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YY/T 0292.2-2020 (YYT 0292.2-2020)

Chinese Standard: 'YY/T 0292.2-2020'
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YY/T 0292.2-2020English155 Add to Cart 0--10 minutes. Auto-delivered. Protection devices against diagnostic medical X-radiation--Part 2: Translucent protective plates YY/T 0292.2-2020 Valid YY/T 0292.2-2020
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BASIC DATA
Standard ID YYT0292.2-2020 (YYT0292.2-2020)
Description (Translated English) Protection devices against diagnostic medical X-radiation--Part 2: Translucent protective plates
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 10,12
Date of Issue 2020-02-25
Date of Implementation 2021-03-01
Older Standard (superseded by this standard) YY 0292.2-1997
Drafting Organization Liaoning Medical Device Inspection and Testing Institute
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 0292.2-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
YY/T 0292.2-2020 / IEC 61331-2:2014
Replacing YY 0292.2-1997
Protection devices against diagnostic medical X-
radiation - Part 2: Translucent protective plates
医用诊断 X射线辐射防护器具
第 2部分: 透明防护板
(IEC 61331-2:2014, 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 ... 5 
3 Terms and definitions ... 6 
4 Geometrical accuracy of translucent protective plates ... 7 
5 Optical quality of material ... 7 
6 ATTENUATION properties ... 8 
7 Marking ... 9 
8 ACCOMPANYING DOCUMENTS ... 10 
9 Statement of compliance with this Part ... 10 
Bibliography ... 11 
Index ... 12 
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 2 of YY/T 0292.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY 0292.2-1997 "Protective devices against diagnostic
medical X-radiation - Part 2: Protective glass plates". Compared with YY
0292.2-1997, the main changes in this Part are as follows:
- Expand the scope of standard application to various types of translucent
protective plates and various radiation qualities and gamma radiation (see
Clause 1);
- Modify the term definition of protective glass plate: from protective
equipment to material plate for manufacturing (see 3.3.1 of the 1997
edition);
- Delete the definitions of the terms: type SC protective glass plate and type
VI protective glass plate (see 3.3.2 and 3.3.3 of the 1997 edition);
- ADD the terms of protective plastic plate and translucent protective plate
(see 3.2 and 3.3);
- Delete the size requirement (see Clause 4 of the 1997 edition);
- Modify the geometrical accuracy and optical quality related requirements of
protective glass plate (see Clause 5 and Clause 6 of the 1997 edition);
- Modify the relevant requirements for lead equivalent and minimum
thickness (see 8.1 of the 1997 edition);
- Modify the marking requirements (see Clause 9 of the 1997 edition);
- Modify the statement of compliance with this standard (see Clause 11 of
the 1997 edition).
This Part, using translation method, is identical to International Electrotechnical
Commission IEC 61331-2:2014 "Protective devices against diagnostic medical
X-radiation - Part 2: Translucent protective plates". Compared with IEC 61331-
2:2014, this Part has made the following changes:
- According to GB/T 1.1, modify some layout formats;
- This Part modifies the errors in IEC 61331-2:2014, involving Table 2 in
Clause 7;
- Delete the normative references GB/T 3358.1-2009 (ISO 3534-1:2007,
IDT), IEC 60601-2-8:2010 and ISO/IEC Guide 99:2007; because these
three documents are only cited in the index.
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 organization of this Part: Liaoning Medical Device Test Institute.
Main drafters of this Part: Liu Jingbo, Xu Xiaobin, Sun Jiawei, Shan Xu, Hao
Suli, Meng Zhaoyang.
The previous editions of the standard replaced by this Part were released as
follows:
- YY 0292.2-1997.
Protection devices against diagnostic medical X-
radiation - Part 2: Translucent protective plates
1 Scope
This Part of YY/T 0292 applies to TRANSLUCENT PROTECTIVE PLATES
used for RADIATION PROTECTION in X-ray diagnosis and in X-ray therapy. It
also applies to TRANSLUCENT PROTECTIVE PLATES used for protection
against GAMMA RADIATION in nuclear medicine and BRACHYTHERAPY with
automatically-controlled AFTERLOADING equipment.
It does not cover other translucent RADIATION PROTECTION materials, e.g.
- leaded glasses or goggles for protection of the OPERATOR'S eyes (eye
spectacles),
- leaded face shields, which cover the entire face of the OPERATOR,
- PATIENT eye protection, and
- thyroid/neck PROTECTIVE DEVICES.
This Part deals with the requirements on
- geometrical accuracy;
- optical quality of the material;
- spectral TRANSMITTANCE;
- radiation ATTENUATION properties;
- marking;
- statement of compliance with this Part.
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.
YY/T 0292.1 Protective devices against diagnostic medical X-radiation - Part
1: Determination of attenuation properties of materials (IEC 61331-1, IDT)
IEC 60601-1 Medical electrical equipment - Part 1: General requirement for
basic safety and essential performance
IEC 60601-1-3 Medical electrical equipment - Part 1-3: General requirement
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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC/TR
60788:2004, IEC 60601-1 and IEC 60601-1-3, and the following apply.
3.1
Protective glass plate
TRANSLUCENT PROTECTIVE PLATE consisting of mineral glass with
SPECIFIED attenuation properties used f......
Related standard: YY/T 0292.1-2020    YY/T 0291-2016
Related PDF sample: YY/T 0291-2016    YY/T 0291-2007