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Can anyone help?
We currently have medical device that has been tested and approved to the necessary ISO standards. The device is a robot that processes samples onto glass plates and through several stations before producing test results.
Some of customers do not need such an elaborate device and are happy with processing the pipetting actions themselves and would like to have the stations situated on a bench and not in the enclosed robot cell.
The question is if we take the components out of the robot and place them randomly on a bench is there a requirement to perform the full ISO60601 tests including EMI?
All components have been individually approved.
Your comments would be much appreciated as I am concerned that if approaching the test house there may be some bias.
We currently have medical device that has been tested and approved to the necessary ISO standards. The device is a robot that processes samples onto glass plates and through several stations before producing test results.
Some of customers do not need such an elaborate device and are happy with processing the pipetting actions themselves and would like to have the stations situated on a bench and not in the enclosed robot cell.
The question is if we take the components out of the robot and place them randomly on a bench is there a requirement to perform the full ISO60601 tests including EMI?
All components have been individually approved.
Your comments would be much appreciated as I am concerned that if approaching the test house there may be some bias.