DCP010505B: CB Report Requirements for Medical Device Design

Chi-Heon Song

Prodigy 10 points

Part Number: DCP010505B

Tool/software:

Hello.

My name is Chi-Heon Song, and I work for a company that develops RFA System in Korea and sells it in the global market.

We are currently conducting a safety test in the laboratory by applying your DC/DC Converter to the RFA System.

According to the opinion of the laboratory, CB Report is required because the DC/DC Converter is a part that is insulated from the Patient Circuit.

If possible, please deliver the CB Report data of the parts.

Thank you.

6 months ago

0 Manuel Alva Hernandez 6 months ago

TI__Genius 15326 points

Hi Chi-Heon,

-Let me ask to my team if there is any isolation certification for this device and I will be back to you.

-What safety certification do your system require? E.g. UL1577, VDE60747, IEC62360, IEC60601?

Thank you

0 Manuel Alva Hernandez 6 months ago in reply to Manuel Alva Hernandez

TI__Genius 15326 points

Hi Chi-Heon,

Unfortunately, DCP010505B is not certified with any of the safety certification, so CB scheme report is not available. Please refer to section 7.3 of DS to get more details on isolation for this device.

Thank you

0 Chi-Heon Song 6 months ago in reply to Manuel Alva Hernandez

Prodigy 10 points

Thank you for your confirmation.

It was the lab's mistake to say that the CB scheme report was necessary, and the lab corrected it that UL Certification is sufficient. I checked section 7.3 you mentioned and confirmed that the file number is E199929. I would like to receive the data.

0 Manuel Alva Hernandez 6 months ago in reply to Chi-Heon Song

TI__Genius 15326 points

Hi Chi-Heon,

After consulting with my team and from previous e2e threads discussions regarding isolation of this device, I came to the conclusion that this device has not being certified by UL14950/E199929. That is why there is no certification/test available in the product folder.

It seems like this device has been tested previously at 1kVac for 1 second hipot test and also it is designed to handle a continuous voltage across isolation barrier of no greater than 60VDC or 42Vrms. This data seems to be based on SELV (safety extra low voltage) by UL1950 but again, it is not certified. This data has been taken so many years ago that I do not think it will be available. You can check links below for more information.

(+) DCP011515DB: Isolation rating changed worst from previous d.s. to last one ? - Power management forum - Power management - TI E2E support forums

(+) Unregulated DC-DC converter - DCP020515DU - Power management forum - Power management - TI E2E support forums

Thank you