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YY/T 0062.1-2024 English PDF

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YY/T 0062.1-2024: Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration
Status: Valid

YY/T 0062.1: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0062.1-2024English379 Add to Cart 4 days [Need to translate] Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration Valid YY/T 0062.1-2024
YY/T 0062-2004English319 Add to Cart 3 days [Need to translate] Determination of the permanent filtration of X-ray tube assemblies   YY/T 0062-2004
YY 0062-1991English199 Add to Cart 3 days [Need to translate] (X-ray tube assembly inherent filtration) Obsolete YY 0062-1991

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Basic data

Standard ID YY/T 0062.1-2024 (YY/T0062.1-2024)
Description (Translated English) Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 18,181
Date of Issue 2024-02-07
Date of Implementation 2025-03-01
Older Standard (superseded by this standard) YY/T 0062-2004
Issuing agency(ies) State Drug Administration
Summary This standard specifies methods for the determination of the inherent filtration and equivalent filtration of the filter material mass of Instructions and declaration of conformity requirements for filter materials. This document applies to X-ray tube components and filter materials for high voltages up to 150kV in medical diagnostic applications. For high voltages greater than 50kV, this document only applies to X-ray tube assemblies with tungsten or tungsten alloy targets.

YY/T 0062.1-2024: Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration


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ICS 11.040.50 CCSC43 Pharmaceutical Industry Standards of the People's Republic of China Replaces YY/T 0062-2004 Medical electrical equipment diagnostic X-ray Part 1.Determination of equivalent filtration and intrinsic filtration (IEC 60522-1.2020,MOD) Released on 2024-02-07 2025-03-01 Implementation The State Drug Administration issued

Table of Contents

Preface III Introduction V 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Determination of mass equivalent filtration 2 4.1 Alignment of X-ray Tube Assembly and Filter Plate 2 4.2 Generation of X-ray Beam for Measurement 2 4.3 Requirements for radiation detectors 2 4.4 Composition of reference materials 3 4.5 Determination of intrinsic filtration 3 4.6 Determination of the equivalent filtration mass of a filter material or stack of filter materials 7 4.7 Simulating X-rays 8 4.8 Conformity test 8 5 Indications and declarations of mass equivalent filtration 8 5.1 Indication of mass equivalent filtration value 8 5.2 Indications and statements regarding inherent filtration 8 5.3 Indications and declarations on filter materials 9 Appendix A (Informative) Historical Background 10 Reference 11

Foreword

This 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 is part 1 of YY/T 0062 "Medical electrical equipment for diagnostic X-rays". YY/T 0062 has been published for the following part. --- Part 1.Determination of equivalent filtration and intrinsic filtration. This document replaces YY/T 0062-2004 "Determination of inherent filtration of X-ray tubes". Compared with YY/T 0062-2004, except for the structural adjustment In addition to the integration and editorial changes, the main technical changes are as follows. a) The scope has been changed (see Chapter 1, Chapter 1 of the.2004 edition); b) The normative references in the terms and definitions have been changed (see Chapter 3, Chapter 3 of the.2004 edition); c) Added the terms and definitions of “filtration material” and “mass equivalent filtration” (see 3.1 and 3.3); d) "Overview" was deleted (see 4.1 of the.2004 edition); e) Added "Alignment of X-ray tube assembly and filter plate" (see 4.1); f) "Test sample" has been deleted (see 4.2 of the.2004 edition); g) "Measurement X-ray beam" has been changed (see 4.2, 4.3 of the.2004 edition); h) The “Requirements for Radiation Detectors” were modified (see 4.3, 4.4 of the.2004 edition); i) The “composition of reference materials” has been changed (see 4.4, 4.5 of the.2004 edition); j) "Determination of inherent filtration" was changed (see 4.5, 4.6 of the.2004 edition); k) Added “Determination of the equivalent filtration mass of filter material or stacked filter material” (see 4.6); l) Added “Simulated X-ray” (see 4.7); m) "Compliance test" has been changed (see 4.8, 4.6 of the.2004 edition); n) The “Indication and Declaration of Equivalent Filtration Quality” has been changed (see Chapter 5, Chapter 5 of the.2004 edition). This document is modified to adopt IEC 60522-1.2020 "Medical electrical equipment for diagnostic X-rays - Part 1.Equivalent filtration and inherent filtration Determination of the past. The technical differences between this document and IEC 60522-1.2020 and their reasons are as follows. --- IEC 60601-1 (see Chapter 3) is replaced by the normative reference GB 9706.1 to adapt to my country's technical conditions; --- IEC 60601-3 (see Chapter 3) is replaced by the normative reference GB 9706.103 to adapt to my country's technical conditions; --- Added GB/T 10149 (see Chapter 3) to adapt to my country's technical conditions. The following editorial changes were made to this document. --- Deleted the notes in IEC 60522-1.2020. 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 provided by the National Technical Committee for Standardization of Medical Electrical Appliances, Medical X-ray Equipment and Appliances Technical Committee (SAC/TC10/ SC1) is responsible for the following. This document was drafted by. Liaoning Medical Device Inspection and Testing Institute, Liaoning Drug Review and Inspection Center, Siemens X-ray Vacuum Technology (Wuxi) Co., Ltd., Institute of Radiation Medicine, Fudan University, Shanghai Siemens Medical Devices Co., Ltd., Hangzhou Kailong Medical Devices Co., Ltd. Co., Ltd., Beijing Weimai Medical Equipment Co., Ltd., Shanghai Liujing Technology Co., Ltd., and Shenzhen Shentu Medical Imaging Equipment Co., Ltd. The main drafters of this document are. Meng Zhaoyang, Chi Ge, Zhang Zhenneng, Liu Haikuan, Jin Yubo, Liu Pu, Wang Yue, Yu Yizhi, Liu Wenlong, Zhu Yubin, Huang Weiqin. The previous versions of this document and the documents it replaces are as follows. ---First issued in.1991 as YY 0062-1991, first revised in.2004 as YY/T 0062-2004; ---This is the second revision.

