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Material Options | Standard Grades | 304 Stainless Steel (general medical applications), 316L Stainless Steel (preferred for implants—superior corrosion resistance and biocompatibility) |
Key Properties | High radial strength, good ductility, excellent corrosion resistance, MRI compatibility | |
Material Standards | ASTM F899, ISO 5832-1, ASTM A269 | |
Base Capillary Tube | Outer Diameter (OD) Range | 0.3 mm – 10.0 mm (customizable) |
Wall Thickness | 0.05 mm – 0.5 mm (ultra-thin wall for low profile devices) | |
Tube Length | Up to 1000 mm (customizable per component requirements) | |
Snake Bone / Stent Design | Pattern Types | Serpentine / sinusoidal rings, helical patterns, dog-bone linkage, flexible cut patterns, bridge and slot configurations, customized per application |
Strut Thickness | 0.05 mm – 0.15 mm (50–150 μm) | |
Strut Width | 0.06 mm – 0.20 mm (60–200 μm) | |
Linkage Structure | Single-stage and multi-stage rotating structures for multi-directional bending | |
Hinge/Connecting Features | Arc-shaped sliding blocks and arc-shaped slideways (concentric arc design) | |
Laser Cutting Specifications | Laser Types | Femtosecond Laser(preferred for minimal HAZ, superior edge quality, strut thickness ≤0.1mm);Fiber Laser(high throughput for thicker walls, ≥0.1mm);Picosecond Laser(intermediate precision) |
Minimum Feature Size | 0.015 mm (15 μm); Typical range: 20–30 μm | |
Cutting Tolerance | ±0.002 mm to ±0.015 mm (±2–15 μm) | |
Heat-Affected Zone (HAZ) | < 0.005 mm (femtosecond laser—virtually no thermal damage) | |
Positioning Accuracy | ≤ ±3 μm | |
Repeatability | Micron-level | |
Cutting Gap / Kerf Width | ≥ 0.015 mm (15 μm) | |
Edge Quality (As-Cut) | Smooth, burr-free, minimal dross | |
Post-Processing | Electropolishing | Removes micro-burrs, smooths strut edges, reduces surface roughness;Essential for fatigue resistance and biocompatibility |
Surface Roughness (Final) | Ra ≤ 0.4 μm (electropolished); Ra ≤ 0.05 μm achievable for critical components | |
Passivation | ASTM A967—enhances corrosion resistance | |
Heat Treatment | Stress relief annealing to restore ductility and eliminate residual stresses | |
Surface Finish Options | As-cut, electropolished, passivated, mechanically polished, bead blasted | |
Performance Characteristics | Flexibility | High multi-directional flexibility due to snake bone linkage structure |
Range of Motion | Large range of motion—improved over traditional riveted snake bone joints | |
Fatigue Resistance | Meets relevant standards; post-laser annealing available for critical components | |
Corrosion Resistance | Excellent (passivated and electropolished surfaces) | |
Biocompatibility | ISO 10993 compliant (cytotoxicity, sensitization, irritation, hemocompatibility) | |
Quality & Compliance | Inspection Equipment | Vision systems, optical comparators, laser micrometers, CMM (Coordinate Measuring Machine) |
Dimensional Verification | 100% critical feature inspection; sample CMM verification | |
Process Validation | IQ/OQ/PQ support; GR&R; Cpk analysis | |
Material Certification | Mill Test Certificate (MTC) per EN 10204 3.1 with full lot traceability | |
Documentation | FAIR (First Article Inspection Report), Dimensional Report, Certificate of Conformance (CoC), Batch Records | |
Quality Standards | Manufactured underISO 13485:2016(Medical Devices) quality management system | |
Regulatory Support | Supports FDA 510(k), PMA, and CE MDR submissions with full documentation packages | |
Cleanliness & Packaging | Cleanliness Standards | Cleaned to meet ISO 13485 and implantable device cleanliness specifications |
Packaging Options | Individual protective packaging, cleanroom packaging (ISO Class 7 or better), sterile barrier systems | |
Sterilization (Optional) | Gamma Irradiation (preferred for stainless steel), Ethylene Oxide (ETO), validated SAL 10 | |
Production Details | Lead Time (Prototype) | 2–4 weeks (design dependent) |
Lead Time (Production) | 6–8 weeks (volume and post-processing dependent) | |
File Formats Accepted | STEP, IGES, DWG, DXF, PDF (detailed 2D flat patterns and 3D geometries) | |
Special Notes | Customization | Pattern geometry, strut thickness, diameter, length fully customizable per customer specifications |
Integrated Design | Single-piece laser-cut construction eliminates riveted joints, improving consistency and reducing cost | |
Radiopacity | Stainless steel provides inherent radiopacity for fluoroscopic visualization |
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