Hazards and hazardous situations: A systematic analysis of hazards and hazardous situations in the context of its intended use, reasonably foreseeable misuse, and characteristics related to safety, provides a clear and comprehensive understanding of different scenarios that may lead to a harm. This exercise allows the identification of all potential hazards associated with a medical device. Depending on the type of a device, and its principle of operation, examples of such characteristics may include sterility, surface roughness, materials of construction, energy sources etc. Learn more about the intended use and reasonably foreseeable misuse in this video.Ĭharacteristics related to safety: It is important to identify all characteristics of a device which may relate to safety. This exercise provides the context and a framework for conducting the risk analysis. In addition, we need to consider all reasonably foreseeable misuses in the context of the intended use. Intended use and reasonably foreseeable misuse: Risk analysis begins with a clear definition and scope of the intended use(s) of a medical device. The risk analysis process involves the following 4 steps: Therefore, for each applicable hazard, all individual risks need to be identified and estimated in terms of the PoH and S. These are the probability of harm (PoH) and the severity of that harm (S). As defined in the standard, there are two elements to the risk of harm associated with a medical device. Risk analysis involves a systematic evaluation of all information available to identify hazards and to estimate the risk. As outlined in Clause 5.1, the manufacturer shall perform risk analysis for the particular medical device as described in clauses 5.2 to 5.5. Risk analysis is a key requirement of ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices.
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