Article 2 These Provisions shall apply to the health examination activities such as radiation protection evaluation and audit of occupational hazards in radiation diagnosis and treatment construction projects, and completion and acceptance of radiation protection facilities.
Third local health administrative departments at or above the county level shall be responsible for the health examination of radiation diagnosis and treatment construction projects within their respective jurisdictions.
The provincial health administrative department is responsible for the health examination of radiotherapy and nuclear medicine construction projects.
The municipal public health administrative department is responsible for the health examination of interventional radiology construction projects.
The health administrative department at the county level is responsible for the health examination of X-ray image diagnosis construction projects.
The health examination of different types of radiation diagnosis and treatment construction projects in the same medical institution shall be undertaken by the health administrative department with higher approval authority.
The provincial health administrative department may adjust the examination and approval authority according to the actual situation in the region.
Article 4 Radiological diagnosis and treatment construction projects are divided into two categories: serious hazards and general hazards according to the possible radioactive hazards and diagnosis and treatment risks.
The serious radiation diagnosis and treatment construction projects include stereotactic radiotherapy devices (γ knife, X knife, etc.). ), electron linac, proton therapy device, heavy ion therapy device, cobalt -60 therapy device, neutron therapy device and afterloading therapy device, positron emission computed tomography (PET) and single photon emission computed tomography (SPECT), and nuclear medical facilities using radiopharmaceuticals. Other radiation diagnosis and treatment construction projects are general hazards.
Article 5 The construction unit shall, at the feasibility demonstration stage and before the completion acceptance, respectively entrust the radiation health technical service institutions with corresponding qualifications to prepare the radiation protection pre-evaluation report of occupational hazards and the radiation protection evaluation report of occupational hazards control effect of radiation diagnosis and treatment construction projects.
Radiological protection evaluation of stereotactic radiotherapy device, proton therapy device, heavy ion therapy device, neutron therapy device, positron emission computed tomography (PET) and other construction projects shall be undertaken by radiation health technical service institutions that have obtained Grade A evaluation qualification.
Article 6 The radiation protection evaluation report of occupational hazards in radiation diagnosis and treatment construction projects is divided into evaluation report and evaluation report form. For construction projects with serious radioactive hazards, an evaluation report shall be prepared. For construction projects with general radioactive hazards, an evaluation report form shall be prepared. At the same time, construction projects with different types of radioactive hazards should prepare evaluation reports according to the more serious categories.
Article 7 The construction unit shall apply to the administrative department of health for pre-evaluation and audit of radiation occupational disease prevention of the construction project before the construction of radiation diagnosis and treatment projects, and submit the following materials:
(a) the application form for pre-evaluation and audit of occupational hazards of radiation protection in radiation diagnosis and treatment construction projects;
(2) Pre-evaluation report on radiation protection of occupational hazards in radiation diagnosis and treatment construction projects;
(3) If the application is entrusted, a certificate of entrustment shall be provided;
(four) other information as prescribed by the provincial health administrative department.
Article 8 Before applying to the health administrative department for examination, the radiation protection pre-evaluation report on occupational hazards of radiation diagnosis and treatment construction projects with serious hazards shall be examined by the radiation health technical service institution undertaking the evaluation, and the experts drawn from the radiation health technical evaluation expert database shall not be less than three fifths of the total number of experts.
To evaluate the pre-evaluation reports of stereotactic radiotherapy device, proton therapy device, heavy ion therapy device, neutron therapy device and positron emission computed tomography (PET) and other projects, the experts drawn from the national radiological health technology evaluation expert database shall be no less than two fifths of the total number of experts.
Whether the pre-evaluation report of radiation protection occupational hazards of radiation diagnosis and treatment construction projects with general hazards needs expert review shall be determined by the provincial health administrative department.
The composition of experts, the opinions of experts, the handling of opinions and the review opinions of the expert group shall be taken as the annex of the pre-evaluation report.
Article 9 The administrative department of health shall complete the pre-evaluation audit within 20 days from the date of acceptance. The examination and approval, give a reply; If the audit does not agree, it shall notify the construction unit in writing and explain the reasons.
Article 10 After the completion of a radiation diagnosis and treatment construction project, the construction unit shall apply to the health administrative department that reviews the pre-evaluation of radiation protection against occupational hazards of the construction project for completion acceptance, and submit the following materials:
(a) the application form for the completion and acceptance of the occupational disease prevention facilities of the radiation diagnosis and treatment construction project;
(two) radiation protection evaluation report on the control effect of occupational hazards in radiation diagnosis and treatment construction projects;
(3) Proof materials for pre-evaluation and audit of occupational hazards in radiation diagnosis and treatment construction projects (photocopies);
(4) If the application is entrusted, a certificate of entrustment shall be provided;
(five) other information as prescribed by the provincial health administrative department.
Article 11 After accepting the application for completion and acceptance, the administrative department of health shall, within the time limit permitted by the administrative department of health, carry out the completion and acceptance of the radiation protection facilities for occupational diseases for construction projects that endanger general categories; For construction projects with serious hazards, experts shall be organized to review the control effect evaluation report within the time limit permitted by the health administrative department, and the occupational disease radiation protection facilities shall be completed and accepted.
Whether the evaluation report of radiation protection and occupational hazard control effect of radiation diagnosis and treatment construction projects with general hazards needs expert review shall be determined by the provincial health administrative department.
Twelfth through the completion of the acceptance of radiation diagnosis and treatment construction projects, the health administrative department shall issue a certificate of acceptance within 20 days after the completion of acceptance; Need rectification, the construction unit shall submit a rectification report, the administrative department of health organization review, confirm that it meets the requirements, and issue a certificate of acceptance; If the completion acceptance is unqualified, the health administrative department shall notify the construction unit in writing and explain the reasons.
Thirteenth pre evaluation and completion acceptance application materials shall meet the following requirements:
(a) the application content is complete, true and accurate, and shall not be altered;
(2) printing on A4 paper;
(three) the application materials in duplicate and stamped with the official seal of the applicant;
(four) the entrustment declaration shall specify the entrusted matters, the name of the entrusting unit, the name of the client and the date of entrustment, and affix the official seal of the entrusting unit.