Højrisikoudstyr
Højrisikoudstyr refers to equipment that, due to its nature, intended use, or potential consequences of failure, poses a significant risk to the health, safety, or security of individuals or the environment. This category encompasses a wide range of items, from medical devices vital for patient care to industrial machinery critical for production processes. The classification of equipment as high-risk is typically based on a thorough risk assessment that considers factors such as the severity of potential harm, the likelihood of an incident, and the vulnerability of those who might be affected.
In the context of medical devices, højrisikoudstyr includes items like pacemakers, artificial heart valves, and ventilators.
The management of højrisikoudstyr involves a comprehensive lifecycle approach. This begins with careful design and manufacturing,