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I understand that per EN 60601, a computer/laptop/PC if placed in a patient environment has to meet the standard as it is considered now a medical device.
My confusion here is what about those laptops that have the cleared/approved software in them that manufacturers give out and is placed near the operting room (OR) for use? How are manufacturers able to get clearance or approval from a system that uses a laptop to operate the procedure or imaging system? Are there other standards I am missing as well?
Any help will be appreciated. Thank you.
My confusion here is what about those laptops that have the cleared/approved software in them that manufacturers give out and is placed near the operting room (OR) for use? How are manufacturers able to get clearance or approval from a system that uses a laptop to operate the procedure or imaging system? Are there other standards I am missing as well?
Any help will be appreciated. Thank you.