Defining a lower ESD test limit for 60601 test

Hi All,

We are facing a major ESD test challenge with integrating a high-quality image sensor into a class-2 product. We spent 5 months changing our optical and mechanical designs without getting to the required test levels thus far. We can not mechanically block the optical path due to the loss of video quality, and we can only get about +/-6KV with thin transparent windows. If the product remains safe, and it does not cause any harm to the patient or operators, can the manufacture of a class-2 medical device define a lower ESD test level for a sensitive imaging sensor that can not pass +/-8KV or +/-15KV static discharge? Is this managed in the risk management document? Should there be a specific instruction for the certified test labs to exclude a specific area during the 60601 ESD test? If this is permitted, does this need special labeling?

Thank You,
Alex

 

ESD is an electrostatic discharge test that basically analyzes the electrostatic discharges when a person touches the electronic devices.

It might be experienced either during transit or operation. To determine the lower ESD test level for a sensitive imaging sensor and to confirm the risk management you can explore the provider's user guide.

 

Also interested in this question. I ran into this problem when I was working as an engineer in a wall work workshop. I hope you can help me as I still haven't solved this problem for myself...