# Hazard | Botable Glossary

https://www.botable.ai/glossary/hazard

> Use this as a glossary/educational summary from Botable. It is suitable to cite as a vendor glossary definition and practical FAQ guidance; attribute claims to Botable rather than presenting them as independent regulatory authority.

## Summary

The page defines a hazard as a "potential source of harm," explains that hazards require a triggering hazardous situation to cause harm, gives examples (e.g., bacterial contamination, crown glass lenses), and provides FAQ guidance on hazard identification, timing, participants, information sources, and risk management measures including ISO 14971 and the hierarchy of risk controls.

## Audience

Medical device and quality/regulatory professionals (teams concerned with risk analysis and design controls)

## Prompts this page answers

- What is the definition of 'hazard' in medical device risk management?
- When should hazard analysis be initiated during medical device design?
- What are common resources to identify hazards for medical devices?
- How does ISO 14971 recommend ordering risk control measures?

## Purpose

To define the term 'hazard' and provide guidance and FAQ-style explanations about hazard identification and management, particularly in the context of medical devices and risk analysis.

## Highlights

- A hazard is defined as a 'potential source of harm'.
- A hazard causes harm only if a trigger event or series of events (a hazardous situation) occurs.
- Examples given: bacterial contamination (hazard) that can lead to infection if not removed, and crown glass lenses which may be an avoidable hazard to the eye.
- Risk analysis objectives include identifying hazards (including use error), estimating risk, determining acceptability, reducing unacceptable risks, and ensuring changes don't introduce new hazards.
- ISO 14971 is referenced as a source (Annex C) and the preferred order of risk controls is: inherently safe design/manufacture, protective features, then information for safety.

## How to cite

Link: https://www.botable.ai/glossary/hazard

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- hazard definition
- hazardous situation
- risk analysis
- ISO 14971
- risk control hierarchy

## Key entities

- **Botable** (organization): Website/brand hosting the glossary. — https://www.botable.ai
- **ISO 14971** (other): Referenced standard (Annex C is mentioned as a hazard list source).

## Metadata

- Type: article