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LMZ35003 UL/UR - no UL file number - UL certification in endproduct?

Other Parts Discussed in Thread: LMZ35003

A UL certified medical device is extended with a new Power over Ethernet interface. Therefore the LMZ35003 is used as Non-Isolated DC/DC converter (48Vdc/5Vdc). Right now the medical device is at laboratory to be tested for basic safety and essential performance as in IEC 60601-1 required. The DC/DC converter is recently placed on the List of Critical components.

1. The LMZ35003 is not listed on UL database, thus no UL file number existing.

2. Until now, no documents from TI are available to get the LMZ35003 certified safety through material & construction proof.

3. Testing in end product seem to result in big disadvantages and high cost, because of extra inspection testings, e.g. high voltage injection, etc.

Are there any customer experiences or expert knowledge on how medical devcies go easiest through basic safety (IEC 60601-1) including the LMZ35003?

Thank you and regards