Powered by Google-Search & Google-Books Chinese Standards Shop Database: 169760 (Aug 8, 2020)
HOME  COVID-19   Quotation   Tax   Examples Standard-List   Contact-Us   View-Cart
  

YY/T 0292.2-2020

Chinese Standard: 'YY/T 0292.2-2020'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0292.2-2020English164 Add to Cart Days<=3 Protection devices against diagnostic medical X-radiation--Part 2: Translucent protective plates Valid YY/T 0292.2-2020
YY/T 0292.2-2020Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

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Older Standard (superseded by this standard) YY 0292.2-1997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
Protection devices against diagnostic medical X-radiation--Part 2.Translucent protective plates
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Replace YY 0292.2-1997
Medical diagnostic X-ray radiation protection equipment
Part 2.Transparent protective plate
2020-02-25 released
2021-03-01 implementation
Issued by the State Drug Administration
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 The geometric accuracy of the transparent protective plate 2
5 Optical properties of materials 2
6 Attenuation performance 2
7 Mark 3
8 Attached documents 4
9 Declaration of conformity with this part 4
Reference 5
Index 6
Preface
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 2 of YY/T 0292.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0292.2-1997 "Medical Diagnostic X-ray Radiation Protective Apparatus Part 2.Protective Glass Panel". This part
Compared with YY 0292.2-1997, the main changes are as follows.
---Expanded the scope of application of the standard to various types of transparent shields and various radiation qualities and gamma radiation (see Chapter 1);
---Modified the term definition of protective glass plate. from protective equipment to material plate for production (see 3.3.1 of the.1997 edition);
--- Deleted the definition of the terms SC type protective glass plate and type VI protective glass plate (see 3.3.2 and 3.3.3 of the.1997 edition);
---Added the terms of protective plastic plate and transparent protective plate (see 3.2 and 3.3);
--- Deleted the size requirements (see Chapter 4 of the.1997 edition);
---Modified the geometric accuracy and optical quality related requirements of the protective glass plate (see Chapter 5 and Chapter 6 of the.1997 edition);
---Relevant requirements for lead equivalent and minimum thickness have been revised (see 8.1 in the.1997 edition);
--- Modified the marking requirements (see Chapter 9 of the.1997 edition);
--- Modified the instructions that comply with this standard (see Chapter 11 of the.1997 edition).
The translation method used in this part is equivalent to the International Electrotechnical Commission IEC 61331-2.2014 "Medical Diagnostic X-ray Radiation Protection Apparatus
Part 2.Transparent protective plate. Compared with IEC 61331-2.2014, this part has been modified as follows.
---Some layout formats have been modified according to GB/T 1.1;
---This part modifies the errors in IEC 61331-2.2014, involving Table 2 in Chapter 7;
---The normative reference documents GB/T 3358.1-2009 (ISO 3534-1.2007, IDT), IEC 60601-2-8.2010 and
ISO /IEC Guide99.2007, because these three documents are only cited in the index.
The Chinese documents that have a consistent correspondence with the international documents cited 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 3.Parallel standard diagnostic X-ray equipment
General requirements for radiation protection (IEC 601-1-3.1994, IDT).
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical X-ray Equipment and Appliance Sub-Technical Committee (SAC/TC10/
SC1) Centralized.
This section was drafted. Liaoning Medical Device Inspection and Testing Institute.
The main drafters of this section. Liu Jingbo, Xu Xiaobin, Sun Jiawei, Shan Xu, Hao Suli, Meng Zhaoyang.
The previous editions replaced by this part are as follows.
---YY 0292.2-1997.
Medical diagnostic X-ray radiation protection equipment
Part 2.Transparent protective plate
1 Scope
This part of YY/T 0292 is applicable to transparent shields used for radiation protection in X-ray diagnosis and X-ray treatment; also suitable
A transparent shield used to protect against gamma radiation in nuclear medicine and brachytherapy with automatic control afterloading equipment.
This section does not apply to transparent radiation protection materials for other appliances, such as.
---Lead glasses or goggles (glasses) used to protect the eyes of the operator;
--- Lead mask covering the entire face of the operator;
--- Protective equipment for the eyes of patients;
---Protective equipment for thyroid and neck.
The requirements specified in this section are.
---Geometric accuracy;
---The optical quality of the material;
---Light transmittance;
---Radiation attenuation performance;
---mark;
---Declaration of compliance with this section.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
YY/T 0292.1 Medical diagnostic X-ray radiation protection equipment Part 1.Determination of material attenuation performance
IEC 60601-1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance
IEC 60601-1-3 Medical Electrical Equipment Part 1-3.General Requirements for Basic Safety and Basic Performance Collateral Standard. Diagnostic X
Radiation protection of ray equipment
IEC /T R60788.2004 Medical electrical equipment term definition compilation
3 Terms and definitions
IEC /T R60788.2004, IEC 60601-1, IEC 60601-1-3 and the following terms and definitions apply to this document.
3.1
Protective glass panel
A transparent protective screen with specified attenuation characteristics, composed of mineral glass and used to manufacture optically clear and transparent protective screens.
Guard plate.
