Medical Device PCB Design
Class I | Class II | Class III | IVD Devices
Calculate trace parameters for medical device electronics. From patient monitors to implantables, ensure your PCB design meets IEC 60601 safety standards and FDA regulatory requirements.
Medical Device Applications
| Application | Device Class | Standard | Key Requirements |
|---|---|---|---|
| Patient Monitoring | Class II | IEC 60601-1 | Low noise, reliable |
| Diagnostic Imaging | Class II | IEC 60601-1 | High-speed, shielded |
| Implantable Devices | Class III | ISO 14708 | Biocompatible, miniature |
| Surgical Equipment | Class II/III | IEC 60601-1 | Sterilization resistant |
Medical PCB Requirements
Patient Safety
IEC 60601-1 compliance mandatory. Proper creepage/clearance distances, double/reinforced insulation for patient-connected parts. Consider leakage current limits.
Reliability & Traceability
Full traceability required for Class II/III. Use qualified components, controlled processes, and maintain design history files (DHF) per FDA 21 CFR Part 820.
EMC Requirements
IEC 60601-1-2 for EMC. Medical devices must operate reliably in hospital EMI environments and not interfere with other equipment. Strict immunity testing.
IEC 60601-1 PCB Considerations
Creepage & Clearance
Leakage Current Limits
Medical Device Design Types
External Devices
- • Patient monitors, infusion pumps
- • Standard high-Tg FR4 often suitable
- • Focus on creepage/clearance
- • EMC compliance critical
- • Conformal coating recommended
Implantable Devices
- • Pacemakers, neural implants
- • Biocompatible materials required
- • Extreme miniaturization
- • Ultra-low power design
- • Hermetic sealing considerations
Diagnostic Imaging
- • X-ray, CT, MRI electronics
- • High-speed data acquisition
- • Controlled impedance for signals
- • Heavy shielding requirements
- • Radiation-resistant where needed
Wearable Medical
- • Continuous glucose monitors, ECG
- • Flexible or rigid-flex PCBs
- • Low power, small form factor
- • Wireless connectivity (BLE)
- • Skin-contact safety considerations
Calculate Medical Device Trace Parameters
Use our free calculators for medical device PCB design. Ensure proper current capacity, safety distances, and impedance control for regulatory compliance.
Medical PCB FAQ
What standards apply to medical PCBs?
IEC 60601-1 for electrical safety, IEC 62304 for software, ISO 13485 for quality management, and FDA 21 CFR Part 820 for US market.
Do I need special materials?
High-Tg FR4 works for most external devices. Implantables need biocompatible materials. Consider halogen-free for environmental requirements.
How important is traceability?
Critical. Document all design calculations, material selections, and manufacturing data. Full traceability is required for FDA submissions.
What about EMC for medical devices?
IEC 60601-1-2 covers EMC. Medical devices have stringent immunity requirements. Good PCB design with proper impedance control and shielding is essential.
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