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GB/Z 130-2025 English PDF

GB/Z 130: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB/Z 130-2025	English	RFQ	ASK	3 days [Need to translate]	(Post-market surveillance of medical devices for manufacturers)		GB/Z 130-2025
GBZ 130-2020	English	495	Add to Cart	0--9 seconds. Auto-delivery	Requirements for radiological protection in diagnostic radiology	Valid	GBZ 130-2020
GBZ 130-2013	English	160	Add to Cart	0--9 seconds. Auto-delivery	Requirements for radiological protection in medical X-ray diagnosis	Obsolete	GBZ 130-2013

Basic data

Standard ID	GB/Z 130-2025 (GB/Z130-2025)
Description (Translated English)	(Post-market surveillance of medical devices for manufacturers)
Sector / Industry	National Standard
Date of Issue	2025-12-03
Date of Implementation	2025-12-03

GBZ130-2020: Requirements for radiological protection in diagnostic radiology

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Requirements for radiological protection in medical X-ray diagnosis ICS 13.100 C 57 GBZ National Occupational Health Standards of the People's Republic of China Replace GBZ 130-2013, GBZ 165-2012, etc. Radiological diagnostic radiological protection requirements 2020-04-03 released 2020-10-01 implementation Issued by the National Health Commission of the People's Republic of China

Foreword...II 1 Scope...1 2 Normative references...1 3 Terms and definitions...1 4 General...2 5 Technical requirements for X-ray equipment protection performance...4 6 Technical requirements for protection facilities of X-ray equipment room...7 7 Protective safety requirements for operation of X-ray equipment...11 8 X-ray equipment room protection testing requirements...13 Appendix A (informative appendix) Examples of pediatric illegitimate imaging examinations...14 Appendix B (Normative Appendix) X-ray equipment room protection testing...15 Appendix C (informative appendix) Lead equivalents of different shielding substances in medical diagnostic X-ray protection...18 Appendix D (informative appendix) Correction method of reading response time of measuring instrument...22 Appendix E (Informative Appendix) Diagnostic Reference Level...24 Appendix F (Informative Appendix) Requirements for Medical Diagnostic X-ray Personal Protective Materials and Supplies...27 Appendix G (informative appendix) Medical diagnostic X-ray protective glass requirements...37 References...41

