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YY/T 0292.1-2020

Chinese Standard: 'YY/T 0292.1-2020'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0292.1-2020English344 Add to Cart Days<=4 Protective devices against diagnostic medical X-radiation--Part 1: Determination of attenuation properties of materials Valid YY/T 0292.1-2020
YY/T 0292.1-2020Chinese19 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

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Older Standard (superseded by this standard) YY/T 0292.1-1997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
Protective devices against diagnostic medical X-radiation--Part 1. Determination of attenuation properties of materials
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Replace YY 0292.1-1997
Medical diagnostic X-ray radiation protective equipment
Part 1. Determination of attenuation properties of materials
(IEC 61331-1..2014, IDT)
Published on February 25, 2020
2021-03-01 implementation
Issued by the State Drug Administration
Foreword
YY/T 0292 "Medical Diagnostic X-ray Radiation Protection Apparatus" is divided into three parts.
--- Part 1. Determination of material attenuation performance;
--- Part 2. Transparent protective board;
--- Part 3. Protective clothing, protective glasses and patient protective curtains.
This part is part 1 of YY/T 0292.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0292.1-1997 "Medical Diagnostic X-ray Radiation Protection Apparatus Part 1. Determination of Material Attenuation Performance".
Compared with YY 0292.1-1997, the main changes are as follows.
--- Increase the reverse wide ray beam condition (see 4.4);
--- Added a method to determine the attenuation rate (see 4.4, 4.5);
--- Increased the scope of application and expanded to photon-emitting radionuclides (see 4.5);
--- Added a method to calculate the attenuation rate of radionuclide emitting photons (see 4.5);
--- Added new standards for X and γ-ray radiation quality for testing (see 4.5.4);
--- Increased the level of lead equivalent (see 5.5);
--- Added the table of attenuation rate, accumulation coefficient and the first half-valence layer under the standard radiated mass of lead filtered with different thickness (see attached
Record A).
The translation method used in this part is equivalent to the use of IEC 61331-1..2014 "Medical Diagnostic X-ray Radiation Protection Apparatus Part 1. Materials
Determination of attenuation performance. Compared with IEC 61331-1..2014, this part has the following editorial changes.
--- Modified some layout formats according to GB/T 1.1;
--- This part revises IEC 60601-1..2005 and IEC 60601-1..2005/AMD1..2012 in normative references to
IEC 60601-1, IEC 60601-1-3..2008 and IEC 60601-1-3..2008/AMD1..2013 modified to IEC 60601-
1-3.
The documents in China that have a consistent correspondence with the normatively cited international documents in this section 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 III, Parallel standard diagnostic X-ray
General requirements for equipment radiation protection (IEC 601-1-3..1994, IDT).
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is composed of the Medical X-ray Equipment and Appliance Sub-Technical Committee (SAC/TC10 /
SC1) Centralized.
This section was drafted. Liaoning Medical Device Inspection and Testing Institute, Beijing Huaren Yikang Technology Development Co., Ltd., Shandong Shuangying Medical
Instruments Co., Ltd.
The main drafters of this section. Jiao Qiang, Jiangnan, Yang Yan, Zhang Songhua, Liu Yang, Lu Ximing.
The previous releases replaced by this section are.
--- YY 0292.1-1997.
Medical diagnostic X-ray radiation protective equipment
Part 1. Determination of attenuation properties of materials
1 Scope
This part of YY/T 0292 is applicable to the production of sheet-shaped materials for protective appliances, which can be used up to 400kV
The X-ray tube voltage produces X-ray radiation and the photon energy reaches 1.3 MeV.
Protection.
This section does not apply to the regular inspection of the attenuation performance of protective equipment before and after use.
This part of YY/T 0292 specifies the method of measurement and representation of the attenuation characteristics of materials.
The attenuation characteristics are given in the following form.
--- decay rate;
--- accumulation factor;
--- Attenuation equivalent.
Where appropriate, together with indications of uniformity and mass per unit area.
This part contains the method for expressing the declared value of attenuation characteristics.
This section does not include.
--- Regular inspection methods for protective appliances, especially protective clothing;
--- Determination method of layered attenuation in radiation beam;
--- Provide a method for measuring the attenuation of walls and other parts of the device for the purpose of ionizing radiation protection.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
IEC 60601-1 Medical Electrical Equipment Part 1. General Requirements for Basic Safety and Basic Performance (Medicalelectricale-
quipment-Part 1. Generalrequirementsforbasicsafetyandessentialperformance)
IEC 60601-1-3 Medical Electrical Equipment Part 1-3. General Requirements for Basic Safety and Basic Performance Parallel Standard. Diagnostic X
Radiation protection of ray equipment (Medicalelectrical equipment-Part 1-3. General requirements for basic safety and
essentialperformance-ColateralStandard. RadiationprotectionindiagnosticX-rayequipment)
IEC /T R60788..2004 Definition of medical electrical equipment glossary (Medicalelectrical equipment-Glossary of
definedterms)
MonographieBIPM-5..2013, TableofRadionuclides1) Monograph BIPM-5..2013, Radionuclide Table
NISTIR5632..2004 (TablesofX-RayMassAttenuationCoefficientsandMassEnergy-Absorp-
tionCoefficients (version1.4) 2) X-ray mass attenuation coefficient and mass energy absorption coefficient
1) MonographieBIPM-5..2013F-92310Sèvres, ISBN92-822-2204-7 (set) International Bureau of Metrology.
2) NISTIR5632..2004 National Institute of Standards and Technology, US Department of Commerce.
Related standard:   YY/T 0292.2-2020  YY/T 0292.2-2020
Related PDF sample:   YY/T 0291-2016  YY/T 0310-2015
   
 
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