YY/T 0634-2022 in English
VALIDOphthalmic instruments—Fundus camcras
- Issued on:2022-07-01
- Implemented on:2023-07-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
Price(USD)：
$280.00
$272.00
$272.00
本文件规定了眼底照相机的要求和试验方法。眼底照相机用于观察、拍摄和记录人眼眼底电子图像，以提供用于诊断的图像信息。
本文件适用于采用照相机成像原理的仪器。
本文件不适用于以下仪器：
在检查过程中接触眼睛的仪器；
使用扫描成像技术、自适应光学成像技术、光学相干断层成像技术（OCT）、多单色光谱成像技术的仪器。
Introduction
Core changes in the standard revision
| Technical dimensions | Requirements of the 2008 version | New requirements of the 2022 version | Clinical significance |
|---|---|---|---|
| Definition of terms | No definition of pixel spacing | Added Fundus pixel spacing (3.4) | Standardize the evaluation indicators of digital imaging equipment |
| Optical radiation safety | Cited GB 9706.1 | Independent chapter (4.4) clarifies the classification of Class 1/2 instruments | Reduce the risk of retinal light damage |
| Optical performance | Color rendering index not specified | Observation light Ra≥85, flash color temperature 3000-6700K (4.2) | Improve the accuracy of vascular imaging |
Analysis of key technical requirements
4.2 Optical performance indicators
The standard implements graded requirements for the resolution of fundus cameras:
- When the field of view angle ≤30°: center ≥80lp/mm, edge ≥40lp/mm
- When the field of view angle ＞30°: center ≥60lp/mm, edge ≥25lp/mm
- Near-infrared imaging needs to be reduced by 1.6 times the standard value
Implementation suggestions
Equipment acceptance test process
- Resolution verification: Use standard target (5.3) to test at a distance of 1m, and pay attention to distinguishing the center/edge area
- Optical radiation safety assessment: Measure the EA-R value according to the process in Appendix A, and Class 2 instruments need to record the cumulative exposure time
- Clinical parameter calibration: Color rendering index measurement must comply with GB/T 5702 method (5.7)
Standard evolution analysis
The 2022 version adopts the ISO 10940:2009 MOD standard. The main technical differences include:
- Add GB 9706.1-2020 electrical safety requirements (4.5)
- Refine the optical radiation test method (5.10)
- Delete outdated terms such as environmental conditions
Sample only — not a preview of YY/T 0634-2022
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