The newest amendment to IEC 60601-1-2 will be taking effect in the United States and the EU by late 2023 and early 2024. These amended standards offer new, and in some cases, stricter guidance meant to protect operators and patients from electromagnetic interference and emissions. Here’s what medical device manufacturers should know about the newest update as they work to bring their products to the market.
What is IEC 60601-1-2?
IEC 60601-1-2 is a collateral international standard to IEC 60601-1 which specifies electromagnetic compatibility (EMC) requirements for medical electrical equipment.
If not addressed, electromagnetic disturbances could compromise the performance or safety of medical electrical equipment. This standard exists to make sure these performance-altering disturbances are not generated and issues requirements for emissions and immunity. Emissions are disturbances that medical electrical equipment may put out, and immunity is concerned with how well the equipment stands up to electromagnetic disturbances.
While power supply units have a small effect on the EMC, it is important to understand what the guidelines are for IEC 60601-1-2, and to acknowledge how all components of your medical electrical device meet these standards.
The two parts of IEC 60601-1-2 refer to general requirements (Part 1) and specific requirements (Part 2). Part 1 lays out the design, construction, and testing requirements for the EMC of medical electrical equipment. Part 2 details specific EMC requirements for types of devices. MRI machines, pacemakers, and defibrillators, for example, all have different requirements.
IEC 60601-1-2 Version 4 – The 2020 Amendment
Medical devices being used in new environments, coupled with the increased usage of wireless communications technologies for medical and non-medical systems and devices have made it necessary to update 60601-1-2 to reflect these changes.
Since December 31, 2018, IEC 60601-1-2 Version 4 has been effective in the U.S., EU, and Canada. However, a new amendment was published in 2020 and will take effect on December 17, 2023 in the U.S. and March 19, 2024 in the EU. With this new standard coming into effect in these areas, it’s important for medical device manufacturers to understand the key differences in the amendment to stay compliant.
How IEC 60601-1-2 fits into IEC 60601
The IEC 60601 standards offer various guidelines corresponding to the safety and performance of medical electrical equipment and systems. Devices that have an applied part that either detects an energy transfer to or from the patient or transfers energy, and one that provides up to one connection to a supply main, would be included in IEC 60601. In vitro devices and implantable devices are covered by other standards.
The general standard, IEC 60601-1, applies to devices that fall under the category of medical electrical devices, and there are more specific standards, clauses, and subclauses for devices of different types that hold specific characteristics.
IEC 60601-1-2, which exists under 60601-1, specifically addresses safety and performance for medical electrical equipment that either can be exposed to electromagnetic disturbances or may generate them, and what thresholds the devices would have to meet for protection against interference (immunity) and how much electromagnetic interference (EMI) can be generated. When manufacturers abide by these requirements, it limits the risk of device malfunction and risk to both operators and patients.
Changes from the third to the fourth edition
Instead of looking at specific circumstances and how compliance can be met in these instances, one of the major changes in the fourth edition of IEC 60601-1-2 has outlined requirements for a test plan that can be used for evaluation. Some of the other major revisions are as follows:
- To reflect the change in defined environments where medical electrical devices are used, the fourth edition divides intended use environments into professional healthcare facilities, home healthcare settings, and special environments that include military installations and industrial zones. This was also done to harmonize the intended use locations with other IEC 60601 published standards.
- The risk management approach now required in this new edition aligns with principles outlined in IEC 60601-1 Edition 3.1, which meet the requirements outlined in ISO 14971. This should also define requirements as they relate to essential performance and basic safety.
- Version 4 has also made the standards for immunity to electrostatic discharge and wireless devices more strict. Electrostatic discharge (ESD) poses a higher risk of damage when devices are exposed to it, and in response, Version 4 includes higher required levels of discharge devices need to be able to sustain. Similarly, testing and the levels used to determine radiofrequency (RF) effects on a medical device have also been modified.
- Information technology equipment (ITE), which includes laptops, computers, and tablets that can impact the essential performance of the medical device or system and serve as a main component of the device, need to also meet EMC requirements, even if they are non-medical on their own.
What needs to be included in the comprehensive test plan?
When developing a test plan, manufacturers need to think about how the medical device will be used, where it will be used, associated performance and safety risks of this use, and what needs to be tested, including:
- Operating modes and device configurations
- How essential performance monitoring will be conducted
- Emissions and immunity test levels
- What passing or failing looks like
Meeting EMC standards with your medical device and power supply unit
Any time a new standard comes around or current standards get revised, it’s important for manufacturers to understand the changes and how they impact their medical electrical devices. Different components of a medical device can have an effect on the EMC, including power supply units. When standards change, especially when they become more stringent, it’s important to know whether the amended standards will apply to what’s in place.
RAM Technologies is prepared for this new standard and our power supplies abide by the new, stricter guidelines outlined by IEC 60601-1-2 Version 4. For more questions about our power supply units and what effect they may have on your EMC, contact us today.
RAM Technologies’ power supplies are 60601-1 3.2 certified and meet 60601-1-2 EMC standards. When you’re designing your medical device and need help with a PSU, contact us for details.
More Resources:
What the FDA Moving to IEC 60601-1 3.2 Means for Manufacturers
Downloadable Guide to IEC 60601-1
Differences Between 3.1 and 3.2 Certification for IEC 60601-1
