Medical device manufacturers need to ensure that their device and all components are compliant with IEC’s latest standard, 60601-1, Revision 3, Amendment 2. This is a key step in the development process that will help you get your medical device to market faster, especially in countries where this standard is recognized, such as the United States.
The FDA has acknowledged IEC 60601-1 3.2 (also known as EN 60601-1 3.2) as a recognized standard since May 30, 2022. On December 17, 2023, it replaced version 3.1, meaning that all new devices heading to market needed to comply with this revised standard to be sold in the U.S.
When you’re looking for a compliant power supply, especially one that offers power in a compact size, what are your options?
Finding IEC 60601-1 3.2-Compliant Power Supply Units
Medical device power supplies need to be able to pass rigorous safety regulations as outlined in IEC 60601 guidelines. Some medical device manufacturers may evaluate both commercial-grade power supplies and medical-grade power supplies. However, only medical-grade power supplies are designed to satisfy the standards that devices need to meet under regulations like 60601-1.
RAM Technologies Offers Three IEC 60601-1 3.2 Certified Medical Device PSUs
RAM Technologies has been preparing for this change to help you meet your power supply unit (PSU) needs. Last year, two of our PC-based PSUs, PFC800PCX and PFC600PCX, were certified under the version 3.2 requirements. Now, we’ve added one more to the list – PFC650SFX.
Our Compact 650-Watt PSU is Now IEC 60601-1 3.2 Certified
The PFC650SFX is a 650-watt SFX medical PC power supply that offers power in a compact size. RAM’s unique MultiLoop Technology, using Silicon Carbide (SiC) technology, can improve reliability and reduce stress loading for your device. The PSU is able to run two high-end graphics cards. It’s ideal for embedded applications that are part of graphics-intensive systems. This power supply comes with a low-noise fan, Smart Fan Technology, and a choice of output cables to match your needs.
Learn more about our medical-grade certified power supplies, make custom requests, or contact us with more questions today.
For questions about our medical-grade certified power supplies, including our compact 650-watt PSU, and for custom requests, contact us today.
More Resources:
Downloadable Guide to IEC 60601-1
Current Trends in the Medical Device Industry
RAM Technologies PFC600PCX and PFC600PCX Approved Under IEC 60601-1 Revision 3 Amendment 2
