YY/T 0774-2019Ultrasound bone sonometers (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY 0774-2010 "ultrasonic bone densitometer". The main technical changes compared with YY 0774-2010 are as follows.

--- Modified the introduction;

--- Revised the scope of the standard (see Chapter 1, Chapter 1 of the 2010 edition);

---Modified the requirements and test methods for ultrasonic sound velocity (SOS) (see 4.2 and 5.3, 2010 editions 4.1.2 and 5.1.2);

---Modified the requirements for broadband ultrasonic attenuation (BUA) (see 4.3, version 4.1.3 of the 2010 edition);

--- Increased the test method for broadband ultrasonic attenuation (BUA) (see 5.4);

--- Removed the definition of T value, Z value (see.2010, 3.5, 3.6);

--- Removed the definition of the function confirmation program (see 3.8 of 2010 edition);

--- Removed the requirements for power supply voltage adaptability (see version 4.2 of 2010);

--- Removed the requirement for continuous working hours (see 4.3 of 2010 edition);

--- Removed the T-value and Z-value parts of the functional requirements (see 4.4.3 of the 2010 edition);

--- Removed the original Appendix A.

Introduction

Ultrasound bone densitometer uses a special ultrasonic transducer to measure the amplitude of the attenuation through the (soft tissue and) bone, measuring the speed of sound and Broadband ultrasound attenuation was calculated and the relevant parameters were calculated to evaluate bone density. Ultrasound bone densitometer

1 Scope

This standard specifies the terms and definitions, requirements and test methods for ultrasonic bone densitometers.

This standard applies to the use of ultrasound principles, by measuring the speed of sound and attenuation characteristics in the bone to evaluate the bone quality of the human body. Instrument.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.9 Medical electrical equipment - Part 2-37. Particular requirements for safety of medical ultrasound diagnostic and monitoring equipment

GB/T 14710-2009 Environmental requirements and test methods for medical appliances

GB/T 15261-2008 Method for measuring acoustic properties of ultrasonic-like tissue materials JJF 1001 General Measurement Terms and Definitions

YY/T 0865.1 Ultrasonic hydrophones Part 1. Measurement and characterization of medical ultrasound fields below 40 MHz

YY/T 0939 Ultrasonic Bone Densitometer Broadband Ultrasonic Attenuation (BUA) Test Method

YY/T 1142 Medical Ultrasound Equipment and Probe Frequency Characteristics Test Method

YY/T 1420 Medical Ultrasound Equipment Environmental Requirements and Test Methods

3 Terms and definitions

The following terms and definitions apply to this document.