>>>welcome 河南大学, You have logged in.
Logout History Contact us  
Font Size:  A A A Search “Fabao” Window English 中文 = 简体  繁体
  Favorite   DownLoad   Print
 
Regulations on the Safety and Protection of Radioisotopes and Radiation Devices (2019 Amendment PKULAW Version) [Effective]
放射性同位素与射线装置安全和防护条例(2019修正) [现行有效]
【法宝引证码】

Regulations on the Safety and Protection of Radioisotopes and Radiation Devices 

放射性同位素与射线装置安全和防护条例

(Promulgated by the Order No. 499 of the State Council of the People's Republic of China on September 14, 2005; revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on July 29, 2014; and amended in accordance with the Decision of the State Council to Amend Certain Administrative Regulations on March 2, 2019) (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》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》修正 )

Chapter I General Provisions 

第一章 总  则

Article 1 This Regulation is formulated for purposes of strengthening the supervision and administration of the safety and protection of radioisotopes and radiation devices, promoting the safe application of radioisotopes and radiation devices, safeguarding the human health and protecting the environment.   第一条 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。
Article 2 The production, sale and use of radioisotopes and radiation devices as well as the transfer, import and export of radioisotopes within the territory of the People's Republic of China shall be governed by this Regulation.   第二条 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 term “radioisotopes” as mentioned in this Regulation shall include radioactive sources and unsealed radioactive substances. 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。
Article 3 The department of ecology and environment of the State Council shall conduct the unified supervision and administration on the safety and protection of radioisotopes and radiation devices throughout this country.   第三条 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 public security department, health department and other departments of the State Council shall, in accordance with their respective functions and the provisions of this Regulation, conduct the supervision and administration on the safety and protection of relevant radioisotopes and radiation devices. 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 departments of ecology and environment and other relevant departments of the local people's governments at and above the county level shall, in accordance with their respective functions and the provisions of this Regulation, conduct the supervision and administration on the safety and protection of radioisotopes and radiation devices within their respective administrative areas. 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。
Article 4 The state shall implement the classified administration of radioactive sources and radiation devices. In accordance with the degree of potential harm of radioactive sources and radiation devices to human health and environment, radioactive sources may be divided, from high to low, into Class I, Class II, Class III, Class IV and Class V, and the specific measures for the classification thereof shall be formulated by the department of ecology and environment of the State Council; radiation devices may be divided into Class I, Class II and Class III, and the specific measures for the classification thereof shall be formulated by the department of ecology and environment of the State Council in consultation with the competent department of health of the State Council.   第四条 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。
Chapter II Licensing and Filing 

