Software Hazard Identification based on IEC 80002-1 Annex B

ISO 14971 provides great assistance when identifying potential Hazards through its annexes, but it does lack a strong identification catalogue for Software Hazards. 

Luckily, IEC TR 80002-1:2009 Annex B comes to rescue. This Technical Report, "Medical device software - Part 1 Guidance on the application of ISO 14971 to medical device software", takes a software angle on ISO 14971, just as the title suggests.

Annex B of the report elaborates on possible software hazards and factors to consider in order to properly assess whether and how they are applicable to a particular device. 

To assist the risk identification of software hazards, we have built this extension, inspired by the Annex B of IEC/TR 80002-1. 

It includes:

  • RVT file for a Software Hazard aspect and a corresponding DOCX Reporting style template
  • 70+ importable potential Software Hazards to assess and integrate into your Risk Assessment

You may of course expand this hazard list with hazards that are particular to your device and the conditions under which it needs to operate.  

This extension package can be combined with other risk identification packages from Aligned or in-house developed approaches by the manufacturer.

The "Software Hazard Identification based on IEC 80002-1 Annex B"  extension is free to Aligned Elements users.

For more information on how to include the hazards in your risk assessment, contact the This email address is being protected from spambots. You need JavaScript enabled to view it. today.