Subclause 4.3 requires that the man

Subclause 4.3 requires that the manufacturer compile a list of known and foreseeable hazards associated withthe medical device in both normal and fault conditions. Subclause 4.4 requires the manufacturer to considerthe foreseeable sequences of events that can produce hazardous situations and harm. According to thedefinitions, a hazard cannot result in harm until such time as a sequence of events or other circumstances(including normal use) lead to a hazardous situation. At this stage the risk can be assessed by estimating bothseverity and probability of occurrence of harm that could result (see Figure E.1).