Define Fault, Double Fault and Normal Conditions - Preparing a Risk Management File

We are preparing a risk management file and are fuzzy on when to use fault, normal and double fault conditions. I need definitions and examples of how they are to be used in risk analysis documents.

Re: Define Fault, Double Fault and Normal Conditions - Preparing a Risk Management Fi

Hello

I saw your profile and noticed that you are from the medical devices field.

Normal and and fault conditions are used in ISO and IEC medical device product standards so you might take a look at them.

Double fault is not used in product standards in general(for example, iEC standards work with the principle of single fault conditions) but ISO 14971 is not restricted to single faults.