The generality of the IEC 60601 standards, is really the best way to understand the idea of “Risk Management” [which is a huge buzzword, as you work through the IEC 60601 standards].

Safety is directly related to Risk management after all the entire goal of IEC 60601 is to manage medical device risk. Put loosely, the goal is not to remove all possible risks and demonstrate through testing that no risk could exist – the goal is to remove as much risk as possible and still be economically profitable and viable as a product.

This Safety testing is done in special Accredited labs that are approved by the regulatory authorities to perform these tests.

the goal of 60601consult is to make people more aware of this rather complex system that the IEC 60601 brings along with its safety measures, whether you are a manufacturer, Test lab or a regulatory authority we can help you achieve your desired safety goals with our years of experience and skill.