YY/T 0128-2023 PDF English
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Protective devices against diagnostic medical X-radiation -- Device and tool
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Protective devices against diagnostic medical X-radiation. Device and tool
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YY/T 0128-2023: PDF in English (YYT 0128-2023) YY 0128-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.50
CCS C 43
YY/T 0128-2023
Replacing YY/T 0128-2004
Protective Devices against Diagnostic Medical X-radiation -
Device and Tool
ISSUED ON. MARCH 14, 2023
IMPLEMENTED ON. MAY 1, 2024
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 6
4 Requirements... 7
5 Inspection Methods... 13
Appendix A (normative) Some Commonly Used Protective Devices and Basic
Requirements... 18
Appendix B (informative) General Guidelines and Preparation Instructions... 23
Bibliography... 27
Protective Devices against Diagnostic Medical X-radiation -
Device and Tool
1 Scope
This document specifies the requirements and inspection methods for the protective devices
and tools against diagnostic medical X-radiation (hereinafter referred to as protective devices).
This document is applicable to protective devices provided to users to shield or attenuate
medical diagnostic X-ray radiation.
This document does not apply to wearable medical diagnostic X-ray radiation protective
supplies.
NOTE 1.the users mentioned in this document include operators (doctors, technicians and nurses),
patients (subjects) and other persons around the patients during radiographic examination
or interventional operations at a medical X-ray tube voltage of 150 kV and below.
NOTE 2.the wearable medical diagnostic X-ray radiation protective supplies include, but are not
limited to. protective skirts, thyroid protective scarves, protective caps, protective gloves,
protective glasses and protective masks, which are used for operator protection, as well
as gonad protective skirts, scrotal protective curtains, ovary protective curtains and dental
protective skirts, which are used for patient protection.
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB 9706.1-2020 Medical Electrical Equipment - Part 1.General Requirements for Basic Safety
and Essential Performance
GB 9706.103 Medical Electrical Equipment - Part 1-3.General Requirements for Basic Safety
and Essential Performance - Collateral Standard. Radiation Protection in Diagnostic X-ray
Equipment
GB 9706.243 Medical Electrical Equipment - Part 2-43.Particular Requirements for the Basic
Safety and Essential Performance of X-ray Equipment for Interventional Procedures
YY/T 0292.1-2020 Protective Devices against Diagnostic Medical X-radiation - Part 1.
Determination of Attenuation Properties of Materials
3.7 protective shield
A constituent unit of the protective device that is made of hard X-ray attenuation material and
provides protection to the users.
3.8 protective curtain
A constituent unit in protective device made of an inner layer of soft X-ray attenuation material
and an outer layer of waterproof knitted fabric or other waterproof soft materials, which
provides protection to the users.
3.9 protective baffle
A constituent unit in protective device made of a combination of X-ray attenuation material and
elastic material or elastic X-ray attenuation material, which provides protection to the users.
3.10 mobile type
A description of the functional characteristic of a protective device capable of being moved
from one place to another on its own wheels or by similar means.
3.11 suspended type
A description of the functional characteristic of a protective device capable of moving and
remaining stationary in the expected space by relying on its own support or suspension.
3.12 table mounted type
A description of the functional characteristic of a protective device capable of being fixed at the
bedside where a fluoroscopy-guided interventional operation equipment performs by its
own connector.
4 Requirements
4.1 Materials and Composition
The key materials and main components constituting the protective device.
---The key materials of the protective device shall be X-ray attenuation materials,
including lead attenuation material, lead-free attenuation material and lead
mixture attenuation material;
---The main part constituting the protective device should be protective shield, protective
curtain, protective baffle or combination thereof made of X-ray attenuation
materials, and a supporting, fixed or suspended structural member;
---Or as some of the commonly used protective devices listed in Appendix A, which shall
comply with the corresponding specific stipulations in Table A.1.