第二章 许可和备案

Article 5 The entities producing, selling and using radioisotopes and radiation devices shall obtain the relevant licenses in accordance with the provisions of this Chapter.   第五条 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。
Article 6 Except for entities using Class I radioactive sources for medical purposes or preparing radioactive pharmaceuticals for positron emission tomography for their own use, the licenses for entities producing radioisotopes, selling and using Class I radioactive sources or selling and using Class I radiation devices shall be issued by the department of ecology and environment of the State Council upon examination and approval.   第六条 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。
The licenses for entities other than those whose licenses shall be issued by the department of ecology and environment of the State Council upon examination and approval shall be issued by the departments of ecology and environment of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government upon examination and approval. 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。
The department of ecology and environment of the State Council shall, before issuing a license to an entity producing radioisotopes, print and submit the application materials to the competent industry department governing the applicant for opinions. 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。
The department of ecology and environment shall notify the public security department and competent department of health at the same level about the examination and approval of license applications and issuance of licenses. 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。
Article 7 To apply for a license, an entity producing, selling or using radioisotopes or radiation devices shall meet the following conditions:   第七条 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:
(1) having the professional technicians appropriate for its scale of production, sale or use, who have the corresponding expertise and protection knowledge and meet the health 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;
(2) having the places, facilities and equipment meeting the national environmental protection standards, occupational health standards and safety and protection requirements; (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;
(3) having a special safety and protection management body or full-time or part-time safety and protection managers, equipped with necessary protective equipment and monitoring instruments; (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;
(4) having sound safety and protection management regulations and rules and emergency response measures for radiation accidents; and (四)有健全的安全和防护管理规章制度、辐射事故应急措施;
(5) If generating radioactive waste gas, waste liquid or solid waste, having the treatment capacity or having a feasible treatment plan to ensure that the radioactive waste gas, waste liquid or solid waste are discharged up to the standard. (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。
Article 8 An entity producing, selling or using radioisotopes or radiation devices shall apply, in advance, for a license to the department of ecology and environment with the examination and approval power, and submit the evidential materials meeting the conditions as prescribed in Article 7 of this Regulation.   第八条 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。
A medical or health institution using radioisotopes or radiation devices for radiation diagnosis and therapy shall also obtain an institutional license for radioactive source diagnosis and therapy technologies and medical radiation. 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。
Article 9 The department of ecology and environment shall, within 20 workdays from the acceptance of an application, complete the examination. If the conditions are met, it shall issue a license to the applicant and make an announcement; otherwise, shall notify the applicant in writing and give reasons.   第九条 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。
Article 10 A license shall mainly contain:   第十条 许可证包括下列主要内容:
(1) the name, address and legal representative of the entity; (一)单位的名称、地址、法定代表人;
(2) the types and scope of activities of the entity; (二)所从事活动的种类和范围;
(3) the term of validity; and (三)有效期限;
(4) the date of issuance and serial number of the license. (四)发证日期和证书编号。
Article 11 Where an entity holding a license changes its name, address or legal representative, it shall, within 20 days from the date of modification registration, apply to the original license-issuing authority for conducting the license modification formalities.   第十一条 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。
Article 12 Under any of the following circumstances, an entity holding a license shall, under the original application procedures, reapply for a license:   第十二条 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:
(1) changing the types or scope of its activities; or (一)改变所从事活动的种类或者范围的;
(2) newly constructing, reconstructing or expanding any facility or place for production, sale or use. (二)新建或者改建、扩建生产、销售、使用设施或者场所的。
Article 13 A license shall be valid for five years. If the term of validity of a license needs to be renewed at the expiry of it, the entity holding the license shall, 30 days prior to the expiry of the term of validity of the license, submit an application for renewal to the original license-issuing authority. The original license-issuing authority shall, from the day of acceptance of the renewal application and before the expiry of the term of validity of the license, complete the examination. If the conditions are met, the original license-issuing authority shall renew the license; otherwise, shall notify the applicant in writing and give reasons.   第十三条 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。
Article 14 Where an entity holding a license terminates, partially or wholly, its activities of production, sale or use of radioisotopes or radiation devices, it shall submit an application to the original license-issuing authority for partial modification or cancellation of the license, and the original license-issuing authority shall modify or cancel the license upon verification.   第十四条 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。
Article 15 It shall be prohibited to be engaged in the production, sale or use of radioisotopes or radiation devices without a license or in violation of the types and scope as specified in a license.   第十五条 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 shall be prohibited to forge, tamper or transfer a license. 禁止伪造、变造、转让许可证。
Article 16 The competent department of foreign trade of the State Council shall, jointly with the department of ecology and environment of the State Council, the General Administration of Customs and the competent industry department governing the entities producing radioisotopes, formulate and publish a catalogue of radioisotopes restricted from import and export and a catalogue of radioisotopes prohibited from import and export.   第十六条 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。
For the import of any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export, the competent department of foreign trade of the State Council shall, after the examination and approval of the department of ecology and environment of the State Council, issue an import license according to the relevant provisions of the state on foreign trade. For the import of any radioisotope outside the catalogue of radioisotopes restricted from import and export and the catalogue of radioisotopes prohibited from import and export, the import formalities shall be handled according to the relevant provisions of the state on foreign trade. 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。
