Ultra Thin Stainless Steel 316L Coil 0.1mm Medical Grade ISO 13485 Certified
Ultra-Thin 0.1mm Stainless Steel Coil, Medical Grade 316L, ISO 13485 Certified
Our Ultra-Thin 0.1mm Medical Grade 316L Stainless Steel Coil is precision-engineered for the healthcare and electronics industries, where micron-level thickness, biocompatibility, and absolute material purity are non-negotiable. Certified under ISO 13485 (Medical Devices Quality Management), this coil meets the stringent requirements for surgical instruments, implantable devices, and diagnostic equipment. The 316L alloy (low carbon variant) ensures exceptional resistance to bodily fluids, sterilization processes, and corrosive cleaning agents. With a flawless surface finish (Ra ≤0.05μm), it eliminates bacterial adhesion risks while enabling high-precision stamping, laser cutting, and micro-forming for cutting-edge medical technologies.
2. Detailed Specifications
| Parameter | Details |
|---|---|
| Material | AISI 316L (UNS S31603) |
| Element Composition | Cr: 16-18%, Ni: 10-14%, Mo: 2-3%, C: ≤0.03%, Mn: ≤2%, Si: ≤1%, Fe: Balance |
| Thickness | 0.1mm (±0.002mm tolerance) |
| Width | 10mm – 500mm (customizable) |
| Surface Finish | Mirror Polish (Ra ≤0.05μm) or Electropolished |
| Tensile Strength | 485 MPa (min) |
| Yield Strength | 170 MPa (min) |
| Elongation | 40% (min) |
| Certifications | ISO 13485, ASTM A240, ISO 9001, REACH, FDA 21 CFR 177.1520 (food/medical) |
| Applications | Micro-surgical tools, implantable sensors, flexible electronics, lab-on-a-chip devices |
3. Advantages of Importing Our Ultra-Thin 316L Coil
Core Benefits
- Medical-Grade Precision: Cold-rolled to ±0.002mm tolerance using nano-level rolling mills for flawless consistency.
- Biocompatibility: Passes ISO 10993-5 cytotoxicity testing, ensuring safety for long-term human contact.
- Fast Turnaround: 7-10 day lead time for custom widths, backed by 24/7 emergency order support.
- Cost Savings: 25% lower cost than U.S./EU suppliers with identical ISO 13485 certification.
Unique Selling Points
- Zero Contamination Guarantee: Produced in ISO Class 7 cleanrooms with full material traceability.
- Advanced Surface Treatments: Electropolishing or PVD coatings available for enhanced corrosion resistance.
- Custom Packaging: Individually wrapped in antistatic, nitrogen-filled pouches to prevent oxidation.
- Global Compliance: Meets FDA (food/medical contact) and EU MDR (Medical Device Regulation) standards.
4. Critical Medical & High-Tech Applications
| Industry | Use Cases |
|---|---|
| Medical Devices | Catheter guidewires, neurostimulator components, endoscope coils, pacemaker casings. |
| Diagnostic Equipment | Lab-on-a-chip microfluidics, MRI machine shims, biosensor electrodes. |
| Flexible Electronics | Wearable health monitors, foldable device hinges, flexible circuit boards. |
| Pharmaceutical | Drug delivery patches, inhaler components, sterile packaging foils. |
| Research | Microelectromechanical systems (MEMS), nanotech prototypes, quantum computing parts. |
FAQ:
Q: Are you a manufacturer or trading company?
A: We are a factory with 12 years of sales experience.
Q: Where is your factory located?
A: Our factory is located in Wuxi City, Jiangsu Province, China.
Q: How can I get samples?
A: There are always pre-production samples before mass production; there is always final inspection before shipment;
Q: What payment methods do you offer?
A: Accepted delivery terms: FOB, CFR, CIF, EXW, Express; Accepted payment currencies: USD, RMB; Accepted payment methods: T/T, L/C,
Credit Card, Western Union, Cash;
Q: What are your after-sales service details?
A: 1) We provide necessary technical support to all customers, such as material properties and heat treatment data suggestions.
2) We provide suitable steel technical parameters for customers in Germany, the United States, Japan, the United Kingdom and other countries.
Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.