Standards · Standard or regulation
ISO 14971
Medical devices, Application of risk management to medical devices
In plain words
What it covers.
The international standard for managing risk across a medical device's whole life. The manufacturer identifies hazards, estimates and evaluates risk, applies controls, checks the overall residual risk is acceptable against the benefit, and keeps watching information from the field. Hospitals use the same thinking for fleet and incident risk.
Who uses it: Manufacturers (required for regulatory approval), design engineers, and hospital engineers doing risk assessments and investigations.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Risk management plan and file
- Hazard identification
- Risk estimation (severity and probability)
- Risk evaluation and acceptability
- Risk control options
- Overall residual risk and benefit-risk
- Production and post-production information
Key points
What engineers need to know.
- Risk is the combination of the probability of harm and the severity of that harm.
- Controls are applied in priority order: inherent safety by design, then protective measures, then information for safety.
- Warnings and training are the weakest control, not the first choice.
- Every control must be verified as implemented and effective.
- Residual risk must be judged against clinical benefit.
- Field data after launch must feed back into the risk file.
- ISO/TR 24971 gives guidance on applying the standard.
Devices
Devices it applies to.
Each device in the Medical City Device Lab, with its Device Library course on the Platform.
Medical City
Where you practise it.
- Patient Safety Investigator
- Hospital Operations Manager
- Biomedical Engineering Design Studio
- Master Clinical Engineering Challenge
- Design Studio risk management stage
- Operations Manager risk register
- Patient Safety recommendations
- S3-M067 supply chain recommendation