Timeliness Valid
Enactment Unit Ministry of Health
Enactment Date 801024
Implementation Date 801024
Expiry Date
Copy No.
Title National Standard of the People's Republic of China (GBW-2-80)
Title General
Article 1 These regulations are formulated for the purpose of strengthening the management of health protection for medical X-ray treatment, and safeguarding the safety of radiotherapists, patients undergoing treatment, and residents.
Article 2 These regulations apply to the production and use of medical X-ray machines (X-ray machines for short).
Article 3 The maximum permissible dose equivalent of occupational exposure to radiation workers, radiation therapy workplace adjacent to and near the area of the limitations of the dose equivalent of staff and residents, according to the requirements of the national radiation protection regulations control.
Article 4 The local radiation health protection departments are responsible for supervising the implementation of these provisions. Part I medical treatment X-ray machine health protection standards
Chapter I Technical Requirements Down
Article 5 The radiation leakage of the X-ray tube head assembly shall not exceed the provisions of the following table: (see the table below)
Article 6 The filter plate must be available which can be exchanged and the specifications are marked on the plate. The deep treatment X-ray machine must have an interlocking device that allows irradiation only after the filter plate has been inserted. ---------- ---------- ---------- ---------- ---- ｜ ｜ ｜ X-ray tube head assembly leakage radiation limit ｜ ｜ ｜ Medical treatment X-ray machine ｜ ---- ---------- ---------- -------｜ ｜ Type ｜ 1 meter from the focal point ｜ 5 centimeters from the surface of the tube head assembly ｜ ｜ ｜ ｜ ｜ ｜ 5 centimeters ---------- ｜--------- --------｜- ---------- ｜ ｜ Tube voltage above 100 ｜ 1 L/h (2.58 x 0.0001 | 30 L/h (7.74 x ｜ ｜ KV (peak) ｜ Coulomb/kg) ｜ 0.001 Coulomb/kg ｜ ｜ ---- --------｜- ---------- ------｜- ---------- ｜ ｜ Pipe voltage 50~100 ｜ 0.1 L/h (2.58× ｜ - ｜ ｜ ｜ KV (peak) ｜ 0.00001 Coulomb/kg) ｜ ｜ ｜ ----- -----｜---- ---------- --- ｜------ ------- ｜ ｜ Pipe voltage below 50 ｜ - ｜ 0.1 Lun/hour (2.58 × ｜ ｜ Kilovolt (peak) ｜ ｜ ｜ 0.00001 Coulomb/kg) ｜ -------- ---------- ---------- ---------- ------
Article 7 After the voltage of the X-ray tube is turned on, the rate of irradiation of the useful beam shall rapidly reach the prescribed value to ensure that the irradiation received by the treatment area of the patient is the same as the calculated value (predetermined irradiation time and time of irradiation). The deviation between the irradiation received by the patient's treatment area and the calculated value (the product of the predetermined irradiation time and the normal irradiation volume rate) is not more than 5%. Otherwise, a motorized shutter must be installed in the window of the X-ray machine and coordinated with an automatic timer. The protection thickness of the shutter should not be less than 10 half-value layers.
Article VIII of the X-ray irradiation rate through the collector tube, shall not be greater than 1 meter from the focal point of the useful beam irradiation rate of 5%.
Article IX in any therapeutic position, the X-ray tube focal point and the center of the fixed diaphragm and the central axis of the collector tube should be in the same straight line. The asymmetry of the useful beam exposure rate in the irradiation field shall be less than 5%.
Article 10 of the console must be equipped with appropriate devices to display: (1) X-ray tube voltage on and off; (2) X-ray tube voltage and current flow; (3) irradiation time; (4) the filter plate material and thickness; (5) shutter opening and closing.
Article XI It is necessary to install a useful beam monitoring integral dosimeter, and automatic timer chain.
Article XII of the components of the X-ray machine, in addition to the X-ray tube, other than the X-ray tube, the level of radiation emitted by the X-ray tube, 5 cm from the equipment shell shall not exceed 20 millirem/hour (5.16 × 0.000001 coulomb/kg).
Article XIII of the X-ray tube must be installed securely, the tube head assembly should be able to lock in any desired position.
Article XIV superficial treatment X-ray machine in the tube head assembly can be controlled by hand on the shell, there must be a device to display the irradiation, and equipped with a protective cap with a thickness of protection greater than 0.5 millimeters of lead equivalent.
Article XV of the product specification should indicate the protective properties of the X-ray machine. Tube head assembly body shell, should be labeled focus position and inherent filtration. Collector tube, should be marked from the focal point to its exit surface distance and the exit surface of the irradiated field area.
Chapter II test methods down
Article XVI of the total uncertainty of the useful beam measurement should be less than 5%, the total uncertainty of the protection monitoring should be less than 30%. Open the shutter, insert the zero filter plate, and cover the socket of the collector cylinder with not less than 10 half-value layers of lead. Perform under the condition of the highest working tube voltage of the X-ray machine and the maximum working tube current corresponding to that voltage. Leakage rays 5 cm from the surface of the tube head assembly shall be measured on average over an area of 10 square centimeters; leakage rays 1 meter from the focal point shall be measured on average over an area of 100 square centimeters.
Article XVII of the X-ray tube head assembly leakage ray test: open the shutter, in the following table listed in the maximum voltage and filtering conditions, measure the collector cylinder exit plane on the irradiation of the field outside the boundary of the average of the rate of exposure at any four points 1 cm. and compare it with the exposure volume rate at the center of the irradiation field at 1 m from the focal point. X-ray machine spare collector cylinder should be tested one by one, measurement, the direction of the outlet should not be scattered within 2 meters from the focal point.
