To categorize the severity of the p

To categorize the severity of the potential harm, the manufacturer should use descriptors appropriate for themedical device. Severity is, in reality, a continuum; however, in practice, the use of a discrete number ofseverity levels simplifies the analysis. In such cases, the manufacturer decides how many categories areneeded and how they are to be defined. The levels can be descriptive (e.g., does not require medicalintervention, requires medical intervention, requires hospitalization, causes death, etc.). They can also besymbolic (S 1 , S 2 , etc.), but, in this case, each symbol should be explicitly defined. In either case, they shouldnot include any element of probability. See the examples in D.3.4.Severity levels will need to be chosen and justified by the manufacturer for a particular medical device underclearly defined conditions of use.