What is 60601 - all you need to know

IEC 60601 refers to a series of international standards that pertain to the basic safety and essential performance of medical electrical equipment. These standards are issued by the International Electrotechnical Commission (IEC), a global organization that develops and publishes international standards for electrical, electronic, and related technologies and has been adopted by CENELEC without technical modification for use in Europe where it is designated EN 60601.

The 60601 series specifically focus on medical electrical equipment and systems. These standards cover a wide range of devices used in the healthcare settings, including but not limited to:

1. Medical electrical equipment: this includes equipment such as electrocardiograms (ECGs), ultrasound machines, X-ray machines, infusion pumps, and defibrillators
2. Medical electrical systems: a combination of medical electrical equipment which may also include certain non-medical electrical equipment, which are interconnected. For example, a battery-operated patient monitor with its charging dock or a CT scanner with its control computer
3. Medical software: This category includes software applications and systems used in medical devices, such as patient monitoring devices, diagnostics, software, and electronic medical records

The EN 60601 standards are designed to ensure the safety and safety related performance of medical electrical equipment and systems. They address aspects such as electrical safety, electromagnetic compatibility, usability, risk management, and essential performance requirements. Compliance with these standards is often a legal requirement for manufacturers selling medical devices in many countries.

It’s important to note that the EN 60601 is a matrix series of standards which contains both collateral (60601-1-X) and particular (60601-2-X) standards. The collateral standards are applied to all device types where they are applicable, however the particular standards are applied only where the device in question is in scope. It is also possible that a single device can be subjected to the requirements for several standards depending on its application or intended use.

When purchasing or using medical electrical equipment, it is essential to ensure that the equipment complies with the relevant EN 60601 standards to guarantee safety and quality.

BSI provides testing services for your product against EN 60601. Talk to us today and start your journey.