Sikkerhedskritiske

Sikkerhedskritiske describes systems, components, or processes where a failure could cause harm to people, the environment, property, or compromise essential mission objectives. In safety engineering and risk management, such systems require rigorous lifecycle processes, thorough hazard analysis, and demonstrable assurance that risks are reduced to acceptable levels. Key features include redundancy, fail-safe design, continuous diagnostics, and independent verification of safety functions.

Standards and frameworks provide structured guidance for developing and operating safety-critical systems. Prominent examples include IEC 61508, which addresses functional safety of electrical/electronic/programmable systems and introduces safety integrity levels (SILs); ISO 26262 for automotive functional safety and automotive safety integrity levels; IEC 62304 for medical device software; IEC 61511 for process safety; and ISO 13849-1 for machinery safety. In aviation and aerospace, DO-178C/DO-254 guide software and hardware safety assurance. Medical devices and other sectors commonly apply risk management standards such as ISO 14971 and regulatory certifications to demonstrate safety.

Lifecycle activities associated with sikkerhedskritiske systems include hazard identification, risk assessment, safety requirements specification, design and implementation with redundancy and diagnostics, verification and validation, and the creation of a safety case or equivalent assurance documentation. Techniques such as HAZOP, FMEA, and fault tree analysis support hazard analysis, while ongoing monitoring, maintenance, and post-market surveillance ensure continued safety.

In Danish usage, sikkerhedskritiske is used to label systems where safety must be demonstrably guaranteed. Examples span aviation flight control, railway signaling, nuclear plant controls, industrial automation, and medical devices. The term underscores the priority given to safety considerations throughout design, operation, and regulation.