This standard specifies the technical requirements for the protective performance of medical diagnostic X-ray machines (excluding C-arm X-ray machines), X-ray machine room protection facilities and medical X-ray diagnostic protective safety operation. This standard applies to the production and use of medical diagnostic X-ray machines. This standard does not apply to special examinations such as interventional radiology, angiography and X-ray CT examinations. GBZ 130-2002 Medical X-ray Diagnostic Health Protection Standard GBZ130-2002 Standard Download Decompression Password: www.bzxz.net

Ics13.100
National occupational health standard of the People's Republic of China GBZ130-2002
Standard for health protection in medical X-ray diagnosis
StandardsforradiologicalprotectioninmedicalX-raydiagnosis
Promulgated on April 8, 2002
Ministry of Health of the People's Republic of China
Implementation on June 1, 2002
1 Scope
Normative references
3 Terms and definitions
4 General provisions
Technical requirements for protective performance of medical diagnostic X-ray machines5.1
General requirements for protective performance of medical diagnostic ray machines5.2
Special requirements for protective performance of fluoroscopic X-ray machinesSpecial requirements for protective performance of photographic X-ray machinesDental X-ray machines Special requirements for protective performance 5.4
Special requirements for protective performance of mammography X-ray machines Special requirements for protective performance of mobile and portable X-ray machines Requirements for protective signs and random documents
Technical requirements for protective facilities in the room of medical diagnostic X-ray machines Requirements for protective safety operation of medical X-ray diagnosis Appendix A (Normative Appendix)
Schematic diagram of test plane of fluoroscopic protection area in standing and supine positions Foreword
This standard is formulated in accordance with the "Law of the People's Republic of China on the Prevention and Control of Occupational Diseases". If there is any inconsistency between the original standard GB8279-2001 and this standard, this standard shall prevail.
Chapters 4 to 7 and Appendix A of this standard are mandatory contents, and the rest are recommended contents. This standard mainly stipulates technical requirements for the protective performance of medical diagnostic X-ray machine products, protective facilities in the room of medical diagnostic X-ray machines, and protective safety operation of medical X-ray diagnosis: The relevant test methods and test requirements are proposed by another mutually complementary national occupational health standard GBZ138-2002 "Medical X-ray Diagnosis Health Protection Monitoring Specification".
Appendix A of this standard is a normative appendix
This standard is proposed and managed by the Ministry of Health
The drafting units of this standard are: Institute of Radiation Protection and Nuclear Safety Medicine, Chinese Center for Disease Control and Prevention, Liaoning Provincial Institute of Labor Health and Occupational Disease Prevention and Control, Liaoning Provincial Institute of Medical Devices. The main drafters of this standard are: Zheng Junzheng, Zhang Zhixing, Xia Lianji. This standard is interpreted by the Ministry of Health.
Medical X-ray Diagnosis Hygiene Protection Standard
1 Scope
GBZ130-2002
This standard specifies the technical requirements for the protection performance of medical diagnostic X-ray machines (excluding C-arm X-ray machines), X-ray machine room protection facilities and medical X-ray diagnostic protection safety operations. This standard applies to the production and use of medical diagnostic X-ray machines. This standard does not apply to special examinations such as interventional radiology, angiography and X-ray CT examinations.
2 Normative References
The clauses in the following documents become the clauses of this standard through reference in this standard. All subsequent amendments (excluding errata) or revisions of dated references are not applicable to this standard. However, parties to agreements based on this standard are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest versions apply to this standard.
GB9706.12-1997 Medical electrical equipment Part 1: General requirements for safety III. Collateral standards General requirements for radiation protection of diagnostic X-ray equipment (idtIEC601-1-3: 1994) IAEA Safety Series No.115 (1996) International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, "International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources"
3 Terms and definitions
The following terms and definitions apply to this standard. 3.1 X-ray tube assembly X-ray tube assembly The assembly in which the X-ray tube is installed in the X-ray tube housing. X-ray tube housing is a container with radiation window for holding X-ray tube, which can protect against X-ray radiation and electric shock. 3.2 X-ray source assembly X-ray tube assembly and beam limiting system. 3.3 Loading
In X-ray generating device, the action of applying electric energy to the anode of X-ray tube. 3.4 Focal spot to skin distance In radiological diagnosis, the shortest distance from the focus of X-ray tube to the skin of the examinee. 4 General provisions
4.1 While developing and utilizing medical X-ray diagnostic technology, the radiation safety and health of medical X-ray diagnostic workers, examinees and the relevant public must be guaranteed. 4.2 The occupational exposure of medical X-ray diagnostic workers should comply with the principles of legitimacy of practice and optimization of protection, and should not exceed the following dose limits:
a) Average annual effective dose of 20mSv for 5 consecutive years; b) Effective dose of 50mSv in any year;
c) Equivalent dose of eye lens 150mSv per year: d) Equivalent dose of hands, feet and skin 500mSv per year. 4.3 The medical exposure of the examinee should comply with the principles of legitimacy of radiation practice and optimization of radiation protection, and avoid unnecessary exposure. For medical X-ray diagnostic examinations that are really necessary for legitimate reasons, the dose of the examinee must be controlled to the lowest level that can be reasonably achieved while obtaining the required diagnostic information. --
Technical requirements for the protective performance of medical diagnostic X-ray machines 5
5.1 General requirements for the protective performance of medical diagnostic X-ray machines 5.1.1 The X-ray tube must be installed in an X-ray tube housing equipped with a beam limiting device, forming part of the X-ray source assembly, before it can be used.
