Medical electronic devices (such as patient monitors, ventilators, infusion pumps, diagnostic instruments, dental equipment, and home healthcare devices) come into direct or indirect contact with patients. Consequently, their safety regulations for power supplies are significantly higher than those for general industrial or consumer products.
An ordinary industrial power supply, even if it shares identical electrical parameters, cannot be used in medical devices that directly contact a patient without undergoing specific medical certifications. This is the most critical distinction between medical-grade and general-purpose power supplies. Therefore, the power supply is not only the driving core of medical electronic equipment but also the first line of defense ensuring the safety of both patients and healthcare personnel.
Under the medical electrical safety standard IEC 60601-1, parts that come into contact with the human body are defined as Applied Parts. Based on the contact site, nature of contact, and electrical shock protection level, the standard strictly classifies them into three categories: Type B (Body), Type BF (Body Floating), and Type CF (Cardiac Floating).
The primary differences in Patient Leakage Current (AC) limits between these three categories under Normal Condition (NC) and Single Fault Condition (SFC) according to IEC 60601-1 are outlined in the table below:
An ordinary industrial power supply, even if it shares identical electrical parameters, cannot be used in medical devices that directly contact a patient without undergoing specific medical certifications. This is the most critical distinction between medical-grade and general-purpose power supplies. Therefore, the power supply is not only the driving core of medical electronic equipment but also the first line of defense ensuring the safety of both patients and healthcare personnel.
Under the medical electrical safety standard IEC 60601-1, parts that come into contact with the human body are defined as Applied Parts. Based on the contact site, nature of contact, and electrical shock protection level, the standard strictly classifies them into three categories: Type B (Body), Type BF (Body Floating), and Type CF (Cardiac Floating).
The primary differences in Patient Leakage Current (AC) limits between these three categories under Normal Condition (NC) and Single Fault Condition (SFC) according to IEC 60601-1 are outlined in the table below:
| Applied Part Type | Normal Condition (NC) Leakage Limit | Single Fault Condition (SFC) Leakage Limit | Isolation & Protection Requirements | Common Contact Nature |
|---|---|---|---|---|
| Type B (Body) | ≤100μA | ≤500μA | Earth grounding is typically used for basic electrical shock protection. | Non-conductive, peripheral contact. |
| Type BF (Body Floating) | ≤100μA | ≤500μA | 2xMOPP; patient side is floating and isolated from the ground. | Surface conductive contact, low invasiveness. |
| Type CF (Cardiac Floating) | ≤10μA | ≤50μA | High-level 2xMOPP with extremely low parasitic capacitance. | Direct contact with heart, blood vessels, or blood. |
Over the years, FranMar International Inc. has been dedicated to providing medical power solutions primarily focused on Type BF specifications (with certain series meeting Type CF standards) that comply with international medical safety standards such as ANSI/AAMI ES60601-1 and IEC/EN 60601-1.
To date, our product line encompasses three core series: Medical AC/DC Adapters, Medical AC/DC Open Frame Power Supplies, and Medical DC/DC Converters. This comprehensive portfolio simplifies the medical safety compliance process and customization requirements for R&D engineers, offers a one-stop-shop procurement service, and helps decision-makers mitigate systemic risks to accelerate Time-to-Market.
To date, our product line encompasses three core series: Medical AC/DC Adapters, Medical AC/DC Open Frame Power Supplies, and Medical DC/DC Converters. This comprehensive portfolio simplifies the medical safety compliance process and customization requirements for R&D engineers, offers a one-stop-shop procurement service, and helps decision-makers mitigate systemic risks to accelerate Time-to-Market.
1. Medical AC/DC Adapters
Medical AC/DC adapters are standalone external power modules suitable for external power supply, portable, or desktop medical devices, such as pulse oximeters, blood pressure monitors, nebulizers, home respiratory care equipment, and handheld dental instruments.
Core Product Series:
- USB Power Delivery & GaN Fast Charging Series (FHMC Series, 60W ~ 240W): Utilizing the latest GaN (Gallium Nitride) technology, this series supports USB PD3.0/3.1 and QC2.0 ~ 4.0 fast charging protocols. The output voltage dynamically adjusts between 5V ~ 28V based on the protocol, making it perfectly suited for next-generation portable medical devices that support USB-C charging. It achieves a maximum efficiency of 92% with a no-load power consumption of < 0.15W, significantly reducing standby power consumption for medical equipment.
