GB/T 39111-2020 in English
VALIDTechnical requirements for dental model 3D scanner
- Issued on:2020-09-29
- Implemented on:2021-10-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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《GB/T 39111-2020牙颌模型三维扫描仪技术要求》由TC99（全国口腔材料和器械设备标准化技术委员会）归口，主管部门为国家药品监督管理局。
Introduction
Interpretation of the core content of the standard
GB/T39111-2020 is my country's first dedicated technical standard for 3D scanners for dental models, which specifies the technical requirements for the equipment in the entire process of data acquisition, processing, and output. The standard particularly emphasizes the hard indicator of scanning accuracy ≤ 30μm, and conducts a comprehensive evaluation through the three dimensions of correctness, precision, and morphological accuracy.
Comparison of key technical requirements
| Indicator type | International standard | GB/T39111 requirement | Test method |
|---|---|---|---|
| Scanning accuracy | ISO12836:2015(50μm) | 30μm | Appendix A 3D deviation analysis |
| Data format | STL general format | Mandatory STL output | 5.2.5 Clause verification |
| Calibration requirements | User optional | Forced self-calibration function | Clause 4.2/5.2.2 |
Key points for standard implementation
Accuracy verification case
Appendix A of the standard stipulates that standard samples made of aviation aluminum (7075) are used to establish true value data through a three-dimensional coordinate measuring machine. A manufacturer's test shows that the root mean square error of the morphological accuracy of 10 repeated scans is 28.5μm, which meets the standard requirement of ≤30μm threshold.
Clinical adaptation requirements
Clause 4.1 clearly requires that the device must support three scanning modes: single tooth model, single jaw model and occlusal model scanning. A clinical institution reported that the occlusal relationship scanning function increased the efficiency of orthodontic treatment design by 40%.
Background of technological evolution
This standard responds to the development trend of digital oral diagnosis and treatment. Compared with the 50μm accuracy requirement generally adopted by the industry in 2015, the threshold is raised to 30μm to meet the needs of high-precision applications such as implant guides. The standard drafting group, in collaboration with Peking University School of Stomatology and other institutions, verified the technical feasibility based on 1,200 clinical data.
Implementation suggestions
- When selecting equipment, focus on verifying the accuracy test report in Appendix A
- Regularly use standard samples to recheck the equipment status (recommended cycle ≤1 year)
- Operators need to be trained to master the data editing functions specified in Article 4.3
- Medical institutions should establish an STL file quality acceptance process
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