YY/T 1419-2016Ultrasound-Test methods of performance for quasi-static strain sonoelasticity (English PDF)
超声准静态应变弹性性能试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1419-2016 is the English-translated version of 超声准静态应变弹性性能试验方法.
YY/T 1419-2016 is the Chinese pharmaceutical industry standard that gives the terms and definitions, the test devices and the methods for assessing the performance of quasi-static ultrasonic strain elastography, using acoustic elastic phantoms.
It sets out the phantom and its inclusions, the acquisition of the strain images and the measurements of contrast, resolution and depth of penetration by which the system is characterised. Issued on 26 January 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1419-2016
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C 41
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- Introduction
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 4 Test conditions
- 5 Test methods
- Appendix A (informative) Recommended Acoustic Elastic Implant Body Mold Technical Data
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. For undated references, the latest edition (including all modifications) applies to this document.
B - type Ultrasonic Diagnostic Equipment GB 10152-2009 JJF 1001 "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
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'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
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
Strain elasticity image can display the minimum target size at the specified depth.
3.6 Strain elasticity geometric error
Strain elasticity image shows the percentage of the target size relative to its actual size. The formula is. (D0-D)/D0 × 100%
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB 10152-2009 — B mode ultrasonic diagnostic equipment
JJF 1001-1998 — General Terms in Metrology and Their Definitions
JJF 1001-2011 — General Terms in Metrology and Their Definitions
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