5.1.2 The radiation window of the X-ray tube assembly should not be larger than that required for the maximum X-ray beam required for its designated application. If necessary, the radiation window may be limited to an appropriate size with the aid of an aperture mounted as close to the focal point as possible. 5.1.3 Except for dental X-ray machines, when the X-ray source assembly operates at the nominal X-ray tube voltage under conditions equivalent to the specified maximum input energy loading for 1 h, the average air kerma of the leakage radiation in any 100 cm area at a distance of 1 m from the focal point should not exceed 1.0 mGyh-1.
5.1.4 For various medical diagnostic X-ray machines, for all configurations that can be used in normal use, the first half-value layer of the X-ray beam projected onto the patient's body surface must meet the requirements of Table 1 respectively. Table 1
Application type
Special applications
Dental applications using intraoral lenses
Other dental applications
Other applications
Normal use range
50~125
Half-value layer of medical diagnostic X-ray machine
X-ray tube voltage (kV)
Note: 1. The half-value layer between each selected value can be obtained by linear interpolation; the selected value
2. Those less than and greater than the selected value in the table can be linearly extrapolated to obtain the corresponding half-value layer. 3 This table is quoted from GB9706.12-1997 (idtIEC601-1-3:1994) Minimum allowable half-value layer (mmAl)
5.1.5 Except for mammography X-ray machines, the mass equivalent filtration of materials blocking the X-ray beam in the X-ray tube assembly must comply with the following provisions:
a) Materials that cannot be removed in normal use should not be less than 0.5mmAl; b) The total filtration of fixed additional filters and non-removable materials that must be removed with tools should not be less than 1.5mmAl.
5.1.6 Except for dental X-ray machines and mammography X-ray machines, the total mass equivalent filtration formed by materials in the X-ray beam projected to the patient should not be less than 2.5mmAl. 5.2 Special requirements for the protective performance of fluoroscopic X-ray machines 5.2.1 In any fluoroscopic working position, the focus of the X-ray tube, the center of the beam limiting device and the center of the fluorescent screen should be in the same straight line. For ordinary fluoroscopic X-ray machines, the deviation between the center of the irradiation field and the center of the fluorescent screen shall not exceed 2% of the distance from the focus to the fluorescent screen.
X-ray machines for fluoroscopy must be equipped with a device that can prevent use when the focal distance is less than 30cm. The sensitivity of the ordinary fluoroscopic X-ray fluorescent screen should not be less than 0.08 (cdm) / (cGymin). The mass equivalent filtration of the X-ray machine diagnostic bed board should not exceed 1mmAl. The fluoroscopic exposure switch should be a normally off switch, otherwise there should be a fluoroscopic time limit device. Under the corresponding test conditions, the air kerma rate of the useful beam entering the subject's body surface should not exceed the control value of Table 2 Table 2 Control value of the air kerma rate of the useful beam entering the subject's body surface X-ray machine type
Ordinary medical diagnostic X-ray machine
X-ray machine with image intensifier
X-ray with image intensifier and automatic
brightness control system
(for interventional radiology)
Surface air kerma rate (mGymin) 50
5.2.7 Under the corresponding test conditions, the air kerma rate on the test plane of the standing and supine fluoroscopic protection areas should not exceed 0.05mGyh- and 0.15mGyhl respectively. See Appendix A (Normative Appendix) for the test plane diagram of the standing and supine fluoroscopic protection area. X-ray machines or cardiovascular imaging equipment with image intensifiers and remote control are not subject to this restriction. 5.3 Special requirements for the protection performance of photographic X-ray machines 5.3.1 Photographic X-ray machines of 200mA and above should have a device for replacing additional filter plates and be equipped with additional filter plates of different specifications.
5.3.2 The X-ray machine should have a beam limiting device that can adjust the irradiation field of the useful beam, and a light field indicator device that can mark the irradiation field should be provided.
