Dec 1, 2021·IEC · StandardActiveHigh impact
IEC 81001-5-1 - secure software lifecycle for health software
IEC 81001-5-1 defines the secure development lifecycle for health software and is the foundational standard for the security risk management activities the FDA and Notified Bodies expect.
What changed
- Establishes secure development lifecycle phases parallel to IEC 62304.
- Defines security risk management vocabulary used by AAMI SW96 and MDCG 2019-16.
Action for manufacturers
Map your SDLC to 81001-5-1 phases; reviewers increasingly expect the standard to be cited as the basis for your security activities.