Electrical Safety for Medical Devices (IEC 60601)

About the IEC 60601-1 Standard

The IEC 60601-1 standard is essential for manufacturers or repair shops of electrically operated medical devices. The standard covers an essential part of compliance with the EU MDR and FDA requirements.

By meeting the requirements of IEC 60601-1, a medical device meets the requirements for Basic Safety. This means that the device remains single fault safe, or the risk remains acceptable during the expected service life.

By meeting the requirements of the standard, a medical device also meets the requirements for Essential Performance. This refers to the performance of a clinical function other than basic safety, where loss or degradation beyond the specific limits causes an unacceptable risk.

What's included in the IEC 60601-1 standard?

• General requirements: risk management, essential performance, expected service life, patient contact, single fault condition
• Testing the equipment
• Classification of the equipment (IEC 60601-1 classification)
• Identification, marking and documents
• Accuracy of controls and instruments, and protection against hazardous output
• Hazardous situations, fault conditions and protection against hazards
• Software and systems
• Construction of the equipment
• Electromagnetic compatibility

The standard is a harmonized standard for the Medical Device Directive. It will be harmonized with the Medical Device Regulation ETA in 2024 as EN 60601-1. The standard includes particular and collateral standards.

About the IEC 60601-1-2 Standard

The IEC 60601-1-2 standard is essential for medical device manufacturers as it covers part of compliance with the EU MDR and FDA requirements.

According to the IEC 60601-1-2, medical equipment and systems are expected to function and perform safely without interfering with other equipment and systems in the electromagnetic environments in which the manufacturer has intended them to be used.

Additionally, the application of electromagnetic immunity standards is essential to ensure the safety of equipment and systems. They should function and perform safely in the electromagnetic environments they are intended to be used throughout their expected service life.

What's included in the IEC 60601-1-2 standard?

General requirements: risk management, non-medical equipment, test conditions 

• Identification, marking and documents
• Documentation of the tests
• Electromagnetic emission and immunity requirements

The IEC 60601-1-2 standard is a harmonized standard for the Medical Device Directive. It will be harmonized with the Medical Device Regulation ETA in 2024 as EN 60601-1-2.