Hello,
I am in the process of minimizing risks for a medical product based on ISO 14971. The norm states that I have to reduce each risk as far as possible, which leads to quite absurd cases where it is really hard for me to determine whether I have to perform mitigation actions.
I am working on the case, that a quartz crystal that provides the time base for a microcontroller might fail. Based on its nature, an integrated quartz crystal should pretty much never fail or oscillate with the wrong frequency. However, the probability is not zero (it never is). In this improbable case, risk mitigation is possible, but excessively difficult and complex. Do I have to perform such mitigation actions or can I argue that the likelihood of a quartz crystal failing or being out of tune is inconceivable? I do not know if there is any possibility of seeing the use of quartz crystals without monitoring the output as state of the art.
Thank you for any input, I am happy for each idea or discussion.
I am in the process of minimizing risks for a medical product based on ISO 14971. The norm states that I have to reduce each risk as far as possible, which leads to quite absurd cases where it is really hard for me to determine whether I have to perform mitigation actions.
I am working on the case, that a quartz crystal that provides the time base for a microcontroller might fail. Based on its nature, an integrated quartz crystal should pretty much never fail or oscillate with the wrong frequency. However, the probability is not zero (it never is). In this improbable case, risk mitigation is possible, but excessively difficult and complex. Do I have to perform such mitigation actions or can I argue that the likelihood of a quartz crystal failing or being out of tune is inconceivable? I do not know if there is any possibility of seeing the use of quartz crystals without monitoring the output as state of the art.
Thank you for any input, I am happy for each idea or discussion.
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