One of the most stringent market sectors for power components in regards to safety standards is the medical industry. Very few industries have such high levels of human-to-system interactions and so power supplies for medical applications must follow their own set of rules and ratings in order to be deemed safe for medical use – entirely separate to Industrial classifications.
We at Components Bureau take this distinction very seriously and recognise the careful consideration medical applications must make. We can help guide medical system designers to find the components with the correct certifications for your desired application, and this article aims to introduce you to the world of medical power supply classifications.
The prevailing safety standards for medical use is the IEC/EN 60601 standard. It is a widely accepted benchmark for medical electrical equipment, and for many countries compliance with the standard is a basic requirement for regulatory approval for any piece of electrical medical equipment. The third edition of this sets out the requirement for MOPs or means of protection.
Means of protection are mostly self-explanatory: they are any means to isolate either patients or operators from the risks of electric shock. Valid MOPs can include safety insulation or protective earth. For the purpose of safety regulation, a protective earth is a fail-safe to protect from electrocution and distinct from a functional earth which is used for reduce electromagnetic interference (EMI).
The extent of a device’s MOPs is dependent on the application of the system, or more accurately whether or not the device will have direct contact and use with patients.
MOOP or MOPP?
Patient-facing devices can include medical lasers for cosmetic surgery, ultrasound probes, blood pressure monitors or CT scanners. These are known as MDs (medical devices). Devices that aren’t used close to patients are known as an in vitro diagnostic medical device (IVDs), and they include devices like centrifuges and blood glucose analysers.
This distinction is important as the type of device dictates what MOPs are required to meet the medical standard. These are distinguished by the two categories: MOOPs and MOPPs.
IVDs are required to meet some level of means of operator protection (MOOP). For most devices adhering to the standard IEC 62368-1, gaining 1xMOOP shouldn’t be too difficult. This is defined as having an isolation of 1500Vac, a 2.5mm creepage and basic isolation. Creepage is the distance between any two points along isolating material. For 2xMOOP, an isolation of 3000Vac and a creepage of 2.5mm is required – along with double insulation.
MOOP classified power systems can be cheaper design, but the added cost of avoiding all patient contact – even accidental – may outweigh the benefits of opting for the lower safety standard.
Medical devices (patient contact devices) need to have means of patient protection (MOPP). For a 1xMOOP, power components must have an isolation of 3000Vac, a creepage of 4mm and basic insulation. If the system requires a 2xMOPP, this is the most stringent standard so far: with an isolation of 4000Vac, a creepage of 8mm and double insulation. It is a 2xMOPP compliance that provides the highest level of safety in a medical device.
If you’re opting for an AC/DC power supply that adheres to only 1xMOPP, introducing a DC/DC converter meeting 1xMOPP can help you gain two means of patient protection. However, most system designers in the medical industry prefer to ensure that all power components reach the necessary standards instead of ‘doubling up’ to increase safety.
If you’re looking for a high-power medical power supply meeting the 2xMOPP standard, the CoolX1000 from Advanced Energy ticks a lot of boxes for performance and more importantly safety.
This AC/DC Power Supply features a silent fanless design with 100% natural convention cooling. There are no vibrations or noise produced by this power component. This power supply meets the IEC60601-1 3rd edition standards for two MOPPs (avoiding the need of using a second DC-DC converter to meet the standard), whilst also meeting the IEC60601-1 4th edition standards for EMC.
For added flexibility and ease of use, this power supply has a wide range of digital management capabilities. To learn more about the advantages of digital control in power supplies and PMBus support, read our article about digitally controlled power supplies.
Delivering up to 1000W of output power in voltages from between 5V and 48V, the CoolX1000 is perfect as a central power supply for multiple subsystems. With 5 outputs and possibly more due to its modular design, AE have made a power supply that meets the unique and ever-changing demands of the medical industry.
If you’re unsure about which standards your application needs to meet, and which power supplies deliver the level of safety required for your system, get in touch with us