性污染防治法》第六十条的规定执行。
The supervision and management of the safety and protection of military radioactive isotopes and radiation-emitting devices shall be implemented in accordance with the provisions of Article 60 of the Law of the People's Republic of China on the Prevention and Control of Radioactive Pollution.
劳动者在职业活动中接触放射性同位素和射线装置造成的职业病的防治，依照《中华人民共和国职业病防治法》和国务院有关规定执行。
The prevention and treatment of occupational diseases caused by workers' exposure to radioactive isotopes and radiation-emitting devices during occupational activities shall be implemented in accordance with the Law of the People's Republic of China on the Prevention and Control of Occupational Diseases and the relevant provisions of the State Council.
放射性同位素的运输，放射性同位素和射线装置生产、销售、使用过程中产生的放射性废物的处置，依照国务院有关规定执行。
The transportation of radioactive isotopes and the disposal of radioactive waste generated during the production, sale, and use of radioactive isotopes and radiation-emitting devices shall be implemented in accordance with the relevant provisions of the State Council.
本条例中下列用语的含义：
The meanings of the following terms in these Regulations:
放射性同位素，是指某种发生放射性衰变的元素中具有相同原子序数但质量不同的核素。
Radioactive isotope refers to a nuclide of an element that undergoes radioactive decay and has the same atomic number but different mass numbers.
放射源，是指除研究堆和动力堆核燃料循环范畴的材料以外，永久密封在容器中或者有严密包层并呈固态的放射性材料。
Radiation source refers to radioactive material that is permanently sealed in a container or has a tight cladding and is in a solid state, excluding materials in the nuclear fuel cycle of research reactors and power reactors.
射线装置，是指X线机、加速器、中子发生器以及含放射源的装置。
Radiation-emitting device refers to X-ray machines, accelerators, neutron generators, and devices containing radiation sources.
非密封放射性物质，是指非永久密封在包壳里或者紧密地固结在覆盖层里的放射性物质。
Unsealed radioactive substance refers to radioactive material that is not permanently sealed in a cladding or firmly consolidated in a covering layer.
转让，是指除进出口、回收活动之外，放射性同位素所有权或者使用权在不同持有者之间的转移。
Transfer means the transfer of ownership or right to use radioactive isotopes between different holders, excluding import, export, and recycling activities.
伴有产生X射线的电器产品，是指不以产生X射线为目的，但在生产或者使用过程中产生X射线的电器产品。
Electrical products that produce X-rays incidentally refer to electrical products that are not intended to produce X-rays but generate X-rays during production or use.
辐射事故，是指放射源丢失、被盗、失控，或者放射性同位素和射线装置失控导致人员受到意外的异常照射。
Radiation accident means the loss, theft, or loss of control of a radioactive source, or the loss of control of radioactive isotopes or radiation-emitting devices resulting in unexpected abnormal exposure of personnel to radiation.
本条例自2005年12月1日起施行。1989年10月24日国务院发布的《放射性同位素与射线装置放射防护条例》同时废止。
These Regulations shall come into force on December 1, 2005. The Regulations on the Protection of Radioactive Isotopes and Radiation-Emitting Devices promulgated by the State Council on October 24, 1989 shall be repealed simultaneously.