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GBZ130-2020: Requirements for radiological protection in diagnostic radiology
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GBZ 130-2020: Requirements for radiological protection in diagnostic radiology

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GBZ NATIONAL OCCUPATIONAL HYGIENE STANDARD ICS 13.100 C 57 Replacing GBZ 130-2013, GBZ 165-2012, etc. Requirements for radiological protection in diagnostic radiology Issued on. APRIL 03, 2020 Implemented on. OCTOBER 01, 2020 Issued by. National Health Commission of the People's Republic of China

Table of Contents

Foreword... 3 1 Scope... 6 2 Normative references... 6 3 Terms and definitions... 6 4 General rules... 8 5 Technical requirements for protection performance of X-ray equipment... 12 6 Technical requirements for protection facilities of machine room of X-ray equipment... 16 7 Protection safety requirements for operation of X-ray equipment... 22 8 Protection testing requirements for machine room of X-ray equipment... 27 Annex A (informative) Examples for pediatric illegitimate imaging examinations ... 28 Annex B (normative) Protection testing of machine room of X-ray equipment ... 29 Annex C (informative) Lead equivalents of different shielding substances in medical diagnostic X-ray protection... 33 Annex D (informative) Correction method for response time of measuring instrument reading... 38 Annex E (informative) Diagnostic reference level... 41 Annex F (informative) Requirements for medical diagnostic X-ray personal protective materials and supplies... 44 Annex G (informative) Requirements for protective glass panel of medical diagnostic X-ray... 58 Bibliography... 63

1 Scope

This Standard specifies requirements for protection in diagnostic radiology, including protection performance of X-ray imaging diagnosis and interventional radiology equipment, equipment room protection facilities, protection safety operation requirements and related protection testing requirements. This Standard is applicable to X-ray imaging diagnosis and interventional radiology. X-ray imaging equipment in radiotherapy and nuclear medicine shall be implemented in accordance with this Standard.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB 18871, Basic Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources GBZ 128, Specifications for individual monitoring of occupational external exposure

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply. 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 the X-ray equipment for diagnosis that is composed of C-frame, X-ray tube assembly and image intensifier (or dynamic flat panel detector), of which the frame and X-ray tube combination can be rotated in one or two directions 3.3 mobile X-ray equipment the mobile medical X-ray equipment that is used carry out operations such as bedside X-ray photography or fluoroscopy 3.4 X-ray diagnostic equipment installed on vehicle the fixed X-ray equipment installed on medical X-ray diagnostic vehicle; it usually is composed of X-ray generator, X-ray imaging device, bed, table, bracket and other auxiliary equipment 3.5 portable X-ray inspection equipment an on-site use inspection device that uses X-rays to conduct safety inspection and personnel rescue; it is usually carried directly by operator to operate on site 3.6 interventional radiology a technology that, under the supervision and guidance of the medical imaging system, through percutaneous needle puncture or introduction of catheters, performs suction injection, drainage or shaping, perfusion, embolization for lumens and blood vessels to diagnose and treat diseases

4 General rules

4.1 Management requirements Medical institutions shall be responsible for the protection and safety of radiation workers, subjects and the public, mainly including. 4.2.3 All new types of medical exposure techniques and methods, before use, shall be judged for legitimacy. Types of medical exposure that have been judged to be justified, when new or important evidence is obtained and a new judgment is required, shall be re-judged for legitimacy. When using all new medical exposure techniques and methods that have passed the justification judgment, they shall be strictly controlled within the scope of their indications. To use new indications, a separate judgment for legitimacy must be made. 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 kind of inspection is legitimate. 4.2.6 X-ray diagnostic group inspection shall prohibit the use of ordinary fluoroscopy inspection methods. Unless there is a clear indication of disease risk, X-ray computed tomography (CT) shall not be used for physical examination. 4.2.9 Mobile and portable X-ray equipment shall not be used for routine inspections. Only when it is not possible or medically does not allow the subject to be sent to a fixed device for examination, and after taking strict corresponding protective measures, can mobile or portable X-ray equipment be used to operate at the bedside. Perform medical imaging examination. 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. 4.4 Quality assurance requirements 4.4.1 Quality assurance program for radiological diagnosis It shall develop a quality assurance program for radiological diagnosis, including. 4.5 Others 4.5.1 See Annex B for X-ray equipment room protection testing. 4.5.2 See Annex C for lead equivalent of different shielding substances in medical diagnostic X-ray protection.

