GBZ 130-2020 PDF English (GBZ 130-2013: Older version)
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Requirements for radiological protection in diagnostic radiology
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Requirements for radiological protection in medical X-ray diagnosis
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GBZ 130-2020: PDF in English GBZ 130-2020
GBZ
NATIONAL OCCUPATIONAL HYGIENE STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
Requirements for radiological protection in diagnostic
radiology
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
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:
a) Layout of the radiological diagnostic equipment workplace, design and
construction of the machine room;
b) Equipped with professionals with reasonable structure suitable for
inspection work;
c) The occupational exposure of workers shall be restricted. Occupational
exposure dose limit shall meet the requirements of GB 18871. Personal
dose monitoring shall meet the requirements of GBZ 128;
d) Perform health checkups for radiology staff before, during and after work.
Regularly perform professional and protective knowledge training.
Respectively establish personal dosage, occupational health
management and education and training files;
e) Develop personnel training guidelines and plans. Train personnel on
professional skills, radiation protection knowledge and relevant legal
knowledge to meet the job requirements for radiation workers;
f) Configure diagnostic equipment, testing instruments and protective
facilities suitable for X-ray inspection. Take all reasonable measures to
prevent equipment failure and human error;
g) Develop and implement a radiation protection management system.
Implement the program for radiological protection quality assurance. Take
reasonable and effective measures. Minimize the consequences of
possible failures and errors;
h) Develop corresponding emergency plans for radiological incidents. It shall,
to possible events, publicize the plan and conduct regular practical
exercises;
i) The radiation damage of the subject shall be reported to the health
administration department in time.
4.2 Legitimacy requirements
4.2.1 Medical exposure shall have sufficient net benefits. In the case of
obtaining the same net benefit, alternative methods of non-medical exposure
shall be used whenever possible. It shall weigh the pros and cons when there
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.
4.2.10 X-ray diagnostic equipment installed on vehicle shall generally be used
during roving physical examinations or medical emergencies. It shall not be
used as conventional X-ray diagnostic equipment in fixed places.
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 shall include the selection
of equipment. In addition to considering economic and social factors, it shall
examine the aspects such as ease of use, quality assurance (including quality
control), evaluation and estimation of subject dose, so that it can get enough
diagnostic information and treatment effect.
4.3.3 Examine the medical X-ray diagnosis that is indeed necessary for
legitimate reasons. Follow the principle for optimization of radiation protection.
Apply relevant diagnostic reference level. In the case of ensuring that sufficient
diagnostic information is obtained, the dose received by the subject shall be as
low as possible.
4.3.4 When performing X-ray diagnostic examination, it shall strictly control the
exposure field range to avoid the sensitive organs or tissues (such as gonads,
eye lens, breast and thyroid) adjacent to the exposure field from being directly
exposed to useful beams.
4.3.5 Medical institutions shall equip the subject with necessary radiation
protection equipment. Take necessary shielding and protective measures for
sensitive organs or tissues adjacent to the exposure field. It is recommended to
use wrapped shielding protection measures for the subject in the CT scan.
4.3.6 Pay special attention to the exposure to the embryo or fetus, especially
the optimal treatment when the pregnant woman's abdomen or pelvis is
irradiated with useful beams or may receive large doses in other ways.
4.3.7 When performing X-ray diagnostic examination, people other than the
subject shall not stay in the machine room. When the subject needs personnel
assistance, the necessary protective measures shall be taken for the escort.
4.3.8 For diagnostic radiology procedures and image-guided intervention
procedures, it shall ensure to use:
time, total number of images, fluoroscopy dose rate, reference point dose
and dose area product.
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.
4.5.3 See Annex D for correction method for reading response time of
measuring instrument.
4.5.4 See Annex E for diagnostic reference level.
4.5.5 See Annex F for requirements for medical diagnostic X-ray personal
protective materials and supplies.
4.5.6 See Annex G for requirements for medical diagnostic X-ray protective
glass panel.
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).
5.1.2 On the X-ray tube components, there shall be a clear focus position mark.
5.1.3 On the X-ray tube components, inherent filtration shall be indicated. All
additional filters shall be marked with their material and thickness.
