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Data Transfer cable For Medical Device


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We are developing a ECG device, for which we would need a data transfer cable. This data cable is custom made and might have some active components like USB controller. The question is do we have to follow any specific standard ? Is IEC 60601-1 applicable? Should the data cable be bio-compatible.? My understanding is the data cable is used to transfer data after the test is done.
Please do share your views.

Thank you
Elsmar Forum Sponsor
I think your data cable meets the definition of an 'accessory' to your device. As such it should meet the requirements of 60601-1. But don't think of testing it as a separate thing - just include it in any tests where it might make a difference.

So the leakage current tests could be repeated - both with and without the data cable connected.

EMC tests should be done with the cable in place (and probably connected and in the process of transferring data).

As for bio-compatibility - that is something to be decided by your 'Risk Analysis'. What is the probability that the cable will be in contact with a patient? for how long? bare skin? broken skin? internal organs? etc etc.


Starting to get Involved
Thanks you Pads38,
Data will be transferred only after the test is completed. Patient will not be having access to the data cable. Data cable will be used by the technicians.
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