Name the edition you rely on
Put ISO 81001-1:2021 in the procedure, the contract and the design file. Add a line that a second edition is in development. That is true today and stays true after publication until you change it.
What changes
What the second edition changes, and why this page will not invent it
The ISO record gives the designation, the stage, the edition, the page count and the abstract. It does not give a change summary. The draft text is not public during the ballot. So the honest answer to "what changed" is: not public yet, and here is what you can do in the meantime.
- The draft is edition 2. The ISO page records the edition and a 62 page draft. The first edition was 61 pages.
- It is at stage 40.20. The DIS ballot was initiated on 5 October 2026 for 12 weeks.
- The title is unchanged. It remains Health software and health IT systems safety, effectiveness and security, Part 1: Principles and concepts.
- The committee is unchanged. ISO/TC 215, Health informatics, with IEC/TC 62/SC 62A.
- The abstract is unchanged in substance. It still describes principles, concepts, terms and definitions across the life cycle, the transition points and the multi-lateral communication at them.
The limit
A revision can change a definition, add a clause, move an annex or change a normative reference without changing the title, the committee or the abstract. The public record cannot tell you which of those happened. A page that lists changes from the title alone is guessing.
What would count as evidence
The published second edition, an ISO change summary, a national body's draft review, or the text itself. None of those is public as at 21 October 2026. When one is, the record changes and the watch sends it.
02 / WHAT YOU CAN DO
Three moves that do not depend on the answer
MOVE ONE
MOVE TWO
Build the register by element
The eight foundational elements in Clause 5 are the stable spine. If the second edition moves a sub-clause, the element and its evidence still stand. The register.
MOVE THREE
Fix the handovers first
Knowledge transfer is where a revision hurts most, because the text and the handover record both change. Start with the four transfer elements at 5.3. Knowledge transfer.
MOV FOUR, FOR A REGULATED PRODUCT
Ask your notified body and your auditor in writing whether edition 1 evidence will still be accepted after edition 2 publishes, and what cut-over date they expect. Record the answer and the date. A verbal assurance from an account manager is not a position you can plan against.
The watch is not a newsletter. It re-reads the official record on a schedule, compares it with the record this site was built from, and emails you only when something changes: the stage, a date, the title, the edition, the page count, the abstract or the text when it lands. If nothing changes, you hear nothing.
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