YY/T 0480-2021 English PDFUS$559.00 ยท In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0480-2021: (General purpose diagnostic X-ray imaging equipment and characteristics of anti-scatter grid for mammography) Status: Valid YY/T 0480: Historical versions
Basic dataStandard ID: YY/T 0480-2021 (YY/T0480-2021)Description (Translated English): (General purpose diagnostic X-ray imaging equipment and characteristics of anti-scatter grid for mammography) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C43 Word Count Estimation: 27,264 Issuing agency(ies): State Drug Administration YY/T 0480-2021: (General purpose diagnostic X-ray imaging equipment and characteristics of anti-scatter grid for mammography)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. (General purpose diagnostic X-ray imaging equipment and characteristics of anti-scatter grid for mammography) ICS 11.040.50 C43 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0480-2004 Diagnostic X-ray Imaging Equipment General and Mammography Characteristics of Anti-Scatter Grids (IEC 60627.2013, IDT) Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration forewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0480-2004 "General Purpose of Diagnostic X-ray Imaging Equipment and Characteristics of Anti-scatter Grid for Mammography". Compared with YY/T 0480-2004, the main changes of this standard are as follows. --- Added the definition of image improvement coefficient (see 3.3.7). --- Modified the instruments used for the measurement of primary radiation transmittance, scattered radiation transmittance and total radiation transmittance (see 5.1.2,.2004 5.1.2 of the year version); --- Modified the definition of phantoms used to test primary radiation transmittance, scattered radiation transmittance and total radiation transmittance (see 5.1.3, 5.1.3 of the.2004 version); --- Increased the deviation of the layout size for testing primary radiation transmittance, scattered radiation transmittance and total radiation transmittance (see 5.1.4). --- Modified the radiation conditions for measurement, using the RQR and RQR-M conditions specified in YY/T 0481-2016 (see 5.1.5, 5.1.5 of the.2004 edition). This standard is equivalent to the International Electrotechnical Commission IEC 60627.2013 "General Diagnostic X-ray Imaging Equipment and Mammography Anti-scattering" Properties of Grids" (in English). Compared with IEC 60627.2013, this standard has the following modifications. --- Modified some arrangement formats according to GB/T 1.1; ---The referenced international standards have corresponding national mandatory standards or national recommended standards (equivalently adopted and with the same version number) and medical The medical device industry standard, in principle, is replaced with the corresponding national or industry standard number, and the rest of the standards retain the original standard number; --- Delete the foreword and introduction of IEC ; --- Figure 4 does not give the unit of the illustrated value in IEC 60627.2013, and "unit is millimeter" is added in the standard conversion. ---All terms are in bold. The Chinese documents that have a consistent correspondence with the international documents normatively cited in this standard 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 Prepare general requirements for radiation protection (IEC 601-1-3.1994, IDT). Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is approved by the National Standardization Technical Committee for Medical Electrical Appliances Medical X-ray Equipment and Appliances Standardization Sub-Technical Committee (SAC/ TC10/SC1) centralized management. This standard was drafted. Liaoning Medical Device Inspection and Testing Institute. The main drafters of this standard. Liu Jingbo, Chen Yong, Sun Jiawei, Xu Xiaobin. The previous editions of the standard replaced by this standard are as follows. ---WS2-231-77; ---YY 0012-1990; ---YY/T 0480-2004. Diagnostic X-ray Imaging Equipment General and Mammography Characteristics of Anti-Scatter Grids1 ScopeThis standard specifies the definition, determination method and representation method of anti-scatter grid characteristics. This standard applies to anti-scatter grids used in medical diagnostic X-ray imaging equipment. Use an anti-scatter grid to reduce the main The effect of scattered radiation from the patient's body on the image receiving area to improve the contrast of the X-ray pattern. This standard only deals with linear grids. Currently, only converging grids are used in mammography, so for mammography anti-scatter grids, this standard is limited to Poly grid. This standard does not apply to acceptance tests. This standard does not address uniformity over the entire area of the grid. This standard applies to the determination of the characteristics of anti-scatter grids under test conditions. Usually, these test conditions are at the site of the responsible party is not available.2 Normative referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document. YY/T 0481-2016 Radiation conditions for the determination of characteristics of medical diagnostic X-ray equipment (IEC 61267.2005, IDT) IEC 60601-1.2005 Medical electrical equipment Part 1.General requirements for basic safety and essential performance (Medical IEC 60601-1.2005/AMD1.2012 IEC 60601-1-3.2008 Medical electrical equipment Part 1-3.General requirements for basic safety and essential performance - Collateral standards. Diagnostics ment) IEC 60601-1-3.2008/AMD1.2013 finedterms)3 Terms and Definitionsas defined in IEC 60601-1.2005 A1.2012, IEC 60601-1-3.2008 A1.2013, IEC /T R60788.2004 and The following terms and definitions apply to this document. ...... |
