There is a difference between a hazard, a hazardous situation and a risk – not only according to ISO 14971. Particularly in the field of medical technology, a comparison of the terms is necessary, as manufacturers must carry out a risk analysis in the risk management process. What criteria should be used to make a distinction? And how you can create a risk analysis? We present it to you.
Hazards
A possible hazard exists when damage can occur due to external causes. For example, if a defective medical device triggers an electric shock or if chemical substances escape in an accident.
According to ISO 14971, the term hazard includes in principle: chemical, thermal or biological hazards, electrical or mechanical energy, electromagnetic radiation and also hazards due to (incorrect) information (e.g. through manuals).
Risk
A risk, on the other hand, is the probability that a person will be injured or property damage will occur as a result of a hazardous situation. Because a medical device is used on or in a human being, it always carries a certain degree of risk.
How high this risk is is illustrated by manufacturers in the risk management file.
ISO 14971 also distinguishes between the terms hazard and hazardous situation. The former represents a potential source of damage. The hazardous situation, on the other hand, is the actual moment when persons or material objects are exposed to a hazard.
The requirements of ISO 14971 in the risk management process for medical devices and in vitro diagnostic medical devices are standardised for Europe and the USA. For manufacturers, this means that during the entire product life cycle, a procedure must be followed to ensure that
Identifying safety-critical areas at an early stage is the goal of PHA. In the process, a higher-level hazard assessment is created in order to be able to define subsequent hazard controls and resulting measures.
One advantage of PHA: risk management is part of the process from the beginning of the product life cycle, because PHA is used both in the requirements analysis and in early phases of the design process of your medical device. Another advantage: costs can potentially be saved by identifying risks at an early stage.
FMEA and Hazard Analysis: What is the difference?
Read more about it now in our blog.
The BAYOOSOFT Risk Manager in the basic module offers you the possibility of recognising hazardous situations at an early stage. This is because Preliminary Hazard Analysis is fully integrated in our specialised solution. You decide for each project:
IVDR – End of the transition period