Medical electrical equipment

Regulation EN 60601:2006 covers the requirements for a medical device covering Medical electrical equipment. This extensive (428 pages) regulation covers the general requirements for basic safety and essential performance (IEC 60601-1:2005).

This regulation is furthermore related to Essential Requirements of Directive 93/42/EEC.

The concept of EN 60601:2006 follows the general requirements for medical devices and comprises, amongst several paragraphs, the below:

• Conditions for application to ME equipment or ME systems.

• Risk management process for ME equipment or ME systems.

• Essential performance.

• Expected service life.