Medical Device Power System

This medical power solution carries comprehensive certifications: IEC 60601-1 3rd edition - International medical electrical equipment safety standard

2xMOPP (Means of Patient Protection) - Double isolation for patient-connected equipment

EN 60601-1 - European medical safety standard

CSA C22.2 No. 60601-1 - Canadian medical safety standard

UL 60601-1 - US medical safety standard

IEC 60601-1-2 - Electromagnetic compatibility for medical devices. These certifications ensure the power supplies meet stringent safety requirements for medical applications. All certifications are maintained throughout the product lifecycle with ongoing testing and surveillance.

Verify required certifications for your target markets. Contact us for certification documentation.

The medical power solution features ultra-low leakage current: Normal condition: <100μA @ 264VAC, 60Hz

Single fault condition: <500μA per IEC 60601-1 requirements

Earth leakage: <300μA typical

Touch current: <100μA

Patient leakage: <10μA for CF (Cardiac Floating) rated equipment. These low leakage currents are achieved through: Optimized transformer design with triple insulated wire

Careful Y-capacitor selection and placement

Isolation barriers meeting 2xMOPP requirements

Comprehensive testing during manufacturing. Low leakage current is critical for patient-connected medical devices to prevent microshock hazards.

Verify leakage current requirements for your medical device class. Contact us for specific test data.

Cosel medical power supplies are suitable for many life-support applications with proper system-level design: Certification basis: IEC 60601-1 3rd edition covers life-support equipment

Reliability: High MTBF and burn-in testing for critical applications

Redundancy: Can be configured in N+1 redundant systems

Monitoring: Power good signals for system status

Alarms: Can interface with equipment alarm systems

Risk management: ISO 14971 risk analysis documentation available. However, life-support equipment requires: System-level safety analysis

Compliance with additional standards (e.g., IEC 62304 for software)

Clinical validation

Regulatory approval (FDA, CE, etc.). Contact our medical power specialists for life-support application support.

Life-support applications require system-level analysis. Contact our medical power specialists for support.

Recommended medical power system configuration: Input protection: Fuse and surge protection device

EMI filter: EAC-06-472 for conducted noise compliance

Main converter: PMA150F-24 for 24V system power

Auxiliary converter: PMA30F-5 for 5V logic power

Output protection: Fuses on all outputs

Monitoring: Power good signals to system controller

Cooling: Natural convection or forced air as required

Enclosure: Patient protection enclosure meeting IP requirements. System design considerations: Grounding: Single point ground to minimize ground loops

Shielding: Proper cable shielding for EMC

Isolation: Maintain isolation barriers throughout system

Documentation: Risk analysis and safety case. Our FAE team provides system design review services.

Contact our FAE team for system configuration recommendations and design review.

Cosel provides comprehensive documentation for medical device regulatory submissions: Safety certificates: IEC 60601-1 CB certificates and national certifications

Test reports: Complete safety and EMC test reports

Risk analysis: ISO 14971 risk management file

Biological evaluation: ISO 10993 biocompatibility assessment

Materials declaration: RoHS, REACH, and conflict minerals statements

Manufacturing: ISO 13485 quality system certification

Change control: Product change notification service

Field data: Reliability and field failure data. This documentation supports: FDA 510(k) submissions

CE marking technical files

NMPA (China) registrations

Health Canada approvals

Other regional registrations. Contact our medical product team for documentation packages.

Contact our medical product team for regulatory documentation packages and submission support.

Selecting the right power rating for medical devices involves: Load analysis: Calculate peak and average power for all system components

Headroom: Add 20-30% margin for reliability and future expansion

Inrush current: Consider startup current requirements

Duty cycle: Account for intermittent high-power modes

Battery charging: Include charging power if applicable

Thermal: Ensure adequate derating for enclosure conditions

Safety: Verify isolation requirements don't compromise power rating. Cosel medical power supplies range from 15W to 1500W. Our PMA series offers 30W, 50W, 100W, 150W, 300W, and 600W options. Contact our FAE team for power budgeting assistance and product selection.

Calculate total system power with 20-30% margin. Contact our FAE team for power budgeting assistance.