5.1.4 Accompanying documents shall describe the following protection-related
properties:
a) Inherent filtration of X-ray tube components;
b) Filtration of X-ray source components;
c) Characteristics of filtration tablets;
d) At 100 cm away from the focal point on the spherical surface, air kerma
rate of leaked radiation;
e) Ways to limit useful harnesses;
e) For X-ray equipment for mammography of which the nominal X-ray tube
voltage does not exceed 50kV, its total filtration shall not be less than
0.03mmMo.
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.
5.2.2 The fluoroscopic exposure switch shall be a normally-off switch, equipped
with fluoroscopic timing and time-limited alarm device.
5.2.3 See 5.8 for special requirements for protection performance of X-ray
fluoroscopy equipment used for interventional radiology, near-stage co-
operation (non-common fluoroscopy).
5.3 Special requirements for protection performance of X-ray equipment
for photography
5.3.1 X-ray equipment for photography of 200 mA and above shall have a
device that can install additional filter plates, equipped with additional filter
plates of different specifications.
5.3.2 X-ray equipment shall have a beam limiting device that can adjust the
useful beam exposure field. It shall provide a light field indicating device that
can mark the exposure field.
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.
5.4.3 Emergency stop button shall be set, so that the beam can be stopped in
time when an accident occurs during the CT scan.
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.
5.5.2 X-ray equipment for dental panoramic tomography shall have beam
limiting device to prevent X-ray from going beyond the plane of X-ray image
5.8.1 X-ray equipment for interventional radiology, near-stage co-operation
(non-common fluoroscopy) shall meet special requirements for protection
performance of corresponding equipment types.
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.
5.8.3 X-ray equipment shall be equipped with devices that can prevent the use
of focal distances less than 20cm.
5.8.4 In intervention operation, the equipment console and the monitor in the
machine room shall be able to display the radiation dosimetry instructions and
multiple exposure dose records of the current subject.
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.
6.1.2 The setting of the machine room (exposure room) of X-ray equipment
shall fully consider the protection and safety of people in adjacent rooms
(including upstairs and downstairs) and surrounding places.
6.1.3 Each fixed X-ray equipment shall have a separate machine room. The
machine room shall meet the layout requirements of the equipment used. If
each dental chair is independently set up in the consulting room, fixed intraoral
dental film machine can be installed in the consulting room for the use of this
equipment. The shielding and layout of the consulting room shall meet the
protection requirements of the intraoral dental film machine room.
machine, mammography, mammary CBCT, intraoral dental radiography,
dental panoramic photography, dental panoramic head photography, oral
CBCT and whole-body bone densitometer shall not exceed 2.5μSv/h;
c) The surrounding dose equivalent rate outside the machine room of
photography programs with short-term, high-dose rate exposure (such as
DR, CR, screen photography) shall not exceed 25μSv/h. When exceeding,
the annual effective dose assessment of personnel outside the machine
room shall be conducted. It shall not be greater than 0.25mSv;
d) When X-ray diagnostic equipment installed on vehicle is working, a
temporary control zone shall be established 3m around the vehicle. The
dose equivalent rate around the boundary of the control area shall meet
the requirements of a) to c) in 6.3.1.
6.3.2 The testing method and testing conditions for radiation shielding
protection of the machine room are in accordance with the requirements of
Clause 8 and Annex B.
6.3.3 It is advisable to use equipment capable of measuring short-time beam
and pulsed radiation fields for measurement. If the measuring instrument does
not meet the response time requirements, it shall conduct response time
correction to its readings. See Annex D for the correction methods.
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.
6.4.2 No debris unrelated to the diagnosis of the equipment shall be stacked in
the machine room.
6.4.3 Power ventilation device shall be installed in the machine room. Maintain
good ventilation.
6.4.4 There shall be an ionizing radiation warning sign outside the door of the
machine room. There shall be a conspicuous working state indicator above the
door of the machine room. The light box shall be set up with visual warning
statements such as "harmful rays, do not enter the light". The waiting area shall
be provided with a notice board for radiation protection precautions.
6.4.5 There shall be an automatic door closing device for side hung door of
machine room. The sliding door of machine room shall be equipped with
management measures to close the machine room door during exposure. The
working state indicator can be effectively associated with the machine room
door.
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.
7.1.2 According to different inspection types and needs, choose to use
appropriate equipment, exposure conditions, exposure fields and
corresponding productive equipment.