- Wall-mount Fixed Plug Series (FRM06, FRM015, FRM024, FRM030, FDM012, FWM030, 4W ~ 30W): Featuring a fixed plug design, this series offers high cost-effectiveness and is ideal for medical devices targeted deep within a single regional market.
- Wall-mount Interchangeable Plug Series (FRM06, FRM015, FRM024, FRM030, 4W ~ 30W): The premier choice for multinational export of medical equipment. The AC plugs can be flexibly swapped based on regional specifications (e.g., US, EU, UK, AU), allowing a single device model to be marketed globally, which significantly reduces inventory and part-number management complexity.
- Desktop Series (FRM015 ~ FRM060, FDM100, FDM130, FDM400, 10W ~ 400W): This series offers the broadest power range and supports multiple AC inlet options (C6, C8, C14, C18). It accommodates everything from small diagnostic instruments to medium and large therapeutic equipment. Notably, the FDM400 delivers up to 400W, purpose-built for high-power medical imaging or therapy devices.
- Waterproof Desktop Series (FWM120, FWM150, IP54, 96W ~ 150W): Boasting an excellent IP54 waterproof and dustproof rating, this series is well-suited for clinical environments prone to fluid contact, dental chair peripherals, or specialized environments requiring frequent cleaning and disinfection.
Engineering & Procurement Selection Tips:
- Confirm the device's maximum output power requirements and recommend reserving a 20% to 30% power margin.
- Determine if the device will be sold in multiple countries; if so, prioritize the interchangeable plug series to streamline global distribution.
- If the device requires fast charging or high power density (e.g., portable ultrasound, tablet-based diagnostics), prioritize evaluating the USB PD / GaN series.
- Verify if the clinical workspace carries a risk of liquid splashing; if yes, select the IP54 waterproof series.
FranMar Recommended Models for Medical AC/DC Adapters:
FranMar Recommended Models for Medical AC/DC Adapters
2. Medical AC/DC Open Frame Power Supplies
Specifically engineered for embedded medical systems (e.g., large-scale laboratory analyzers, biochemical diagnostic equipment, surgical devices), this line stresses high efficiency and minimal footprint. Built as internal power supplies, open frame units are mounted directly inside the medical device chassis, with the system integrator or system manufacturer bearing responsibility for final system-level safety certifications.
FranMar offers standard industrial footprints (such as 3"x2", 4"x2", 5"x3") to maintain absolute compatibility with standard embedded chassis. Simultaneously, they feature dual protection architectures for both Class I and Class II, helping clients easily pass system-level EMI Class B compliance. With a broad power spectrum (30W ~ 1100W), it serves as the core power solution for large, fixed medical equipment.
FranMar offers standard industrial footprints (such as 3"x2", 4"x2", 5"x3") to maintain absolute compatibility with standard embedded chassis. Simultaneously, they feature dual protection architectures for both Class I and Class II, helping clients easily pass system-level EMI Class B compliance. With a broad power spectrum (30W ~ 1100W), it serves as the core power solution for large, fixed medical equipment.
- Power Range: 30W ~ 1100W
- Flexible Multi-output Options:
- Single Output (30W ~ 1100W): Covers the widest power spectrum, ideal for equipment requiring a single voltage source (ranging from the RPS-30 series up to the high-power embedded FPM1100 1100W series).
- Dual Output (40W ~ 650W): Tailored for circuit designs requiring two distinct voltage rails (such as +12V / -12V or +5V / +24V), featuring low leakage current (e.g., RPD-60, RPD-75 series).
- Triple Output (40W ~ 650W): Ideal for multi-rail setups (e.g., RPT-60, FPM110 series).
- Quad Output (45W ~ 160W): Intended for highly integrated, multi-module precision medical instrumentation (e.g., FPM110 multi-output systems).
Common Applications:
- Patient Monitors
- Ventilators and Anesthesia Machines
- Medical Imaging Equipment (Ultrasound consoles, X-ray peripheral circuitry)
- Dental Chair Control Systems
- Laboratory Biochemical Diagnostic Analyzers
Engineering & Procurement Selection Tips:
- Flexibly choose between single, dual, triple, or quad-output power supplies based on the combined voltage demands of individual sub-modules on the PCB.
