Cardiac Pacemaker Components Machining
We specialize in high-precision CNC machining for cardiac pacemaker parts, leveraging biocompatible materials and ultra-tight tolerances down to ±0.001 mm. From connectors and electrodes to complex structural housings, we deliver custom-machined components tailored to your 2D/3D CAD specifications.
Operating under an ISO 13485-certified medical quality management system, our production covers rigorous end-to-end quality control—from raw material traceability to sterile packaging. Supported by a dedicated medical R&D team, we assist clients with DFM design optimization, material selection, and validation testing.
Designed for class III implantable medical devices, our components excel in biocompatibility, hermetic sealing, and long-term implantation reliability.
| Core Components | Material | Key Machining Parameters | Technical Value |
|---|---|---|---|
| Titanium Alloy Housing | Ti-6Al-4V ELI (Medical-Grade Titanium Alloy) | • Dimensional tolerance: ±0.001 mm • Flatness: ≤0.0008 mm • Laser welding seal, air tightness: < 1×10⁻⁹ Pa·m³/s | Excellent biocompatibility, resistance to body fluid corrosion, and protection of internal circuits |
| Electrode Connection Base | Titanium Alloy + Ceramic Insulation Ring | • Concentricity: ≤0.001 mm • Thread tolerance: 4H/4g • Surface roughness: Ra 0.02 µm | Ensures stable electrode insertion/extraction and lossless signal transmission |
| Sealing Insulation Plug | Medical-Grade PEEK / Polyimide | • Geometric tolerance: ±0.002 mm • Fitting clearance with housing: ≤0.0015 mm | Resistant to autoclave sterilization, no aging or leakage during long-term implantation |
| Internal Positioning Bracket | Titanium Alloy / Medical-Grade Stainless Steel | • Dimensional tolerance: ±0.0015 mm • Perpendicularity: ≤0.001 mm | Fixes circuits and batteries, avoiding displacement after implantation |
Common materials
| Metals | Plastics |
|---|---|
| Titanium Grade 5 (Ti-6Al-4V ELI) | Medical-Grade PEEK |
| Pure Titanium (Grade 2) | Polyimide (PI) |
| Platinum-Iridium (Pt-Ir) | PTFE |
| 316LVM Medical Stainless Steel | UHMWPE |
Machining Process and Quality Inspection Standards
Core Processes:5-axis linkage CNC precision machining utilizing medical-grade tooling (PCD/CBN); cryogenic cutting (titanium alloy machining temperature < 150°C) to prevent thermal deformation and material structural damage; ion beam polishing on key sealing surfaces for superior surface integrity.
Quality Control: Coordinate Measuring Machine (CMM) for 100% critical dimension inspection; helium mass spectrometer leak detection for 100% hermetic seal testing; biocompatibility testing (cytotoxicity and hemolysis rate) meeting ISO 10993 standards; defect rate strictly controlled below 0.05%.
Compliance Adaptation: Fully certified under ISO 13485 Medical Device Quality Management System; all raw materials come with full traceability and FDA/CE-compliant biocompatibility test reports, fully supporting the registration requirements for Class III implantable medical devices.
Precision machining for cardiac pacemaker components—compatible with medical-grade titanium and platinum-iridium alloys. Combining micron-level tolerances with advanced laser sealing, we deliver exceptional biocompatibility and airtight performance tailored for long-term implantable medical applications.
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