EVS-EN 60601-1:2006/A1:2013+A12:2014

EN 60601-1 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. EN 60601-1:2006/A1:2013+A12:2014 modifies the European standard EN 60601-1:2006. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.

In this amendment you can find:

— the relationship between EN 60601-1 and the essential requirements of EU Directive 90/385/EEC on active implantable medical devices,

— normative references to international publications with their corresponding European publications,

— the relationship between EN 60601-1 and the essential requirements of EU Directive 93/42/EEC on medical devices.