Complying with electronic safety and performance standards is a key part of establishing your reputation and gaining market access as an electronics manufacturer. One vital aspect of this process is adhering to the IEC/EN 60601 standards.

As specialists in IEC/EN 60601 testing and compliance, we can help you achieve compliance with this important industry standard for your product. Contact us online via email or call us at 866-540-5287 to request a quote or ask a question about the process.

You can also learn more about IEC/EN 60601 testing below, including how testing works, why it’s required for CE and UKCA certification, and common subparts of the 60601 standard. 

What is IEC/EN 60601?

IEC/EN 60601 is a series of technical industry standards designed to ensure the performance and safety of electrical equipment. 

Developed by the International Electrotechnical Commission (IEC), the 60601 standards have been adopted in Europe as European Norm (EN) standards. In both IEC and EN forms, these standards exist to ensure medical electrical devices are safe and offer optimal performance.

IEC/EN 60601 sets minimum performance requirements for electrical medical equipment and devices. The aim of the standards are to ensure that medical electrical devices available in the EU and/or UK are safe for end users and offer optimal performance in normal conditions. 

These standards apply to medical electrical devices that are used in the diagnosis, treatment and/or monitoring of patients. 

As with other international standards, compliance with IEC/EN 60601 is critical if you intend to market your device in markets that require this standard or its harmonized equivalent, such as the European Union and United Kingdom. 

IEC/EN 60601 and CE Marking

If you plan to market your medical electrical device in the European Economic Area (EEA), it’s required to comply with IEC/EN 60601. Compliance allows your device to receive a CE mark — an official indicator that the device meets EU health, safety and environmental regulations. 

Adhering to IEC/EN 60601 standards is a key step towards achieving a CE mark for your device and demonstrating to customers and regulators that your device meets EU standards.

IEC/EN60601 and UKCA Marking

Since the UK exited the European Union, electronics are now required to receive the UKCA, or UK Conformity Assessment, in order to enter the market. The UKCA marking is mandatory for products placed on the market in most regions of the UK (England, Wales and Scotland). 

Compliance with IEC/EN 60601 standards is required in order to obtain the UKCA marking for medical equipment and enter the UK market. 

IEC/EN 60601-1

IEC/EN 60601-1 is a standard within the IEC/EN 60601 series. It sets out general requirements for the basic safety and electrical performance of medical devices. This part of the standard sets requirements to prevent risks related to:

• Electrical shocks
• Mechanical hazards
• Unwanted radiation

Compliance with the IEC/EN 60601-1 standard is essential for demonstrating that your device is safe for both operators and patients. 

IEC/EN 60601-2

While IEC/EN 60601-2 primarily covers general requirements, IEC/EN 60601-2 focuses on the requirements of specific types of medical equipment. 

For example, this standard focuses on performance and safety criteria for specific devices and pieces of equipment, such as defibrillators, surgical lasers, MRI machines, and other electronic equipment used in a clinical setting. 

Compliance with IEC/EN 60601-2 is important if you manufacture medical equipment designed for specific environments and/or purposes. 

60601 Testing Process

Testing for IEC/EN 60601 compliance typically involves several key steps:

• Pre-testing evaluation. Before conducting lab testing, it’s common to conduct an early, preliminary assessment of your device against IEC/EN 60601 standards. This can help to identify any non-conformities and other areas that may require adjustments.
• Documentation review. Prior to lab testing, all technical documentation for your device, such as design specifications, user manuals, and risk assessments, is reviewed to check that it complies with the standard’s requirements.
• Lab testing. During lab testing, your device undergoes rigorous tests within a controlled environment to assess its electrical safety, electromagnetic compatibility (EMC), thermal and mechanical safety.
• Performance testing. In addition to safety testing, lab testing for IEC/EN 60601 involves evaluating your device to ensure it meets essential performance requirements.
• Compliance report and certification. Following successful testing, a compliance report is prepared. If your electrical device meets all of the testing criteria under IEC/EN 60601, a certification of compliance is issued. 

Contact Us About 60601 Testing

Compliance with IEC/EN 60601 is an important step towards achieving a CE or UKCA mark for your medical device. 60601 testing is a key part of this process, as lab testing verifies that your device meets the standard and is eligible for certification and market entry.

As an accredited testing lab, we can complete testing for your medical device and help you get FCC, CE, UKCA and other compliance markings.

To request a quote for testing and compliance for your device, or to ask our engineering team and compliance experts a question, contact us online or call us at 866-540-5287.