Article 17 To apply for importing any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export, the applicant shall meet the following requirements:   第十七条 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:
(1) The importing entity has obtained a license corresponding to its activities; (一)进口单位已经取得与所从事活动相符的许可证;
(2) The importing entity has a plan for disposing of the imported radioisotopes after the expiry of their usage period; if Class I, Class II or Class III radioactive sources are imported, it shall have a document of commitment that the original exporter is responsible for recovery; (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;
(3) The imported radioactive sources shall have clear labels and necessary descriptive documents; the labels of Class I, Class II and Class III radioactive sources shall be engraved on the bodies or the sealed shells of the radioactive sources, and the labels of Class IV and Class V radioactive sources shall be recorded in the corresponding descriptive documents; and (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;
(4) If the imported radioisotopes are sold to any other entity for use, the importing entity shall have a written agreement concluded with the entity using them and a photocopy of the license obtained by the entity using them. (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。
Article 18 An entity importing any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export shall submit an import application to the department of ecology and environment of the State Council, and provide the evidential materials meeting the requirements of Article 17 of this Regulation.   第十八条 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。
The department of ecology and environment of the State Council shall, within 10 workdays from the day of acceptance of an application, complete the examination. If the conditions are met, it shall make an approval; otherwise, shall notify the applicant in writing and give reasons. 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 customs office shall handle the relevant import formalities based on the import license for radioisotopes. Where the packaging materials of the imported radioisotopes are subject to quarantine according to law, the quarantine shall be implemented in accordance with the relevant laws and administrative regulations of the state on quarantine. 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。
For any imported radioactive source, the department of ecology and environment of the State Council shall determine the radioactive source code corresponding to its label at the same time. 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。
Article 19 To apply for transferring radioisotopes, the applicant shall meet the following requirements:   第十九条 申请转让放射性同位素,应当符合下列要求:
(1) The entities as the transferor and transferee shall hold the licenses corresponding to their activities; (一)转出、转入单位持有与所从事活动相符的许可证;
(2) The entity as the transferee shall have a plan for disposing of the radioisotopes after the expiry of their usage period; and (二)转入单位具有放射性同位素使用期满后的处理方案;
(3) Both parties to the transfer shall have concluded a written agreement on the transfer. (三)转让双方已经签订书面转让协议。
Article 20 To transfer radioisotopes, the entity as the transferee shall submit an application to the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and provide the evidential materials meeting the requirements of Article 19 of this Regulation.   第二十条 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。
The department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 15 workdays from the day of acceptance of the application, complete the examination. If the conditions are met, it shall make an approval; otherwise, shall notify the applicant in writing and give reasons. 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。
Article 21 The entities as the transferor and transferee of radioisotopes shall, within 20 days from the day of completion of the transfer, file a report on the transfer respectively with the departments of ecology and environment of the people's governments of provinces, autonomous regions or municipalities direct under the Central Government where they are located.   第二十一条 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。
Article 22 An entity producing radioisotopes shall maintain an account book of radioisotope products, and in accordance with the coding rules of the department of ecology and environment of the State Council, uniformly code its produced radioactive sources. The account book of radioisotope products and the coding list of radioactive sources shall be filed with the department of ecology and environment of the State Council.   第二十二条 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。
The produced radioactive sources shall have clear labels and necessary descriptive documents. In particular, the labels of Class I, Class II and Class III radioactive sources shall be engraved on the bodies or the sealed shells of radioactive sources, and the labels of Class IV and Class V radioactive sources shall be recorded in the corresponding descriptive documents. 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 department of ecology and environment of the State Council shall be responsible for establishing a radioisotope filing information management system to share information with the relevant departments. 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 radioisotopes not included in the product account book and uncoded radioactive sources shall not leave factory and be sold. 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。
Article 23 Where an entity holding radioactive sources returns any waste or used radioactive source to the production entity or the original exporter or delivers it for storage to an entity engaged in the centralized storage of radioactive wastes, it shall, within 20 days from the day of completion of the said activity, file a report on it with the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located.   第二十三条 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。
Article 24 For the radioisotopes produced and imported before the implementation of this Regulation, the entity holding the radioisotopes shall, within 6 months from the day when this Regulation comes into force, handle the filing formalities at the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government shall uniformly code the radioactive sources.   第二十四条 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。
Article 25 Where an entity using radioisotopes needs to displace the radioisotopes to another province, autonomous region or municipality directly under the Central Government for use, it shall handle the filing formalities at the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where the radioisotopes are to be used on the basis of a photocopy of its license, and accept the supervision and administration by the local department of ecology and environment.   第二十五条 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。
Article 26 To export any radioisotope included in the catalogue of radioisotopes restricted from import and export, the evidential materials indicating that the importer may legally hold the radioisotopes shall be provided, and the department of ecology and environment of the State Council shall, in accordance with the relevant laws and international treaties and agreements concluded or acceded to by China, handle the relevant formalities.   第二十六条 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。
The export of radioisotopes shall be governed by the relevant provisions of the state on foreign trade. 出口放射性同位素应当遵守国家对外贸易的有关规定。
Chapter III Safety and Protection 

