Medical Device Component Reliability
Application type: Medical Equipment Manufacturer
Engineering Note
This application note explains the material selection and validation route. Actual projects should be confirmed against drawings, standards, process windows, sample testing and commercial availability.
Application Fit
Confirm whether the material system fits the service condition before comparing only by price or material name.
Validation Route
Sample validation should cover dimensions, conductivity, bonding, surface condition, joining process and environmental reliability.
RFQ Fields
Provide drawing, specification, tolerance, application, annual demand, packaging and inspection document requirements together.
The Challenge
Develop corrosion-resistant, biocompatible components for long-term implantable devices
Review Route
Utilized precision-engineered nickel clad copper (NCC) for critical components
Procurement Value
100% pass rate in accelerated lifetime testing, approved for clinical implantable use
Project Timeline
Material Selection
NCC wire with 27% nickel for biocompatibility barrier
Testing
Passed ISO 10993 biocompatibility & 10-year accelerated life
Approval
Approved for clinical implantable device use
Background
Long-term implantable medical devices — from cardiac pacemakers to neurostimulators — demand conductor materials that remain reliable for a decade or more inside the human body. A leading Medical Equipment Manufacturer developing next-generation neurostimulation systems needed a wire that combined excellent conductivity with superior corrosion resistance and biocompatibility, while being drawable to ultra-fine diameters for minimally invasive leads.
The Challenge
The device manufacturer required a conductor material that would:
- Maintain stable electrical performance over a 10+ year implant duration in a corrosive physiological environment
- Pass ISO 10993 biocompatibility testing for direct tissue contact
- Be drawn to 0.05 mm diameter for ultra-fine lead assemblies
- Resist nickel-ion release at the surface to prevent allergic reactions in sensitive patients
The Solution: Raytron NCC Wire
We supplied our Nickel Clad Copper (NCC) Wire with a 27% nickel ratio, engineered for medical-grade performance:
- Construction: Oxygen-free copper core clad with 27% nickel by volume, providing a continuous nickel barrier against body-fluid corrosion
- Biocompatibility: Nickel surface fully compliant with ISO 10993-1 (cytotoxicity, sensitization, irritation), with verified low nickel-ion release rates
- Drawability: Successfully drawn to 0.05 mm ultra-fine wire — enabling the smallest lead diameters for minimally invasive implants
- Metallurgical bond: Cladding metallurgically bonded, designed to resist delamination during drawing, coiling, or long-term implantation
Results
- Accelerated Life Testing: All samples passed simulated 10-year accelerated life tests according to agreed test items
- Simulated Lifespan: Successfully completed 10-year equivalent corrosion cycling with no measurable resistance increase
- Biocompatibility: Full ISO 10993 compliance confirmed, approved for direct tissue contact
- Ultra-Fine Capability: Wire drawn to 0.05 mm diameter — the thinnest in class — enabling next-generation micro-lead designs
Need a Similar Engineering Review?
Send the drawing, application and target specification so Raytron can help review material routes, validation priorities and RFQ fields.