YY/T 0010-2020 in English
VALIDParticular specifications for dental intra-oral X-ray equipment
- Issued on:2020-06-30
- Implemented on:2021-06-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$214.00
本标准规定了口内成像牙科X射线机的术语和定义、系统构成、要求和试验方法。本标准适用于使用口腔内X射线影像接收器，用于拍摄牙齿X射线照片的X射线机。本标准不适用于使用口腔外X射线影像接收器成像的X射线机。
Introduction
Background of Standard Update and Technological Evolution
This standard replaces the YY/T 0010-2008 version. The main technological evolution is reflected in:
| Update dimensions | 2008 version | 2020 version |
|---|---|---|
| Standard name | Oral X-ray machine | Intraoral imaging dental X-ray machine |
| Equipment type | Handheld type is not included | Requirements for handheld devices are added |
| Image receiver | Electronic receiver is not specified | Performance indicators of electronic image receivers are added |
| Focus skin distance | No lower limit specified | ≥20cm mandatory requirement |
Analysis of core technical requirements
1. Equipment classification and composition
According to the structure, it is divided into four types: fixed, mobile, portable, and handheld. The basic components include:
- X-ray generating device (including high-voltage generator)
- Telescopic arm system (horizontal rotation ≥40°)
- Electronic image receiver (optional component)
2. Key performance indicators
| Parameter category | Technical requirements | Test method |
|---|---|---|
| X-ray tube voltage | ≥60kV, bin increment≤5kV | GB9706.3-2000 50.104.1 |
| Loading time | Binned according to R10/R20 priority number system | Deviation＜±(10%+1ms) |
| Image uniformity | R/Vm≤2.5% | 5 sampling point grayscale analysis |
Special requirements for electronic image receivers
Test case: When using a 6mm pure aluminum attenuation phantom:
- A 0.05mm lead test card is required for line pair resolution testing
- The IQF index needs to be calculated for low contrast resolution
- The image uniformity sampling area is 10%×10%
Implementation recommendations
Manufacturers need to pay special attention to:
- Handheld devices must provide a Radiation Safety Manual
- Electronic receiver products need to add Three image performance tests
- The drop test height is adjusted from 5cm to 50cm hardwood board
It is recommended to establish a Loading factor combination verification process to ensure compliance with the overload protection requirements of 5.3.5.
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