What they are and where they stand

  • IEC 62304 sets software lifecycle processes for medical device software.
  • IEC 60601 is the family of standards for the basic safety and essential performance of medical electrical equipment.

IEC 62304 edition 2 is delayed. According to a September 2026 update from QuickBird Medical, the IEC now lists 26 October 2028 as the expected publication date, later than the April 2027 date forecast in 2025, because of the volume of comments on the 2025 Committee Draft. Only the second Committee Draft has been released. The draft would:

  • replace software safety classes A, B, and C with two process rigor levels, I and II;
  • add explicit requirements for AI and ML lifecycles;
  • point to other standards, such as IEC 81001-5-1, for cybersecurity;
  • extend scope to all health software, not only medical devices.

In the EU, a new edition only gains practical force once listed as a harmonised standard, so the same source expects real effect around 2030. Edition 1 (with its amendment) remains the version to use today.

Where to find it

  • IEC Webstore and national bodies sell IEC standards.
  • FDA’s recognized consensus standards database lists which editions FDA recognizes.

Licence terms: why “permission required”

The IEC Webstore terms (version updated 4 August 2025) are even more direct than ISO’s:

  • You may not use IEC publications to develop any algorithm, model, software, or AI tool, including ML systems.
  • You may not put IEC products into AI technologies, “whether publicly available AI tools or privately licensed AI tools,” without IEC’s specific, express permission.
  • Bots, scripts, or other methods “to data mine or scrape IEC Products” need IEC’s written permission.
  • Copying, modifying, or creating derivative works needs written permission, AI or not.

Purchase is governed by a separate licence agreement that sets user and network limits.

Using IEC standards in AI responsibly

  1. Keep IEC PDFs out of AI tools and RAG indexes unless IEC has given express permission.
  2. Request permission in writing for any planned AI use, and keep the reply.
  3. Analyze your own artifacts: software development plans, SOUP lists, risk files, and test reports.
  4. Reference clause numbers rather than standard text.
  5. Track edition status and FDA recognition so teams know which edition applies.
  6. Prepare for edition 2 by reviewing your process against public summaries, not the restricted drafts.

Common mistakes

  • Assuming a private, licensed AI tool is allowed. IEC’s terms name private tools explicitly.
  • Planning a transition to edition 2 as though it will be published in 2027.
  • Using unofficial copies of draft standards.
  • Pasting clauses into prompts “just to check” a requirement.

Checklist

  • IEC PDFs removed from AI indexes unless permitted
  • Written permission requested where needed
  • Own artifacts used for AI analysis
  • Prompts reference clause numbers
  • Edition and recognition status tracked
  • Edition 2 plan updated for the 2028 date

How AskDona helps

AskDona analyzes your own software lifecycle records, for example checking that every software item has documented requirements, tests, and risk links, and shows the evidence in your files. It does not need licensed IEC text to do this.

Run a sample software lifecycle traceability check

AskDona shows the evidence; your software quality team decides.

Editor’s note. This article is general information, not legal advice. The “permission required” rating comes from our source list and is a first-pass judgment, not a legal opinion. Confirm your licence with IEC or your national standards body.

FAQ

When will IEC 62304 edition 2 be published? The IEC currently lists 26 October 2028, according to a September 2026 report.

Can I upload IEC 62304 into a private AI tool? Not without IEC’s express permission. Its terms cover both public and private AI tools.

What will change in edition 2? Draft changes include two rigor levels instead of classes A to C, AI and ML lifecycle requirements, and a wider health software scope.

Which edition should I use now? The current edition, until edition 2 is published and recognized.

References

All pages opened and checked by October 26, 2026.

SourceWhat it supports
IEC Webstore: Terms and conditions (updated Aug 4, 2025)AI, ML, scraping, and derivative work restrictions
QuickBird Medical: IEC 62304 edition 2 delayed (Sep 10, 2026)New date 26 Oct 2028; draft changes; EU harmonisation timing