W
I am pretty new for regulatory tests of medical devices for FDA. REcently, we are going to do EMC (IEC60601-1-2) tests for our device. So hope that somebody can help me for the following issue.
I know that we should do the risk analysis before we do the EMC tests. I came across an article "Standards and Certification Basic Standard: IEC 60601-1-2 - Essential Performance, Risk Analysis And Immunity Testing".
In the article, one example is "Case #4: Home Use Patient Monitoring System..". It is said that after the risk analysis, "In this case, the requirements state that it is not necessary to perform immunity
tests to declare compliance.". I am little confused about this statement. If I understand correctly, the device is used to monitor patients at home, and it will generate some measurements for physicians to review. If there is no good immunity, noises will be added to the generated measurements, which means some measurements can be totally screwed up. If physicians make a medical judgment based on the wrong measurements, it can be very harmful to patients. Do I understand this scenario correctly? Your any suggestions and comments will be highly appreciated. Many thanks.
I know that we should do the risk analysis before we do the EMC tests. I came across an article "Standards and Certification Basic Standard: IEC 60601-1-2 - Essential Performance, Risk Analysis And Immunity Testing".
In the article, one example is "Case #4: Home Use Patient Monitoring System..". It is said that after the risk analysis, "In this case, the requirements state that it is not necessary to perform immunity
tests to declare compliance.". I am little confused about this statement. If I understand correctly, the device is used to monitor patients at home, and it will generate some measurements for physicians to review. If there is no good immunity, noises will be added to the generated measurements, which means some measurements can be totally screwed up. If physicians make a medical judgment based on the wrong measurements, it can be very harmful to patients. Do I understand this scenario correctly? Your any suggestions and comments will be highly appreciated. Many thanks.