IPC-6012E Certified 304/316L Coils | High-Frequency Signal Integrity | Aerospace-Grade Surface Finish

Medical-Device Grade Stainless Steel Coils with Bio-Compatible Surfaces
Ultra-clean 316L and 304L coils compliant with ISO 13485:2016 and USP Class VI standards, featuring pharmaceutical-grade passivation and electropolished surfaces for implantable device manufacturing.

Critical Specifications
▸ ​Biocompatibility Certification:

• Cytotoxicity Test (ISO 10993-5)
• USP Class VI Plastic Compliance
• Surface Porosity <0.5μm

▸ ​Precision Manufacturing:

• RA ≤0.35μm Mirror Finish
• Laser Micro-Cutting (±5μm Accuracy)
• Cleanroom Class 100 Packaging

Medical Industry Compliance
✔ FDA 21 CFR Part 820
✔ EU MDR 2017/745
✔ ASTM F138/F139 Surgical Steel
✔ ISO 22463 Cleanliness Verification

Advanced Processing Suite
• Vacuum Plasma Welding
• Micro-Punching (0.2-5mm Holes)
• CNC Decoiling with <0.1% Material Loss
• Hydrogen Bake-Out Process

Quality Assurance 4.0
✓ SEM Surface Analysis
✓ XPS Elemental Mapping
✓ AES Depth Profiling
✓ TGA-DSC Thermal Analysis

Specialized Packaging

• Nitrogen-Flushed Sealed Pouches
• Particle Count Certification (<10 pcs/m²)
• RFID Sterility Tracking
• Gamma Radiation-Ready Containers

Technical Advantages

• Non-Magnetic 316L Variants Available
• Electromagnetic Shielding (30dB-1GHz)
• Stress-Corrosion Cracking Threshold >200MPa
• RoHS/REACH 2.0 Full Compliance