Foreword

5.1, 6.3.3, 6.4.6, 6.4.10, and 7.6.2 of this standard are recommended clauses, and the rest are mandatory clauses. This standard is formulated in accordance with the "Law of the People's Republic of China on Occupational Disease Prevention and Control" This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces GBZ 130-2013 "Radiation Protection Requirements for Medical X-ray Diagnosis", GBZ 165-2012 "X-ray Computed Tomography" Radiological Protection Requirements, GBZ 176-2006 “Standard for Medical Diagnostic X-ray Personal Protective Materials and Supplies”, GBZ 177-2006 “Convenience Radiological Diagnosis Department of Portable X-ray Inspection System Radiation Health Protection Standard, GBZ 179-2006 Basic Requirements for Radiation Protection of Medical Exposure Points, GBZ /T 180-2006 "Specifications for radiation shielding of medical X-ray CT computer rooms", GBZ /T 184-2006 "Medical diagnostic X-ray protective glass Standard for Glass Plates, GBZ 264-2015, Radiation Protection Requirements for Vehicle-mounted Diagnostic X-ray Machines, GB 16348-2010, Medical X-ray Diagnosis Radiation Health Protection Standards for Examined Persons." Compared with the above standards, the main technical changes except for editorial changes are as follows. - Delete the relevant requirements for the quality control of dental X-ray equipment (see 4.4.1, 4.4.2 and Table 5 of GBZ 130-2013); -Modified the minimum tube voltage requirements for dental X-ray equipment (see 5.5.1, 4.4.1 of GBZ 130-2013); -Modified the evaluation requirements for the protection and detection of CT computer rooms (see 6.3, 4.2.1 of GBZ /T 180-2006); - Modified the evaluation requirements for the protection testing of the camera room (see 6.3, 5.4 of GBZ 130-2013); -Modified the evaluation requirements for the protection of vehicle equipment (see 6.3, 6.1 and 6.2 of GBZ 264-2015); -Modified the configuration requirements of personal protective equipment and auxiliary protective facilities (see 6.5.1 and Table 4, GBZ 130-2013 5.9 and Table 4); --Added examples of pediatric illegitimate imaging examinations (see Appendix A); - Deleted the requirements for the half-value layer of X-ray equipment (see Appendix A of GBZ 130-2013); - Deleted interventional radiology equipment, X-ray equipment operating in the same room near the platform, the surrounding dose equivalent rate on the fluoroscopy protection area test plane Testing (see B.1.2 of Appendix B of GBZ 130-2013); --- Increased the protective testing requirements for bone densitometer equipment (see Appendix B, B.1); -Modified the requirements of the attention points in the protection and inspection of the X-ray equipment room (see 8.1, GBZ 130-2013, 7.2); --Added the requirements for the location of the attention points in the protection testing of the X-ray equipment room (see Appendix B, B.2); - Delete the detection method of focal distance (see GBZ 130-2013 Appendix B, B.2); --Modified the detection conditions of X-ray equipment room protection testing (see Appendix B, B.1, GBZ 130-2013 Appendix B, B.6); ---Added the requirements for the inspection phantom for the protection inspection of the X-ray equipment room (see Appendix B, B.4); --- Added the measurement result processing requirements of the X-ray equipment room protection inspection (see Appendix B, B.5); --Modified the three fitting parameters related to the X-ray radiation attenuation of gypsum board and brick for different tube voltages (see Table C.3 in Appendix C, GBZ 130-2013 Appendix D, Table D.3); --- Added the method for correcting the reading response time of measuring instruments (see Appendix D); --Modified the radiation dose and diagnostic reference level of common CT examination items for adult subjects (see Table E.2 in Appendix E, GBZ 179-2006 Appendix A, Table A.2); ---Modified the radiation dose and diagnostic reference level of common CT examination items of child subjects (see Table E.3 in Appendix E, GBZ 165-2012 Appendix A, Table A.3); -Modified the inspection cycle of personal protective materials and supplies (see F.2.8 of Appendix F, 13.2 of GBZ 176-2006); --- Added relevant requirements for interventional protective gloves (see F.6 of Appendix F); - Delete the service life of personal protective materials and supplies (see 13.3 of GBZ 176-2006); --Relevant contents of the basic requirements for radiological diagnosis and radiation protection have been revised (see 4.1～4.4, Chapter 4 and Chapter 5 of GBZ 179-2006, 6.1, 6.2.1, 6.3.1, 6.3.2, 6.4 and 7.2). Drafting organizations of this standard. Institute of Radiation Protection and Nuclear Safety Medicine, Chinese Center for Disease Control and Prevention, Beijing Center for Disease Control and Prevention, Shanxi Institute of Radiation Medicine, Eastern Academy of Medical Sciences, Guangdong Provincial Occupational Disease Prevention and Control Institute, Jiangsu Provincial Center for Disease Control and Prevention, Military Medicine of the Academy of Military Sciences Institute of Radiation Medicine, Tianjin Center for Disease Control and Prevention. The main drafters of this standard. Xu Hui, Yue Baorong, Fan Yaohua, Wei Kedao, Lou Yun, Yu Ningle, Deng Daping, Zou Jianming, Shang Yingqing, Tranquility, Wang Jin, Liu Ya, Zhang Zhen, Feng Zechen, Li Hailiang, Huang Weixu, Yang Chunyong. This standard replaces GBZ 130-2013, GBZ 165-2012, GBZ 176-2006, GBZ 177-2006, GBZ 179-2006 The radiological diagnosis part of the GBZ /T 180-2006, GBZ /T 184-2006, GBZ 264-2015, GB 16348-2010. The previous releases of GBZ 130-2013 are as follows. --GB 8279-1987, GB 8279-2001, GBZ 130-2002; --WS/T 190-1999, GBZ 138-2002. The previous releases of GBZ 165-2012 are as follows. --GBZ 165-2005. The previous releases of GB 16348-2010 are as follows. --GB 16348-1996; --GB 16349-1996; --GB 16350-1996. Radiological diagnostic radiological protection requirements

1 Scope

This standard specifies the protection requirements for radiological diagnosis, including the protection performance of X-ray imaging diagnosis and interventional radiology equipment, and the protection of equipment rooms Facilities, protective safety operation requirements and related protective testing requirements. This standard applies to X-ray imaging diagnosis and interventional radiology. X-ray imaging equipment in radiotherapy and nuclear medicine shall be implemented with reference to this standard.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document. GB 18871 Basic standard for ionizing radiation protection and radiation source safety GBZ 128 Specification for personal monitoring of occupational external exposure

