Quality Manual

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Risk Management Criteria

1 Purpose
In this document necessary risk acceptance criteria for risk management activities are defined as required
in the harmonized standard EN ISO 14971:2007.

2 Severity ranking
Example below…

Severity
Catastrophic CA (3) The he hazard can directly cause death or serious injury.

Critical CR (2) The hazard can indirectly cause death or serious injury.
The hazard can directly cause moderate injury.
Marginal MA (1) The hazard can indirectly cause moderate injury.
The hazard can directly cause minor injury.
Negligible NE (0) The hazard can indirectly cause minor injury.
The hazard can cause no clinical effect.

3 Possibility ranking
Example below…

Possibility
High H (3) Likely to happen, often, frequent
Medium M (2) Can happen, but not frequently
Low L (1) Unlikely to happen, rare, remote
Negligible N (0) Will not happen, “Impossible”

4 Risk level
Example below…

A risk is acceptable if the outweighed by the benefit. The consequences for not using the device must be
considered, as well as risks introduced by using the device, when describing the criteria for acceptable and
unacceptable risks.

Direct risks introduced are few and moderate, due to the low level of energy used (current, voltage). Indirect
risks are mainly the same as when not using the device, but less severe.

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CA (3) A U U U

CR (2) A A U U

MA (1) A A A U

NE (0) A A A A

Severity N (0) L (1) M (2) H (3)

Probability

A risk is acceptable if the outweighed by the benefit. The consequences for not using the device must be
considered, as well as risks introduced by using the device. Direct risks introduced are few and moderate, due
to the low level of energy used (current, voltage). Indirect risks are mainly the same as when not using the
device, but less severe.

Green represents acceptable risk level.

Yellow represents acceptable risk, but where risk mitigation shall be considered anyway. The benefit
overweighs the risk, but as some marginal consequences cannot be ruled out completely, risk mitigation is
still strongly recommended.

Red represents unacceptable risk, i.e., the benefit is outweighed by the risk.

For all unacceptable risks risk control measure(s) must be identified. The measures shall either minimize the
probability that the risk is realized or minimize the severity. The measures shall take the risk down to an
acceptable level.

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