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ISOUSB211: 60601 Medical certificate and Production

Part Number: ISOUSB211

Is there an expected time frame for obtaining the planned 60601 certification for this device? I realise you are at the mercy of test houses, but any update would be appreciated.

I assume this is the last hurdle to transitioning the part to Production status. Any guidance on when this will be?

Need to know so can assess risk on designing the part into a medical device.

Thanks