ISO 13485 · Medium · 13 min lesson
Risk management process: hazards, hazardous situations and risk estimation under ISO 14971
ISO 14971:2019 clauses 4, 5 and 6, ISO 13485:2016 clauses 7.1 and 7.3.3, EU MDR Annex I section 3
What you will learn
- Describe the ISO 14971 process and the content of the risk management plan, including acceptability criteria set before analysis.
- Distinguish hazard, hazardous situation and harm and build the sequence of events using intended use and foreseeable misuse.
- Estimate severity and probability of harm and evaluate each risk against the criteria in the plan.
Key takeaways
- ISO 14971 is a lifecycle loop: plan, analyse, evaluate, control, review and feed back production information.
- The plan, including acceptability criteria, is approved before the analysis (clauses 4.2 and 4.4).
- A hazard is a source of harm, a hazardous situation is an exposure, harm is injury; link them by sequences of events (5.4).
- Intended use and reasonably foreseeable misuse are documented first (5.2); estimates of severity and probability need a recorded basis (5.5).
- Each risk is evaluated against the plan's criteria; a failed criterion leads to risk control (clause 6).
Free practice question
Halden is drafting the risk file for the Pulsar P2. The team lists 'over infusion' as a hazard. A reviewer asks them to show how a nurse could cause an over infusion in normal ward work.
What does clause 5.4 expect the team to add?
The sequence of events leading to a hazardous situation, such as a syringe swap with an open latch exposing the patient to free flow.
Correct. Clause 5.4 requires hazards, sequences of events and hazardous situations to be identified and documented, so the path to over infusion is shown.
A longer list of outcomes such as under infusion and delay.
Not quite. More outcomes are only more harms; clause 5.4 asks for sources of harm and the situations that expose people to them.
A statement that nurses are trained, which removes the need for analysis.
Not quite. Clause 5.2 requires reasonably foreseeable misuse to be considered, so training does not remove the need for analysis.
Nothing, since over infusion is a recognised hazard in the standard.
Not quite. Clause 3 defines a hazard as a potential source of harm, and over infusion describes an outcome, so it needs a source.
Key terms
- hazard: A potential source of harm (ISO 14971:2019 clause 3).
- hazardous situation: A circumstance in which people, property or the environment are exposed to one or more hazards.
- harm: Injury or damage to the health of people, or damage to property or the environment.
- risk: The combination of the probability of occurrence of harm and the severity of that harm.
- severity: A measure of the possible consequences of a hazard.
- reasonably foreseeable misuse: Use not intended by the manufacturer that can result from readily predictable human behaviour (clause 5.2).
- risk management plan: The document under clause 4.4 defining scope, responsibilities, acceptability criteria and verification of controls.
- risk management file: The set of records and documents produced by risk management (clause 4.5).
Official sources
- ISO 14971:2019 Medical devices - Application of risk management to medical devices
- Starfish Medical: Medical device risk management and the change from ALARP to AFAP (ISO 14971:2019+A11:2021 and the MDR)
- Med Dev Insider: Master ISO 14971:2019, clause 5
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.