What is EN 60601-1-2:2015?

EN 60601-1-2:2015 is a technical standard that specifies the requirements and tests for general safety and essential performance of medical electrical equipment. It is titled "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests." This standard provides guidelines for manufacturers to ensure their medical devices are safe and reliable in terms of electromagnetic compatibility.

Why is EN 60601-1-2:2015 important?

In the medical field, the proper functioning of equipment is critical for patient safety. The use of electronic medical devices has become increasingly common, and they are often exposed to various sources of electromagnetic disturbances in their environment. If not adequately protected, these devices can malfunction or produce inaccurate results, which could have severe consequences for patients. EN 60601-1-2:2015 ensures that medical electrical equipment can operate safely and effectively, even in the presence of electromagnetic disturbances.

Key requirements of EN 60601-1-2:2015

EN 60601-1-2:2015 sets out specific requirements to assess the electromagnetic immunity and emissions of medical electrical equipment. These requirements include testing the equipment's ability to withstand certain levels of disturbances caused by electromagnetic phenomena, such as electrostatic discharge, radiofrequency fields, and power frequency magnetic fields. The standard also provides guidelines for labeling and documenting the equipment's electromagnetic compatibility performance, allowing healthcare professionals to select appropriate devices for their intended use.

The impact on medical device manufacturers

Compliance with EN 60601-1-2:2015 is mandatory for medical device manufacturers who wish to sell their products in the European Union and other markets where this standard is recognized. Manufacturers must ensure that their devices meet the stringent requirements specified in the standard and conduct the necessary tests to demonstrate compliance. Additionally, ongoing monitoring and assessments are required to maintain compliance throughout the product lifecycle. Failure to comply with the standard can result in regulatory penalties, market restrictions, and damage to a manufacturer's reputation.