DEKRA Product Testing

Does your medical equipment comply with the latest IEC 60601 laws and regulations?

IEC 60601 certification

Testing electrical medical equipment

The IEC 60601 standard is an international standard for the safety and performance requirements of medical electrical equipment. As a manufacturer, meeting basic safety standards is essential. An IEC 60601 certification not only ensures that you meet legal requirements, but it also strengthens the confidence that your customers have in the safety and reliability of your products.

IEC 60601 consists of a series of standards, each addressing specific technical aspects of medical electrical equipment. Compliance based on IEC 60601 is part of the legal requirements described in the Medical Device Regulation (MDR) guidelines. It is your responsibility as a manufacturer to identify all applicable standards and recommendations documents for medical devices. Therefore, take a look at the IEC standards and CB scope and read them carefully.

What is tested according to the IEC 60601 standards?

Electrical medical devices are susceptible to electromagnetic field interference from power and interface cables and other external influences such as mobile phones, security gates and so on. IEC 60601 describes that equipment may not cause disturbances in the environment by generating excessively strong magnetic fields. An EMC test (electromagnetic compatibility test) confirms that your devices meet the electromagnetic compatibility criteria.

The trend of interconnectivity has now also reached the world of electrical medical equipment. More and more manufacturers are developing products with built-in wireless connectivity. These are interesting developments, but they are not without risks. DEKRA's radio frequency (RF) testing services are designed to test RF requirements within IEC 60601. These tests are an essential part of the certification process to ensure that your products with a wireless interface fully comply with national and international standards.

For Class I devices, a self-declaration is sufficient to obtain the CE marking (which is required to sell your product within the EU). Evidence of compliance with the relevant standards (such as EN 60601 safety standards) should still be part of your technical documentation in this context.

Devices in Class II involve higher risks. It is therefore necessary that a Notified body assesses the compliance of your product with the Medical Device Regulation (MDR) based on your technical documentation. This requires the inclusion of reports and certifications relevant to the applicable standards for your electrical medical equipment.

The evaluation of the technical usability enables you to identify the risks associated with correct or incorrect use. Testing according to IEC 60601 ensures that all parties involved use your device safely.

The software and cybersecurity of your medical devices are also included in the compliance testing under IEC 60601. The software can be embedded in the medical devices themselves or used standalone. These parts are mainly found in active devices. Standalone software is considered an active medical device when used in conjunction with a medical device.

Certify for IEC 60601 in 7 steps

The certification process

Do you want to demonstrate that you work according to the applicable standards? DEKRA's accredited testing laboratory is ready to assist you. Complying with all laws and regulations is not an easy task. That is why DEKRA's experts are ready to help you. We guide you through the entire process: from pre-compliance to certification against the necessary standards of IEC 60601.

In addition to your IEC 60601 certification

What else can DEKRA support you with?

We guide you from start to finish through the certification process of the IEC 60601 standard. DEKRA also supports developers and manufacturers with the services below.

Regulatory approval

Obtain regulatory approval through DEKRA's Notified Body. Please note that regulatory approvals may run concurrently with our compliance testing procedures.

ISO Type 5 certification

DEKRA Mark is a quality mark that demonstrates that your product has been thoroughly tested and meets all required safety standards. Since the quality mark is based on internationally recognized standards, it is your passport to global access for your product.

More about DEKRA Mark

International certifications

Our experts help you reach new and emerging markets worldwide. For example, if you want to sell your medical electrical devices in the US or Canada, our NRTL accredited laboratory is ready to help you with your CB certification for the North American market.

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IEC 60601 whitepaper

What is the impact of the recent changes to the IEC 60601 standard? Request the free whitepaper via the button below.

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How can I avoid non-conformity during my IEC 60601 certification?

In our experience, the early detection of non-conformities contributes to a smoother and faster testing procedure. View the 10 most important tips from our experts for good preparation for your IEC 60601 certification.

10 essential tips for compliance

Curious about what our experts recommend? Read these 10 tips before you start certifying your electrical medical equipment.

10 essential tips for medical device certification (PDF, 2 MB)

What are relevant standards and documentation for IEC 60601?

When will the latest edition of IEC 60601 be released?

Why is DEKRA the right choice for your EN 60601 compliance?

Is DEKRA accredited for IEC 60601?