May 3, 2022

The Transition Period Ending: Ensure Compliance with EN 60601-1-2:4.0 and 4.1

Electrical and electronic devices will always generate some level of unwanted interference, but as more and more devices become connected through the Internet of Things, the need for ensuring they can function without interference has grown substantially. This is particularly important for those devices found within the medical device industry, where these pieces of equipment are heavily depended on to perform their life-saving duties.

Medical devices must be completely safe and functional – they cannot fail or malfunction in their roles just because of cell phone or radio interference, or else someone’s life could potentially be on the line. Conversely, these medical devices must not emit too strong a level of electromagnetic emissions that negatively impact other things within their environment.

That’s where the IEC 60601-1-2 standard comes in, requiring a high level of electromagnetic compatibility (EMC) from medical devices in order for them to properly operate and coexist with other electronic devices in the field.

In September 2020, the latest EMC standard for medical devices, IEC 60601-1-2 4.1, was published. This new edition came with a three-year transition period from the previous version (4.0), but as of December 17, 2023, the Food and Drug Administration (FDA) will no longer accept IEC 60601-1-2 4.0 testing and reports.

It’s crucial to be prepared for these upcoming changes to the standard in order to ensure your organization as a whole is ready to observe and adhere to IEC 60601-1-2 4.1 ahead of schedule. Here’s how to ensure the smooth transition from 4.0 to 4.1.

Back to the Basics: Defining Electromagnetic Compatibility & IEC 60601-1-2

First, it’s important to return to the basics and clearly understand the purpose of this harmonized standard in relation to medical device manufacturing.

Electromagnetic compatibility (EMC) is defined as the ability for medical equipment and systems to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment. An EMC test plan is important to facilitate adequate planning so that these tests can be reliably reproduced and accurately performed by the device manufacturer. When the test plan is put together properly, it allows the manufacturing laboratory comprehensive guidance on the expected outcomes and ways in which the tests must be conducted.

EMC medical device standard IEC 60601-1-2 applies to the basic safety and essential performance of all medical electrical equipment and medical electrical systems that may encounter electromagnetic disturbances in their environment.

In 2020, there was an amendment published to the 4th version of the standard. Together, these two documents now make up the latest edition 4.1.

The Main Changes in IEC 60601-1-2 Edition 4.1

The standards committee identified a variety of important changes that were urgent enough to include in the amendment as opposed to waiting until a later edition is published. These changes include:

Testing at both minimum and maximum input voltage levels at any one frequency for conducted emissions, voltage dips, and short interruptions.
Required power frequency magnetic field at either 50 or 60 Hz as long as the frequency is the same as what is used to power the medical equipment or medical system.
Conducted Immunity I/O cables less than 1 meter is required for all patient cables.
A new test specification for Enclosure Port Immunity to Proximity Magnetic Fields has been added under Table 11 of the medical standard – using IEC 61000-4-39 test and measurement techniques, which requires Magnetic field testing in 3 spot frequencies (30KHz, 134.2KHz, and 13.56MHz).

Being prepared for the upcoming changes to IEC 60601-1-2 4.1 is crucial to your organization’s overall success. See how Nemko’s experts can help your team prepare for these upcoming changes and ensure your production processes continue without delay.

About Nemko

As a significant international player in the world of electromagnetic compatibility testing, Nemko offers an array of comprehensive testing and certification solutions, meeting the regulatory requirements for a wide range of product categories found across the globe. Learn more about our extensive medical device testing services, including preparing for IEC 60601-1-2 4.1 before the transition period is up.

Tags: Product testing , Electromagnetic compatibility (EMC) , Healthcare & medical devices