第三章 安全和防护

Article 27 An entity producing, selling or using radioisotopes or radiation devices shall be responsible for the safety and protection of its radioisotopes or radiation devices, and be liable for the radioactive hazards caused by it according to law.   第二十七条 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。
The competent industry department governing the entities producing radioisotopes shall strengthen the administration of the safety and protection work of production entities, and conduct supervisory inspection on their implementation of laws, regulations and national standards on a regular basis. 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。
Article 28 An entity producing, selling or using radioisotopes or radiation devices shall provide the education and training on safety and protection knowledge for its personnel directly engaged in the activities of production, sale or use, and make assessment; and no person failing the assessment shall take any of such positions.   第二十八条 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。
The key positions on radiation safety shall be taken by the registered nuclear safety engineers. The directory of key positions on radiation safety shall be formulated and published by the department of ecology and environment of the State Council in consultation with the relevant departments of the State Council. 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。
Article 29 An entity producing, selling or using radioisotopes or radiation devices shall, strictly in accordance with the provisions of the state on personal dose monitoring and health management, conduct personal dose monitoring and occupational health examination of its personnel directly engaged in the activities of production, sale or use, and maintain personal dose files and occupational health care files.   第二十九条 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。
Article 30 An entity producing, selling or using radioisotopes or radiation devices shall conduct annual assessment of the status of safety and protection of its radioisotopes or radiation devices, and make rectification immediately after finding any safety risk.   第三十条 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。
Article 31 Where an entity producing, selling or using radioisotopes or radiation devices needs to be terminated, it shall conduct a clear-up and registration of its radioisotopes and radiation wastes and properly dispose of them in advance, and shall not leave any safety risk. Where an entity producing, selling or using radioisotopes or radiation devices is changed, the entity after the change shall be responsible for disposing of them, except as otherwise agreed on by the parties before the change; however, the agreement shall not relieve the parties from the obligation of disposal.   第三十一条 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。
For the waste or used radioactive sources and radioactive wastes not safely disposed of by an entity producing, selling or using radioisotopes or radiation devices which is terminated before this Regulation comes into force, the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located shall put forward a disposal plan, and timely dispose of them. The funds needed shall be appropriated by the people's government at or above the provincial level. 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。
Article 32 Where an entity producing or importing radioactive sources sells Class I, Class II or Class III radioactive sources to other entities for use, it shall conclude an agreement on recovery of waste or used radioactive sources with the entity using the radioactive sources; the entity using the radioactive sources shall, under the agreement on recovery of waste or used radioactive sources, return the waste or used radioactive sources to the production entity or original exporter. If it is indeed unable to return them to the production entity or original exporter, it shall deliver them for storage to a relevant qualified entity engaged in the centralized storage of radioactive wastes.   第三十二条 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。
The entity using the radioactive sources shall, according to the requirements of the department of ecology and environment of the State Council, pack up Class IV and Class V waste or used radioactive sources and deliver them for storage to a relevant qualified entity engaged in the centralized storage of radioactive waste. 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。
Article 33 The places using Class I, Class II and Class III radioactive sources, the places producing radioisotopes, and the radiation devices generating radioactive contamination after the end of operation shall be decommissioned according to law.   第三十三条 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。
Article 34 An place producing, selling, using or storing radioisotopes or radiation devices shall, in accordance with the relevant provisions of the state, set up obvious radioactive signs, and in accordance with the relevant national safety and protection standards, set up safety and protection facilities, necessary protection and safety interlocks, alarm devices or working signals at its entrance. The places of production adjustment and use of radiation devices shall have the safety measures for preventing misoperations and preventing their personnel and the general public from accidental irradiation.   第三十四条 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。
Obvious radioactive signs and warnings in Chinese shall be put on the packaging containers of radioisotopes and the equipment and radiation devices containing radioisotopes; where the radioactive signs can be put on the radioactive sources, they shall be put on at the same time. The obvious radioactive signs or danger signs shall be put on the transport vehicles of radioisotopes and radiation devices containing radioactive sources in accordance with the relevant provisions of the state. 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。
Article 35 Radioisotopes shall be kept separately, and shall not be kept together with inflammable, explosive, corrosive and other articles, and special persons in charge of keeping shall be designated. When radioisotopes are stored, taken, used or returned, they shall be registered and checked, so that the accounts correspond to the articles. The safety measures for preventing fire, water, theft, loss, sabotage and leakage of rays shall be taken at the storage places of radioisotopes.   第三十五条 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。
For the radioactive sources, the corresponding multi-layer protection and safety measures shall be established on the basis of the seriousness of their potential hazards, and the mobile radioactive sources shall be inventoried on a regular basis to ensure that they are in the specified locations and have reliable safeguards. 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。
Article 36 Where the radioisotopes or radiation devices are used outdoors or in the field, a safety and protection area shall be demarcated in accordance with the national safety and protection standards, obvious radioactive signs shall be set up, and when necessary, special persons shall be appointed for vigilance.   第三十六条 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。
A radioisotope tracer test shall not be carried out in the field without the approval of the department of ecology and environment of the people's government at or above the provincial level in consultation with the relevant departments. 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。
Article 37 The radiation protection equipment, equipment and radiation devices containing radioisotopes, products containing radioactive substances, and electrical products generating concomitant X-rays shall meet the requirements of radiation protection. Products not up to the standard shall not leave factory and be sold.   第三十七条 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。
Article 38 A medical or health institution using radioisotopes or radiation devices for radiation diagnosis and therapy shall, in accordance with the relevant provisions of the competent department of health of the State Council and the national standards, formulate a quality assurance plan appropriate for its items of diagnosis and therapy, comply with the quality assurance monitoring rules, and under the principle of “appropriate medical irradiation and optimal radiation protection”, avoid all unnecessary irradiation and notify in advance the patients and the examinees of the potential effects of radiation to health.   第三十八条 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。
Article 39 When recovering and smelting waste metals, a metal smelting plant shall take necessary monitoring measures to prevent radioactive substances from melting into its products. If any problem is found in the monitoring, it shall timely notify the department of ecology and environment of the people's government at or above the districted city level of the place where it is located.   第三十九条 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。
Chapter IV Emergency Disposal of Radiation Accidents 