5.3.3 The sum of the deviations between the light field and the corresponding edge of the irradiation field should not exceed 2% of the vertical distance (S) from the focus of the X-ray tube to the light field. That is, as shown in Figure 1: a+a≤0.02S, b+b2≤0.02S. Light field
Radiation boundary
Figure 1 Schematic diagram of deviation between light field and radiation field
5.4 Special requirements for protective performance of dental X-ray machine 5.4.1 The X-ray working voltage of dental X-ray machine shall meet the requirements of Table 3. Table 3
Tube voltage limit of dental X-ray machine
Application type
Various applications
Intraoral radiography
Cephalometrics
Maximum nominal
X-ray tube voltage (kV) allowed
Minimum X-ray tube voltage (kV) allowed in normal use
5.4.2 When the X-ray source assembly is operated at the nominal X-ray tube voltage under the conditions equivalent to the specified maximum loading of 1h, the average air kerma rate in any 100cm area at 1m from the focus shall not exceed mGyh. www.bzxz.net
5.4.3 Dental X-ray machines with a nominal X-ray tube voltage not exceeding 70kV shall have a total filtration of not less than 1.5mmAL. 5.4.4: Dental panoramic tomography X-ray machines shall have a beam limiting device to prevent the X-ray beam from exceeding the plane of the X-ray image receiver.
5.4.5 The X-ray source assembly of intraoral dental photography can limit the X-ray beam with the help of a light collecting tube so that the X-ray beam is limited to a circle with a diameter not exceeding 6cm. 5.4.6 For different applications, a device must be equipped to prevent the use of focal-skin distances less than the requirements of Table 4. Table 4 The shortest focal-skin distance for dental X-ray photography should be
Dental photography with a nominal X-ray tube voltage below 50kV Dental photography with a nominal X-ray tube voltage above 60kV Dental photography with extraoral films under conditions of reduced focal-skin distance Dental panoramic tomography
5.4.7 The length of the cable connecting the exposure switch should not be less than 2m. 5.5 Special requirements for the protective performance of mammography X-ray machines. Shortest focal-skin distance (cm)
5.5.1 X-ray machines for mammography with molybdenum targets and a nominal X-ray tube voltage not exceeding 50 kV shall have a total filtration of not less than 0.03 mm thick key filter.
5.5.2 X-ray machines used for geometric mammography must be equipped with a device that prevents the use of focal-skin distances less than 20 cm.
5.5.3 The mass equivalent filtration of the mammography X-ray support table shall not be greater than 0.3 mmAl. 5.6 Special requirements for the protective performance of mobile and portable X-ray machines. 5.6.1 X-ray machines must be equipped with a device that prevents the use of focal-skin distances less than 20 cm. 5.6.2 X-ray machines used for indirect fluoroscopy during surgery with a fixed distance from the focal point to the image receptor and an image receiving surface not exceeding 300 cm2 shall have a beam limiting device to reduce the X-ray field on the image receptor plane to less than cm2.
5.7: Requirements for protective markings and accompanying documents
5.7.1 The focal position shall be clearly marked on the X-ray tube housing. 5.7.2 The X-ray tube assembly shall indicate its inherent filtration. The additional filters shall indicate their material and thickness. 125
573 In normal use, all parts of the medical diagnostic X-ray machine that can be disassembled and are related to the requirements of this standard shall be clearly and legibly marked, and corresponding instructions shall be given in the accompanying documents. 5.7.4 The accompanying documents shall describe the following protection-related performances: a)
Inherent filtering of the X-ray tube assembly;
Filtering of the X-ray source assembly;
Characteristics of the filter;
Methods for limiting the useful beam;
The irradiation field of the useful beam at various distances from the focus to the image receiver; Distance from the focus to the image receiving surface:
g) Loading conditions:
Description of the focal-skin distance under various conditions of use
Attenuation equivalent of the x-ray beam by each component located in the useful beam: Measures suitable for effective protection of stray radiation by medical x-ray diagnostic staff in normal use. 5.7.5 The accompanying documents of portable x-ray machines shall clearly indicate that the machine is not suitable for routine fluoroscopy. 5.7.6 For various special and special occasions of x-ray machines, the accompanying documents shall specify the corresponding protective measures that must be taken under various application conditions.
Technical requirements for protective facilities in medical diagnostic X-ray machine rooms 6
6.1 The setting of medical diagnostic X-ray machine rooms must fully consider the protection and safety of adjacent rooms and surrounding places, and can generally be located at one end of the ground floor of the building.
6.2 The machine room should have sufficient usable area. For newly built X-ray machine rooms, the room for single-tube 200mA X-ray machine should be no less than 24m2, and the room for double-tube machine should be no less than 36m.
Dental X-ray machines should have a separate room.
6.3 The wall facing the useful wire bundle in the camera room should have a protective thickness of 2mm lead equivalent, and the other side walls should have a protective thickness of 1mm lead equivalent.
