riskkrav

Riskkrav are formal requirements that specify the level of risk reduction and safeguards a system must achieve. They are derived from hazard analyses and risk assessments and are used to guide design decisions, verification activities, and regulatory compliance. The concept is used in various Nordic and European contexts to denote risk-oriented requirements, often described in terms of safety or performance criteria that must be met.

In practice, riskkrav translate identified hazards into measurable targets, such as acceptable residual risk levels, mandatory safety features, or performance thresholds for protections. They help ensure that risk control measures are implemented and that the remaining risk falls within what stakeholders and regulators deem acceptable. By defining concrete obligations, riskkrav support traceability from hazard identification through to verification and validation.

Riskkrav are distinct from risk criteria. Risk criteria describe how risk is evaluated, including methods for scoring likelihood and severity. Riskkrav, by contrast, specify the concrete conditions a system must satisfy to meet an acceptable level of risk, providing a basis for design, testing, and certification.

Establishing riskkrav typically involves hazard analysis, risk estimation, determination of acceptable residual risk, selection of control measures, and documentation for traceability. Verification and validation activities are then used to demonstrate compliance with the requirements and to support regulatory approval.

Applications span safety-critical industries such as medical devices, automotive, aviation, and software security. Standards like ISO 31000 and ISO 14971 offer guidance on risk management and risk acceptance, while domain-specific standards provide additional requirements for hazard controls and safety integrity.