第四章 辐射事故应急处理

Article 40 Based on the nature, severity, controllability, scope of impact and other factors of radiation accidents, radiation accidents may be divided, from high to low, into four grades: especially serious radiation accidents, serious radiation accidents, large radiation accidents and ordinary radiation accidents.   第四十条 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。
The term “especially serious radiation accident” means that any Class I or Class II radioactive source is lost, stolen or out of control, which results in a large extent of serious radioactive contamination, or that any radioisotope or radiation device is out of control, which results in the acute deaths of 3 or more people. 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。
The term “serious radiation accident” means that any Class I or Class II radioactive source is lost, stolen or out of control, or that any radioisotope or radiation device is out of control, which results in the acute deaths of 2 or less people or the severe acute radiation illnesses or certain disabled organs of 10 or more people. 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。
The term “large radiation accident” means that any Class III radioactive source is lost, stolen or out of control, or that any radioisotope or radiation device is out of control, which results in the severe acute radiation illnesses or certain disabled organs of 9 or less people. 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。
The term “ordinary radiation accident” means that any Class IV or Class V radioactive source is lost, stolen or out of control, or that any radioisotope or radiation device is out of control, which results in the irradiation of people beyond the annual dose limit. 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。
Article 41 The department of ecology and environment of the people's government at or above the county level shall, jointly with the public security department, health department, department of public finance and other departments at the same level, work out a radiation emergency preparedness plan, and report it to the people's government at the same level for approval. A radiation emergency preparedness plan shall cover:   第四十一条 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:
(1) the emergency response body and division of functions; (一)应急机构和职责分工;
(2) the organization and training of emergency personnel and the equipment, funds and material preparations for emergency response and relief; (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;
(3) the grading of radiation accidents and emergency response measures; and (三)辐射事故分级与应急响应措施;
(4) the procedures for the investigation, reporting and disposal of radiation accidents. (四)辐射事故调查、报告和处理程序。
An entity producing, selling or using radioisotopes or radiation devices shall, according to the possible risks of radiation accidents, work out its own emergency preparedness plan and make good preparation for emergency response. 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。
Article 42 When a radiation accident occurs, the entity producing, selling or using radioisotopes or radiation devices shall immediately start up its emergency plans, take emergency measures, and immediately report to the local department of ecology and environment, public security department and competent department of health.   第四十二条 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。
The department of ecology and environment, public security department and competent department of health shall, after receiving the report of any radiation accident, immediately send persons to the spot to conduct on-the-spot investigation, take effective measures to control and eliminate the impact of accident, and at the same time, report the information on the radiation accident to the people's government at the same level and the department of ecology and environment, public security department and competent department of health of the people's government at the next higher level. 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。
After receiving the report of any radiation accident, the local people's government at or above the county level and the relevant departments thereof shall, under the provisions on classified reporting of accidents, timely report the information on the radiation accident to the people's government at the next higher level and the relevant departments thereof. After the occurrence of any especially serious radiation accident or any serious radiation accident, the people's government of a province, autonomous region or municipality directly under the Central Government where the accident occurs and the relevant departments of the State Council shall report to the State Council within 4 hours; under special circumstances, the people's government of the place where the accident occurs and the relevant departments thereof may directly report to the State Council, and at the same time, report to the people's government at the next higher level and the relevant departments thereof. 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。
It shall be prohibited to make any delay, concealment, falsehood, or omission in the reporting of radiation accidents. 禁止缓报、瞒报、谎报或者漏报辐射事故。
Article 43 When a radiation accident occurs or there is any evidence that a radiation accident is likely to occur, the department of ecology and environment of the people's government at or above the county level shall have the power to take the following interim control measures: 请你喝茶  第四十三条 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:
(1) ordering the stop of an operation causing or likely to cause any radiation accident; and (一)责令停止导致或者可能导致辐射事故的作业;
(2) organizing the control of the accident scene. (二)组织控制事故现场。
Article 44 At the occurrence of a radiation accident, the relevant people's government at or above the county level shall, according to the grade of the radiation accident, start up and organize the implementation of the corresponding emergency preparedness plan.   第四十四条 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。
The department of ecology and environment, the public security department and the competent department of health of the people's government at or above the county level shall, in accordance with their respective functions, do a good job in the corresponding emergency responses to radiation accidents: 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:
(1) The department of ecology and environment shall be responsible for the emergency response to and the investigation, disposal, determination of the nature and grade of a radiation accident, and assist the public security department in monitoring and recovering the lost or stolen radioactive sources; (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;
(2) The public security department shall be responsible for the case filing, investigation and recovery of lost and stolen radioactive sources; and (二)公安部门负责丢失、被盗放射源的立案侦查和追缴;
(3) The competent department of health shall be responsible for the medical emergency response to a radiation accident. (三)卫生主管部门负责辐射事故的医疗应急。
The department of ecology and environment, the public security department and the competent department of health shall timely notify each other of the information on the emergency responses to, the investigation, disposal, determination of the nature and grade, case filing and investigation of and the medical emergency response to a radiation accident. The department designated by the State Council shall, according to the nature and grade of a radiation accident as determined by the department of ecology and environment, be responsible for the notification of relevant international information. 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。
Article 45 An entity in which a radiation accident occurs shall immediately send the persons who may suffer from radiation damage to the hospital designated by the local competent department of health or the hospital which is qualified to treat patients with radiation injuries to have them examined and treated, or request the hospital to immediately send staff to the accident scene to take treatment measures.   第四十五条 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。
Chapter V Supervisory Inspection 

