YY/T 0128-2023 English PDF (YYT0128-2023)

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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 satis...