YY/T 1419-2016 English PDF

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YY/T 1419-2016: Ultrasound. Test methods of performance for quasi-static strain sonoelasticity
Status: Valid

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Basic data

Standard ID: YY/T 1419-2016 (YY/T1419-2016)
Description (Translated English): Ultrasound. Test methods of performance for quasi-static strain sonoelasticity
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C41
Classification of International Standard: 11.040.50
Word Count Estimation: 10,168
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Quoted Standard: GB 10152-2009; JJF 1001
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies terms, definitions, test devices, and methods for the detection of quasi-static ultrasonic strain elasticity using acoustic elastomeric molds. This standard is applicable to quasi-static strain elastic imaging of human tissue using ultrasonic echo imaging.

YY/T 1419-2016: Ultrasound. Test methods of performance for quasi-static strain sonoelasticity

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Ultrasound.Test methods of performance for quasi-static strain sonoelasticity ICS 11.040.50 C41 People's Republic of China Pharmaceutical Industry Standard Test method of ultrasonic quasi - static strain elasticity 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I Introduction II 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Test conditions 2 5 Test methods 3 Appendix A (informative) Recommended Acoustic Elastic Implant Body Mold Technical Data 5

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Standardization Technical Committee of medical ultrasound equipment standardization sub-technical committee (SAC/TC10/SC2) Go back. The drafting of this standard. the State Food and Drug Administration Hubei Medical Device Quality Supervision and Inspection Center, Shantou City ultrasound equipment research Owned company, Shenzhen Mindray Biopharmaceutical Electronics Co., Ltd. The main drafters of this standard. Jiang Shilin, Guo Jingfeng, Guan Zhiyong, Wang Zhijian, Xuanyuan Kai, Li Qiang, Guo Chong Chong.

Introduction

The elastic modulus is an important mechanical characteristic of the material. The Young's modulus of human tissue is closely related to its physiological and pathological conditions The diagnosis of disease has important reference value. At present, based on ultrasonic pulse echo imaging platform for elastic imaging technology and equipment in the past decade To get the rapid development of clinical research has become a hot spot. As a new imaging technology, it extends the connotation of ultrasound diagnosis theory Ultrasound diagnosis range, make up for the lack of conventional ultrasound, so that modern ultrasound diagnostic technology is more perfect. Ultrasound elastography has a different implementation in technology. Taking into account the ultrasonic elastic imaging technology and equipment is still in development, this standard Only on the current relatively mature quasi-static ultrasonic strain elasticity imaging provides a technical test method, there is no provision for quantitative technical indicators parameter. The technical indicators for the methods proposed by this standard may not be available on some equipment. The users of this standard may choose Choose to use. Test method of ultrasonic quasi - static strain elasticity

1 Scope

This standard specifies the terms, definitions, test devices and the use of acoustic elastomeric molds for quasi-static ultrasonic strain elasticity imaging performance. method. This standard is applicable to quasi-static strain elastic imaging of human tissue using ultrasonic echo imaging.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. B - type Ultrasonic Diagnostic Equipment GB 10152-2009 JJF1001 "General Metrology Terms and Definitions"

3 terms and definitions

GB 10152-2009 Definitions and the following terms and definitions apply to this document. 3.1 Quasi - static Ultrasonic Strain Elastic Imaging By the surface of the pressure from the outside, or the use of breathing, heart beat and other pressure generated by ultrasonic echo, through the pressure before and after The acquisition of the RF signal processing, access to local strain distribution and image display technology. 3.2 Strain elasticity detection depth Depthofpenetrationofstrainelastographic The maximum depth of the target acoustic window can be detected and displayed, and the target has a specified Young's modulus ratio (target/back King) and the specified size. Unit. mm, mm. 3.3 Young's modulus than Young'smodulusratio Young's modulus ratio, in this document, refers to the modulus of the measured area (target) Young's modulus and background material Young's modulus ratio. 3.4 Strain ratio Strainratio Quasi - static strain elasticity imaging process, the ratio of the measured area (target) to the background material strain in the phantom. 3.5 Strain elasticity spatial resolution spatialresolutionofstrainelastographic Strain elasticity image can display the minimum target size at the specified depth. 3.6 Strain elasticity geometric error geometric error Strain elasticity image shows the percentage of the target size relative to its actual size. The formula is. (D0-D)/D0 × 100% ......

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