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Software Hazard Analysis - Definitions

Hazard – A possible source of danger or a condition, which could result in human injury.

Hazard Analysis – Identification of hazards and their initiating causes.

Hazard Mitigation – Reduction in the severity of the hazard, the likelihood of the occurrence, or both.

Major Level of Concern – The Level of Concern is major if operation of the software associated with device function directly affects the patient, operator, and/or bystander so that failures or latent flaws could result in death or serious injury to the patient, operator, and/or bystander, or if it indirectly affects the patient, operator, and/or bystander (e.g., through the action of care provider) such that incorrect or delayed information could result in death or serious injury to the patient, operator, and/or bystander.

Moderate Level of Concern – The Level of Concern is moderate if the operation of the software associated with device function directly affects the patient, operator, and/or bystander so that failures or latent design flaws could result in non-serious injury to the patient, operator, and/or bystander, or if it indirectly affects the patient, operator, and/or bystander (e.g., through the action of the care provider) where incorrect or delayed information could result in non-serious injury of the patient, operator, and/or bystander.

Minor Level of Concern – The Level of Concern is minor if failures or latent design flaws would not be expected to result in any injury to the patient, operator, and/or bystander.

Serious Injury – as adopted from the Medical Device Reporting (MDR) regulation in the Code of Federal Regulations 21 CFR 803.3 (aa), means an injury or illness that either:

1.      is life threatening, or

2.      results in permanent impairment of a body function or permanent damage to a body structure, or

3.      necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Permanent – for the purpose of this document, permanent means irreversible impairment or damage to a body structure or function excluding trivial impairment or damage.

Primary Tag – Unique identifier that identifies a specific row in a table. For example, a Hazard Tag is a primary tag that is used to define the hazard.

Foreign Tag – A link that points to another table. This is the primary tag for the row being referred to in another table. For example, a table that includes Hazard Tags is using them as foreign tags to link to the Hazard Table.