The consolidated standard IEC 60601-1, ed. 3.1 “Medical electrical equipment. Part 1: General requirements for basic safety and essential performance” was released in August 2012.
As transition periods differ from country to country, changing to the new edition is no simple feat for manufacturers wishing to meet all the requirements of various markets at the same time. A few markets still require compliance with edition 2, while others have already changed to edition 3 or even edition 3.1.
A new Med-Info published by TÜV SÜD now supplies manufacturers with key information on the transition. The Med-Info provides a clear overview of the situations in the individual countries, summarized in a table. For a free download of the Med-Info, click on the link below.