Introduction

YY/T 0062 "Medical Electrical Equipment for Diagnostic X-ray" is intended to consist of two parts. --- Part 1.Determination of equivalent filtration and intrinsic filtration. Part 1 replaces YY/T 0062-2004. --- Part 2.Guidance and rationale for quality equivalent filtration and permanent filtration. Part 2 provides the technical background of Part 1. Scenery and basic principles. The scope of application of this document has undergone significant adjustments compared to YY/T 0062-2004. For medical diagnosis and radiotherapy X-ray tube assemblies, the scope of application of this document no longer includes radiotherapy X-ray tube assemblies. The range is adjusted to X-ray tube components and filter materials below 150kV in medical diagnostic applications, and the equivalent filtration related information of the filter materials is increased. YY/T 0062-2004 only covers inherent filtration, this document also covers filtering the X-ray beam on the patient. Materials, this refers to materials in additional filter plates, beds, breast compression devices and restraining devices. For these materials, the term "filter material" is introduced. The historical background of this document is shown in Appendix A. Medical electrical equipment diagnostic X-ray Part 1.Determination of equivalent filtration and intrinsic filtration

1 Scope

This document describes the method for determining the inherent filtration of X-ray tube assemblies and the equivalent filtration of the filter material mass. Requirements for the declaration of conformity of the components in the accompanying documents and the marking of the X-ray tube assembly, as well as the indication and declaration of conformity of the filter material Require. This document applies to X-ray tube assemblies and filter materials for medical diagnostic applications with high voltages up to 150 kV. 50kV, This document applies only to X-ray tube assemblies with tungsten or tungsten alloy targets. NOTE 1 The filter material in the X-ray beam may be removable or non-removable; it may be mounted in any position or have any shape (e.g., tapered thickness). Although usually plane-parallel material, it is perpendicular to the reference axis. Examples of filter materials include additional filters, patient beds (such as under-bed X-ray tube sets) Materials in breast restraints, breast compression devices, or breast compression devices. NOTE 2 The methods and declarations of conformity given in this document apply only to flat plate filter plates, but the methods are applicable to any type of non-flat plate filter plates. In some cases, further data such as field size, filter geometry/position, etc. are included in order to produce useful results. Note 3.This document does not contain requirements for any specific values of inherent filtration. For X-ray equipment used for diagnostic purposes, the filtration requirements are given in GB 9706.103- 2020 or applicable specific standards. NOTE 4 The determination method described in this document is intended for type testing. It is not intended for user testing.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance (GB 9706.1-2020, IEC 60601-1.2012,MOD) GB 9706.103 Medical electrical equipment Part 1-3.General requirements for basic safety and essential performance Collateral standard. Diagnostic X Radiation protection of radiation equipment (GB 9706.103-2020, IEC 60601-1-3.2013, MOD) GB/T 10149 Terminology and symbols for medical X-ray equipment IEC 61674.2012 Medical electrical equipment Ionization chambers and/or semiconductor detector dosimeters for use in X-ray diagnostic imaging Note 3.GB/T 19629-2005 Medical electrical equipment Ionization chambers and (or) semiconductor detector dosimeters used in X-ray diagnostic imaging (IEC 61674.1997,IDT)

3 Terms and definitions

The terms and definitions defined in GB/T 10149, GB 9706.1, GB 9706.103 and the following apply to this document. 3.1 Filtering material A material that has a filtering effect on the X-ray beam between the X-ray tube assembly and the patient.

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