Article XVIII of the collector cylinder on the useful beam transmittance test: -------- ---------- ---------- ------ ｜Maximum voltage (kV, |100｜150｜200｜250｜300｜400 ｜ Peak) --------｜- --- --- --- --- --- --- --- --- --- ｜ Filtration (mm copper)｜0.2｜0.5｜ 1 ｜ 2 ｜ 3 ｜ 5 ｜ --------- ---------- ---------- -----
Article 19 Test of asymmetry of useful beams: For the spare light collector of the X-ray machine, the irradiation rate of four points in the corresponding irradiation field, which are 2 centimeters away from the neighboring boundaries, shall be tested one by one, and the average of each point shall be taken as the same as the average of the other points. For the spare collector of the X-ray machine, the irradiation rate of four points in the corresponding irradiation field, which are all 2 centimeters away from the adjacent boundary, should be tested one by one, and the asymmetry of the irradiation field should be measured by the relative deviation of each point from the average value. When measuring, there should be no scatterer within 2 meters from the focus in the direction of the outlet.
Chapter III acceptance rules
Article 20 of the X-ray machine protection performance in line with the requirements of this standard, should be the production unit of technical inspection department for inspection, after passing the relevant departments before acceptance.
Article 21 in the following cases should be carried out type test (all items specified in this standard for testing): (1) new products before production; (2) continuous production of products, should be not less than once a year; (3) more than one year between the start of production; (4) in the design, process or material changes. (1), (4) type test should be conducted in conjunction with the local radiation health protection department. Type test results should be sent to the local radiation health protection department for the record. Part II medical treatment X-ray health protection rules Chapter IV Protective Facilities
Article 22 of the treatment room must be set up to give full consideration to the safety of the surrounding environment. Deep treatment room must be separated from the control room. The treatment room should have a sufficient area for use, generally not less than 30 square meters is appropriate. The room shall not pile up debris.
Article 23 The walls of the treatment room in the direction of useful beam illumination shall be designed in accordance with the original ray shielding requirements, and the remaining directions may be designed in accordance with the leakage of rays and scattered rays shielding requirements. In the treatment room of the X-ray machine for deep treatment below 250 kV, the thickness of the walls in the direction of illumination of the non-useful beams of radiation shielding shall be 2mm of lead equivalent.
Article 24 The windows of the treatment room must be reasonably set up. Observation windows can be set in the direction of non-useful beams of light on the wall, and have the same side wall shielding effect.
Article 25 must be installed outside the door of the treatment room, work lights, and installation of interlocking devices. Irradiation can only be realized after the door is closed.
Chapter V Rules of Operation
Article 26 Radiotherapy workers must be trained in radiation hygiene and protection, radiation hygiene and protection knowledge, strict grasp of the indications for X-ray therapy, the correct and reasonable use of X-ray therapy.
Article 27 X-ray machine operators must strictly abide by the operating procedures. Regularly check the performance of the X-ray machine and protective equipment, found that the problem, timely and properly dealt with before use.
Article 28 According to the specific circumstances of the patient's treatment, the treatment program should be carefully determined and checked in advance. Attention to the selection of appropriate irradiation and irradiation conditions (including X-ray tube voltage, current, filtration conditions, focal length, irradiation field and irradiation time and other factors), and carefully positioned, as far as possible, so that the patient's treatment area of the irradiated dose is controlled in the clinical treatment of the minimum required to minimize unnecessary irradiation.
Article 29 of the irradiation treatment process, X-ray machine operators must always monitor the console and the patient, and timely exclusion of all kinds of accidents.
Article 30 During the irradiation of deep treatment X-ray machine, there should be no other persons in the treatment room except the patient receiving treatment.
Article 31 The operator of the shallow treatment X-ray machine must utilize local shielding or distance protection. Clinical need for staff to work with a maximum voltage of not more than 50 kV X-ray tube in hand, must wear protective gloves and not less than 0.25 mm lead equivalent apron, and only by the staff holding the equipment to control the X-ray tube power. Part III of the medical treatment X-ray health protection management
Chapter VI Management
Article 32 of the local radiation health protection departments, the production and use of medical treatment X-ray machine units should strengthen the management of health protection. A registration system shall be established for the use of medical therapeutic X-ray machines.
Article 33 Where the new construction, expansion, alteration of the X-ray treatment room, in the choice of address and building protection facilities, etc., must comply with the requirements of these provisions.
Article 34 The building design should be reviewed in advance by the local radiation health protection department. Before being put into use, it shall be inspected and qualified by the health protection department before it is put into use.
Article 35 The use of units of X-ray machines and protective facilities should establish technical files, maintenance and timely registration and archiving.
Article 36 After the installation of X-ray machine, X-ray output, line quality, beam uniformity and stability must be measured and calibrated before being put into use, the use of the process should be regularly tested. Generally, the X-ray output should be tested at least once a month.
Article 37 The use of units should be set up full-time (part-time) personnel responsible for the unit's radiation health protection work.
Article 38 The radioactive workers who are in contact with X-ray for medical treatment shall have personal dose and health records. The file should be transferred with the staff, the original unit should be kept in its copy.
Article 39 The personnel who are going to work in the medical treatment of X-ray must undergo a physical examination, and those who are not feeling well are not allowed to take part in the radiotherapy work. Regular medical checkups are required after work.
Article 40 Whenever radiotherapy workers are found to be in discomfort, necessary measures shall be taken in time.