NOTE. in a few circumstances, protective shield, protective curtain and protective baffle can also
independently become a protective appliance without the help of supporting, fixed or
suspended structural members, for example, the medical X-ray protective cloth in
Appendix A.
4.2 Structure and Basic Mechanical Functions
The structure and basic mechanical functions of the protective device.
---The size and shape of the protective shield, protective curtain, protective baffle or
combination thereof in the protective device shall provide necessary protection for the
users, and avoid or reduce the users’ exposure to unnecessary radiation;
---Through the movement, rotation and lifting, etc. of the supporting, fixed or suspended
structural members in the protective device, the protective shield, protective curtain,
protective baffle or combination thereof can be conveniently positioned between the
users and the X-ray source or scattered radiation generation area at any time;
---The protective device shall not hinder necessary operation and use;
---Or as some of the commonly used protective devices listed in Appendix A, which shall
comply with the corresponding specific stipulations in Table A.2.
4.3 Protective Performance Indicators
4.3.1 Lead equivalent class
The lead equivalent of the protective device shall be no less than its lead equivalent class.
The lead equivalent class of the protective device.
---It shall be any one or a set of 0.25 mmPb, 0.35 mmPb, 0.50 mmPb, 1.0 mmPb and 2.0
mmPb;
---Or the protective device is some of the commonly used protective devices listed in
Appendix A, which shall comply with the corresponding specific stipulations in Table
A.3.
4.3.2 Effective shielding area
The effective shielding area of the protective device.
---It shall not be less than the value specified by the protective device;
---Or as some of the commonly used protective devices listed in Appendix A, which shall
comply with the corresponding specific stipulations in Table A.3.
NOTE. the lead equivalent class and effective shielding area are indicators that reflect the
protective capability of the protective device, but do not represent the actual protective
residual risk if it or its components become unbalanced;
d) If a protective device with a mass of 25 kg or above may cause imbalance due to
pushing, pulling, leaning and placing, etc., a permanently affixed, clear and easily
legible mark shall be provided (see safety mark 5 in Table D.2 of GB 9706.1-2020),
to warn of the risk of imbalance.
4.6.1.2 Protection against fall hazard
If applicable, the following requirements shall be satisfied.
a) For protective devices with supporting or suspended structural members, the safety
factor of the supporting or supported components shall at least satisfy the
corresponding stipulations in rows 1 to 6 of Table 21 in GB 9706.1-2020;
b) The movable parts of the supporting or suspended components shall be connected in
such a way that they will not fall under a single fault;
c) If a mechanical protective device is used for the movable parts of supports or
suspensions, then, the mechanical protective device.
1) When the connecting parts fall off, the mechanical protective device shall be able
to be automatically activated;
2) When the mechanical protective device is activated, there shall be identifiable
prompts and warning displays;
3) The tensile safety factor of the mechanical protective device shall comply with
the stipulations of Table 21 in GB 9706.1-2020.
4.6.1.3 Protection against pierce or puncture hazard
In accordance with the requirements of 9.3 in GB 9706.1-2020, sharp corners and sharp edges
on any accessible surface of the protective device that may cause injury or damage shall be
avoided or covered.
4.6.1.4 Protection against splash hazard
For mobile or suspended protective devices, if the protective shield or part of the protective
shield uses lead glass with an area greater than or equal to 0.24 m2, then, the lead glass shall be
pasted with anti-splash film on both sides or use laminated lead glass.
4.6.2 Safety requirements for active protective devices
4.6.2.1 In addition to comply with mechanical hazard protection safety in 4.6.1, active
protective devices shall also comply with other relevant requirements in GB 9706.1-2020.
4.6.2.2 The electromagnetic compatibility performance of active protective devices shall
comply with the requirements of YY 9706.102.
4.7 Appearance
4.7.1 The surface of the soft X-ray attenuation material in the protective device shall be free
of scratches, tears, speckles and stains. If the X-ray attenuation material and surface adopt.
