Cardiac Pacemaker
Our cardiac pacemaker parts are crafted from biocompatible materials to ensure human safety and compatibility, with a machining precision of ±0.001mm that meets rigorous medical device requirements. We provide custom CNC machined components for cardiac pacemakers, such as connectors, electrodes, and structural parts, offering tailored solutions based on clients’ 2D/3D drawings. Adhering to ISO 13485 medical device quality management system, our production process includes full-process quality control from raw material inspection to final sterile packaging, ensuring compliance with global medical regulations. Our professional R&D team, experienced in medical device components, offers technical support for design optimization, material selection, and performance testing.
As an implantable medical device, cardiac pacemaker components must meet requirements for biocompatibility, sealing performance, micron-level precision, and long-term implantation stability.
| Core Components | Material | Key Machining Parameters | Technical Value |
| Titanium Alloy Housing | Ti-6Al-4V ELI (Medical-Grade Titanium Alloy) | Dimensional tolerance ±0.001 mmFlatness ≤0.0008 mmLaser welding sealing, 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 mmThread tolerance 4H/4gSurface roughness Ra 0.02 μm | Ensures stable electrode insertion/extraction and undiminished signal transmission |
| Sealing Insulation Plug | Medical-Grade PEEK / Polyimide | Geometric tolerance ±0.002 mmFitting 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 mmPerpendicularity ≤0.001 mm | Fixes circuits and batteries, avoiding displacement after implantation |
Machining Process and Quality Inspection Standards
Core Processes: 5-axis linkage CNC precision cutting with medical-grade tools (PCD/CBN); cryogenic cutting (titanium alloy cutting temperature ＜150℃) to avoid material structure damage; ion beam polishing for key sealing surfaces to ensure surface integrity.
Quality Control: Coordinate Measuring Machine (CMM) for 100% inspection of key dimensions; helium mass spectrometer leak detector for 100% air tightness testing; biocompatibility tests (cytotoxicity/hemolysis rate) up to standard; defect rate controlled below 0.05%.
Compliance Adaptation: Compliant with ISO 13485 Medical Device Quality Management System; materials can provide FDA/CE biocompatibility reports; suitable for registration requirements of implantable medical products.
Precision machining of cardiac pacemaker components, adapted to medical-grade titanium alloy/platinum-iridium alloy, with micron-level tolerance + laser sealing, dual compliance with biocompatibility and air tightness requirements, suitable for implantable medical applications.