YY/T 1809-2021 in English
VALIDAdditive manufacturing for medical applications―Verification methods of cleaning and cleaning effectiveness of metal powder used in powder-bed fusion process
- Issued on:2021-09-06
- Implemented on:2022-09-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$146.00
本标准规定了医用增材制造粉末床熔融成形工艺残留金属粉末清洗方法及清洗效果的验证方法。
本标准适用于清洗方法的选择和清洗效果的有效性评价。
Introduction
Core Value and Technical Background of the Standard
YY/T 1809-2021 is my country's first special cleaning standard for powder bed fusion forming process, filling the gap in technical specifications for the post-processing of additively manufactured medical devices. The standard is formulated based on the topological optimization of the porous structure of the device, solving the industry pain point that traditional cleaning methods are difficult to completely remove internal residual powder (20-100μm).
Comparative Analysis of Cleaning Processes
| Process Type | Applicable Scenarios | Key Parameters | Residual Risk |
|---|---|---|---|
| High-Pressure Medium Cleaning | Surface and Macropores | Pressure ≥3MPa | Micropore Residue |
| Ultrasonic Cleaning | Microstructure | Frequency 40-80kHz | Cavitation Damage |
| Chemical Cleaning | Complex Structure | pH 6-8 | Reagent residues |
Technical points of the verification method
Industrial CT detection specifications
Clause 5.7 of the standard clearly requires that the CT resolution should be able to identify particles ≥D50 (usually 50-80μm). Attention should be paid to the following during detection:
- Scanning layer thickness ≤ 1/3 of the minimum characteristic size of the particles
- FDK iterative reconstruction algorithm is used
- Grayscale threshold discrimination ≥ 15%
Implementation suggestions
Recommended combination solutions for different types of devices:
- Orthopedic implants: high pressure cleaning + ultrasonic + weighing verification
- Porous stents: chemical cleaning + CT inspection + destructive testing
- Surgical instruments: acoustic dry cleaning + optical inspection
Technology evolution analysis
Compared with ASTM F3335-20, this standard innovatively proposes:
- Quantitative indicator of final cleaning water conductivity ≤5.1μS/cm (25℃)
- Introduce acoustic dry cleaning process to deal with heat-sensitive materials
- Establish a corresponding relationship matrix between cleaning and verification methods
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