ISO 14971 risk matrix & register
Define your severity and probability scales, set the acceptability of each cell and score your hazards before and after risk control. Everything is saved in your browser.
A working aid, not a risk management file. ISO 14971 requires you to define your own risk acceptability criteria in your risk management plan, based on your policy, the state of the art and your device. Your data stays in your browser.
ISO 14971 risk matrix & register
Scales
Severity of harm
Probability of occurrence of harm
Scale names follow common qualitative examples in ISO/TR 24971.
Risk acceptability matrix
Click a cell to change it: Acceptable → Review (reduce further / benefit-risk) → Not acceptable.
Risk register
| Hazard | Hazardous situation | Harm | S | P | Risk | Risk control measure | S′ | P′ | Residual |
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FAQ
Does ISO 14971 prescribe a risk matrix?
No. ISO 14971:2019 requires the manufacturer to define criteria for risk acceptability in the risk management plan. A matrix of severity and probability is a common way to express those criteria, and ISO/TR 24971 gives examples.
What happened to ALARP?
ISO 14971:2019 does not use ALARP. In the EU, the MDR requires risks to be reduced as far as possible without adversely affecting the benefit-risk ratio, so “acceptable” cells should still be reviewed for further reduction where practicable.
Should probability refer to the hazard or the harm?
To the occurrence of harm. Where it helps, split it into the probability of the hazardous situation occurring and the probability of that situation leading to harm.