The side walls of the fluoroscopy room should have a protective thickness of 1mm lead equivalent. For machine rooms in multi-storey buildings, the ceiling and floor should be considered as the corresponding side walls, and full attention should be paid to the protection and safety of the upper and lower adjacent rooms. The doors and windows of the machine room must be reasonably set and have the same protection thickness as the walls where they are located. The layout of the machine room should be reasonable, and no sundries unrelated to the diagnosis work should be piled up. 6.4 The machine room should be well ventilated. There should be an ionizing radiation sign outside the machine room door, and a conspicuous working indicator light should be installed. 6.5 The waiting position for the examinee should be appropriately selected, and corresponding protective measures should be taken. 6.6 The photography operation table of the X-ray machine should be placed in a protective facility with a lead equivalent protection thickness of 0.5mm. 6.7. Each X-ray machine should be equipped with an appropriate amount of various auxiliary protective equipment that meets the protection requirements, such as lead rubber gloves, lead rubber aprons, lead protective seats, etc.
6.8 Each X-ray room should be equipped with various auxiliary protective equipment specifically for the examinee, as well as various equipment for fixing the body position of special examinees.
7 Requirements for safe operation of medical X-ray diagnosis and protection7.1 Medical X-ray diagnostic workers must be proficient in business technology and radiation protection knowledge, conscientiously cooperate with relevant clinical physicians to make a good judgment on the legitimacy of X-ray examinations, correctly understand its scope of application, and pay attention to reviewing previous examination data to avoid unnecessary additional examinations, and use X-ray diagnosis reasonably. 7.2 Medical diagnostic X-ray machines should be subject to quality control inspections in accordance with relevant regulations. 7.3 According to different diagnostic examination types and needs, choose to use appropriate equipment and corresponding various auxiliary protective equipment (including for the examinee).
7.4 Refer to the medical exposure guidance level of radiological diagnosis in the International Basic Safety Standard (IAEA Safety Series No. 115, 1996), carefully select various operating parameters, and strive to ensure that the radiation received by the examinee is the minimum dose required to achieve the expected diagnosis.
7.5 In addition to clinically necessary fluoroscopic examinations, photographic examinations should be used as much as possible. 7.6 Workers who use ordinary fluorescent screen fluoroscopy must fully adapt to the dark before fluoroscopy. Under the premise of not affecting the diagnosis, "high voltage, low current, thick filter" and small irradiation field should be used as much as possible. 7.7 When conducting digestive tract examinations, special attention should be paid to controlling irradiation conditions and avoiding repeated irradiation. Effective protective measures should be taken for both staff and examinees.
7.8 During photography, the staff must replace the additional filter plate according to the different X-ray tube voltages used. 7.9 During photography, the staff should strictly adjust the irradiation field according to the required irradiation site, so that the useful beam is limited to the range of actual clinical needs and matches the imaging device. Appropriate protective measures should be taken for the non-irradiated parts of the subject. 7.10 During photography, the staff should perform exposure operations in protective facilities such as shielded rooms (areas), and should pay close attention to the subject through observation windows 5
, etc.
7.11 During X-ray photography, the staff should pay attention to the reasonable selection of film and the combination of film and intensifying screen, and pay attention to the quality assurance of darkroom operation technology. 7.12 During X-ray examination, whenever feasible, appropriate shielding protection should be taken for the radiation-sensitive organs of the subject (such as gonads, eye lenses, breasts and thyroid glands, etc.) 7.13 When performing X-ray examination, attention should be paid to the protection of the subjects waiting for examination. During photography, other personnel should not stay in the machine room except the subject being examined. During fluoroscopy, the examinees who are to enter the machine room for waiting for examination at the same time should be properly placed and have corresponding shielding and protection measures.
7.14 Only when it is impractical or medically unacceptable to send the examinee to a fixed device for examination and appropriate protective measures (including distance and shielding protection, etc.) are taken, can a mobile or portable X-ray machine be used for examination. Portable X-ray machines are not suitable for routine fluoroscopy. 7.15 In X-ray examination, appropriate fixed position measures can be taken for special examinees such as children. Pregnant women who have legitimate reasons for examination should pay attention to protecting the embryo or fetus as much as possible. When the examinee needs to be supported, appropriate protective measures should also be taken for the supporter.
7.16 In the clinical teaching of radiological diagnosis, students must be educated on radiation protection knowledge and pay attention to their protection; it is strictly forbidden to increase the exposure time of teaching cases at will. Appendix A
(Normative Appendix)
Sketch of the test plane of the protection area for standing and supine fluoroscopyThe numbers in the projection area of ​​the sketch are the test point positions. 1300
Test plane 1
Fluorescence display.
Irradiation field.
Test plane
Figure A1 Schematic diagram of test plane in standing position and protection area (digital unit: mm)
Carbon optics
Bed test plane
Bed test plane
System center
Schematic diagram of test plane in supine position and protection area (digital unit: mm)
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.