Release 2 of "Q&A with UL - IEC 60601 3rd edition"

Includes Addendum on Power Supplies

The "Q&A with UL IEC 60601 3rd edition" provides responses to questions asked by UL customers, from the technical experts themselves.  These are the experts who participate in the international standards writing process and have knowledge about the background and intent of the standards. 

In Release 2, UL has added specific information on how to approach power supply certification and as a component in end product medical devices within the scope of IEC 60601 3rd edition. 

The regulatory environment is changing quicker than our publication cycle.  We also have two updates from the Release 2:

1. The current version of the Test Report Form (TRF) is now Version G.
2. The IECEE has published the guidance for completing the Risk Management TRF on their website.  You can download it from the IECEE Operational Documents webpage under Reference OD-2044: ttp://www.iecee.org/Operational_documents/od-cb_index.html

You can download your free copy of the Q&A  Release 2 at http://www.ul.com/medical under "Additional resources."

UL offers many services to support your transition to the 3rd edition, including training, gap assessments, desktop assessments and more.  For more information, visit UL's IEC 60601 web pages or contact UL for a quote.  

This annoucement has already been posted on the UL Health Sciences LinkedIn group.  Click the link to join: