IEC 62304 Software Safety Classification: A Complete Guide

Software safety classification is one of the most critical decisions you’ll make when developing medical device software. IEC 62304 requires you to classify your software as Class A, B, or C based on the potential harm it could cause to patients or users.

Understanding Software Safety Classes

Class A: No Injury or Damage to Health

Software Class A is assigned when no injury or damage to health is possible. This is the least stringent classification.

Examples:

• Software that only provides non-critical information displays
• Administrative software with no impact on device operation
• Data logging software with no control functions

Class B: Non-Serious Injury

Software Class B applies when the software could contribute to non-serious injury.

Examples:

• Software controlling temporary, non-critical therapy
• Diagnostic software with physician oversight
• Software with limited control over device operation

Class C: Death or Serious Injury

Software Class C is required when the software could contribute to death or serious injury.

Examples:

• Software controlling life-sustaining functions
• Autonomous diagnostic software
• Software controlling critical therapy delivery

Decision Tree for Classification

1. Can the software contribute to a hazardous situation?

   • No → Class A
   • Yes → Continue to step 2

2. Could the hazardous situation result in serious injury or death?

   • Yes → Class C
   • No → Class B

Impact on Development Requirements

Your software safety class determines which IEC 62304 requirements apply.

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