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 X-ray imaging diagnosis A technology that uses X-ray penetration and other properties to obtain image information of human organs and tissues to diagnose diseases. 3.2 C-arm X-ray equipment C-arm X-ray equipment It is composed of C-frame, X-ray tube assembly, image intensifier (or dynamic flat panel detector) and other components. X-ray equipment for diagnosis in which the line tube assembly can be rotated in one or two directions. Note. C-arm X-ray equipment is divided into fixed C-arm and mobile C-arm according to its usage. 3.3 Mobile X-ray equipment Movable medical X-ray equipment for performing bedside X-ray photography or fluoroscopy. 3.4 X-ray diagnostic equipment installed on vehicle The fixed X-ray equipment installed on the medical X-ray diagnostic vehicle is usually composed of X-ray generators, X-ray imaging devices and And it is composed of auxiliary equipment such as bed, table and bracket. Note. The vehicle-mounted diagnostic X-ray equipment can be divided into fluoroscopy vehicle, photography vehicle, fluoroscopy vehicle, and mammography vehicle. 3.5 Portable X-ray inspection equipment An on-site inspection device that uses X-rays to conduct safety inspections and personnel rescue. Generally, the operator can directly Pick up and carry and operate on site. 3.6 Interventional radiology Under the supervision and guidance of the medical imaging system, percutaneous needle puncture or introduction of catheters for suction injection, drainage, or shaping of lumens, blood vessels, etc. Perfusion, embolization, etc., to diagnose and treat diseases. 3.7 Accompanying documents Documents that accompany the device, equipment, auxiliary equipment or accessories, including those provided for the assembler, installer and user of the equipment Important information, especially information related to safety. 3.8 Diagnostic reference level; DRL Guidance level for medical exposure A level used in medical imaging diagnosis, indicating that the dose given to the subject by a given radiological procedure under routine conditions is Whether the program is abnormally high or abnormally low.

