GB/T 45265-2025 in English
VALIDGeneral technical requirements for additive manufacturing of lower limb prostheses
- Issued on:2025-02-28
- Implemented on:2025-06-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$117.00
| Standard No: | GB/T 45265-2025 |
| Document status: | VALID |
| Title in English: | General technical requirements for additive manufacturing of lower limb prostheses |
| Title in Chinese: | 下肢假肢增材制造通用技术要求 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2025-02-28 |
| Implemented on: | 2025-06-01 |
| Chinese Classification: | C45-Extracorporeal circulation, artificial organ and prosthesis device |
| Professional Classification: | GB-National Standard |
| Related Topics: | additive manufacturing
Counterfeit additive manufacturing Prosthetics additive Increased edition Stress Manufacturing Technology |
《GB/T 45265-2025下肢假肢增材制造通用技术要求》由TC148（全国残疾人康复和专用设备标准化技术委员会）、全国增材制造标准化技术委员会联合归口，主管部门为民政部。
Introduction
Core Technology Innovations of the Standard
GB/T 45265-2025 systematically standardizes the application standards of additive manufacturing technology in the field of lower limb prostheses for the first time, breaking through the limitations of traditional processes:
| Technical Dimension | Traditional Process | Additive Manufacturing Process |
|---|---|---|
| Data Collection Accuracy | ±2mm | ±0.5mm |
| Personalized Adaptation Cycle | 2-3 Weeks | 3-5 Days |
| Complex Structure Implementation | Limited | Topology optimization freedom |
Analysis of key technical requirements
5.1 Specifications for residual limb data collection
The standard clearly requires the use of 3D scanners, CT/MRI and other equipment to achieve non-invasive and precise data collection, and specifically stipulates:
- Bony protrusions require landmarks
- Photography specifications for different amputation positions (sitting/standing)
- STL/AMF/IGES multi-format output requirements
5.3 Additive manufacturing process control
Clinical case: A tertiary hospital uses PA12 powder bed fusion process to produce thigh prosthesis socket, post-processing uses micro-sandblasting polishing technology to reduce the surface roughness from Ra12μm to Ra3.2μm.
Technical Guide for Material Selection
| Material Type | Applicable Parts | Tensile Strength |
|---|---|---|
| TPU Elastomer | Syme Prosthetic Interface | ≥40MPa |
| PEEK | Load-bearing Structural Parts | ≥90MPa |
Standard Implementation Recommendations
- Medical institutions should establish digital prosthetic studios and configure industrial-grade 3D scanners and Dual laser SLS equipment
- Manufacturers need to develop intelligent alignment software modules according to the requirements of 5.4.3 alignment
- Regularly conduct gait analysis and evaluation in 6.5 wearing inspection
Technology evolution trend
This standard lays the foundation for the development of intelligent prostheses, and in the future it will integrate:
- Embedded sensor technology
- Adaptive topology optimization algorithm
- Biologically compatible gradient materials
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