---Sewing mode, the stitches shall be even and straight, and there shall be no obvious
skipped or broken stitches;
---Heat-sealing mode, the heat-sealing strips shall be flush and there shall be no cracks.
4.7.2 The surface, such as. lead glass and lead acrylic panels, of transparent X-ray attenuation
material in the protective device shall be smooth, without cracks, obvious impurities, bubbles
and scratches.
4.7.3 The metal structural parts in the protective device.
---If the surface is sprayed or spray-painted, then, the surface shall be completely covered
by the coating, basically smooth, without obvious bubbles, spots and wrinkles, without
relatively deep scratches, and consistent in color;
---If they are made of stainless steel, then, the outer surface shall be frosted, brushed or
polished.
4.8 Specification Markings
The content and example of the specification markings of the protective devices in this
document are as follows.
a) Pbb) /c) d) YY/T 0128-2023e)
a) Enterprise name or brand abbreviation;
b) Lead equivalent class (mmPb) of the protective device;
c) Voltage value or voltage range (kV) of the X-ray tube used for detection.
1) When the protective device uses lead X-ray attenuation material, and the voltage
value of the X-ray tube used for detection should be 120 kV, and marked as 120;
2) When the protective device uses lead-free X-ray attenuation material or lead
mixture X-ray attenuation material for stray radiation protection, which is
mainly scattered radiation, the voltage values of the X-ray tube used for
detection shall be 50 kV, 70 kV, 90 kV and 110 kV, and marked as 50-110;
3) When lead-free X-ray attenuation material or lead mixture X-ray attenuation
material is used for radiation protection, including X-ray radiation beams with
X-ray tube voltage up to 150 kV, the voltage values of the X-ray tube used for
or / and on the labels.
---Recommended methods for the cleaning and disinfection of the protective device before
use and / or daily;
---For protective devices used in a sterile environment, it shall be stated that physical
isolation mode is recommended for the users, for example, wrapping them with
disposable sterile transparent plastic films. Inform the users how to use the preset
structure of the protective device or utilize relevant structural parts to tie or hang the
disposable sterile transparent plastic films.
5 Inspection Methods
5.1 Materials and Composition
Conduct visual inspection of the protective device and check the bill of materials, which shall
comply with the stipulations of 4.1.
5.2 Structure and Basic Mechanical Functions
Conduct the inspection through visual inspection and / or by means of the following gauges or
methods.
---Use a meter ruler to measure the movement or lifting range;
---Use an angle ruler to measure the rotation angle range;
---Use your arms to press down on the upper protective baffle. After lowering the height
by 5 cm, release the pressure and observe the recovery of the upper protective baffle.
It shall be determined that they comply with the corresponding stipulations of Table A.2 for
some commonly used protective devices listed in Appendix A in 4.2.
5.3 Protective Performance Indicators
5.3.1 Lead equivalent class
5.3.1.1 Tube voltage value and other radiation mass of X-ray beams
The selection of the tube voltage value and other radiation mass of X-ray beams for detection.
---Protective devices intended to shield or reduce stray radiation, which is mainly
scattered radiation, and the X-ray attenuation material is lead-free attenuation
material or lead mixture attenuation material. the tube voltage value of the X-ray
radiation beams used to detect lead equivalent shall be 50 kV, 70 kV, 90 kV and 110
kV;
---Protective devices intended to shield or reduce X-ray radiation beams with X-ray tube
voltage up to 150 kV, and the X-ray attenuation material is lead-free attenuation
material and lead mixture attenuation material. the tube voltage value of the X-ray
radiation beams used to detect lead equivalent shall be 60 kV, 80 kV, 100 kV, 120 kV
and 150 kV;
---Protective devices using lead attenuation material. the tube voltage value of the X-ray
radiation beams used to detect lead equivalent should be 120 kV;
---The radiation mass of the X-ray radiation beams used to detect lead equivalent shall
also comply with other requirements specified in Table 1 of YY/T 0292.1-2020.
