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2005年国务院颁布的《放射性同位素与射线装置安全和防护条例》第8条第2款规定,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,应当获得放射源诊疗技术和医用辐射机构许可。为加强放射诊疗工作的管理,保证医疗质量和医疗安全,保障放射诊疗工作人员、患者和公众的健康权益,卫生部于2006年发布了《放射诊疗管理规定》〔1〕和《放射诊疗许可证发放管理程序》〔2〕,对使用放射性同位素、射线装置进行临床医学诊断、治疗和健康检查的放射诊疗活动进行许可管理。经过这些年的实施有一些问题值得讨论。
Article 2, paragraph 2, of the “Regulations on Safety and Protection of Radioisotopes and Radiators” promulgated by the State Council in 2005 stipulates that medical and health institutions that use radioisotopes and radiation devices for radiation diagnosis and treatment shall obtain the permission of radioactive sources diagnosis and treatment technologies and medical radiation agencies. In order to strengthen the management of radiological diagnosis and treatment work, ensure medical quality and medical safety, and ensure the health rights and interests of radiologists, patients and the general public, the Ministry of Health issued the “Provisions on Radiological Examination and Management” (1) and the “Radiology Medical and Medical Examination Permit Dispensation Management Procedures ”(2) Permitting management of radiological diagnosis and treatment activities for clinical diagnosis, treatment and health examination using radioactive isotopes and radiation devices. After some years of implementation there are some issues worth discussing.