Class B EMI
Leakage Current 0.4W No-Load
Up to 90%
OCP / OVP / OTP
>250k Hours MTBF
per Bellcore TR-332
5940 VDC Isolation
Input to Output
Medical 60601-01, 3rd Edition Safety Approvals
• 4 x 6. 5 x 1.6” U-Channel Footprint
• 2xMOPP and BF Rated Safety Level
• Single Output Models from 5~48 VDC
- Top Mount Fan Cover
- End Mount Fan Cover + IEC-320 Inlet
- Single Wire Current Share + Diode
• 3 Year Warranty
EOS Power has shipped >40 million
high-efficiency, high-density power supplies
since its inception in 1991. High performance
and reliability with a variety of options for safety,
isolation, packaging, connectors and more, make
EOS an ideal partner for a world of applications.
Request a free evalution unit
for your next application!
Top-Mount Fan Option
End-Mount Fan Option
What is one of the most critical
considerations to ensure patient safety
when developing a medical device?
Pilgrim Quality Solutions
The most critical consideration is the patient: who
are they, who will be using the device, and what’s the
intended use of the device? There are multiple design considerations
that impact patient safety that must be evaluated, such as human
factors, instructions for use, interfaces, and even maintenance plans.
Additionally, to ensure patient safety, consideration must be given to
the identification of known issues across systems and components
so they are not reintroduced to the user population.
Leveraging previous lessons learned allows for the identification and
evaluation of potentially critical characteristics that are already evident
elsewhere. The information captured during the lifecycle of similar products; the review of manufacturing nonconformances, CAPAs, and Change
Orders; and feedback from customers in complaint/adverse event reporting systems – all contribute to current and future patient safety. MDT
The IEC 60601-1 standard for basic safety
and essential performance of medical
devices deals with many functional issues.
They are typically addressed by manu-
facturers in their risk management files to
ensure the device does not harm the patient while doing
its job and are highly device specific.
One item that is often completely missed or off the
mark is patient isolation, even though IEC 60601-1
requires and explains it. Patients must be isolated from
mains or any high voltage and from the SiP/SoP or I/O.
This can be done through simple distance (creepage and
clearance) and through insulation. For example, manufacturers need to have reinforced insulation rated for their
internal voltage, yet basic insulation rated at 240Vac from
the patient and SiP/SoP to other parts. To achieve this,
manufacturers need to fulfill construction requirements
and conduct follow-up testing such as electric strength
and leakage to verify the design’s effectiveness. MDT