NOTE. since the lead equivalent value of lead attenuation material hardly changes with the tube
voltage of the detected X-ray radiation beams, the X-ray tube voltage value for the lead
equivalent detection of lead attenuation material should all be 120 kV.
5.3.1.2 Test method
Adopt the X-ray radiation beams that comply with the radiation mass specified in 5.3.1.1,
under the configuration of wide beam conditions specified in 4.3 or the reverse wide beam
conditions specified in 4.4 of YY/T 0292.1-2020, carry out the test. The lead equivalent class
of the protective device shall comply with the stipulations of 4.3.1.
5.3.2 Effective shielding area
Through the detection and size measurement of lead equivalent at multiple locations or
sampling at multiple locations, the effective shielding area of the protective device shall
comply with the stipulations of 4.3.2.
5.4 Mobility and Stability
5.4.1 Mobile protective device
Place the mobile protective device on a hard and flat horizontal ground (for example, a concrete
floor covered with 2 mm ~ 4 mm thick vinyl flooring material), and measure the external force
required to propel the protective device at a speed of 0.4 m/s 0.1 m/s, and this external force
is applied at a distance of 1 m from the ground. If the height of the mobile protective device
does not exceed 1 m, the external force shall be applied at the highest point and shall comply
with the stipulations of 4.4.1.
5.4.2 Suspended protective device
Adopt the methods specified below to respectively measure the horizontal and vertical starting
forces of the suspended protective device.
---The starting force in the horizontal direction shall respectively be measured when the
extension arm is locked with the fixed shaft and the spring arm is locked with the
extension arm. Use a tension gauge to pull the handle position of the suspended
protective shield or protective curtain in a horizontal and orthogonal direction, or
c) If the movable parts of the supporting or suspended components adopt a mechanical
protective device, then.
1) When the connecting parts fall off, observe whether the mechanical protective
device is automatically activated, which shall comply with the stipulations of 1)
in 4.6.1.2 c);
2) Observe whether there are identifiable prompts and warning displays during
startup, which shall comply with the stipulations of 2) in 4.6.1.2 c);
3) By whether the tensile strength applied during the tensile strength test of the
mechanical protective device is greater than or equal to the product of the
declared tensile safety factor and the total load, determine the safety factor,
which shall comply with the stipulations of 3) in 4.6.1.2 c).
NOTE. the total load of the protective device is equal to the sum of the gravity generated
by the supporting or suspended objects and related components and the vertical
downward starting force they may be subject to.
5.6.1.3 Protection against pierce or puncture hazard
Through observation and touch, determine the protection against pierce or puncture hazard,
which shall comply with the stipulations of 4.6.1.3.
5.6.1.4 Protection against splash hazard
Through visual observation, inspect the lead glass or check the bill of materials of the lead glass,
and determine the protection against splash hazard, which shall comply with the stipulations of
4.6.1.4.
5.6.2 Active protective device
5.6.2.1 In accordance with the method specified in the relevant stipulations of GB 9706.1-2020,
conduct the determination, which shall comply with the stipulations of 4.6.2.1.
5.6.2.2 In accordance with the method specified in the relevant stipulations of YY 9706.102,
conduct the determination, which shall comply with the stipulations of 4.6.2.2.
5.7 Appearance
Conduct the inspection through visual inspection, which shall comply with the stipulations of
4.7.1, 4.7.2 and 4.7.3.
5.8 Specification Markings
Check the specification markings in the instructions and labels, which shall comply with the
stipulations of 4.8.
Appendix B
(informative)
General Guidelines and Preparation Instructions
B.1 General Guidelines
This Appendix provides the preparation guidelines and brief preparation instructions for the
main chapters and clauses of this document. The purpose is to help understand and grasp the
requirements of this document and improve its effective application by explaining the relevant
chapters and clauses of this document and providing additional guidance.
