Overview of IEC 60601-1 Standards and References

What is IEC 60601?

The IEC 60601 series is an internationally recognized standard for the safety and essential performance of medical electrical equipment.

It sets requirements for the design, construction, and testing of electrical medical devices to ensure their safety for both patients and healthcare providers. The series includes several important sub-standards, with IEC 60601-1 as the base standard, IEC 60601-1-XX as the collateral standards, and IEC 60601-2-XX as the particular standards.

• IEC 60601-1 (Base Standard): This standard outlines general safety and performance requirements for all medical electrical equipment, ensuring that devices function correctly and are safe for patient use.
• IEC 60601-1-XX (Collateral Standards): These are additional standards that address specific aspects of medical electrical equipment, such as electromagnetic compatibility, usability, and alarms. They complement the base standard and are essential for specific use cases in medical environments.
• IEC 60601-2-XX (Particular Standards): These standards apply to specific types of medical devices, ensuring that unique requirements and safety concerns related to specific equipment (e.g., defibrillators, infusion pumps) are addressed.

IEC 60601-1:

IEC 60601-1 is the fundamental standard for the safety and essential performance of medical electrical equipment. It sets out the basic requirements for electrical medical devices to ensure that they do not pose any risk to patients, users, or the environment during normal use or under abnormal conditions. The standard covers general safety requirements for electrical equipment, including mechanical hazards, electrical hazards, and requirements for the overall functionality of the device.

Collateral Standards (IEC 60601-1-XX):

The IEC 60601-1-XX standards are referred to as collateral standards. These standards provide additional requirements for medical electrical equipment that are not covered in the base IEC 60601-1 standard. Each collateral standard focuses on a specific aspect of the equipment's safety or performance. These standards are designed to be applied in conjunction with IEC 60601-1 and provide a more detailed and specific set of requirements that address issues such as electromagnetic interference, usability, and alarm systems.

Particular Standards (IEC 60601-2-XX)

The IEC 60601-2-XX standards are known as particular standards. These standards apply to specific types of medical electrical equipment and define the safety and performance requirements unique to those devices. They build on the base and collateral standards but address the specialized needs of individual device types, such as pacemakers, defibrillators, infusion pumps, and more. The goal is to ensure that medical devices operate safely and effectively in their specific intended medical contexts.

Intertek Solutions for IEC 60601-1

As a Nationally Recognized Testing Laboratory (NRTL) approved by OHSA, Intertek is an industry leader providing Testing, Certification and in-lab support to help you navigate the requirements of the IEC 60601 series of standards. With our team of experts globally, Intertek is positioned to help determine standard applicability and execution. Through standards testing, you can support your safety claims throughout North America, Europe and beyond. We offer end-to-end solutions from product development, to review of the Risk Management File and supporting documentation, to comprehensive testing to the 60601/80601 series of standards, including an array of Collateral (IEC 60601-1-X) and Particular (IEC 60601-2-X) Standards. Intertek is your trusted partner throughout the testing process.

IEC 60601 Resources