5 Technical requirements for protection performance of X-ray equipment

5.1 General requirements 5.1.1 On the outlet of X-ray equipment, a beam limiting system shall be installed (such as beam limiter, diaphragm). 5.1.4 Accompanying documents shall describe the following protection-related properties. 5.2 Special requirements for protective performance of X-ray equipment for fluoroscopy 5.2.1 The minimum focal distance of the C-arm X-ray equipment shall not be less than 20cm. The minimum focal distance of another X-ray equipment for fluoroscopy shall not be less than 30cm. 5.4 Special requirements for protection performance of CT equipment 5.4.1 Before the scanning process starts, it shall specify CT operating conditions used during a scan procedure. 5.4.2 For any CT scan procedure, it shall display dose information on the operator console. 5.5 Special requirements for protection performance of X-ray equipment for dental photography 5.5.1 The nominal value of the tube voltage when using dental X-ray equipment shall not be less than 60kV. 5.8.2 In the machine room, there shall be control keys for the staff to successfully switch between fluoroscopy and photography functions without changing the operating position. 5.9 Special requirements for protection performance of X-ray diagnostic equipment installed on vehicle 5.9.1 X-ray diagnostic equipment installed on vehicle shall meet special requirements for protection performance of its corresponding device type. 5.9.2 X-ray diagnostic equipment installed on vehicle shall be equipped with beam limiting device to ensure that the X-ray does not exceed the plane of the image receiver.

6 Technical requirements for protection facilities of machine room of X-ray equipment

6.1 Layout of machine room of X-ray equipment 6.1.1 X-ray equipment, doors, windows and pipeline ports of the machine room shall be set up reasonably. Try to avoid direct exposure to doors, windows, pipeline openings and staff operating positions with useful harnesses. 6.1.5 Except bedside photography equipment, portable X-ray equipment and X-ray diagnostic equipment installed on vehicle, with regard to the X-ray equipment machine room for new construction, reconstruction and expansion projects and technological transformation and technology introduction projects, the minimum effective use area and minimum unilateral length shall meet the requirements of Table 2. 6.4 Workplace protection of X-ray equipment 6.4.1 The machine room shall be equipped with observation windows or camera monitoring devices. The location set shall be convenient to observe the state of the subject as well as the opening and closing of the protective door. 6.4.10 The entrance to the machine room shall be in a position with relatively low scattered radiation. 6.4.11 The selection of the workplace of X-ray diagnostic equipment installed on vehicle shall fully consider the staying conditions of the surrounding personnel. The X-ray useful harness shall avoid the route where people stay and move.

7 Protection safety requirements for operation of X-ray equipment

7.1 General requirements 7.1.1 Radiology staff shall be proficient in business technology, receive radiation protection and relevant legal knowledge training to meet the job requirements of radiological staff. 7.1.7 During case teaching, the exposure time and number of exposures shall not be arbitrarily increased. 7.1.8 The method of improving the exposure conditions of photography shall not be used. Improve the development effect of expired film. 7.2 Protection safety requirements for operation of X-ray equipment for fluoroscopy 7.2.1 It shall try to avoid the use of ordinary fluoroscopy. Avoid lying fluoroscopy during use. Staff who use ordinary fluorescent screen fluoroscopy shall do adequate dark adaptation before fluoroscopy. 7.2.2 When performing gastrointestinal angiography, the exposure conditions shall be strictly controlled and repeated exposure shall be avoided. Effective protective measures shall be taken for staff and subjects. 7.4 Protection safety requirements for operation of CT equipment 7.4.1 CT staff shall, according to actual clinical needs, correctly select and optimize equipment working parameters. While meeting the needs of diagnosis, minimize the subject's exposure dose. 7.4.2 When conducting CT examination to children, it shall correctly select scanning parameters, so as to reduce the exposure dose and optimize the CT application of children. 7.5 Protection safety requirements for operation of X-ray equipment for dental photography 7.5.1 Oral film shall be fixed in place. Otherwise, the subject shall support himself. 7.6 Protection safety requirements for operation of mammography X-ray equipment 7.6.1 The thyroid area of the mammography subject shall be protected.

