Sinbo 精密 specializes in 制造 医疗 grade 不锈钢 零件 that meet the highest standards of quality and biocompatibility. 我们的ISO 13485 认证 quality management system ensures that every component we produce adheres to stringent 医疗 device regulations and requirements. We work 具有医疗 grade 不锈钢s 包括316L、17-4 PH,和304L, which 是 广泛使用 in surgical instruments, implantable devices, and diagnostic equipment.
我们的先进 CNC 加工 能力 include 5-axis milling, Swiss turning, and micro-加工 for ultra-precise 医疗 组件. We maintain 严格 公差s of ±0.005mm and offer specialized 表面处理es such as electro抛光 and passivation to enhance biocompatibility and corrosion resistance. 我们的cleanroom 制造 environment and rigorous quality control 工艺es ensure contamination-free 生产 of 医疗 device 零件.
We support 医疗 device manufacturers 来自原型 development through full-scale 生产. 我们的engineering team provides comprehensive DFM (Design for 制造) support optimized for 医疗 应用, ensuring regulatory compliance and 经济高效 生产. With FDA compliant 工艺es and full traceability documentation, we help our 定制ers navigate the 复杂 regulatory landscape of the 医疗 device industry.
| Material Grades | 316L, 17-4 PH, 304L, 316LVM, 420 Medical Grade 不锈钢 |
| 工艺 | CNC Milling, Swiss Turning, Micro-Machining, 5-Axis Machining |
| 公差 | ±0.005mm (±0.0002") |
| 表面光洁度 | Electropolished (Ra 0.4), Passivated, Mirror Polished |
| Size Range | Micro-components to 300mm diameter |
| 交货期 | 5-10 days (standard), 3-5 days (express) |
| 最小订购量 | 10 pieces (prototypes), 100 pieces (production) |
| 认证s | ISO 13485, ISO 9001, FDA合规, IATF 16949 |
Low carbon version of 316 具有优异 corrosion resistance and biocompatibility. 广泛使用 for surgical instruments and implantable devices.
Precipitation hardening 不锈钢 具有高强度 and hardness. Used for surgical tools, dental instruments, and orthopedic devices.
Low carbon austenitic 不锈钢 具有优异 formability and corrosion resistance. Suitable for non-implantable 医疗 devices.
Vacuum melted 316L 具有ultra-low impurity levels. Premium grade for critical implantable 应用 and surgical instruments.
Martensitic 不锈钢 具有high hardness and wear resistance. Used for cutting instruments, scalpels, and surgical blades.
We 能够 machine various specialty 医疗 grade 不锈钢 合金s based on your specific application requirements and 规格.
Scalpels, forceps, retractors, clamps, and 精密 surgical tools requiring sharp edges and durability
Joint replacement 组件, bone screws, plates, and fixation devices for orthopedic 应用
Dental tools, orthodontic 组件, implant abutments, and 精密 dental device 零件
Stents, catheter 组件, valve 零件, and 精密 cardiovascular 医疗 device 组件
精密组件 for diagnostic instruments, imaging equipment, and laboratory devices
Surgical table 组件, hospital bed 零件, and 医疗 equipment hardware requiring 精密 and durability
医疗 Device QMS
Compliant
可追溯性
制造
ISO 13485:2016
ISO 9001:2015
IATF 16949:2016
ISO 14001:2015
我们的最小起订量 是 10 pieces for 原型s and 100 pieces for 生产 runs. We 能够 accommodate lower quantities for 医疗 device development projects 具有appropriate documentation and quality requirements.
Standard 交货期 是 5-10 days for 医疗 grade 不锈钢 零件. Express service 具有3-5 day turnaround 是 available for urgent projects. 交货期s may vary based on 复杂ity, quantity, and quality requirements.
Yes, we 是 ISO 13485:2016 认证 for 医疗 device 制造. 我们的quality management system 是 designed to meet the specific requirements of the 医疗 device industry, including regulatory compliance and traceability.
Yes, we provide full 材料 traceability 包括mill certificates、heat lot numbers,和complete documentation for all 医疗 grade 不锈钢 材料s used in 生产. 这种ensures regulatory compliance and 质量保证.
我们为医疗 零件 as it enhances biocompatibility, removes surface contaminants, and improves corrosion resistance提供electro抛光 (Ra 0.4 or better), passivation, mirror 抛光, and bead blasting. Electro抛光 是 particularly recommended。
