IEC 60601-1-2 Testing & Compliance for Medical Devices

What is IEC 60601-1-2?

IEC 60601-1-2 is an International Electrotechnical Commission standard that governs electromagnetic compatibility (EMC) for medical devices. It’s a part of the large and complex 60601 family of standards. Achieving compliance with this IEC 60601-1-2 is a critical step in ensuring that your device can function safely and meets the Food and Drug Administration’s (FDA) requirements. 

In order to achieve compliance with IEC 60601-1-2, your device will need to pass a range of tests to measure and assess its electromagnetic emissions, immunity to emissions from other devices, and general electrical performance and reliability. This testing must be completed by an accredited laboratory.

Compliance Testing is an ANSI accredited testing lab with 60 years of experience testing products and achieving compliance with CE, FCC and other regulations for electronic devices. Using our modern EMC testing equipment, we can support your testing needs and ensure your device meets the IEC 60601-1-2 standards required for market access in the United States.

Our laboratory has been accredited by the ANSI National Accreditation Board (ANAB), has an A+ Better Business Bureau rating, and works with manufacturers in the United States, Canada, European Union, Australia, New Zealand, Korea, Japan and other countries. We have a wealth of experience testing nearly every type of electronic medical device on the market.

Why is IEC 60601-1-2 Compliance Important?

If you’re planning to bring a medical device to market, achieving compliance with IEC 60601-1-2 is critical for several reasons. First, it serves as an important indicator that your device meets EMC standards, meaning it can function in an environment with other electronic equipment. Second, meeting IEC 60601-1-2 demonstrates that your device meets standards set by regulators, such as the FDA. Meeting these regulatory requirements is critical for gaining access to the United States market.

The 60601 family of standards is extremely extensive — in total, there are thousands of pages of detailed, highly technical requirements across the various 60601 standards. As specialists in IEC 60601 compliance, we can ensure your device meets all requirements under 60601-1-2 and any other relevant standards that are required to gain market access.

Why Work With Compliance Testing?

As specialists in electronic device testing and compliance, we’ve been helping medical device companies and other electronics manufacturers complete testing and achieve compliance with regulatory standards since 1963. Our team can assist you with everything from IEC testing and compliance to FCC Part 15, European Conformity (CE) and other common marks required for electronic devices and equipment.

From the earliest stages of your design and development process to the moment you launch your product to market, we assist you every step of the way to make achieving compliance easy. Our engineers and compliance specialists are available by phone or email, making it easy for you to get in touch throughout your project and stay up to date as testing is completed and progress is made.

How You Will Benefit From Working With Us

60+ Years of Experience

We’ve been in business since 1963 and have worked with many notable brands to acquire CE and other certification marks. Our well-trained engineers and testing experts are conversant with CE marking regulations and are ready to help you with everything yo uneed to get your product’s CE mark.