High Purity Medical Titanium Wire for Implantable Devices

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High Purity Medical Titanium Wire for Implantable Devices
Details
Material: Grade 1 CP (pure titanium) / Grade 23 ELI (Ti-6Al-4V)
Standard: ASTM F67 / ASTM F136 / ISO 5832-3
Diameter: 0.1mm – 3.0mm
Length: 500mm – 5000mm (straight) or coil
Surface: Polished (Ra ≤ 0.1μm) or electropolished
Category
Medical Titanium Wire
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Description

What it is 

 

 

Implantable devices go inside the body. Pacemaker leads. Neurostimulator wires. Cochlear implant electrodes. Drug delivery ports. Cardiac monitoring loops.

High purity medical titanium wire for implantable devices is made for these applications. Not commercial wire. Not industrial. Medical grade. Extra clean. Extra pure. Extra traceable.

The wire stays in the body for years. Decades sometimes. It cannot corrode. Cannot release ions. Cannot break.

 

 

Why purity matters 

 

 

Commercial titanium wire works for many things. But implantable devices are different.

Requirement Commercial wire Medical implant wire
Oxygen control ±0.10% ±0.02% (ELI)
Iron control Loose Tight (≤0.25%)
Surface contamination May exist None
Traceability Limited Full heat to implant
Biocompatibility testing No Yes (per ISO 10993)

High purity medical titanium wire for implantable devices meets the strictest standards. ASTM F67 for pure titanium. ASTM F136 for alloy. ELI chemistry. Low oxygen. Low iron.

 

 

Which grade for implantable devices 

 

 

Grade Material Purity Best for
Grade 1 CP Pure titanium ≥99.5% Pacemaker leads, neurostimulators
Grade 23 ELI Ti-6Al-4V ≥98.8% Structural leads, high strength

Grade 1 is the purest titanium available. 99.5% minimum. No aluminum. No vanadium. Used for devices where minimal metal ion release is critical.

Grade 23 ELI has higher strength. Used for devices that need both strength and biocompatibility. Still very pure. ELI means Extra Low Interstitial - lower oxygen and iron.

For high purity medical titanium wire for implantable devices, Grade 1 is often chosen for maximum purity. Grade 23 ELI when strength matters more.

 

 

Material specifications 

 

 

Grade 1 CP (ASTM F67)

Property Value
Purity (min) 99.5%
Tensile (min) 240 MPa
Yield (min) 170 MPa
Elongation ≥ 24%
Density 4.51 g/cm³
Modulus 105 GPa

 

Grade 23 ELI (ASTM F136)

Property Value
Tensile (min) 860 MPa
Yield (min) 795 MPa
Elongation ≥ 10%
Density 4.43 g/cm³
Modulus 110 GPa

 

 

Chemical composition - Grade 1 (ASTM F67) 

 

 

Element Max limit
Oxygen 0.18%
Iron 0.20%
Carbon 0.08%
Nitrogen 0.03%
Hydrogen 0.012%
Titanium ≥99.5%

No aluminum. No vanadium. No nickel. Just pure titanium.\

 

Chemical composition - Grade 23 ELI (ASTM F136)

Element Max limit
Oxygen 0.13%
Iron 0.25%
Carbon 0.08%
Nitrogen 0.05%
Hydrogen 0.012%
Aluminum 5.5 – 6.5%
Vanadium 3.5 – 4.5%

 

 

Common diameters for implantable devices 

 

 

Diameter (mm) Device Application
0.1 – 0.2 Pacemaker leads Cardiac pacing
0.2 – 0.3 Neurostimulator leads Spinal cord stimulation
0.3 – 0.4 Cochlear implant electrodes Inner ear
0.4 – 0.6 Drug delivery port catheters Subcutaneous ports
0.6 – 0.8 Cardiac monitoring loops Loop recorders
0.8 – 1.2 Implantable pump components Drug infusion
1.2 – 2.0 Structural leads High strength applications
2.0 – 3.0 Device housings (wire form) Custom shapes

 

 

Where it goes 

 

 

  • Pacemaker leads. Wire carries electrical signal from pacemaker to heart. Sits in the bloodstream. Must not corrode. Must not clot. Surface must be ultra-smooth. 0.1mm to 0.2mm diameter. Grade 1. Electropolished.
  • Neurostimulator leads. Spinal cord stimulator. Deep brain stimulation. Wire implanted near nerves. Flexes with body movement. Needs good fatigue life. Grade 1 or Grade 23 ELI depending on design.
  • Cochlear implant electrodes. Array of wires in the cochlea. Stimulate auditory nerve. Very small. 0.3mm diameter. Grade 1. High purity. No toxic ions.
  • Drug delivery port. Catheter from port to vein. Wire reinforced. Small diameter. Grade 1. Smooth surface prevents clotting.
  • Cardiac monitoring loop. Loop recorder under skin. Wire loop senses heart rhythm. Grade 1. Biocompatible. Long term.

For high purity medical titanium wire for implantable devices, each application demands ultra-clean surface and tight chemistry control.

 

 

Why electropolished surface for implantable devices 

 

 

Implantable devices touch blood. They touch tissue. Rough surfaces cause clots. Cause inflammation.

