Simeonov Georgi
European Commission DG ENER-D3 Radiation Protection, Office EUFO 04/4178, Luxembourg L-2920, Luxembourg
Radiat Prot Dosimetry. 2015 Jul;165(1-4):34-8. doi: 10.1093/rpd/ncv031. Epub 2015 Apr 12.
The recently published Council Directive 2013/59/Euratom ('new European Basic Safety Standards', EU BSS) modernises and consolidates the European radiation protection legislation by taking into account the latest scientific knowledge, technological progress and experience with implementing the current legislation and by merging five existing Directives into a single piece of legislation. The new European BSS repeal previous European legislation on which the national systems for radiation protection in medicine of the 28 European Union (EU) Member States are based, including the 96/29/Euratom 'BSS' and the 97/43/Euratom 'Medical Exposure' Directives. While most of the elements of the previous legislation have been kept, there are several legal changes that will have important influence over the regulation and practice in the field all over Europe-these include, among others: (i) strengthening the implementation of the justification principle and expanding it to medically exposed asymptomatic individuals, (ii) more attention to interventional radiology, (iii) new requirements for dose recording and reporting, (iv) increased role of the medical physics expert in imaging, (v) new set of requirements for preventing and following up on accidents and (vi) new set of requirements for procedures where radiological equipment is used on people for non-medical purposes (non-medical imaging exposure). The EU Member States have to enforce the new EU BSS before January 2018 and bring into force the laws, regulations and administrative provisions necessary to comply with it. The European Commission has certain legal obligations and powers to verify the compliance of the national measures with the EU laws and, wherever necessary, issue recommendations to, or open infringement cases against, national governments. In order to ensure timely and coordinated implementation of the new European legal requirements for radiation protection, the Commission is launching several actions including promotion and dissemination activities, exchange and discussion fora and provision of guidance. These actions will be based on previous experiences and will rely on the results of recent and ongoing EU-funded projects. Important stakeholders including the Euratom Article 31 Group, the association of the Heads of European Radiological protection Competent Authorities (HERCA) and different European professional and specialty organisations will be involved.
最近公布的欧盟理事会指令2013/59/Euratom（“新欧洲基本安全标准”，欧盟BSS）通过考虑最新科学知识、技术进步以及当前立法实施方面的经验，并将五项现有指令合并为一项单一立法，对欧洲辐射防护立法进行了现代化和整合。新欧洲BSS废除了此前28个欧盟成员国医学辐射防护国家体系所依据的欧洲立法，包括96/29/Euratom“BSS”指令和97/43/Euratom“医疗照射”指令。虽然此前立法的大部分内容得以保留，但有几项法律变更将对全欧洲该领域的监管和实践产生重要影响，其中包括：（i）加强正当性原则的实施并将其扩展至医学照射的无症状个体，（ii）更多关注介入放射学，（iii）剂量记录和报告的新要求，（iv）医学物理专家在成像方面的作用增强，（v）预防和跟进事故的新要求集，以及（vi）在将放射设备用于非医疗目的人群（非医疗成像照射）的程序方面的新要求集。欧盟成员国必须在2018年1月之前执行新的欧盟BSS，并实施必要的法律、法规和行政规定以确保合规。欧盟委员会有某些法律义务和权力来核查国家措施是否符合欧盟法律，并在必要时向各国政府发出建议或开启违规调查程序。为确保及时、协调地实施欧洲关于辐射防护的新法律要求，委员会正在开展多项行动，包括推广和传播活动、交流和讨论论坛以及提供指导。这些行动将基于以往经验，并依赖近期和正在进行的欧盟资助项目的成果。重要利益相关者，包括Euratom第31条小组、欧洲放射防护主管当局负责人协会（HERCA）以及不同的欧洲专业和专业组织都将参与其中。
