YY/T 0063-2024 English PDFUS$769.00 · In stock
Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0063-2024: Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics Status: Valid YY/T 0063: Historical versions
Basic dataStandard ID: YY/T 0063-2024 (YY/T0063-2024)Description (Translated English): Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C43 Classification of International Standard: 11.040.50 Word Count Estimation: 38,371 Date of Issue: 2024-07-08 Date of Implementation: 2025-07-20 Older Standard (superseded by this standard): YY/T 0063-2007 Issuing agency(ies): State Drug Administration YY/T 0063-2024: Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics---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. ICS 11.040.50 CCSC43 Pharmaceutical Industry Standards of the People's Republic of China Replaces YY/T 0063-2007 Medical electrical equipment Medical diagnostic X-ray tube assemblies Focal spot size and related characteristics (IEC 60336.2020,MOD) Released on 2024-07-08 2025-07-20 Implementation The State Drug Administration issued Table of ContentsPreface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Determination of focal characteristics evaluation 3 4.1 Key Features Statement 3 4.2 X-ray tube assembly longitudinal axis 3 4.3 X-ray tube assembly reference axis 3 4.4 Evaluation direction of focal length 3 4.5 Evaluation direction of focal width 3 4.6 Evaluation direction of deformation focus 3 5 Focus Camera Settings 4 5.1 Overview 4 5.2 Slit Camera Aperture 4 5.3 Pinhole Camera Aperture 5 5.4 Receiver 5 5.5 Test layout 5 5.6 Total uncertainty of the camera setup 8 6 X-ray photography 9 6.1 General 9 6.2 Operating conditions 9 6.3 Determination of focal slit radiographs, focal pinhole radiographs and focal line spread function 10 6.4 Conformity statement for focal pinhole radiographs 10 6.5 Line spread function conformity statement 11 7 Determination of focal spot size and focal spot nominal value 11 7.1 Overview 11 7.2 Determination of focal spot size 11 7.3 Specifying the nominal value of focal point 12 7.4 Statement of Conformity 13 7.5 Conformity marking 13 8 Determination of Modulation Transfer Function 14 8.1 Overview 14 8.2 Calculation and Representation of Modulation Transfer Function 14 8.3 Declaration of Conformity14 9 Alternative measurement methods for determining nominal focal values 15 Appendix A (Informative) Focus Star Card Radiograph 16 Appendix B (Informative) Defocus Value 18 Appendix C (Informative) Star Card Limit Resolution 19 Appendix D (Informative) Alignment of reference axes 21 Appendix E (Informative) Historical Background 23 References 30 Index 31ForewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document replaces YY/T 0063-2007 "Focal Characteristics of Medical Electrical Equipment Medical Diagnostic X-ray Tube Assemblies" and is consistent with Compared with YY/T 0063-2007, in addition to structural adjustments and editorial changes, the main technical changes are as follows. a) The scope has been changed (see Chapter 1, Chapter 1 of the.2007 edition); b) The terms and definitions have been changed (see Chapter 3, Chapter 3 of the.2007 edition); c) Added the evaluation direction of deformation focus (see 4.6); d) Deleted "5.2 Test equipment" (see 5.2 of the.2007 edition); e) Added "Slit camera aperture" (see 5.2); f) Added "pinhole camera aperture" (see 5.3); g) Added "receiver" (see 5.4); h) The “Test Layout” has been changed (see 5.5, 5.3 of the.2007 edition); i) Changed “Total uncertainty of camera settings” (see 5.6, 5.4 of the.2007 edition); j) Changed "Overview" (see 6.1, 6.1 of the.2007 edition); k) Changed "Operating conditions" (see 6.2, 6.2 of the.2007 edition); l) Changed "Determination of focal slit radiographs, focal pinhole radiographs and focal line spread function" (see 6.3,.2007 edition) 6.3); m) Added "Line spread function conformity statement" (see 6.5); n) "7 Determination of the line spread function" was deleted (see Chapter 7 of the.2007 edition); o) Deleted "9 Determination of modulation transfer function" (see Chapter 9 of the.2007 edition); p) "10 Focus star card radiographs" (see Chapter 10 of the.2007 edition) was deleted; q) Deleted "11-star card limit resolution" (see Chapter 11 of the.2007 edition); r) "12 Defocus