As a medical device manufacturer, it’s important to be aware of relevant regulations and industry standards. One of these standards is IEC 60601-1-2, which regulates the electromagnetic compatibility (EMC) of medical devices.

What is IEC 60601-1-2?

IEC 60601-1-2 is part of the IEC 60601 standards produced by the International Electrotechnical Commission (IEC), a worldwide electronics standardization body. 

IEC 60601 is a series of international standards for medical equipment. IEC 60601-1-2 is called a “collateral standard” or “supplemental standard,” as it provides additional standards for device compliance beyond the 60601 general standard.

More specifically, IEC 60601-1-2 focuses on the electromagnetic compatibility of devices used in a medical environment. Electromagnetic compatibility, or EMC, refers to the ability of devices to function correctly without causing electromagnetic interference to other devices. 

You can think of EMC as a way for electrical devices to coexist peacefully without affecting each other’s functions. 

This is critical for medical devices, as many hospital operating rooms, wards and offices contain numerous devices that are essential for keeping patients healthy.

Why is IEC 60601-1-2 Important?

IEC 60601-1-2 Promotes Safety

Medical devices are absolutely critical tools in healthcare. They can range from simple devices such as thermometers to heart monitors and other complex equipment. These devices need to operate safely and reliably in both medical and home settings.

Due to the number of electronic devices in these environments, the electromagnetic spectrum can become congested, increasing the risk of interference in devices without EMC.

IEC 60601-1-2 ensures that electromagnetic disturbances don’t compromise the performance, safety or function of these devices.

Global Market Access

Another major reason for IEC 60601-1-2’s importance is market access. Many countries place restrictions on medical devices, requiring them to comply with this standard in order to go onto the market.

For example, IEC 60601-1-2 is harmonized under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in the EU. Compliance with IEC 60601-1-2 could be needed in order to gain the CE mark for your device.

Other markets, such as the United States and Canada, recognize the IEC 60601 standards for medical devices, often via localized versions of the standards. 

Achieving Compliance With IEC 60601-1-2

Understand How the Standard Works

If you plan to design your device for full IEC 60601-1-2 compliance from the beginning, consider acquiring a copy of the standard from the IEC webstore.

You’ll want to familiarize yourself with the standards requirements regarding emissions (the total level of electromagnetic noise that’s emitted from your device) and immunity (how resistant your device is to electromagnetic noise from other devices). 

Assess Your Device

Review your medical device’s design and functionality. How might it emit electromagnetic noise that interferes with other devices? Are there any potential design problems or components that may be affected by external sources of electromagnetic interference?

Our experts can help you assess your device and identify potential issues that may stop it from achieving compliance with IEC 60601-1-2.

Carry Out Testing for Your Device

In order to verify that your device meets the emission and immunity standards set forth as part of IEC 60601-1-2, you’ll need to conduct a series of tests with an accredited lab partner.

As specialists in IEC compliance, we can carry out IEC 60601-1-2 EMC testing for your device to ensure it complies with the standard. Tests for IEC 60601-1-2 include:

• Emissions testing, which checks the levels of electromagnetic noise produced by your device.
  
• Immunity testing, which involves subjecting your device to electromagnetic disturbance to see if it remains functional and safe for use. 

For more information about IEC 60601-1-2 testing, or to request a quote for testing your device, contact us online or call our team at 866-540-5287.

If Necessary, Make Adjustments

It’s far from uncommon for devices to fail IEC 60601-1-2 compliance tests. If your device fails to pass through the testing process, it’s best to view it as an opportunity to improve its design and address any issues that prevent it from having optimal emissions and immunity. 

Our team can assist you in recommending changes to your device and, if necessary, completing additional testing to help you achieve IEC 60601-1-2 compliance. 

Seek Certification

After your device meets the IEC 60601-1-2 requirements, you can seek certification by working with a recognized certification body. We can assist you to receive certification for your product, access relevant markets, and ensure your device remains fully IEC 60601-1-2 compliant. 

Talk to Our Experts About IEC 60601-1-2 Testing & Compliance

IEC 60601-1-2 is an important standard that ensures medical devices are safe to use, both in a medical setting and in everyday life. As a manufacturer of medical devices, it’s critical that your device meets the IEC 60601-1-2 standards to be safe for users.

As specialists in lab testing and regulatory compliance, we can help you carry out testing and achieving IEC 60601-1-2 compliance for your product.

For more information, to request a free quote, or to talk to our engineers, contact us online or call us at 866-540-5287.