YY/T 0795-2022Particular specification for dental cone-beam computed tomography equipment (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

This document replaces YY/T 0795-2010 "Special Operating Conditions for Oral X-ray Digital Tomography Equipment".

Compared with YY/T 0795-2010, except for structural adjustment and editorial changes, the main technical changes are as follows.

--- Modified the scope (see Chapter 1, Chapter 1 of the.2010 edition);

--- Modified normative references (see Chapter 2, Chapter 2 of the.2010 edition);

--- Modified terms and definitions (see Chapter 3, Chapter 3 of the.2010 edition);

--- Modified the composition (see Chapter 4, Chapter 4 of the.2010 edition);

--- Delete the requirements and test methods for image signal-to-noise ratio, reconstruction time and thickness of selected layers (see 5.4.1, 5.4.5, 5.4.6 of the.2010 edition and 6.4.1, 6.4.5, 6.4.6);

--- Increased requirements and test methods for voxel size (see 5.4.4 and 6.4.4);

--- Added special requirements and test methods for children (see 5.5 and 6.5);

--- Delete the requirements for load-bearing (see 5.6 of the.2010 edition);

--- Removed the requirements for appearance (see 5.9 of the.2010 edition);

--- Increased the requirements and test methods for bone mineral density (see 5.7 and 6.7);

--- Modified the software function (see 5.8, 5.8 of the.2010 edition);

--- Added requirements and test methods for doses (see 5.9 and 6.9);

--- Increased requirements and test methods for external interlocking devices (see 5.10 and 6.10);

--- Added requirements and test methods for quality assurance (see 5.13 and 6.13);

--- Added supplementary requirements and test methods for random documents (see 5.14 and 6.14);

--- Modified the quantitative evaluation method of spatial resolution, low contrast resolution and uniformity (see 6.4).

1 Scope

This document specifies the composition, requirements and tests of oral and maxillofacial cone beam computed tomography equipment (hereinafter referred to as oral CBCT). method.

This document applies to oral CBCT equipment including the use of image intensifiers or flat panel detectors as image acquisition devices. this document Not applicable to curved tomography and cephalometric photography parts of oral CBCT equipment, see YY/T 1732 for relevant requirements.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies 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 9706.103-2020 Medical Electrical Equipment Part 1-3.General Requirements for Basic Safety and Essential Performance Collateral Standards. Radiation protection of diagnostic X-ray equipment

GB 9706.228-2020 Medical Electrical Equipment Part 2-28.Basic Safety and Fundamentals of Medical Diagnostic X-ray Tube Assemblies Can special requirements

GB 9706.254-2020 Medical Electrical Equipment Part 2-54.Basic Safety and Fundamentals of X-ray Photography and Fluoroscopy Equipment Can special requirements

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

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

YY/T 1466 Oral X-ray Digital Tomography Equipment Bone Densitometry Evaluation Method

YY 9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Safety Collateral Standard. Electromagnetic Compatibility Requirements and Tests

3 Terms and Definitions GB/T 10149 and the following

terms and definitions apply to this document.