Finish Ra Blood contact Tissue response
Electropolished ≤ 0.05μm Excellent Minimal
Polished ≤ 0.1μm Good Low
Ground ≤ 0.4μm Poor Moderate

Electropolishing removes surface imperfections. Removes embedded particles. Creates a passive oxide layer. Smoother than mechanical polishing.

For high purity medical titanium wire for implantable devices, electropolished is the standard for blood-contacting devices.

 

 

Corrosion resistance in the body 

 

 

Body fluids are corrosive. Saline. Proteins. Cells. pH varies.

Commercial grade titanium may have inclusions. Impurities. These become corrosion sites.

Medical grade high purity titanium has minimal inclusions. No surface contaminants.

Test Requirement
ASTM F2129 cyclic polarization Pass
ISO 10993-5 cytotoxicity Pass
ISO 10993-10 sensitization Pass
ISO 10993-11 systemic toxicity Pass

Our wire passes all standard biocompatibility tests.

 

 

Fatigue life for long-term implants 

 

 

Implantable devices flex. Heart beats. Body moves. Diaphragm contracts.

Pacemaker lead sees 70 million cycles per year. That's 70 million bends.

Material Fatigue limit Suitability for high-cycle implants
Grade 1 CP 200-250 MPa Good
Grade 23 ELI 500-600 MPa Excellent
Stainless 316L 300-400 MPa Fair (nickel)

For high-cycle applications like pacemaker leads, Grade 1 with smooth surface is proven. For higher stress, Grade 23 ELI.

 

 

Surface defects - zero tolerance 

 

 

Implantable wire cannot have:

Defect Acceptance
Pits None
Scratches >0.01mm depth None
Embedded particles None
Burrs None
Oxide discoloration None (must be silver)

We inspect every lot. Surface analysis report available.

 

 

Coating options 

 

 

Some implantable devices need coatings.

Coating Purpose Application
PTFE Insulation Pacemaker leads
Silicone Biostable insulation Neurostimulator
Gold Conductivity Electrode tips
Iridium oxide Stimulation efficiency Cochlear implants

We supply uncoated wire. Coating applied by device manufacturer. Our wire surface is prepared for coating adhesion.

 

 

Traceability - full chain 

 

 

Implantable devices are Class III medical devices. Highest risk. Highest scrutiny.

Every high purity medical titanium wire for implantable devices comes with:

Document Provided
Heat number Yes
Mill test report Yes
ASTM F67 or F136 cert Yes
Chemical analysis Yes
Mechanical test results Yes
Surface finish report Yes
Biocompatibility test summary Upon request

EN 10204 3.1 standard. 3.2 with third-party witness.

We retain samples from every heat for 10+ years.

 

 

FAQ 

 

 

Q: Grade 1 or Grade 23 ELI for pacemaker leads?

A: Grade 1. Pacemaker leads need maximum purity and flexibility. Grade 1 is softer. Better fatigue in bending. No aluminum or vanadium.

Q: What diameter for a pacemaker lead?

A: 0.1mm to 0.2mm. Very thin. Must fit through veins into the heart.

Q: Electropolished or polished for blood contact?

A: Electropolished. Ra ≤ 0.05μm. Smoother surface reduces thrombogenicity. Less clot formation.

Q: What about nickel in Grade 23 ELI?

A: Grade 23 ELI has no nickel. Both grades are nickel-free. Safe for nickel-sensitive patients.

Q: Can you supply wire in continuous coils for automated winding?

A: Yes. Coils up to 10km for fine wire. Spools available. Continuous length means no splices in your device.

Q: Lead time?

A:

Order type Lead time
Stock diameters (0.1mm – 1.0mm) 10-14 days
Non-stock sizes 4-6 weeks
Electropolished Add 5-7 days

Q: Sample wire for qualification?

A: Yes. 5 meter sample. Pay shipping. Material free for evaluation. Credit back on first production order over $20,000.

Q: Packaging for clean room?

A: Straight lengths in ultra-clean sealed tubes. Coils on clean spools in double anti-static bags. Labels show heat number, diameter, length, lot number, ASTM spec.

Q: Do you have ISO 13485 certification?

A: Yes. We are ISO 13485 certified for medical implant wire. Audited annually. Full quality system.

 

 

 

The bottom line

 

 

Implantable devices stay in the body for years. The wire must be pure. Clean. Strong. Safe.

High purity medical titanium wire for implantable devices delivers that.

Feature Benefit
Grade 1 CP 99.5% pure, no Al/V
Grade 23 ELI High strength, ELI chemistry
Electropolished surface Ultra-smooth, blood compatible
No nickel No allergic reactions
Full traceability Regulatory ready
ISO 13485 Medical device quality system

For pacemaker leads. For neurostimulators. For cochlear implants. For drug delivery ports.

Pure enough for the heart. Strong enough for the body. Clean enough for long-term implant.

 

Contact

 

 

Need a quote on high purity medical titanium wire for implantable devices? Tell us grade (Grade 1 or Grade 23 ELI), diameter, length (straight or coil), quantity, and surface finish requirements. Include any biocompatibility documentation needs. We'll reply within 24 hours.

Email: kristy@mt-titanium.com

WhatsApp: +86-17391509251

 

 

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