第五章 监督检查

Article 46 The departments of ecology and environment and the relevant departments of the people's governments at and above the county level shall, in accordance with their respective functions, conduct supervisory inspection of the entities producing, selling or using radioisotopes or radiation devices.   第四十六条 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 inspected entities shall cooperate, report the true information, and provide necessary materials, and shall not reject or obstruct the inspection. 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。
Article 47 The department of ecology and environment of the people's government at or above the county level shall be equipped with radiation protection and safety supervisors. The position of radiation protection and safety supervisor shall be taken by the professionals who are engaged in radiation protection, have the radiation protection and safety knowledge and are recognized by the department of ecology and environment of the people's government at or above the provincial level. The radiation protection and safety supervisors shall receive training and assessment on expertise on a regular basis.   第四十七条 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。
Article 48 Where, in the supervisory inspection, the department of ecology and environment of the people's government at or above the county level finds that any entity producing, selling or using radioisotopes or radiation devices fails to comply with the original conditions for issuing a license, it shall order such an entity to make rectification within a prescribed time limit.   第四十八条 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。
The supervisory inspection officers shall, when conducting the supervisory inspection according to law, show their certificates, and keep confidential the technical secrets and business secrets of the inspected entities. 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。
Article 49 Any entity or individual shall have the right to report any violation of this Regulation to the department of ecology and environment and other relevant departments; and have the right to report any failure of the department of ecology and environment and other relevant departments to legally perform their duties of supervision and administration to the people's government at the same level and the relevant department of the people's government at the next higher level. The relevant people's government, department of ecology and environment and other relevant departments receiving such reports shall timely verify and handle them.   第四十九条 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。
Chapter VI Legal Liability 

