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YY/T 0292.1-2020 (YYT 0292.1-2020)

Chinese Standard: 'YY/T 0292.1-2020'
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BASIC DATA
Standard ID YYT0292.1-2020 (YYT0292.1-2020)
Description (Translated English) Protective devices against diagnostic medical X-radiation--Part 1: Determination of attenuation properties of materials
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 21,242
Date of Issue 2020-02-25
Date of Implementation 2021-03-01
Older Standard (superseded by this standard) YY/T 0292.1-1997
Drafting Organization Liaoning Medical Device Inspection and Testing Institute, Beijing Huaren Yikang Technology Development Co., Ltd., Shandong Shuangying Medical Device Co., Ltd.
Administrative Organization National Medical Appliance Standardization Technical Committee Medical X-ray Equipment and Appliance Sub-Technical Committee (SAC / TC 10 / SC 1) ��
Regulation (derived from) Announcement No. 18 of 2020 by the State Administration of Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 0292.1-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
YY/T 0292.1-2020 / IEC 61331-1:2014
Replacing YY/T 0292.1-1997
Protective devices against diagnostic medical X-
radiation - Part 1: Determination of attenuation
properties of materials
医用诊断 X射线辐射防护器具
第 1部分: 材料衰减性能的测定
(IEC 61331-1:2014, IDT)
ISSUED ON: FEBRUARY 25, 2020
IMPLEMENTED ON: MARCH 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 6 
3 Terms and definitions ... 6 
4 Methods to determine the ATTENUATION RATIO ... 7 
5 Determination of ATTENUATION properties ... 19 
6 Statement of compliance ... 23 
Annex A (Informative) Tables of ATTENUATION RATIOS, BUILD-UP FACTORS
and first HALF-VALUE LAYERS ... 24 
Bibliography ... 27 
Index ... 28 
Foreword
YY/T 0292 "Protective devices against diagnostic medical X-radiation" is
divided into three parts:
- Part 1: Determination of attenuation properties of materials;
- Part 2: Translucent protective plates;
- Part 3: Protective clothing, eyewear and protective patient shields.
This Part is Part 1 of YY/T 0292.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY/T 0292.1-1997 "Protective devices against diagnostic
medical X-radiation - Part 1: Determination of attenuation properties of
materials". Compared with YY/T 0292.1-1997, the main changes in this Part
are as follows:
- ADD the inverse broad beam condition (see 4.4);
- ADD the methods to determine the attenuation ratio (see 4.4 and 4.5);
- INCREASE the scope of application and extend to photon-emitting
radionuclides (see 4.5);
- ADD the method for calculation of the attenuation ratio for photon-emitting
radionuclides (see 4.5);
- ADD new standard for X and γ-ray radiation quality for testing (see 4.5.4);
- ADD the lead equivalent class (see 5.5);
- ADD the tables of attenuation ratios, build-up factors and first half-value
layers under standard radiation qualities filtered by different thicknesses of
lead (see Annex A).
This Part, using translation method, is identical to IEC 61331-1:2014 "Protective
devices against diagnostic medical X-radiation - Part 1: Determination of
attenuation properties of materials". Compared with IEC 61331-1:2014, this
Part has made the following editorial changes:
- According to GB/T 1.1, modify some layout formats;
- This Part revises IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 in
the normative references to IEC 60601-1; revises IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013 to IEC 60601-1-3.
China’s documents which have a consistent correspondence with the
international documents normatively referenced in this Part are as follows:
- GB 9706.1-2007 Medical electrical equipment - Part 1: General
requirements for safety (IEC 60601-1:1988, IDT);
- GB 9706.12-1997 Medical electrical equipment - Part 1: General
requirements for safety - 3. Collateral standard: General requirements for
radiation protection in diagnostic X-ray equipment (IEC 601-1-3:1994, IDT).
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority of this document shall
not be held responsible for identifying any or all such patent rights.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of Subcommittee on Medical X-ray
Equipment and Appliances, National Technical Committee 10 on Medical
Electrical Equipment of Standardization Administration of China (SAC/TC
10/SC 1).
Drafting organizations of this Part: Liaoning Medical Device Test Institute,
Beijing Huaren Health Science & Technology Developing Co., Ltd., Shandong
Double Eagle Medical Device Co., Ltd.
Main drafters of this Part: Jiao Qiang, Jiang Nan, Yang Yan, Zhang Songhua,
Liu Yang, Lv Ximing.
The previous editions of the standard replaced by this Part were released as
follows:
- YY/T 0292.1-1997.
Protective devices against diagnostic medical X-
radiation - Part 1: Determination of attenuation
properties of materials
1 Scope
This Part of YY/T 0292 applies to materials in sheet form used for the
manufacturing of PROTECTIVE DEVICES against X-RADIATION of
RADIATION QUALITIES generated with X-RAY TUBE VOLTAGES up to 400
kV and gamma radiation emitted by radionuclides with photon energies up to
1.3 MeV.
This Part is not intended to be applied to PROTECTIVE DEVICES when these
are to be checked for the presence of their ATTENUATION properties before
and after periods of use.
This Part of YY/T 0292 specifies the methods of determining and indicating the
ATTENUATION properties of the materials.
The ATTENUATION properties are given in terms of:
- ATTENUATION RATIO;
- BUILD-UP FACTOR;
- ATTENUATION EQUIVALENT;
together with, as appropriate, an indication of homogeneity and mass per unit
area.
Ways of stating values of ATTENUATION properties in compliance with this Part
are included.
Excluded from the scope of this Part are:
- methods for periodical checks of PROTECTIVE DEVICES, particularly of
PROTECTIVE CLOTHING,
- methods of determining ATTENUATION by layers in the RADIATION BEAM,
and
- methods of determining ATTENUATION for purposes of protection against
IONIZING RADIATION provided by walls and other parts of an installation.
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are applicable to this document.
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
IEC 60601-1-3 Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential performance - Collateral
Standard: Radiation protection in diagnostic X-ray equipment
IEC/TR 60788:2004 Medical electrical equipment - Glossary of defined terms
Monographie BIPM-5:2013, Table of Radionuclides1)
NISTIR 5632:2004 Tables of X-Ray Mass Attenuation Coefficients and Mass
Energy - Absorption Coefficients (version 1.4)2)
3 Terms and definitions
Related standard: YY/T 0292.2-2020    YY/T 0291-2016
Related PDF sample: YY/T 0291-2016    YY/T 0291-2007