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Clause 6.3 — Risk acceptance criteria

Subclause 6.3 specifies requirements to define risk acceptance criteria under FprEN 40000-1-2:2026. Acceptance criteria determine whether identified risks require active treatment or can be accepted.

What Clause 6.3 requires​

Requirements​

  • [RMA-02-RQ-01]: Define, justify, and document risk acceptance criteria for the product context (6.2), including:
    • Relevant regulatory factors (safety and privacy legislation).
    • Supply chain considerations (contractual agreements, downstream integrators, risk sharing).
    • Nature of known risks (user health and safety, impact severity, inherent functional risks).
    • State of the art.

Outputs and Assessment​

  • Output: Documented product cybersecurity risk acceptance criteria (C6.3-OUT-01) and applied methodology (C6.3-OUT-02).
  • Assessment Criteria: PASS assigned when documented criteria exist, align with the product context, and cover all required factors.

How CVD Portal supports compliance​

CVD Portal provides structured risk criteria documentation, evaluable acceptance rules, and deterministic artifact generation:

  • Evaluable acceptance rules: Define ordered acceptance rules with condition triggers (impact, likelihood, interface restrictions, user capabilities) and mandatory justifications.
  • Automated acceptance decisions: Evaluate risks against configured rules to determine whether a risk is acceptable, not acceptable (naming the triggering rule), or undecided (when no rules are configured).
  • Standard 5x5 scoring grid: Score each risk from its likelihood (1 to 5) and impact (1 to 5) into Low, Medium, High, or Critical bands on a fixed 1 to 25 scale.
  • Six-factor basis (6.3.3): Record the six required factors (regulatory requirements, contractual obligations, known risks, user nature, product nature, state of the art) in the assessment data.
  • Risk criteria documentation (C6.3-OUT-01): Generate the product risk acceptance criteria document from the standard scoring scales, the six-factor basis, and the evaluated acceptance rules.
  • Standardized risk methodology (C6.3-OUT-02): Generate the CRA risk assessment and treatment methodology document automatically.
  • Enforced treatment justifications: Enforce written justifications for any risk marked as accepted or transferred during validation.