第六章 法律责任

Article 50 Where, in violation of this Regulation, the department of ecology and environment of the people's government at or above the county level commits any of the following acts, the directly responsible person in charge and other directly liable persons shall be given administrative sanctions; if a crime is constituted, they shall be subject to the criminal liability:   第五十条 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:
(1) issuing a license to an entity not meeting the conditions as prescribed in this Regulation or approving an entity not meeting the conditions as prescribed in this Regulation to import or transfer radioisotopes; (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;
(2) After finding that any entity without a lawful license produces, sells or uses radioisotopes or radiation devices without authorization, failing to investigate and punish it, or after receiving a report on such an activity, failing to handle it according to law; (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;
(3) after finding that any entity imports or transfers radioisotopes without a lawful approval, failing to investigate and punish it, or after receiving an report on such an activity, failing to handle it according to law; (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;
(4) failing to perform the duties of supervision and administration of the entities with lawful licenses, or after finding any act in violation of this Regulation, failing to investigate and punish it; or (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;
(5) any other misfeasance in the supervision and administration of the safety and protection of radioisotopes and radiation devices. (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。
Article 51 Where, in violation of this Regulation, the department of ecology and environment or any other relevant department of the people's government at or above the county level commits any of the following acts, the directly responsible person in charge and other directly liable persons shall be given administrative sanctions; if a crime is constituted, they shall be subject to the criminal liability:   第五十一条 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:
(1) making any delay, concealment, falsehood or omission in the reporting of radiation accidents; or (一)缓报、瞒报、谎报或者漏报辐射事故的;
(2) failing to work out an emergency response preparedness plan for radiation accidents according to the relevant provisions, or failing to legally perform the duties of emergency response to radiation accidents. (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。
Article 52 Where, in violation of this Regulation, any entity producing, selling or using radioisotopes or radiation devices commits any of the following acts, the department of ecology and environment of the people's government at or above the county level shall order it to stop the violation and make a correction within a prescribed time limit; if the entity fails to make a correction within the time limit, shall order cessation of its production or business, or its license shall be revoked by the original license-issuing authority; if there is any illegal income, shall confiscate such illegal income; if the illegal income is 100,000 yuan or more, shall impose a fine of not less than the amount but not more than five times the amount of the illegal income on it; if there is no illegal income or the illegal income is less than 100,000 yuan, shall impose a fine of not less than 10,000 yuan but not more than 100,000 yuan on it:   第五十二条 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:
(1) being engaged in the production, sale or use of radioisotopes or radiation devices without a license; (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;
(2) failing to be engaged in the production, sale or use of radioisotopes or radiation devices in accordance with the provisions of the 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;
(3) when changing the types or scope of its activities or newly constructing, reconstructing or expanding any facility or place for production, sale or use, failing to reapply for a license according to the relevant provisions; (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;
(4) where a license needs to be renewed at the expiry of its term of validity, failing to handle the renewal formalities according to the relevant provisions; or (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;
(5) importing or transferring radioisotopes without approval. (五)未经批准,擅自进口或者转让放射性同位素的。
Article 53 Where, in violation of this Regulation, any entity producing, selling or using radioisotopes or radiation devices fails to handle the license modification formalities according to law when changing its name, address or legal representative, the department of ecology and environment of the people's government at or above the county level shall order it to make a correction within a prescribed time limit, and give it a warning; if it fails to make a correction within the time limit, its license shall be temporarily detained or be revoked by the original license-issuing authority.   第五十三条 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。
Article 54 Where, in violation of this Regulation, any entity producing, selling or using radioisotopes or radiation devices fails to handle the license modification or cancellation formalities according to the relevant provisions when terminating partially or wholly its activities of production, sale or use, the department of ecology and environment of the people's government at or above the county level shall order it to stop the violation and make a correction within a prescribed time limit, and if it fails to make a correction within the time limit, shall impose a fine of not less than 10,000 yuan but not more than 100,000 yuan on it; if any radiation accident is caused and a crime is constituted, it shall be subject to the criminal liability.   第五十四条 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。
Article 55 Where, in violation of this Regulation, any entity forges, tampers or transfers a license, the department of ecology and environment of the people's government at or above the county level shall capture the forged or tampered license or the original license-issuing authority shall revoke its license, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan on the violator; if a crime is constituted, the violator shall be subject to the criminal liability.   第五十五条 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, in violation of this Regulation, any entity forges, tampers or transfers the approval documents for the import or transfer of radioisotopes, the department of ecology and environment of the people's government at or above the county level shall capture the forged or tampered approval documents or the original approval authority shall revoke the approval documents, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan on the violator; if the circumstances are serious, the original license-issuing authority may revoke the license; if a crime is constituted, the violator shall be subject to the criminal liability. 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。
Article 56 Where, in violation of this Regulation, any entity producing, selling or using radioisotopes commits any of the following acts, the department of ecology and environment of the people's government at or above the county level shall order it to make a correction within a prescribed time limit, and give it a warning; if it fails to make a correction within the time limit, its license shall be temporarily detained or be revoked by the original license-issuing authority:   第五十六条 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:
(1) failing to file a report according to the relevant provisions when transferring any radioisotope in or out; (一)转入、转出放射性同位素未按照规定备案的;
(2) failing to file a report according to the relevant provisions when transferring any radioisotope to any other province, autonomous region or municipality directly under the Central Government for use; or (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;
(3) failing to file a report according to the relevant provisions when returning any waste or used radioactive source to the production entity or original exporter or delivering them for storage to an entity engaged in the centralized storage of radioactive wastes. (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。
Article 57 Where, in violation of this Regulation, any entity producing, selling or using radioisotopes or radiation devices commits any of the following acts, the department of ecology and environment of the people's government at or above the county level shall order it to stop the violation and make a correction within a prescribed time limit; and if it fails to make a correction within the time limit, shall impose a fine of not less than 10,000 yuan but not more than 100,000 yuan on it:   第五十七条 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:
(1) when using any radioisotope or radiation device outdoors or in the field, failing to demarcate a safety and protection area and set up the obvious radioactive signs in accordance with the relevant national safety and protection standards; or (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;
(2) conducting a radioisotope tracer test in the field without approval. (二)未经批准擅自在野外进行放射性同位素示踪试验的。
Article 58 Where, in violation of this Regulation, any entity producing radioisotopes commits any of the following acts, the department of ecology and environment of the people's government at or above the county level shall order it to make a correction within a prescribed time limit, and give it a warning; if it fails to make a correction within the time limit, shall capture its radioisotopes which are not reported for filing purpose and uncoded radioactive sources according to law, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan on it, while its license may be temporarily detained or be revoked by the original license-issuing authority:   第五十八条 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:
(1) failing to maintain an account book of its radioisotope products; (一)未建立放射性同位素产品台账的;
(2) failing to uniformly code its produced radioactive sources according to the coding rules formulated by the department of ecology and environment of the State Council; (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;
(3) failing to file the account book of its radioisotope products and the coding list of radioactive sources with the department of ecology and environment of the State Council; or (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;
(4) allowing any radioisotope not included in its product account book or any uncoded radioactive source to leave factory or selling the same. (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。
Article 59 Where, in violation of this Regulation, any entity producing, selling or using radioisotopes or radiation devices commits any of the following acts, the department of ecology and environment of the people's government at or above the county level shall order it to stop the violation and make a correction within a prescribed time limit; if it fails to make a correction within the time limit, the original license-issuing authority shall designate an entity capable of disposal to make the disposal or decommissioning on behalf of the violator, the fees shall be borne by the entity producing, selling or using radioisotopes or radiation devices, and a fine of not less than 10,000 yuan but not more than 100,000 yuan shall be imposed on the violator:   第五十九条 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:
(1) failing to dispose of any waste or used radioactive source according to the relevant provisions; or (一)未按照规定对废旧放射源进行处理的;
(2) failing to decommission any place using Class I, Class II or Class III radioactive source, any place producing radioisotopes, or any radiation device producing radioactive contamination after the end of operation, according to the relevant provisions. (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。
Article 60 Where, in violation of this Regulation, any entity producing, selling or using radioisotopes or radiation devices commits any of the following acts, the department of ecology and environment of the people's government at or above the county level shall order it to stop the violation and make a correction within a prescribed time limit; and if it fails to make a correction within the time limit, shall order cessation of its production or business, and impose a fine of not less than 20,000 yuan but not more than 200,000 yuan on it; if a crime is constituted, it shall be subject to the criminal liability:   第六十条 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:
(1) failing to assess the status of safety and protection of its radioisotopes or radiation devices according to the relevant provisions, or failing to make timely rectification after finding any hidden safety risk; or (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;
(2) failing to set up safety and protection facilities and radioactive signs at the places of production, sale, use or storage of radioisotopes or radiation devices according to the relevant provisions. (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。
Article 61 Where, in violation of this Regulation, any entity causes a radiation accident, the original license-issuing authority shall order it to make a correction within a prescribed time limit, and impose a fine of not less than 50,000 yuan but not more than 200,000 yuan on it; if the circumstances are serious, the original license-issuing authority shall revoke its license; if any violation of the public security administration is constituted, the public security organ shall impose a public security punishment according to law; if a crime is constituted, it shall be subject to the criminal liability.   第六十一条 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。
If any damage is caused to any other person due to a radiation accident, it shall assume the civil liability according to law. 因辐射事故造成他人损害的,依法承担民事责任。
Article 62 Where any entity producing, selling or using radioisotopes or radiation devices is ordered to make rectification within a prescribed time limit, and it fails to do so within the time limit or fails to meet the original conditions for issuing a license even after rectification, the original license-issuing authority shall temporarily detain or revoke its license.   第六十二条 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。
Article 63 An entity whose license is legally revoked for any violation of this Regulation or which forges or tampers a license shall not apply for a license within five years.   第六十三条 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。
Article 64 The division of powers to impose administrative punishment of the departments of ecology and environment of the local people's governments at and above the county level shall be determined by the people's government of a province, autonomous region or municipality directly under the Central Government.   第六十四条 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。
Chapter VII Supplementary Provisions 

