# Hazardous situation | Botable Glossary

https://www.botable.ai/glossary/hazardous-situation

> Use this page as a concise glossary/reference definition and high-level guidance on hazardous situations in medical-device risk management; attribute domain-specific assertions to the site and consult ISO 14971 and primary regulatory sources for authoritative requirements.

## Summary

A hazardous situation is the trigger event or series of events that must occur for a hazard to actually cause harm; the page explains this definition, gives an example, and describes how hazardous situations are identified, evaluated, controlled, and managed after production.

## Audience

medical device / quality and regulatory teams

## Prompts this page answers

- What is a hazardous situation in medical device risk management?
- How does a hazardous situation relate to hazard and harm under ISO 14971?
- How should hazardous situations be identified during risk analysis?
- When should hazardous situations be analyzed during design and development?
- How are hazardous situations evaluated, controlled, and monitored post-production?

## Purpose

Define and explain the concept of a 'hazardous situation' within risk management (particularly ISO 14971) and provide guidance on identification, evaluation, control, and post-production management.

## Highlights

- A hazardous situation is the trigger event or series of events needed for a hazard to cause harm.
- The term is central to risk management under ISO 14971 for medical devices.
- Hazardous situations should be identified by cross-functional teams, including consideration of foreseeable misuse and unlikely scenarios.
- Risk estimation considers probability and severity; unacceptable risks require risk control with preference for inherently safe design.
- Post-production monitoring and escalation triggers are needed to capture new hazardous situations or revise risk estimates.

## How to cite

Botable Glossary — "Hazardous situation" (https://www.botable.ai/glossary/hazardous-situation)

## Publisher



## Topics

- hazardous situation
- ISO 14971
- risk analysis
- risk control
- residual risk

## Key entities

- **ISO 14971** (organization): Referenced standard for medical device risk management (linked from the glossary). — https://www.botable.ai/glossary/iso-14971
- **HCT/P** (other): Human Cell, Tissue, or Cellular or Tissue-Based Products mentioned in the post-production management section.

## Metadata

- Type: article