7.1.3 Reasonably choose various operating parameters. Under the condition of
ensuring that the expected diagnostic target is achieved, minimize the exposure
dose received by the subject.
7.1.4 If the equipment has a child check mode option, this mode shall be used
when examining children. If there is no child check mode, the irradiation
parameters shall be adjusted appropriately (such as tube voltage, tube current,
irradiation time). And strictly limit the exposure field.
7.1.5 When X-ray equipment is exposed, doors and windows connected to the
machine room shall be closed.
7.1.6 Radiation workers shall receive personal dose monitoring according to
GBZ 128.
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.
7.1.9 Staff shall carry out exposure operations in shielded protective facilities
and shall closely observe the state of the subject through the observation
window.
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.
7.6.1 The thyroid area of the mammography subject shall be protected.
7.6.2 According to breast type and compression thickness, choose the right
target/filter material combination. It is advisable to use the automatic exposure
control function of photographic equipment. Obtain stable collection effect to
meet protection optimization requirements.
7.7 Protection safety requirements for operation of mobile and portable
X-ray equipment
7.7.1 Mobile and portable X-ray equipment shall meet the protection and safe
operation requirements of their corresponding equipment.
7.7.2 When using mobile X-ray equipment for X-ray inspection in the ward, it
shall take protective measures for the subject of adjacent bed (within 2m range).
The useful harness shall not be directed towards other subjects.
7.7.3 When exposed, staffs shall protect themselves. Choose a reasonable
standing position. Ensure that the subject's posture can be observed during
exposure.
7.7.4 Those who need to operate the inspection system at close range shall
wear a lead rubber apron or perform the operation after moving the lead
protective screen. The configuration of productive equipment and protective
facilities shall meet the requirements of 6.5.
7.7.5 Around temporary outdoor operation sites, guardrails or warning signs
shall be set up to prevent unrelated persons from entering.
7.7.6 When performing bedside operations on non-emergency, critical, and
severe subjects, reasonable operating time shall be determined. For example,
avoid the time period when doctor’s intensive rounds and family visits are
concentrated.
7.7.7 Whenever mobile X-ray equipment is used for bedside operations, the
staff operating the X-ray equipment shall perform the obligation to inform all the
personnel on site in advance. And ensure that no unrelated persons are present
in the control area.
7.7.8 Those who assist the subject in X-ray examination shall perform the
obligation of notification in advance and obtain their consent. After the escort
wears personal protective equipment, the bedside operation can be carried out.
7.7.9 When using mobile X-ray equipment to perform bedside operations, try to
use downward projection as much as possible. If the horizontal projection
method is used for inspection, except for subjects undergoing radiological
examination, it shall avoid using harnesses directly towards other people nearby.
10m) between the outer surface of the carriage and the window surface of the
building where people are used for office or residence. If the compartment floor
is not shielded, the waiting area under the vehicle shall be 3m away from the
surface of the vehicle. It is not limited for fluoroscopy work.
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:
a) Protection testing indicators and requirements for machine room of X-ray
equipment shall comply with the provisions of 6.3;
b) Protection testing for machine room of X-ray equipment shall be based on
tour testing. Focus on testing of local shielding and gaps of focus points.
Focus points shall include four-sided walls, floor, ceiling, machine room
door, operation room door, observation window, daylighting
window/window body, film box, pipeline opening, staff operating position.
Point selection shall be representative;
c) Testing points of X-ray diagnostic equipment installed on vehicle usually
shall include: outside the machine room on vehicle; doors, observation
windows, and aisles connected to the machine room; locations where staff
and other personnel in vehicle often stay. The testing points outside the
vehicle are located in a temporary control area 3m outside the vehicle.
Testing points usually shall include: 1 point each in the front and rear
directions; at least 3 points on each side of the vehicle body.
8.2 Radiation protection safety facilities of machine room of X-ray equipment
shall be subjected to the completion acceptance. During use, regular inspection
and testing shall be carried out. The period of regular testing is one year.
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.
Annex F
(informative)
Requirements for medical diagnostic X-ray personal protective materials
and supplies
F.1 Scope
This Annex applies to the personal protection of radiation workers when the
tube voltage of X-ray equipment is less than or equal to 150kV. It is also
applicable to the personal protection of X-ray subjects. It does not apply to lead-
containing-glass glasses and lead-containing PMMA face shields.