B.2 Guidelines
The preparation guidelines of this document are as follows.
---The design of the protective devices shall be based on the principles of protection and
safety optimization. minimize unnecessary X-ray radiation to the users.
---The design of the protective devices shall match their auxiliary role and emphasize the
practicability and usability.
---Based on the differences in the protection modes adopted by the protective devices and
X-ray equipment. the protection mode of X-ray equipment is to reduce the absorbed
dose of the users by actively controlling the amount of X-ray radiation beam exposure
and the incident surface, and by actively controlling the leaked radiation and
protecting against residual radiation; the protection mode of the protective devices is
mainly to reduce the absorbed dose of the users by protecting against scattered
radiation. This document emphasizes the importance of the design of protection
against scattered radiation, especially the importance of the design of protection
against scattered radiation in designated effective occupied areas during
fluoroscopy-guided interventional operations.
---Since the requirements for the protective effect of operators performing fluoroscopy-
guided interventional operations in the designated effective occupied areas are
stipulated in WS 76-2020, in the design of suspended medical X-ray protective shield,
table mounted type medical X-ray protective curtain, mobile medical X-ray
protective curtain and medical X-ray protective surgical plate, this document has
considered how to satisfy the requirements for the surrounding dose equivalent rate
(Sv/h) on the detection plane of the fluoroscopy protective area specified in row 7 of
Table B.1 in WS 76-2020 in the lead equivalent class and effective shielding area
size. In addition, the suspended medical X-ray protective shield and table mounted
type medical X-ray protective curtain have passed the test verification in compliance
with WS 76-2020.
---In accordance with the risk management requirements for medical device products,
through risk analysis, risk assessment, and risk and benefit evaluation, this document
selects some provisions applicable to passive products from GB 9706.1-2020 regarding
the protection against mechanical hazard.
NOTE. the “fluoroscopy protective area” described in row 7 of Table B.1 in WS 76-2020 can be
comprehended as the designated effective occupied areas mentioned in this document.
For the designated effective occupied areas, see 13.4 of GB 9706.103-2020.
B.3 Preparation Instructions of Some Chapters and Clauses
B.3.1 Scope
Compared with the original standard, the scope of this document is no longer limited to specific
medical diagnostic X-ray radiation protective devices or tools, instead, it extends to all
protective devices or tools except wearable medical diagnostic X-ray radiation protective
equipment.
This document makes major adjustments to the items related to protective devices and tools in
the original standard. In addition to deleting products such as protective room, protective door
and protective chair that no longer belong to the category of medical devices or currently have
little market demand, wearable protective equipment, such as protective glasses, protective
mask and thyroid protective curtain are also deleted; the “protective shield” in the original
standard is modified into “mobile medical X-ray protective shield”, the “suspended protective
curtain” in the original standard is modified into “suspended medical X-ray protective shield”,
and the “protective curtain next to the examination bed (or photography bed, etc.)” is modified
into “table mounted type medical X-ray protective curtain” or “mobile medical X-ray protective
curtain”.
B.3.2 Terms and definitions
In addition to citing some terms and definitions defined in GB 9706.1-2020, GB 9706.103, GB
9706.243, YY/T 0292.1 and IEC/TR 60788, this document also defines the following terms and
definitions that are quite important to this document.
---Lead equivalent class is defined as a magnitude used in this document to express and
classify the X-ray attenuation properties of protective devices. When compared to lead
equivalent, lead equivalent class.
1) In addition to expressing the magnitude, it also has the concept of class; it is not
an arbitrary value, but a set of specific values that represent the X-ray attenuation
properties;
2) Specifies the conditions of lead equivalent class. including not only specific
regulations on the radiation mass of the X-ray beams used for lead equivalent
detection, but also regulations on the determination of inspection results (for
information on the specified conditions of lead equivalent class, see 5.5.3 of YY/T
0292.1-2020).
...... Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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