value" was deleted (see 12 in the.2007 edition); s) Changed "Alternative measurement methods for determining nominal focal values" (see Chapter 9, Chapter 13 of the.2007 edition); t) "Determination of focal characteristics using digital X-ray image detectors" was deleted (see Appendix B of the.2007 edition). This document is modified to adopt IEC 60336.2020 "Focal spot dimensions and related characteristics of medical diagnostic X-ray tube assemblies for medical electrical equipment". The technical differences between this document and IEC 60336.2020 and their reasons are as follows. --- Replaced IEC 60601-1 with Chapter 3 of GB 9706.1, which is modified to adopt international standards; --- IEC 60601-3 is replaced by GB 9706.103 (see Chapter 3), which is a modified international standard. The following editorial changes were made to this document. ---All terms are in bold; ---The appendices have been numbered in the order mentioned in the main text. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is prepared by the National Technical Committee for Standardization of Medical Electrical Appliances, Medical X-ray Equipment and Appliances Standardization Subcommittee (SAC/ TC10/SC1). This document was drafted by. Liaoning Medical Device Inspection and Testing Institute, Wuhan United Imaging Medical Technology Co., Ltd., Siemens X-ray Air Technology (Wuxi) Co., Ltd., Hangzhou Kailong Medical Equipment Co., Ltd., and Van Ruishi Imaging Equipment (China) Co., Ltd. The main drafters of this document are. Guo Baijun, Wang Yanan, Zhang Xi, Zhang Zhenneng, Ding Kai, Song Tao, Sun Wei and Sun Jiawei. The previous versions of this document and the documents it replaces are as follows. ---First issued in.1991 as YY/T 0063-1991, first revised in.2000, second revised in.2007; ---This is the third revision. Medical electrical equipment Medical diagnostic X-ray tube assemblies Focal spot size and related characteristics1 ScopeThis document applies to the focal point of medical diagnostic X-ray tube assemblies operating at X-ray tube voltages of 150 kV and below. This document describes a test method for the determination of the following using a digital detector. a) The focal point size expressed as the focal point nominal value, ranging from 0.1 to 3.0; b) Line spread function; c) one-dimensional modulation transfer function; d) Focal pinhole radiograph. This document also describes the means of demonstrating compliance. In the informative appendices, star card imaging (see Appendix A) and defocus values (see Appendix B) are described.2 Normative referencesThe contents of the following documents constitute the essential clauses of this document through normative references in this text. The version corresponding to that date applies to this document; for undated referenced documents, their latest versions (including all amendments) apply to this document. GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and essential performance (IEC 60601-1. 2012,MOD) GB 9706.103-2020 Medical electrical equipment Part 1-3.General requirements for basic safety and essential performance Collateral standard. Diagnostic Radiation protection for X-ray equipment (IEC 60601-1-3.2013, MOD) YY/T 0064-2016 Electrical and load characteristics of medical diagnostic X-ray tube assemblies (IEC 60613.2010, IDT) Note. GB/T 5465.2-2008 Graphical symbols for electrical equipment Part 2.Graphical symbols (IEC 60417DB.2007, IDT) definedterms)3 Terms and definitionsIEC TR60788.2004, YY/T 0064-2016, GB 9706.1-2020 and GB 9706.103-2020 and the following The following terms and definitions apply to this document. 3.1 actual focal spot The area on the target surface that stops the accelerated particle beam. NOTE. Regarding the accelerated particles, only the expected primary beam is included. 3.2 Defocus value blooming value The ratio of two limiting resolutions obtained under specific loading conditions. NOTE. The defocus value is a characteristic of the effective focal spot of the X-ray tube. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0063-2024_English be delivered?Answer: Upon your order, we will start to translate YY/T 0063-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 6 working days. 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