With lives on the line, medical technology cannot fail!
Safe and Reliable Medical Power Supplies
to bring Next Generation Medical Devices to Life!
- Medical Robots for Surgery
- Healthcare Services Robots
- Holographic Anatomy Surgery Assistance
- Intelligent Surgical Tools
- 3D Medical Printing (Prosthesis and Artificial Organs)
- MRI and X-Ray Machines with Instant Detection of Disease Areas
Latest Industry Trends
New Standards for Patient Safety
Created with patient safety in mind, 21 CFR Part 820.5, MDSAP, MDR (21 CFR Part 803) and ISO 13485:2016 are new supplier control initiatives for medical device manufacturers.
The most significant change is inclusion of higher EMC requirements and updated immunity standards for use in areas outside of hospitals and less controlled environments.
The medical industry’s concern regarding hold-up time has increased since the release of the EN 60601-1-2; 2015 (Ed4) immunity standard. Primarily created to address the growing number of products used in home healthcare, this standard specifies multiple AC voltage dips ranging from 20ms to 5 seconds. The longer outages are addressed by batteries or ensuring that no harm will occur to the patient or operator if the power supply output voltage drops out of the regulation band.
BF compliant designs having 1.5kVAC Output - Ground and 4kVAC Input - Output Isolation spacings for withstand voltage, special transformer design and construction, meets Safety defined creepage distances, air clearances, leakage currents.
Reduced length of hospital stays, increased number of outpatient clinics/services leads to increasing popularity of portable, home medical equipment. Since proper grounding can't be guaranteed in uncontrolled locations (outside of hospitals), IEC 60601-1-11 requires that Class II equipment protect non-professional users from electrical shock by approaching all home settings as if they do not have protective earth ground wiring.
Specifies requirements for a quality management system where an organization demonstrates its ability to consistently meet customer/regulatory requirements (through risk management).
Inappropriate or "uncontrolled" changes, which can affect the safety and reliability of products and directly impact public health and safety, has prompted the FDA’s increased scrutiny of medical device manufacturers' supplier controls. The power solution is an essential safety-critical component in many medical devices.
High-end equipment in the Medical market is known for long product lifecycles (up to 20+ years). Optimum performance throughout the lifecycle is supported by high quality E-Caps and conservative electrical and thermal derating, allowing reduced field failures.
Peak power load capability for 2-3 minutes. Conduction cooled units and special attention to parameters help achieve this.
Patient and operator vicinity environments require quiet or silent power supplies. Convection and conduction cooled units help with this trend.
We are one of the oldest and most trusted manufacturers of high quality medical power supply solutions. According to IHS Market's 2018 AC-DC & DC-DC Merchant Market report, we became the leading power supply manufacturer for the medical device market in 2017.
Our convection-cooled ML series was released in 1979, which featured a modular design for multiple outputs. This enabled medical device engineers to use a single-unit "fanless" solution that provided low acoustic noise.
We are certified and approved to design and manufacture power supplies for medical applications using our own testing facilities to generate UL and CB safety reports and test data. Our medical power supplies are approved for the latest medical safety standards and meet 4th Edition EMC compliance requirements. Multiple ISO 13485 manufacturing facilities demonstrate our ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Explore our products and see why TDK-Lambda leads the market in medical power solutions.
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Our expertise is based on 30+ years of experience powering healthcare products for major medical OEMs.
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