Begin Your Risk Analysis with Intended Use and Foreseeable Misuse
Exeed Regulatory Compliance
OCTOBER 12, 2020
Reasonably Foreseeable Misuse: The keyword here is “reasonable”. Let us take the example of a disposable face mask. Once this scope and definition is clearly established, the next step is to consider all reasonably foreseeable misuses. The normal use, use-error and abnormal use scenarios are illustrated in the following figure.
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