Product Announcement from TÜV Rheinland
TUV Rheinland is educating customers on changes to medical testing with adoption of IEC 60601-1 3rd Edition.
Manufacturers of electromedical devices will find substantial changes to the 3rd Edition of IEC 60601-1. Most notable is the requirement of additional risk analysis. It's crucial to understand the changes in the Standard.
Starting your transition early allows for advanced planning for compliance of your medical device testing and can reduce risk associated with the new requirements.