4 General

4.1 Management requirements Medical institutions should be responsible for the protection and safety of radiation workers, subjects and the public, including. a) The layout of the radiological diagnostic equipment workplace, the design and construction of the computer room; b) Equipped with professionals with reasonable structure suitable for inspection work; c) The occupational exposure of workers should be restricted. The occupational exposure dose limit should comply with the provisions of GB 18871. Quantity monitoring shall meet the requirements of GBZ 128; d) Carry out health checkups for radiological diagnosis and treatment staff before, during and after work, and conduct regular professional and protective measures Knowledge training, and establish personal dosage, occupational health management and education training files respectively; e) Develop personnel training guidelines and plans, and train personnel on their professional skills, radiation protection knowledge and relevant legal knowledge, so that they Meet the job requirements of radiation workers; f) Configure diagnostic equipment, testing instruments and protective facilities suitable for X-ray inspection, and take all reasonable measures to prevent Prepare failures and human errors; g) Formulate and implement a radiation protection management system, implement a radiological protection quality assurance program, and adopt reasonable and effective measures to make it possible The consequences of failures and errors are minimized; h) Develop a corresponding emergency plan for radiological incidents, respond to possible incidents, publicize the plan and conduct actual exercises on a regular basis; i) Radiation damage to the examinee should be reported to the health administrative department in time. 4.2 Legitimacy requirements 4.2.1 Medical exposure should have sufficient net benefits. In the case of obtaining the same net benefits, alternatives to non-medical exposure should be used as much as possible Method, when there is no alternative method, the pros and cons should be weighed, and it is judged that the benefits of medical exposure to the individual or society receiving diagnosis or treatment are greater than Medical exposure is justified when it may cause radiation hazards. 4.2.2 The use of X-ray inspection should be judged for legitimacy, and non-X-ray inspection methods are preferred. For those that do not meet the principle of legitimacy, X-ray inspection should not be performed. 4.2.3 All new types of medical exposure technologies and methods should pass the legitimacy judgment before use; the types of medical exposures that have been judged to be legitimate, When new or important evidence is obtained and a new judgment is required, it shall be re-judgment of legitimacy. Use all judged by legitimacy New medical irradiation techniques and methods should be strictly controlled within the scope of their indications. When new indications are to be used, they must be carried out separately. Sexual judgment. 4.2.4 The legitimacy of each medical exposure practice should be judged according to the purpose of diagnosis and treatment and the characteristics of the exposed persons. If a certain medical exposure It is usually judged as illegitimate, and when it needs to be used under special circumstances, the legitimacy should be judged case by case. Practicing physicians and related medical technicians The staff should use the previously existing diagnostic information and medical records of the subject related to the planned irradiation as much as possible to avoid unnecessary repeated irradiation. 4.2.5 When the group inspection enables the public to gain enough benefits to compensate for the economic and social costs (including radiation hazards), This inspection is justified. 4.2.6 X-ray diagnostic group inspection should prohibit the use of ordinary fluoroscopy inspection methods; unless there is a clear indication of disease risk, otherwise X-ray computed tomography device (CT) should not be used for physical examination. 4.2.7 It is necessary to strengthen the judgement of the legitimacy of diagnostic medical exposures for pregnant women and women who may become pregnant, especially for abdominal and pelvic examinations; There are clinically good reasons to request that a woman who is pregnant or who may become pregnant can receive radiation that will cause her abdomen or pelvis to be irradiated Learn to check, otherwise such exposure should be avoided. 4.2.8 The legitimacy of children’s diagnostic medical exposure should be strictly judged. For examples of pediatric illegitimate imaging examinations, see Appendix A. 4.2.9 Mobile and portable X-ray equipment should not be used for routine inspections. Only when it cannot be achieved or is not medically allowed to send the subject Mobile or portable X-ray equipment can only be used when the fixed equipment is inspected and strict corresponding protective measures are taken Operate at the bedside and perform medical imaging examinations. 4.2.10 Vehicle-mounted diagnostic X-ray equipment should generally be used during roving physical examinations or medical emergencies, and should not be used as routine X-rays in fixed locations Diagnostic equipment. 4.3 Protection optimization requirements 4.3.1 The basic goal of optimizing the protection of subjects in X-ray diagnostic and interventional radiology procedures is to maximize the benefits beyond the hazards. 4.3.2 The optimization process of medical exposure should include the selection of equipment. In addition to considering economic and social factors, it should be easy to use and quality assurance. (Including quality control), evaluation and estimation of the subject’s dose, etc., so that sufficient diagnostic information and therapeutic effects can be obtained fruit. 4.3.3 For medical X-ray diagnostic examinations that are indeed necessary for justified reasons, the principle of optimization of radiological protection should be followed, and appropriate After closing the diagnostic reference level, the dose received by the subject should be as low as possible while ensuring that sufficient diagnostic information is obtained. 4.3.4 When performing X-ray diagnostic inspections, the scope of the irradiation field should be strictly controlled to avoid sensitive organs or tissues adjacent to the irradiation field (such as The gonads, eye lens, breast and thyroid) are directly irradiated by useful beams. 4.3.5 The medical institution shall equip the subject with necessary radiological protective equipment, and take necessary measures for sensitive organs or tissues adjacent to the irradiation field. Shield protective measures. It is recommended to use wrapped shielding protection measures for the examinee in CT scan. 4.3.6 Special attention should be paid to the irradiation of embryos or fetuses, especially when pregnant women’s abdomen or pelvis is irradiated by useful beams or may Optimal treatment when receiving large doses in other ways. 4.3.7 When performing X-ray diagnostic inspections, no persons other than the subject should stay in the computer room. When the subject needs assistance At the time, necessary protective measures should be taken for the escort. 