ISO 14971 – Risk Analysis and Risk Estimation
11 July 2011
During June, this blog explored risk management and risk identification as it relates to ISO 14971. Today, the related topic of risk assessment (risk analysis + risk evaluation) will be examined.
Risk analysis is important as it forces a manufacturer to systematically determine current and potential hazards and to estimate the risks related to a specific medical device. After identifying foreseeable hazardous situations both in normal and fault conditions taking into consideration the intended use of their device, a manufacturer needs to estimate risks by using available information to determine the probability of occurrence of harm and severity of harm associated with each of these hazardous situations.
But what about risk evaluation?
Risk evaluation is a decision made by the manufacturer once risks have been estimated and acceptable risk levels and criteria have been established. The estimated risks should be evaluated against the risk acceptability criteria to determine an appropriate level of risk reduction or mitigation, if necessary.
ISO 14971 offers great guidance for manufacturer throughout the risk assessment process. Annex E is especially useful, as it contains examples of hazards, foreseeable sequences of events and hazardous situations. Annex C, D and G of ISO 14971 also offer great guidance for manufacturers (Annex C - Questions that can be used to identify medical device characteristics that could impact on safety, Annex D - Risk concepts applied to medical devices, Annex G - Information on risk management techniques).