第七章 附  则

Article 65 The supervision and administration of the safety and protection of military radioisotopes and radiation devices shall be governed by Article 60 of the Law of the People's Republic of China on the Prevention and Control of Radioactive Pollution .   第六十五条 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。
Article 66 The prevention and control of occupational diseases caused to workers by their contact with radioisotopes and radiation devices in the occupational activities shall governed by the Law of the People's Republic of China on the Prevention and Control of Occupational Diseases我不休息我还能学 and the relevant provisions of the State Council.   第六十六条 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。
Article 67 The transportation of radioisotopes and the disposal of radioactive wastes generated in the processes of production, sale and use of radioisotopes and radiation devices shall be governed by the relevant provisions of the State Council.   第六十七条 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。
Article 68 The following terms as used in this Regulation shall have the following meanings respectively:   第六十八条 本条例中下列用语的含义:
The term “radioisotopes” refers to the nuclide in a certain element with radioactive decay, which has the same atomic number but different mass. 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。
The term “radioactive sources” refers to the solid radioactive materials permanently sealed in containers or tightly wrapped, other than the materials in the category of nuclear fuel circulation in research reactors and power reactors. 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。
The term “radiation devices” refers to X-ray devices, accelerators, neutron generators and other devices containing radioactive sources. 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。
The term “unsealed radioactive substances” refers to the radioactive substances which are not permanently sealed in the shell or do not tightly solidify in the cover layer. 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。
The term “transfer” refers to the transfer of the ownership of or the use right to any radioisotope between different holders, excluding import, export and recovery activities. 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。
The term “electrical products generating concomitant X-rays” refers to the electrical products which, not for the purpose of generating X-rays, generate X-rays in the process of production or use of them. 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。
The term “radiation accident” refers to the loss, theft or loss of control of any radioactive source or the accidental abnormal irradiation caused by the loss of control of any radioisotope or radiation device. 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。
Article 69 This Regulation shall come into force on December 1, 2005. The Regulation on the Protection against Radiation from Radioisotopes and Radiation Devices promulgated by the State Council on October 24, 1989 shall be abolished simultaneously.   第六十九条 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。
     
     
Scan QR Code and Read on Mobile
【法宝引证码】        北大法宝en.pkulaw.cn
Message: Please kindly comment on the present translation.
 
Confirmation Code:
Click image to reset code
 
  Translations are by lawinfochina.com, and we retain exclusive copyright over content found on our website except for content we publish as authorized by respective copyright owners or content that is publicly available from government sources.

Due to differences in language, legal systems, and culture, English translations of Chinese law are for reference purposes only. Please use the official Chinese-language versions as the final authority. Lawinfochina.com and its staff will not be directly or indirectly liable for use of materials found on this website.

We welcome your comments and suggestions, which assist us in continuing to improve the quality of our materials as we dynamically expand content.
 
Home | About us | Disclaimer | Chinese