8 Protection testing requirements for machine room of X-ray equipment

8.1 Radiation dose testing of protective facilities of machine room of X-ray equipment and around the machine room shall meet the following requirements. 8.3 During normal use, medical institutions shall check the working state indicator light outside the door, the door closing device of the machine room door daily. Conduct regular inspection for other protective facilities. GBZ NATIONAL OCCUPATIONAL HYGIENE STANDARD ICS 13.100 C 57 Replacing GBZ 130-2013, GBZ 165-2012, etc. Requirements for radiological protection in diagnostic radiology Issued on. APRIL 03, 2020 Implemented on. OCTOBER 01, 2020 Issued by. National Health Commission of the People's Republic of China

Table of Contents

Foreword... 3 1 Scope... 6 2 Normative references... 6 3 Terms and definitions... 6 4 General rules... 8 5 Technical requirements for protection performance of X-ray equipment... 12 6 Technical requirements for protection facilities of machine room of X-ray equipment... 16 7 Protection safety requirements for operation of X-ray equipment... 22 8 Protection testing requirements for machine room of X-ray equipment... 27 Annex A (informative) Examples for pediatric illegitimate imaging examinations ... 28 Annex B (normative) Protection testing of machine room of X-ray equipment ... 29 Annex C (informative) Lead equivalents of different shielding substances in medical diagnostic X-ray protection... 33 Annex D (informative) Correction method for response time of measuring instrument reading... 38 Annex E (informative) Diagnostic reference level... 41 Annex F (informative) Requirements for medical diagnostic X-ray personal protective materials and supplies... 44 Annex G (informative) Requirements for protective glass panel of medical diagnostic X-ray... 58 Bibliography... 63

1 Scope

This Standard specifies requirements for protection in diagnostic radiology, including protection performance of X-ray imaging diagnosis and interventional radiology equipment, equipment room protection facilities, protection safety operation requirements and related protection testing requirements. This Standard is applicable to X-ray imaging diagnosis and interventional radiology. X-ray imaging equipment in radiotherapy and nuclear medicine shall be implemented in accordance with this Standard.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB 18871, Basic Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources GBZ 128, Specifications for individual monitoring of occupational external exposure

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply. 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 the X-ray equipment for diagnosis that is composed of C-frame, X-ray tube assembly and image intensifier (or dynamic flat panel detector), of which the frame and X-ray tube combination can be rotated in one or two directions 3.3 mobile X-ray equipment the mobile medical X-ray equipment that is used carry out operations such as bedside X-ray photography or fluoroscopy 3.4 X-ray diagnostic equipment installed on vehicle the fixed X-ray equipment installed on medical X-ray diagnostic vehicle; it usually is composed of X-ray generator, X-ray imaging device, bed, table, bracket and other auxiliary equipment 3.5 portable X-ray inspection equipment an on-site use inspection device that uses X-rays to conduct safety inspection and personnel rescue; it is usually carried directly by operator to operate on site 3.6 interventional radiology a technology that, under the supervision and guidance of the medical imaging system, through percutaneous needle puncture or introduction of catheters, performs suction injection, drainage or shaping, perfusion, embolization for lumens and blood vessels to diagnose and treat diseases

4 General rules

4.1 Management requirements Medical institutions shall be responsible for the protection and safety of radiation workers, subjects and the public, mainly including. 4.2.3 All new types of medical exposure techniques and methods, before use, shall be judged for legitimacy. Types of medical exposure that have been judged to be justified, when new or important evidence is obtained and a new judgment is required, shall be re-judged for legitimacy. When using all new medical exposure techniques and methods that have passed the justification judgment, they shall be strictly controlled within the scope of their indications. To use new indications, a separate judgment for legitimacy must be made. 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 kind of inspection is legitimate. 4.2.6 X-ray diagnostic group inspection shall prohibit the use of ordinary fluoroscopy inspection methods. Unless there is a clear indication of disease risk, X-ray computed tomography (CT) shall not be used for physical examination. 4.2.9 Mobile and portable X-ray equipment shall not be used for routine inspections. Only when it is not possible or medically does not allow the subject to be sent to a fixed device for examination, and after taking strict corresponding protective measures, can mobile or portable X-ray equipment be used to operate at the bedside. Perform medical imaging examination. 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. 4.4 Quality assurance requirements 4.4.1 Quality assurance program for radiological diagnosis It shall develop a quality assurance program for radiological diagnosis, including. 4.5 Others 4.5.1 See Annex B for X-ray equipment room protection testing. 4.5.2 See Annex C for lead equivalent of different shielding substances in medical diagnostic X-ray protection.

