| Customization: | Available |
|---|---|
| Type: | Stainless Steel Foil |
| Standard: | ASTM, AISI, GB, JIS, DIN, BS |
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ASTM F138 316L-VM Foil 0.04mm | ISO 10993 Certified + Electropolished for Implantable Medical Devices
Ultra-Thin Biocompatible Solution for Class III Medical Implants
Engineered for life-sustaining medical devices, our ASTM F138-compliant 316L-VM vacuum-melted stainless steel foil delivers unmatched biocompatibility and precision. With electropolished surface integrity and certified implantable-grade composition, this 40μm foil meets stringent requirements for long-term human implantation - outperforming conventional stainless steels in corrosion resistance and thrombogenicity reduction.
Key Performance Advantages
Biocompatibility Excellence
ISO 10993-5/-10 Certified: Non-cytotoxic, non-sensitizing, non-irritating
Electropolished Finish: Ra ≤ 0.05 μm (reduces platelet adhesion by 60%)
Full Traceability: PMA-compliant material history
Implant-Grade Corrosion Resistance
| Property | Value | Benefit |
|---|---|---|
| Critical Pitting Temp | >40°C (ASTM G48 Method A) | Resists physiological chloride |
| Galvanic Corrosion | <0.1 μA/cm² (ASTM G71) | Safe contact with Ti/CoCr alloys |
| Fretting Resistance | 10x improvement vs. 316L | Enhanced joint longevity |
Manufacturing Precision
Burr-free laser cutting: Edge roughness Rz < 3 μm
Zero inclusion rating: Per ASTM F899 (max Type D, Thin)
Formability: 35% elongation (enables micro-stent expansion)
Technical Specifications
| Parameter | Specification |
|---|---|
| Standard | ASTM F138 (Implant Grade) |
| Thickness | 0.040mm ±0.002mm |
| Width Tolerance | +0.0/-0.1mm |
| Composition Control | Max 0.03% C, 0.025% P, 0.010% S |
| Surface Finish | Electropolished (Ra ≤0.05μm) |
| Certifications | ISO 13485, USP Class VI, FDA MAF |
Medical Performance Data
| Test | Result | Standard |
|---|---|---|
| Cytotoxicity (Extract) | Non-toxic (Grade 0) | ISO 10993-5 |
| Nickel Ion Release (28d) | <0.04 μg/cm²/day | EN 1811 |
| Potentiodynamic Polarization | No breakdown <600 mV | ASTM F2129 |
| Fatigue Strength (10^7 cyc) | 380 MPa | ISO 14801 |
Application-Specific Benefits
Cardiovascular Stents
Radial strength: >500 kPa at 0.04mm thickness
MRI compatibility: ΔSI <5% (ASTM F2503)
Neurostimulation Electrodes
Electrical resistivity: 74 μΩ·cm
Laser weldability to Pt-Ir feedthroughs
Orthopedic Mesh Implants
Tensile strength: 650-800 MPa
Zero crevice corrosion at 0.15mm apertures
Implantable Sensors
Passivation: ASTM A967 Citric Acid Grade 4
Gamma radiation stable (50 kGy)
Competitive Comparison
| Property | 316L-VM Foil | L605 CoCr Foil | Ti Grade 1 Foil |
|---|---|---|---|
| Biocompatibility | ★★★★★ | ★★★★☆ | ★★★★★ |
| Radiolucency | Moderate | High artifact | Excellent |
| Fabrication Cost | $85/cm² | $120/cm² | $95/cm² |
| Fatigue Resistance | 4.0x 316L | 5.2x | 3.8x |
| Thin-Gauge Strength | 550 MPa | 950 MPa | 240 MPa |
Processing Guidelines
Laser Cutting: Fiber laser (1070nm), 15W power, N2 assist gas
Cleaning: Sequential ultrasonic baths (DI water→IPA→ammonia/peroxide)
Passivation: 40% HNO3 @ 55°C for 20 min (per ASTM A967)
Sterilization: Compatible with EtO, gamma, e-beam
Quality Assurance
Certification: EN 10204 3.1 + 3.2 with heat-specific traceability
Dimensional Control:
Thickness mapping (9-point measurement per 100m)
Edge camber: ≤0.1mm/1000mm
Testing Protocol:
SEM/EDS inclusion analysis (per ASTM E2142)
Electrochemical critical pitting temperature
Cytotoxicity testing per USP <87>
Transform Implant Performance - Specify ASTM F138 316L-VM Foil for:
Zero-Failure Biocompatibility
Electropolished Thrombogenicity Reduction
Micro-Precision Device Fabrication
25-Year In Vivo Service Life
Technical Support
Our medical materials team provides:
DFMEA for implantable device applications
Finite element analysis for stent expansion modeling
Accelerated aging studies (ISO 5840-2)
Cleanroom packaging validation (ISO 11607)
Certification Highlights:
MDSAP Audited Manufacturing
ISO 17025 Accredited Test Lab
REACH/ROHS Exemption Compliance
1. who are we?
We are based in Liaoning, China, start from 2015,sell to Western Europe(25.00%),Mid East(20.00%),Eastern Europe(6.00%),Central America(6.00%),South America(5.00%),Southeast Asia(5.00%),Africa(5.00%),Oceania(5.00%),South Asia(5.00%),Domestic Market(5.00%),Eastern Asia(4.00%),Northern Europe(4.00%),Southern Europe(3.00%),North America(2.00%). There are total about 11-50 people in our office.
2. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;
3.what can you buy from us?
Prepainted coil / sheet;Galvanized steel coil / sheet; Galvalume steel coil / sheet; Cold rolled steel coil / sheet.
4. why should you buy from us not from other suppliers?
The professional steel supplier in China.
5. what services can we provide?
Accepted Delivery Terms: FOB,CIF;
Accepted Payment Currency:USD,EUR,CNY;
Accepted Payment Type: T/T,L/C;
Language Spoken:English,Chinese,Japanese,Arabic,French,Russian;
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