D
dwayneq
I am trying to determine methods to help set an electrical/electronic medical device's expected service life. In reviewing other similar devices the standard appears to be 5 years which is what I have for our device. However, I need to be able to back this up with good rationale and testing for submission to my notified body today and and in the futher. The required testing is well outlined in IEC 60601-1 for requirements up through the expected service life as well as our own performance requirements. What is missing is how to set this for a new product based on industry based rationale or upfront testing. Of course real-time evaluations will happen during the product's lifetime but you can't wait 5 years to set an expected service life.
Any assistance with this is greatly appreciated.
Any assistance with this is greatly appreciated.