YY/T 0748.1-2009Ultrasonics—Pulse-echo scanner - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response (English PDF)

Foreword

This part of IEC 61391-1:2006 "ultrasonic pulse-echo scanners - Part 1. Techniques for calibrating spatial measurement systems and system point spread function Art method of measuring the number of response "degree of consistency as equivalent.

This section of the Appendix A, Appendix B and Appendix C is a normative appendix.

Terminology Part 3 defined, appear in standard text indicated in bold.

This section is expected to form part of two or more of publication.

--- Part 1 relates to a system for calibrating spatial measurement systems and the point spread function response technology and methods of measurement;

--- Part 2 will involve the system sensitivity, dynamic range and low contrast resolution measurements. This section YY/T Section 10748 of.

This part of the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2) Centralized.

This section drafted by. State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center.

Introduction

Ultrasonic pulse echo scanner with a thin, narrow beam of pulsed ultrasound scanning body region of interest, and received back from the tissue interface Waves, thereby generating ultrasound tissue image within the scan plane. The use of various types of ultrasonic transducers are working in the ultrasonic signal transmitter (pick Closed) mode. In medical practice, the widespread use of ultrasound scanner for many soft tissues and organs in the human body for imaging.

Test methods described in this section has been widely recognized and for all types of devices. Manufacturers can use this part of the party Method to develop technical performance specifications of their products, the user can use this standard method to test the performance of these technologies, these measurements are not available in Movies Under loud instrument working normally, in the appendix describes the typical phantom. The structure of the phantom is not detailed provisions, but describes The structure of the specific modes to be announced together with the type of application and the internal structure of the overall test results and test. The phantom has a similar s product.

Performance parameters and select the corresponding measurements provided for manufacturer's technical requirements and expected the same of diagnostic applications, in different Comparison provides a basis for similar types of manufacturers of devices. The results by the standard tests used to obtain permits than Than the manufacturer's specifications, and is expected to recommend the use of set of results and data obtained by the method, it is determined whether the device is suitable for performance diagnosis When broken applications, it will provide a useful criterion. This section focuses on the image measured by digital technology, but also includes for through Through the visual inspection method. Discuss other visual inspection methods can be found in the way YY/T 0703-2008 (IEC 61390:1996, IDT) 1).

1) Figures in square brackets for the reference number.

Diagnostic system has more than one specific system optional components, such as when the ultrasonic transducers, each identified option constitutes a separate system. If, however, the majority of meaningful machine control settings and accessories were tested, it is considered fully evaluated sex machine can. Of course, the device can further evaluation, but wish to use as a case rather than the conventional requirement.

1 Scope

YY/T 0748 provisions of this section within the 0.5MHz ~ 15MHz ultrasonic frequency range, the calibration space measurement tools and ultrasound imaging The method of the point spread function of the device, this section covers the following types based on the principle of ultrasonic echo ultrasound scanner.

--- Mechanical sector scanner;

--- Electronic phased array sector scanner;

--- Electronic linear array scanner;

--- Electronic convex array sector scanner;

--- Based on the above four scanning mechanism bladders scanner;

--- Reconstruction system.

2 Normative references

The following documents contain provisions which, through reference YY/T 0748 and become part of the provisions of this section. For dated references, All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

GB/T 16540-1996 acoustic characterization of ultrasonic fields in the frequency range of 0.5MHz ~ 15MHz and measuring hydrophone Control law (eqv IEC 61102:1991)

YY/T 0458-2003 simulated Doppler blood flow phantom technical requirements (IEC 61685:2001, MOD)

3 Terms and Definitions

The following terms and definitions apply YY/T 0748 to the present section.