Hello all,
I have a medical device that contains a part that needs to be temporarily used inside the patient's body to achieve its intended use. In pre-compliance tests, I've observed failure of essential performance for radiated immunity when this part is just exposed to air. However, it would seem that this test is not representative of the intended use as when this part is inside the body, any RF energy in the environment would be attenuated by the patient body and thus, have a much lesser effect on the medical device.
What are people's thoughts?
I have a medical device that contains a part that needs to be temporarily used inside the patient's body to achieve its intended use. In pre-compliance tests, I've observed failure of essential performance for radiated immunity when this part is just exposed to air. However, it would seem that this test is not representative of the intended use as when this part is inside the body, any RF energy in the environment would be attenuated by the patient body and thus, have a much lesser effect on the medical device.
What are people's thoughts?