Royal Decree 601/2019 on justification and optimization: Practical aspects

M.M. Pérez-Peña del Llano , F. Matute Teresa , Á. Morales Santos
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Abstract

The Royal Decree 601/2019 of 18th October is the result of the partial transposition into the Spanish legal system of the Euratom Directive 59/2013. This Royal Decree includes the mandates of the Directive related to the need to justify and optimize medical exposure, including that of asymptomatic people, proposal of stricter requirements regarding the information that must be provided to the patient, registration and notification of the doses of medical-radiological procedures, use of reference levels for diagnosis and the availability of dose-indicating devices. The article reviews the most relevant aspects and novelties related to the principles of justification, optimization, dose control and the obligations derived from the right to information and consent. This Royal Decree considers essential for radiologists to develop a high level of competence and a new list of responsibilities and functions, which are detailed and analysed in this article.

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关于合理化和优化的第601/2019号皇家法令:实践方面
10月18日的第601/2019号皇家法令是欧洲原子能共同体第59/2013号指令部分纳入西班牙法律体系的结果。该皇家法令包括与证明和优化医疗暴露(包括无症状人群的医疗暴露)的必要性相关的指令授权,关于必须向患者提供的信息的更严格要求的建议,医疗放射程序剂量的登记和通知,用于诊断的参考水平的使用以及剂量指示装置的可用性。本文回顾了与正当性、最优化、剂量控制原则以及知情权和同意权所产生的义务有关的最相关的方面和新颖之处。这项皇家法令认为,放射科医生必须培养高水平的能力和新的职责和职能清单,本文对此进行了详细分析。
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