- For high-power equipment (such as 400W ~ 1100W imaging or therapeutic devices), it is highly recommended to select high-power, high-density series like FPM301 ~ FPM1100.
- Crucial Safety Reminder: R&D teams must submit the entire assembled device for complete system-level IEC 60601-1 certification. An open-frame power supply is categorized only as a critical component and cannot be independently deemed as a system-level safety certificate.
FranMar Recommended Models for Medical Open Frame Power Supplies:
FranMar Recommended Models for Medical Open Frame Power Supplies
3. Medical DC/DC Converters
These are compact, isolated DC/DC power modules, mostly packaged in SIP (Single In-line Package) or DIP/DIL (Dual In-line Package) form factors. They can be soldered directly onto PCBs for internal secondary power conversion, signal isolation, or localized voltage regulation.
FranMar's products provide a reinforced isolation voltage of 4000VAC to 5000VAC, parasitic capacitance <20pF, and ultra-low leakage currents ≤5μA. They serve as the critical board-level components required to elevate system safety protection from Type BF to the ultimate Type CF classification.
FranMar's products provide a reinforced isolation voltage of 4000VAC to 5000VAC, parasitic capacitance <20pF, and ultra-low leakage currents ≤5μA. They serve as the critical board-level components required to elevate system safety protection from Type BF to the ultimate Type CF classification.
- Power Range: 1W ~ 6W medical-grade onboard modules.
- Core Series:
- DMW Series (DMW03, DMW06, 3W ~ 6W): Utilizes standard DIP packaging and offers multiple input/output voltage configurations (such as DMW03-41 to DMW03-56, etc.). Select models feature Remote On/Off capabilities, making intelligent, system-level power management exceptionally convenient.
- DYM Series (DYM01, DYM02, 1W ~ 2W): Enclosed in a compact SIP-7 package and fully certified to 60601-1 medical standards, this series is perfectly suited for space-constrained, ultra-low power circuits like sensors or signal isolation stages.
Common Applications:
- Physiological signal and data isolation within Patient-Connected Circuits.
- Powering micro-sensor modules and ECG/physiological signal acquisition circuits.
- Scenarios mandating an extra second layer of electrical isolation between the main power supply and patient-contact circuits.
- Localized, high-precision voltage conversion inside portable diagnostic gear.
Engineering & Procurement Selection Tips:
- Verify that the required isolation voltage level and leakage current specifications fully comply with the safety prerequisites dictated by patient-direct contact circuits (e.g., invasive cardiac surgical equipment).
- If your system requires software or hardware logic to toggle the power status, give preference to models supporting the Remote On/Off function (such as the DMW03-4x/5x series).
- For ultra-compact portable devices where board space is heavily restricted, prioritize the small footprint SIP-7 package DYM series.
FranMar Recommended Models for Medical DC/DC Converters:
FranMar Recommended Models for Medical DC/DC Converters
4. Frequently Asked Questions (FAQ)
Q1: What is the single biggest difference between a medical-grade power supply and a general industrial power supply?
A: The primary core difference lies in the patient safety protection level and strict leakage current limitations. Medical power supplies must thoroughly comply with IEC/EN 60601-1 standards, incorporating a 2xMOPP dual isolation defense design, and leakage currents must generally be restricted below 100μA (whereas industrial power supply leakage limits are vastly more permissive). Consequently, even if an industrial power supply offers the identical wattage, voltage, and physical footprint, it is strictly forbidden to substitute it into medical hardware that contacts a patient.
Q2: How should I interpret leakage current specifications? Is ≤100μA considered safe?
A: Leakage current refers to the tiny alternating currents (AC) that might cross into a patient or operator's body from the power supply under Normal Condition (NC) or Single Fault Condition (SFC). IEC 60601-1 establishes disparate leakage upper boundaries depending on the equipment category (Type B, BF, or CF). A value of ≤100μA represents a highly exceptional medical-grade Type BF standard (under Normal Condition). However, if your equipment is categorized as Type CF, which directly interfaces with the heart (requiring ≤10μA in Normal Condition), the front-end AC/DC power supply must be paired with FranMar's ultra-low parasitic capacitance (< 20pF) medical DC/DC converters to perform secondary isolation and attain total compliance.
