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Prerequisites

  • An open HARA document in risksheet mode
  • Access to the Catalogs space containing:
    • HazardsCatalog — 68 hazard entries organized by IEC 60601 taxonomy
    • Standard Harms — 25 harm entries with severity levels

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What Are the Catalogs?

The Medical Device Safety Solution includes two reusable catalogs that serve as reference libraries for HARA analysis:
CatalogWork Item TypeEntriesPurpose
Hazards Cataloghazard68IEC 60601 hazard taxonomy with hierarchical categories
Standard Harmsharm25Standardized harms with pre-assigned severity (1-5)
diagram

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Hazards Catalog Structure

The Hazards Catalog follows the IEC 60601 medical device hazard taxonomy organized as a 4-level hierarchy:
LevelExample Categories
L1 (Top)Energy
L2Electrical, Mechanical, Thermal, Acoustic, Radiation, Leakage Current
L3Earth Leakage, Ultrasonic, Infrasound, Sound Pressure, Electric Fields
L4Enclosure Leakage (specific to leakage current)
The hierarchy uses Polarion outline numbering within heading-based categories (h3 for categories, h4 for subcategories, div elements for individual hazards).
The current catalog defines detailed sub-levels primarily for the Energy hazard category. Other IEC 60601 categories (biological, chemical, operational) exist as top-level entries but may not have the same depth of sub-categorization.
  1. In the HARA risksheet, locate the Hazard column (Level 2 in the hierarchy)
  2. Click the hazard cell for your risk record
  3. The picker opens showing hazards from the Hazards Catalog document
  4. Search or browse to find the appropriate hazard entry
  5. Select it to create the hasHazard link
Multiple risk records can link to the same hazard from the catalog. For example, an “Electrical shock” hazard may appear in multiple use step contexts, each with a different hazardous situation and harm.
  1. In the HARA risksheet, locate the Harm column (Level 4 in the hierarchy)
  2. Click the harm cell for your risk record
  3. The picker opens showing entries from the Standard Harms catalog
  4. Select the specific harm (e.g., “Burns”, “Electric shock injury”, “Death”)
  5. The hasHarm link is created

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Step 3: Verify Auto-Populated Severity

After linking a harm:
  1. Check the Harm Severity column (harm.severity) — it is automatically populated from the linked harm item
  2. This column is read-only (styled with creadonly CSS) — severity is managed in the Standard Harms catalog, not on individual risk records
The severity scale:
IDLevelDescription
1NegligibleTemporary discomfort, inconvenience
2MinorTemporary injury, no medical intervention
3SeriousInjury requiring medical intervention
4Critical (default)Permanent impairment or life-threatening
5CatastrophicPatient death
Harm severity defaults to Critical (level 4) if not explicitly assigned. This implements a conservative approach where unassessed harms are treated as life-threatening until evaluated.

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Step 4: Review Linked Catalog Entries

After linking hazards and harms, you can review the catalog documents directly:
  • Hazards Catalog: Navigate to Catalogs/HazardsCatalog in the Polarion document view. Hazards show ID and status fields in the rendering layout.
  • Standard Harms: Navigate to Catalogs/Standard Harms. Harms show severity in the end column and sidebar.
Catalog documents have nextedySheetConfig set to “No Sheet”, meaning they are managed through the standard Polarion document interface — not through risksheet. To add new hazards or harms, edit the catalog document directly, then link from the HARA risksheet.

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Adding New Entries to Catalogs

If your hazard identification reveals a hazard or harm not in the existing catalogs:
  1. Open the appropriate catalog document in Polarion
  2. Create a new work item (hazard or harm type) at the correct position in the hierarchy
  3. For harms, assign the appropriate severity level (1-5)
  4. Return to the HARA risksheet and link the new entry

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Best Practices

  • Always use catalog entries rather than free-text descriptions for hazards and harms — this ensures consistency across risk records and supports reporting
  • Review the full catalog before creating new entries — the desired hazard may already exist under a different category
  • Use the IEC 60601 taxonomy when organizing new hazard entries to maintain standards compliance
  • Validate severity assignments in the Standard Harms catalog periodically as the risk analysis matures
Hazards Catalog document structure (HazardsCatalog/module.xml), Standard Harms document structure (Standard-Harms/module.xml), harm severity enumeration (harm-severity-enum.xml), HARA risksheet configuration (HARATemplate/risksheet.json), cascade mappings for hazard taxonomy (mappings.xml).