YY/T 0724-2021Particular specifications for dual-energy X-ray absorptiometry (English PDF)

Foreword

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

This standard replaces YY/T 0724-2009 "Special technical conditions for dual-energy X-ray bone densitometer". Corresponding to YY/T 0724-2009 Compared with the editorial changes, the main technical changes are as follows.

---Modified the classification (see 4.1, 4.1 in the.2009 edition);

---Modified the composition (see 4.2, 4.2 of the.2009 edition);

---Modified X-ray irradiation (see 5.4, 5.8 in the.2009 edition);

---Added a detector;

--- Modify the bone density measurement (see 5.6, 5.4 in the.2009 edition);

---Modified the frame and/or supporting device (see 5.7, 5.5 of the.2009 edition);

---Modified report output and software functions (see 5.8, 5.6 of the.2009 edition);

---Modified the appearance (see 5.10, 5.9 of the.2009 edition);

---Modified the security (see 5.12, 5.11 of the.2009 edition);

---Modified the test method of X-ray irradiation (see 6.4, 6.8 in.2009 edition);

---The test method of the detector has been added (see 6.5);

---Modified the test method of bone density measurement (see 6.6, 6.4 of the.2009 edition);

---Modified the test method of the frame and/or supporting device (see 6.7, 6.5 of the.2009 edition);

---Modified the test method of report output and software function (see 6.8, 6.6 of the.2009 edition);

---Modified the test method of appearance (see 6.10, 6.9 of the.2009 edition);

---Modified the test phantom (see Appendix A, Appendix A of the.2009 edition);

1 Scope

This standard specifies the terms and definitions, classification and composition, requirements and tests of dual-energy X-ray bone densitometers (hereinafter referred to as bone densitometers) method.

This standard applies to bone densitometers based on the dual-energy X-ray absorption method. This product is mainly used to measure the bone density of human bones Measurement and analysis. This standard does not apply to X-ray computed tomography equipment (CT machine) for bone density measurement devices.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB 7247.1 Safety of Laser Products Part 1: Equipment Classification and Requirements

GB 9706.1 Medical Electrical Equipment Part 1: General Requirements for Safety

GB 9706.11 Medical electrical equipment Part 2: Special requirements for the safety of medical diagnostic X-ray source components and X-ray tube components

GB 9706.12 Medical electrical equipment Part 1: General safety requirements III. Parallel standards for radiation protection of diagnostic X-ray equipment common enquiries

GB 9706.14 Medical electrical equipment Part 2: Special requirements for the safety of auxiliary equipment of X-ray equipment

GB/T 10149 Terms and Symbols for Medical X-ray Equipment

YY/T 0291 Environmental requirements and test methods for medical X-ray equipment

YY 0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard

3 Terms and definitions

The following terms and definitions defined in GB/T 10149 apply to this document.