4.3.8 For diagnostic radiology procedures and image-guided intervention procedures, ensure that. a) Appropriate medical radiology equipment and software; b) Appropriate techniques and parameters to implement the minimum medical exposure required to achieve the clinical purpose of the radiological procedure on the subject, At the same time, it takes into account the acceptable image quality related specifications and related diagnostic reference levels formulated by related professional institutions. 4.4 Quality assurance requirements 4.4.1 Radiological diagnosis quality assurance program A radiological diagnosis quality assurance program should be developed, which should include. a) Image quality evaluation; b) The subject's dose evaluation; c) The measurement of the physical parameters of the radiation generator and the inspection of the imaging device when it is put into use and after it is put into use; d) Regularly check the corresponding physical factors and clinical factors used in diagnosis; e) Document related procedures and results; f) Dosimetry and monitoring instruments, corresponding calibration and verification of operating conditions; g) Corrective actions, tracking and results evaluation procedures; h) It is stipulated that various X-ray equipment and places should be tested by a qualified organization and can be used only after being qualified. 4.4.2 Measurement and calibration The requirements for measurement and calibration in the quality assurance program include. a) The dose measuring instrument used should have a continuous and valid verification certificate, calibration certificate or other traceability certification documents that meet the requirements Pieces; b) In X-ray diagnostic examinations, appropriate dosimetry related to the dose of the subject should be used; c) The relevant quantities in interventional radiology include total fluoroscopy time, total number of images, fluoroscopy dose rate, reference point dose and dose area Product etc. 4.5 Other 4.5.1 See Appendix B for X-ray equipment room protection testing. 4.5.2 Refer to Appendix C for the lead equivalents of different shielding substances in medical diagnostic X-ray protection. 4.5.3 Refer to Appendix D for the correction method of reading response time of measuring instrument. 4.5.4 Refer to Appendix E for diagnostic reference level. 4.5.5 Refer to Appendix F for the requirements of medical diagnostic X-ray personal protective materials and supplies. 4.5.6 Refer to Appendix G for requirements for medical diagnostic X-ray protective glass panels. 5 Technical requirements for X-ray equipment protection performance 5.1 General requirements 5.1.1 A beam limiting system (such as beam limiter, diaphragm, etc.) should be installed on the outlet of X-ray equipment. 5.1.2 The X-ray tube assembly should have a clear focus position mark. 5.1.3 The inherent filter should be marked on the X-ray tube assembly, and all additional filters should be marked with their material and thickness. 5.1.4 The accompanying documents shall describe the following performance related to protection. a) Inherent filtration of X-ray tube components; b) Filtration of X-ray source components; c) The characteristics of the filter; d) The air kerma kinetic energy rate of the leaking radiation on the spherical surface 100 cm away from the focal point; e) Methods of limiting useful harnesses; f) The size of the useful beam irradiation field at various distances from the focal point to the image receiver; g) The maximum and minimum distances from the focal point to the image receiving surface; h) Tube voltage and tube current loading conditions; i) Explanation of focal distance under various conditions of use; j) The attenuation equivalent of the X-ray beam by the bed plate and the grid in the useful harness; k) CT random files should provide isodose diagrams describing the distribution of stray radiation around the equipment; l) X-ray equipment for interventional radiology and near-stage co-operation (non-ordinary fluoroscopy) should provide isodose diagrams in the accompanying documents, Describe the distribution of stray radiation around the equipment and the value of stray radiation at typical positions of the staff, so that the staff can choose the protection plan; m) The accompanying documents of the vehicle-mounted diagnostic X-ray equipment shall state the surrounding dose equivalent rate level of the temporary control area, the layout of the site and the protection design drawing; n) For X-ray equipment used in various special and special occasions, the corresponding protective measures that must be taken under various application conditions should be specified. 5.1.5 Regarding the filtered content in the random file, it should meet. a) Except for mammography equipment, the non-removable filtering parts in normal use should be no less than 0.5 mmAl; b) Except for mammography equipment, filters that can only be removed with tools and inherent filtration (non-detachable) total filtration should be Not less than 1.5 mmAl; c) Except for X-ray equipment for dental photography and mammography, X-rays have an equivalent total filtration formed by all substances in the harness. Not less than 2.5 mmAl; d) For dental X-ray equipment with a nominal X-ray tube voltage not exceeding 70 kV, the total filtration should not be less than 1.5 mmAl; e) For mammography dedicated X-ray equipment with a nominal X-ray tube voltage not exceeding 50 kV, the total filtration should not be less than 0.03 mmMo. 5.2 Special requirements for the protective performance of X-ray equipment for fluoroscopy 5.2.1 The minimum focal distance of the C-arm X-ray equipment should not be less than 20 cm, and the minimum focal distance of the other X-ray equipment for fluoroscopy should not be less than 30 cm. 5.2.2 The fluoroscopy exposure switch should be a normally-off switch, equipped with fluoroscopy timing and time-limited alarm devices. 5.2.3 The special requirements for the protective performance of X-ray fluoroscopy equipment used in interventional radiology and near-stage co-operation (non-ordinary fluoroscopy) are shown in 5.8. 5.3 Special requirements for the protective performance of X-ray equipment for photography 5.3.1 X-ray equipment for photography of.200 mA and above should be equipped with a device that can install additional filter plates and be equipped with additional filter plates of different specifications. 5.3.2 X-ray equipment should have a beam limiting device that can adjust the irradiation field of the useful beam, and a light field indicating device that can mark the irradiation field should be provided. 5.4 Special requirements for the protective performance of C...