Definition
Per ISO 14971:2019, a hazard is a potential source of harm. Examples include electrical energy, mechanical force, thermal conditions, radiation, and software malfunctions. Hazards are not harm themselves — they are the source or mechanism that could lead to a hazardous situation and ultimately to harm.Custom Fields
Hazard work items use standard Polarion fields (Title, Description, Status) plus the IEC 60601 hazard taxonomy cascade fields:| Field | Type | Description |
|---|---|---|
title | String | Hazard name (for example, “Electrical Energy - Leakage Current”) |
description | Rich Text | Detailed description of the hazard source |
status | Enum | Standard workflow status (Draft, In Review, Pending Approval, Approved, Rejected, Obsolete) |
IEC 60601 Hazard Taxonomy
The solution implements a 4-level cascading hazard classification aligned with IEC 60601-1:
Level 2 Categories (under Energy)
| L2 ID | Label |
|---|---|
electrical | Electrical |
mechanical | Mechanical |
thermal | Thermal |
acoustic | Acoustic |
radiation | Radiation |
static_discharge | Static Discharge |
leakage_current | Leakage Current |
voltage | Voltage |
magnetic_fields | Magnetic Fields |
electrical_fields | Electrical Fields |
electrical_energy | Electrical Energy |
potential | Potential |
Hazard Catalog
The solution includes a pre-populated Hazards Catalog document in the Catalogs space containing 68 hazard entries. This catalog serves as a reusable library:- When creating risk records in the HARA risksheet, the
hasHazardlink column lets you pick from the catalog - New hazards can be added to the catalog as needed
- Hazards are shared across all risk documents in the project
Link Roles
| Role | Direction | Target Type | Description |
|---|---|---|---|
hasHazard | Incoming | riskRecord | Risk records that reference this hazard |
hasHazard role. A single hazard can be referenced by multiple risk records (one-to-many relationship from hazard to risk records).
HARA Risksheet Column
In the HARA risksheet, the Hazard column appears at Level 2 of the hierarchy:| Level | Entity |
|---|---|
| L1 | Use Step |
| L2 | Hazard |
| L3 | Hazardous Situation (Event) |
| L4 | Harm |
itemLink type that connects to hazard work items via the hasHazard link role.
Related Pages
- Identify Hazards and Harm Scenarios — How to identify and link hazards in the HARA risksheet
- Use Hazard and Harm Catalogs — How to use the pre-populated catalog
- IEC 60601 Hazard Taxonomy — Conceptual overview of the 4-level taxonomy
- IEC 60601 Hazard Taxonomy Cascade — Complete enumeration reference for all cascade levels
- Harm (harm) — The harm work item type (linked from risk records alongside hazards)