ISO 14971 risk matrix

FAQ

What does ISO 14971 require for medical device risk management?

ISO 14971:2019 requires a documented, lifecycle-long process: a risk management plan, risk analysis (intended use, reasonably foreseeable misuse, hazards, and hazardous situations), risk evaluation against your acceptability criteria, risk control and verification of its effectiveness, evaluation of overall residual risk, a risk management review before release, and production and post-production activities. The records are kept in a risk management file.

Does ISO 14971 require a 5×5 risk matrix or an RPN?

No. ISO 14971 does not prescribe a particular matrix, scale, or risk priority number. Manufacturers define their own severity and probability scales and risk acceptability criteria in the risk management plan, based on a documented policy. A 5×5 matrix is a common convention, and RPN comes from FMEA practice rather than from the standard itself.

What is the difference between a hazard, a hazardous situation and harm?

In ISO 14971, a hazard is a potential source of harm; a hazardous situation is a circumstance in which people, property, or the environment are exposed to one or more hazards; and harm is injury or damage to the health of people, or damage to property or the environment. Probability of harm is often estimated as the probability of the hazardous situation occurring combined with the probability that it leads to harm.

In what order should risk control options be applied?

ISO 14971 sets a priority order: first inherently safe design and manufacture, then protective measures in the medical device itself or in the manufacturing process, and then information for safety and, where appropriate, training of users. Information for safety alone should not be the first answer when design changes are practicable.

Does ISO 14971:2019 use ALARP?

ISO 14971:2019 leaves risk acceptability criteria to the manufacturer’s policy and does not mandate ALARP. For the EU market, the MDR general safety and performance requirements call for reducing risks as far as possible without adversely affecting the benefit-risk ratio, so EU technical documentation is typically assessed against that expectation.

How does ISO 14971 connect to IEC 62304 and IEC 62366-1?

Both standards plug into the ISO 14971 process. IEC 62304 uses the severity of harm a software failure could contribute to when setting the software safety class, and IEC 62366-1 usability engineering identifies use-related hazards and use errors whose risks are then evaluated and controlled in the risk management file.