YY/T 0128-2023 English PDF (YY/T0128-2023)

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YY/T 0128-2023: Protective devices against diagnostic medical X-radiation -- Device and tool
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) Pbb) /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 chang...