5 Technical requirements for protection performance of X-ray equipment

5.1 General requirements 5.1.1 On the outlet of X-ray equipment, a beam limiting system shall be installed (such as beam limiter, diaphragm). 5.1.4 Accompanying documents shall describe the following protection-related properties. 5.2 Special requirements for protective performance of X-ray equipment for fluoroscopy 5.2.1 The minimum focal distance of the C-arm X-ray equipment shall not be less than 20cm. The minimum focal distance of another X-ray equipment for fluoroscopy shall not be less than 30cm. 5.4 Special requirements for protection performance of CT equipment 5.4.1 Before the scanning process starts, it shall specify CT operating conditions used during a scan procedure. 5.4.2 For any CT scan procedure, it shall display dose information on the operator console. 5.5 Special requirements for protection performance of X-ray equipment for dental photography 5.5.1 The nominal value of the tube voltage when using dental X-ray equipment shall not be less than 60kV. 5.8.2 In the machine room, there shall be control keys for the staff to successfully switch between fluoroscopy and photography functions without changing the operating position. 5.9 Special requirements for protection performance of X-ray diagnostic equipment installed on vehicle 5.9.1 X-ray diagnostic equipment installed on vehicle shall meet special requirements for protection performance of its corresponding device type. 5.9.2 X-ray diagnostic equipment installed on vehicle shall be equipped with beam limiting device to ensure that the X-ray does not exceed the plane of the image receiver.

6 Technical requirements for protection facilities of machine room of X-ray equipment

6.1 Layout of machine room of X-ray equipment 6.1.1 X-ray equipment, doors, windows and pipeline ports of the machine room shall be set up reasonably. Try to avoid direct exposure to doors, windows, pipeline openings and staff operating positions with useful harnesses. 6.1.5 Except bedside photography equipment, portable X-ray equipment and X-ray diagnostic equipment installed on vehicle, with regard to the X-ray equipment machine room for new construction, reconstruction and expansion projects and technological transformation and technology introduction projects, the minimum effective use area and minimum unilateral length shall meet the requirements of Table 2. 6.4 Workplace protection of X-ray equipment 6.4.1 The machine room shall be equipped with observation windows or camera monitoring devices. The location set shall be convenient to observe the state of the subject as well as the opening and closing of the protective door. 6.4.10 The entrance to the machine room shall be in a position with relatively low scattered radiation. 6.4.11 The selection of the workplace of X-ray diagnostic equipment installed on vehicle shall fully consider the staying conditions of the surrounding personnel. The X-ray useful harness shall avoid the route where people stay and move.

7 Protection safety requirements for operation of X-ray equipment

7.1 General requirements 7.1.1 Radiology staff shall be proficient in business technology, receive radiation protection and relevant legal knowledge training to meet the job requirements of radiological staff. 7.1.7 During case teaching, the exposure time and number of exposures shall not be arbitrarily increased. 7.1.8 The method of improving the exposure conditions of photography shall not be used. Improve the development effect of expired film. 7.2 Protection safety requirements for operation of X-ray equipment for fluoroscopy 7.2.1 It shall try to avoid the use of ordinary fluoroscopy. Avoid lying fluoroscopy during use. Staff who use ordinary fluorescent screen fluoroscopy shall do adequate dark adaptation before fluoroscopy. 7.2.2 When performing gastrointestinal angiography, the exposure conditions shall be strictly controlled and repeated exposure shall be avoided. Effective protective measures shall be taken for staff and subjects. 7.4 Protection safety requirements for operation of CT equipment 7.4.1 CT staff shall, according to actual clinical needs, correctly select and optimize equipment working parameters. While meeting the needs of diagnosis, minimize the subject's exposure dose. 7.4.2 When conducting CT examination to children, it shall correctly select scanning parameters, so as to reduce the exposure dose and optimize the CT application of children. 7.5 Protection safety requirements for operation of X-ray equipment for dental photography 7.5.1 Oral film shall be fixed in place. Otherwise, the subject shall support himself. 7.6 Protection safety requirements for operation of mammography X-ray equipment 7.6.1 The thyroid area of the mammography subject shall be protected.

8 Protection testing requirements for machine room of X-ray equipment

8.1 Radiation dose testing of protective facilities of machine room of X-ray equipment and around the machine room shall meet the following requirements. 8.3 During normal use, medical institutions shall check the working state indicator light outside the door, the door closing device of the machine room door daily. Conduct regular inspection for other protective facilities. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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