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ISO7742: IEC60601-1(ED3.1) 8.8.2: Min distance through insulation

Part Number: ISO7742

Hi team,

My customer will use ISO7742 for medical equipment and provided a question.

According to IEC60601-1(ED3.1) 8.8.2, for peak working voltage greater than 71V, min distance through insulation have to be >0.4mm.

Does "2MOPP(means of Patient Protection) per CSA 60601-1:14 and IEC60601-1 Ed.3.1 250Vrms(DW-16) max " in datasheet table 7.7 satisfy this requirement?

I'm looking forward to hearing back from you.

Best regards,

Shota Mago

  • Hi Mago-san,

    Thank you for posting to E2E! Please allow us some time to confirm this with our standards expert.


    Best,
    Manuel Chavez

  • Hi Migo-san,

    >0.4mm DTI requirements for this standard correspond to devices with lower voltage withstand capabilities, like optocouplers. Optocouplers have isolation dielectrics with low electric field strengths and possibly high defect rates, so the requirement asks for greater DTI to compensate.

    TI's isolators meet reinforced isolation ratings for voltages greater than 71V despite having shorter distances through isolation due to their stronger dielectric. CSA and IEC 60601-1 allow isolators with stronger dielectrics to be classified as "thin-film" insulators which meet this standard through certified test data instead of per the distance through insulation spec only.

    In short, ISO7742's CSA certification does satisfy the requirements you asked about and can be found here (on page 42), and it is listed in the device datasheet as shown below:


    Please let me know if you have additional questions.


    Respectfully,
    Manuel Chavez

  • Hi Manuel-san

    Thanks for your answer!

    Best regards,

    Shota Mago