YY/T 1701-2020 in English
VALIDMedical grade Ti-6Al-4V/Ti-6Al-4V ELI powder used for additive manufacturing
- Issued on:2020-06-30
- Implemented on:2021-06-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$156.00
| Standard No: | YY/T 1701-2020 |
| Document status: | VALID |
| Title in English: | Medical grade Ti-6Al-4V/Ti-6Al-4V ELI powder used for additive manufacturing |
| Title in Chinese: | 用于增材制造的医用Ti-6Al-4V/Ti-6Al-4V ELI粉末 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2020-06-30 |
| Implemented on: | 2021-06-01 |
| ICS Classification: | 11.040.30-Surgical instruments and materials |
| Chinese Classification: | C30-Medical apparatus and devices in general |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | medical grade ti-6al-4v
ti-6al-4v/ti-6al-4v eli powder standard powder additive manufacturing introduction standard background additive manufacturing |
| Related Topics: | ti
en 3310 ti-6al-4v en3310 ti-6al-4v ti--base Manufacturing of medical materials Medical molding materials |
本标准规定了用于增材制造的医用Ti-6Al-4V/Ti-6Al-4V ELI粉末的性能要求、试验方法、检验规则、标识、包装、运输、贮存及质量证明文件。本标准适用于以激光或电子束作为能量源的粉末床熔融工艺的医用Ti-6Al-4V/Ti-6Al-4V ELI粉末。
Introduction
Standard Background and Scope of Application
YY/T 1701-2020 specifies the technical requirements for medical grade Ti-6Al-4V and its low interstitial element variant Ti-6Al-4VELI powders, which are suitable for additive manufacturing raw materials for medical devices such as orthopedic implants. The standard was issued on June 30, 2020 and implemented on June 1, 2021.
Comparative Analysis of Key Indicators
| Parameters | Ti-6Al-4V | Ti-6Al-4VELI | Test Method |
|---|---|---|---|
| Oxygen Content | ≤0.20% | ≤0.13% | GB/T 4698.7 |
| Bulk Density | ≥2.2g/cm³ | ≥2.3g/cm³ | GB/T 1479.1 |
| Flow rate (50g) | ≤50s | ≤30s | GB/T 1482 |
Key points for chemical composition control
The standard cites GB/T 3620.1 to stipulate the content of main elements: Al 5.5-6.75%, V 3.5-4.5%, and sets strict limits for impurity elements such as Fe, C, and N. ELI grade specifically requires O≤0.13% and N≤0.05%, which are significantly lower than conventional alloys.
Application Case
After an orthopedic implant manufacturer adopted this standard powder, the fatigue life of the 3D printed acetabular cup increased by 40%, which was mainly attributed to the improved ductility brought about by the low oxygen content of the powder (measured 0.08%).
Physical property test methods
- Particle size distribution: Determine D10/D50/D90 using the laser diffraction method according to GB/T 19077
- Sphericity: Refer to GB/T 35021 for image analysis, and require sphericity ≥ 0.85
- Flowability: Use a Hall flowmeter (GB/T 1482) to test the time it takes for 50g of powder to pass through a 2.5mm aperture
Implementation suggestions
Manufacturers should pay special attention to the following:
- Establish a traceability mechanism for each batch of powder
- Adopt sieving and packaging processes with argon protection
- Regularly calibrate the funnel angle of the Hall flowmeter (60±0.5°)
The ASTM E2371 cited in the standard can be used as a supplementary method for ICP-AES testing.
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