F.2 General requirements for design, materials and use
F.2.1 The operator’s protective equipment shall be designed so that it can be
easily put on and off by himself.
F.2.2 The protective equipment of the subject shall be designed to be
convenient to use and can be correctly placed on the part that needs protection
by the subject.
F.2.3 The effective attenuation material shall be evenly distributed. It shall
contain elements with high atomic number.
F.2.4 The attenuation performance shall not change under normal use.
F.2.5 All external and internal surfaces accessible by protective equipment shall
be easy to clean and disinfect.
F.2.6 There shall be no un-layered or uncoated surfaces with lead or lead
compounds that may be touched.
F.2.7 According to the difference of the energy and intensity of X-ray in the
workplace or according to the requirements of relevant standards, choose
different types and lead equivalent protective materials and supplies.
F.2.8 Personal protective materials and supplies in use shall be checked at least
once a year. Prevent degradation of protection quality due to aging, fracture or
damage. If aging, fracture or damage is found, replace it in time.
F.2.9 Protective gloves shall at least reach the minimum effective attenuation
equivalent required. There shall be no breaks on its entire surface, front and
back, including fingers and wrists.
and rear pieces are different, it can also be applied to the rear piece. For
example, 0.35mmPb (front), 0.25mmPb (rear);
d) X-ray tube voltage used to determine attenuation equivalent value is
attached to F.3.5c). Mark it as "/X-ray tube voltage" in kV. For example:
/100kV;
e) According to the requirements in Table F.1, give the letter symbols of the
corresponding size;
f) Product production date.
Example:
Heavy protective apron: XYZ H 0.3mmPb/100kV LM
F.4 Protective gloves
F.4.1 Design requirements
F.4.1.1 Protective gloves shall be seamless to cover the entire hand, at least
half of the forearm. The inner lining of the glove shall be washable.
F.4.1.2 Protective gloves shall be designed to individually wrap the thumb.
Other fingers shall also be wrapped separately. The shaft of the thumb sleeve
shall be able to face the palm so that the top of the thumb can touch the top of
the index finger.
F.4.1.3 Protective gloves shall be designed so that the wearer’s fingers are easy
to close and grip and the wrist joint of the hand can move freely laterally.
F.4.1.4 In order to check the protective materials during routine inspection, any
jacket material shall be detachable.
F.4.2 Materials
F.4.2.1 The protective materials, inner and outer covering materials used for
protective gloves shall be soft.
F.4.2.2 The lead equivalent of protective materials for making protective gloves
shall not be less than 0.25mmPb.
F.4.2.3 When making protective gloves, the protective materials used shall be
visually inspected for cracks and gaps. Identify them.
F.4.3 Dimensions
Protective gloves shall basically have the shape shown in Figure F.1 and meet
the standard dimensions given in Table F.2.
a) Names or trademarks of manufacturer and supplier, such as XYZ;
b) Attenuation equivalent value expressed in lead thickness is expressed in
“mmPb”, such as 0.25mmPb;
c) X-ray tube voltage used to determine attenuation equivalent value is
attached to F.5.4b). Mark it as "/X-ray tube voltage" in kV. For example:
/120kV;
d) If applicable, "standard size" shall be indicated, such as M;
e) Product production date.
Example:
Mitten protective gloves: XYZ 0.25mmPb/120kV M
F.6 Intervention protective gloves
F.6.1 Design requirements
F.6.1.1 Intervention protective gloves shall be seamless and non-porous to
cover the entire hand, at least half of the forearm.
F.6.1.2 Intervention gloves conform to the physiological structure of the human
hand. They are designed to wrap the thumb separately and other fingers shall
also be wrapped separately. The shaft of the thumb sleeve shall be able to face
the palm so that the top of the thumb can touch the top of the index finger.
F.6.1.3 Interventional protective gloves shall be designed so that the wearer’s
fingers are easy to close and grip and the wrist joint of the hand can move freely
laterally.
F.6.1.4 Intervention protective gloves shall be impervious to water. Stretching
performance shall be convenient for staff to wear in interventional surgery
environment. Gloves should fit the staff's hands to facilitate the operation of
surgical instruments by s......
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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