This is the base document. It applies to medical electrical equipment. It covers general requirements for electrical safety, mechanical safety, protection against fire, and labeling. The current active version is generally the 3rd Edition , with the 2nd Edition being phased out globally.

Medical electrical equipment is among the most safety-critical devices in the world. A failure in a ventilator, defibrillator, or surgical laser can result in catastrophic injury or death. To mitigate these risks, the International Electrotechnical Commission (IEC) developed the series of standards.