Re:Killed by a Machine: The Therac-25
by HeyLaughingBoy on Monday August 01, 2016 @02:58PM
(#12204966)
Yes, this is to avoid the problem many an FMEA (Failure Modes Effects Analysis) meeting agonizes over: "it's possible for the software to fail in this way, but how do we quantify the probability of it happening so we can calculate the risk factor?" By assuming that if it can happen, then it will" you remove any handwaving from the equation.
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I think the language has the side-effect that you describe, and I think that it is beneficial, but I don't know if that is the reason that the language was added to the IEC-62304 regulation.
Thank you for a helpful observation. It had not occurred to me.