Note. The toughness of the transparent protective plate composed of mineral glass does not affect the attenuation characteristics nor the optical and geometric characteristics.
3.2
Protective plastic sheet
A transparent plastic material with specified attenuation characteristics, which is composed of transparent plastic materials and used to make optically clear and transparent protective screens.
Ming protection board.
3.3
Transparent protective board
A board with prescribed attenuation characteristics, made of transparent materials and used to make optically clear and transparent protective screens.
3.4
Transmittance
In the visible light range, the ratio of the transmitted flux to the incident radiant flux under certain conditions.
Note. SI unit. 1.In actual industrial glass, the transmittance is usually described by "%".
Source. GB/T 7247.14-2012, 2.69 revision-the definition was revised to stipulate in the range of visible light, and the entry notes were expanded
Extend to industrial glass.
4 The geometric accuracy of the transparent protective plate
4.1 Flatness and minimum thickness
All points on each of the two surfaces of the transparent protective plate shall be contained in two parallel planes 0.3mm apart.
The actual thickness on the entire area of the transparent protective plate shall not be less than the minimum thickness value.
The minimum thickness of the transparent protective plate shall be indicated by "mm".
Note. The minimum thickness on the entire area of the board is related to the effectiveness of radiation protection.
4.2 Edge
The edges of the protective glass plate should be chamfered.
5 Optical properties of materials
5.1 Non-uniformity
Streaks, bubbles, non-uniformity and surface defects that hinder clarity should not appear.
5.2 Transmittance
Under the condition of glass thickness of 10mm and light wavelength of 550nm, the transmittance of the protective glass plate shall not be less than 80%. Determine the transmittance test
The uncertainty of the test method should not exceed 2%. This uncertainty applies to the 95% confidence level.
6 Attenuation performance
6.1 Determination of lead equivalent
Note. The radiation protection shielding required for a special purpose is usually estimated by the thickness of lead, so it is necessary to know the lead equivalent of the transmission shield.
The lead equivalent of the transparent protective plate shall be determined and specified in accordance with the method described in YY/T 0292.1.Lead equivalent should use narrow beam
Conditions or wide beam conditions, in YY/T 0292.1 Table 1 and Table 2 select the appropriate radiation quality to determine. If because of lack of suitable
When the measurement is impossible, such as the radiation quantum radiation of special radionuclides, it can be described in YY/T 0292.1
Method of calculation.
The selected conditions should refer to 6.4 and Chapter 7 to indicate that N represents narrow beam conditions, B represents wide beam conditions, and C is used to calculate lead equivalent.
All conditions are allowed, but ultimately the user decides to adopt the most suitable conditions according to the application of its radiation protection shielding.
6.2 Uniformity
The lead equivalent value in the entire area of the transparent protective plate shall not be less than the specified value.
6.3 Minimum thickness and lead equivalent
Note 1.The transparent protective plate is usually customized according to its lead equivalent, so the relationship between the minimum thickness and the corresponding lead equivalent is useful.
For the X-ray tube voltage of 50kV~150kV listed in Table 1 of YY/T 0292.1, the protective glass plate
The ratio of the lead equivalent defined in reference 6.1 to the minimum thickness defined in reference 4.1 shall not be less than 0.22.Minimum thickness and their lead equivalent
See Table 1 for examples.
Note 2.The exact value of the ratio of lead equivalent and minimum thickness in the protective glass plate depends on the radiation quality.
6.4 Information
The relevant lead equivalent information should be marked in mmPb and the method and radiation quality or radionuclide specified for use should be given at the same time.
Or provide the required information in the form of a random document, or refer to the mark in Chapter 7 to ensure that the required information can be obtained.
If maintenance must be performed with cleaning agents, sufficient guidance on applicable cleaning agents should be included in the accompanying documents.
7 mark
The protective glass plate shall be marked with the permanent mark in Table 2 on one of its flat surfaces. This mark can be clearly recognized from the other surface
No, and should be marked on a distance not less than 10mm from a corner.
8 Attached documents
If the protective glass panel is to provide accompanying documents, the accompanying documents should clearly state the identification corresponding to the protective glass panel.
All markings required by Chapter 7 shall be described in the accompanying documents.
9 Declaration of compliance with this section
If a protective glass plate is to be declared in compliance with this part, it should be specified in the following form, for example.
1) The name of the manufacturer or supplier.
2) Trademark or glass type.
3) Minimum thickness.
4) Lead equivalent.
5) Description of lead equivalent measurement harness conditions or calculations.
6) X-ray tube voltage in kV or gamma radiation energy or radionuclide code in keV.
7) The release year of this part.
references
Related standard:   YY/T 0292.1-2020  YY/T 0292.1-2020
Related PDF sample:   YY/T 0291-2016  YY/T 0310-2015
   
 
Privacy   ···   Product Quality   ···   About Us   ···   Refund Policy   ···   Fair Trading   ···   Quick Response
Field Test Asia Limited | Taxed in Singapore: 201302277C | Copyright 2012-2020