Q3: What is 2xMOPP, and why is it mandatory for medical device design?
A: MOPP stands for Means of Patient Protection. According to the IEC 60601-1 standard, whenever a piece of equipment directly or indirectly interacts with a patient, the power supply must provide two independent layers of patient protection (2xMOPP) to prevent any high-voltage leakage from the primary mains loop. 2xMOPP mandates that the isolation barrier between the primary and secondary sides withstands at least 4000VAC, maintains an 8mm creepage distance, and employs robust double insulation. Sourcing a power supply from FranMar that is already 2xMOPP certified completely removes the burden of designing and validating isolated circuitry from scratch, substantially accelerating system compliance and market entry.
Q4: Can FranMar's medical power supplies be customized? What is the development lead time?
A: Providing long-term support for "high-mix, low-volume" customization and modification requests has always been at the core of FranMar's operations. The entire spectrum of FranMar medical power supplies can be modified based on specific client requests, including adapting multi-output voltage configurations, replacing specialized medical connectors, adjusting enclosure mechanical dimensions, or integrating unique features (such as Remote Control lines or battery backup UPS capabilities). Custom project lead times depend on design complexity and whether safety re-certification is required. For minor customizations involving only cosmetic wire harnesses or cords, samples can be delivered within 2 to 4 weeks. For deep customization involving internal schematic shifts and formal safety re-submission, timelines will align with safety agency windows. We strongly advise looping in the FranMar expert team during the early phases of your project to optimize your product launch timeline.
A: The primary core difference lies in the patient safety protection level and strict leakage current limitations. Medical power supplies must thoroughly comply with IEC/EN 60601-1 standards, incorporating a 2xMOPP dual isolation defense design, and leakage currents must generally be restricted below 100μA (whereas industrial power supply leakage limits are vastly more permissive). Consequently, even if an industrial power supply offers the identical wattage, voltage, and physical footprint, it is strictly forbidden to substitute it into medical hardware that contacts a patient.
Q2: How should I interpret leakage current specifications? Is ≤100μA considered safe?
A: Leakage current refers to the tiny alternating currents (AC) that might cross into a patient or operator's body from the power supply under Normal Condition (NC) or Single Fault Condition (SFC). IEC 60601-1 establishes disparate leakage upper boundaries depending on the equipment category (Type B, BF, or CF). A value of ≤100μA represents a highly exceptional medical-grade Type BF standard (under Normal Condition). However, if your equipment is categorized as Type CF, which directly interfaces with the heart (requiring ≤10μA in Normal Condition), the front-end AC/DC power supply must be paired with FranMar's ultra-low parasitic capacitance (< 20pF) medical DC/DC converters to perform secondary isolation and attain total compliance.
Q3: What is 2xMOPP, and why is it mandatory for medical device design?
A: MOPP stands for Means of Patient Protection. According to the IEC 60601-1 standard, whenever a piece of equipment directly or indirectly interacts with a patient, the power supply must provide two independent layers of patient protection (2xMOPP) to prevent any high-voltage leakage from the primary mains loop. 2xMOPP mandates that the isolation barrier between the primary and secondary sides withstands at least 4000VAC, maintains an 8mm creepage distance, and employs robust double insulation. Sourcing a power supply from FranMar that is already 2xMOPP certified completely removes the burden of designing and validating isolated circuitry from scratch, substantially accelerating system compliance and market entry.
Q4: Can FranMar's medical power supplies be customized? What is the development lead time?
A: Providing long-term support for "high-mix, low-volume" customization and modification requests has always been at the core of FranMar's operations. The entire spectrum of FranMar medical power supplies can be modified based on specific client requests, including adapting multi-output voltage configurations, replacing specialized medical connectors, adjusting enclosure mechanical dimensions, or integrating unique features (such as Remote Control lines or battery backup UPS capabilities). Custom project lead times depend on design complexity and whether safety re-certification is required. For minor customizations involving only cosmetic wire harnesses or cords, samples can be delivered within 2 to 4 weeks. For deep customization involving internal schematic shifts and formal safety re-submission, timelines will align with safety agency windows. We strongly advise looping in the FranMar expert team during the early phases of your project to optimize your product launch timeline.