Regulations on the Administration of Radiological Diagnosis and Treatment
Chinese People's **** and State Ministry of Health Decree No. 46
Minister Gao Qiang
January 24, 2006
Modified on January 19, 2016 in accordance with the "Decision of the National Health and Family Planning Commission on the Revision of the Interim Management Measures for Short-Term Practice of Medicine by Foreign Doctors in China and Other 8 Departmental Rules and Regulations" (National Health and Family Planning Commission Decree No. 8)
Chapter I General Provisions
Article 1 In order to strengthen the management of radiological diagnosis and treatment, to ensure medical quality and safety, and to safeguard the health rights and interests of radiological diagnosis and treatment staff, patients and the public, based on the Prevention and Control of Occupational Diseases Law of the People's Republic of China, the Regulations on the Safety and Protection of Radioisotopes and Radiological Devices and the Regulations on the Administration of Healthcare Institutions and other laws and administrative regulations. Regulations on the Management of Medical Institutions" and other laws and administrative regulations, the formulation of these provisions.
Article 2 of the provisions of this regulation applies to carry out radiological diagnosis and treatment of medical institutions.
The radiotherapy work referred to in these provisions refers to the use of radioisotopes, radiation devices for clinical medical diagnosis, treatment and health examination activities.
Article 3 of the Ministry of Health is responsible for the national supervision and management of radiotherapy work.
Local people's governments at or above the county level, the administrative department of health is responsible for the supervision and management of radiological diagnosis and treatment work in the administrative region.
Article 4 of the radiotherapy work in accordance with the diagnosis and treatment of risk and technical difficulty is divided into four categories of management:
(a) radiation therapy;
(b) nuclear medicine;
(c) interventional radiology;
(d) X-ray diagnostic imaging.
Medical institutions to carry out radiological diagnosis and treatment work, should have the radiological diagnosis and treatment work carried out by its appropriate conditions, by the location of the local health administrative department at or above the county level of radiological diagnosis and treatment technology and medical radiation agency licensing (hereinafter referred to as radiological diagnosis and treatment licensing).
Article 5 of the medical institutions shall take effective measures to ensure radiation protection, safety and quality of radiation therapy in accordance with relevant regulations, standards and norms.
Chapter II conditions of practice
Article VI of the medical institutions to carry out radiological diagnosis and treatment work, should have the following basic conditions:
(a) with the approved registration of medical imaging diagnosis and treatment subjects;
(b) in line with the relevant national standards and regulations of radiological diagnosis and treatment of premises and supporting facilities;
(c) quality control and safety protection of special (part-time) managers. (C) has quality control and safety protection of full-time (part-time) management personnel and management system, and is equipped with the necessary protective equipment and monitoring instruments;
(D) the generation of radioactive waste gas, waste liquids, solid waste, has to ensure that the radioactive waste gas, waste, solid waste discharge capacity or feasible treatment program;
(E) has a radiological incident emergency response plan.
Article VII of the medical institutions to carry out different categories of radiological diagnosis and treatment work, shall have the following personnel:
(1) to carry out radiation therapy work, shall have:
1. Intermediate or higher professional and technical qualifications of radiation oncologists;
2. Pathology, medical imaging professionals and technicians;
3. Medical physicists with bachelor's degree or above or intermediate or above professional and technical job qualifications;
4. Radiation therapy technicians and maintenance personnel.
(2) to carry out nuclear medicine, should have:
1. Intermediate or higher professional and technical qualifications of nuclear medicine physician;
2. Pathology, medical imaging professionals and technicians;
3. Undergraduate degree or above, or intermediate or above, professional and technical qualifications of technicians or nuclear medicine technicians.
(C) to carry out interventional radiology work, should have:
1. Undergraduate degree or above, or intermediate or above professional and technical qualifications of radiographers;
2. Radiographic technologists;
3. Relevant medical and surgical professionals and technicians.
(d) to carry out diagnostic X-ray imaging work, should have a professional radiographer.
Article VIII of the medical institutions to carry out different types of radiotherapy work, should have the following equipment:
(1) to carry out radiation therapy work, at least one tele-radiotherapy device, and simulation of localization equipment and the corresponding treatment planning system and other equipment;
(2) to carry out the work of nuclear medicine, with nuclear medicine equipment and other related equipment;
(C) to carry out interventional radiology work, with a medical diagnostic X-ray machine with image intensifier, digital subtraction device and other equipment;
(D) to carry out diagnostic X-ray imaging work, there are medical diagnostic X-ray machine or CT machine and other equipment.
Article IX of the medical institutions shall be equipped with and use of safety protection devices, radiation detection instruments and personal protective equipment in accordance with the following requirements:
(a) radiation therapy sites should be set up in accordance with the appropriate standards of multiple safety interlock systems, dose monitoring systems, image monitoring, intercom devices and fixed dose monitoring alarm devices; equipped with radiotherapy dosimeters, dose scanning devices and personal Dose alarms;
(B) to carry out nuclear medicine work, with specialized radioisotope dispensing, injection, storage sites, radioactive waste shielding equipment and storage sites; equipped with activity meter, radioactive surface contamination monitors;
(C) interventional radiology and other X-ray imaging diagnostic workplaces should be equipped with staff protective equipment and personal protective equipment for the examinee. (d) The X-ray imaging workplace should be equipped with staff protective equipment and personal protective equipment for the examinee.
Article 10 of the medical institutions shall set up conspicuous warning signs for the following equipment and places:
(a) equipment and containers containing radioisotopes and radioactive waste, with the sign of ionizing radiation;
(b) radioisotopes and radioactive waste storage sites, with a warning sign of ionizing radiation and the necessary text description;
(c) Radiological diagnosis and treatment of the entrance to the workplace, there is a warning sign of ionizing radiation;
(d) radiological diagnosis and treatment of the workplace should be in accordance with the requirements of the relevant standards are divided into the control area, the supervision area, the import and export of the control area and other appropriate location, there is a warning sign of ionizing radiation and the work of the indicator light.