ISO 81001-1 — Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts
Document status what the publisher asserts
unknown
No status read is recorded for this entry — this record has not read a publisher surface for it, which is a fact about this record and not about the publisher. A status read is recorded for 7 of 132 tracked entries, 5 of which banked a passage.
Evidence state what this record holds
source access limited — the publisher’s licence or its access policy limits what this record takes from the source
/api/v1/instruments.json.
What this record holds for this entry, rung by rung, each mark derived from a field, a count or a stored reading. Rungs in the order the record acquires them, from what an entry is to what has been checked about it. The order is fixed; a rung’s position says nothing about any entry.
✓ held — this record holds it, and the sentence beside it names what from · — nothing held — no reading of this rung is recorded — nobody has looked, which is not the same as looking and finding nothing · △ held in part — part of it is held, or it is held under a limit the sentence states
No rung on this entry carries a measured absence. That is not the same as every rung being held: 6 of the 12 rungs are marked as holding nothing, which records that no reading has run rather than that a reading found nothing.
Each term states what this record does for this entry and what it does not, derived from the entry’s own fields and its own series. It is a record of coverage, not a finding about the document.
decay_class This entry’s record is frozen, which takes it out of the verification queue and out of the unverified count. The reason its record carries is “paywalled stage tracked”.licence_class The text is restricted, so this record cites and links it and does not reproduce, excerpt or diff it.resolution_strategy Resolution is “metadata only”, which is the value that means no document is retrieved for this entry: what is fetched is a publisher surface about it.The test an entry is admitted under is published in full, with its negative limb and its worked examples, at the inclusion rule. What this record holds about THIS entry's admission is below, each line naming the store it was read from.
Filed core. For that label this archive undertakes to put an entry's status to a person. The label records what this archive undertakes for a class of entries. It states no finding about this one, and it is not a ranking.
Frozen. The text is not public by licence, so it is not retrieved, hashed or diffed here. No stage or step wording has been read from the publisher for this entry. What is recorded is the publisher's own address, and a dated series of what that address returned on each day it was requested — including the days it refused. Why the text is not taken, and what is recorded instead.
Frozen does not mean abandoned. This entry is still fetched and hashed every day and its observation series continues; it is excluded only from the verification queue and from the unverified count, because a status that cannot be established is not outstanding work.
Not yet verified. The status of this instrument has not been confirmed against its primary source. It is recorded as unknown rather than estimated. Consult the primary source (opens in new tab) directly.
Resolution: metadata only · no document resolved
What this archive can and cannot establish about this entry. The full text is not public by licence; the ISO Online Browsing Platform serves front matter only. Nothing is hashed; the publisher's own catalogue metadata is tracked instead. DECISIONS-NEEDED #25a recorded a 403 to an identified client; that 403 was reproduced on 2026-08-08 against a known-good ISO URL, which makes it evidence about ISO's transport policy and not about this document. Whether the 2021 edition is still current was not measured.
No status has been confirmed against the primary source. Recorded as unknown rather than estimated.
The source was retrieved, but no phrase stating a regulatory status was found near a mention of this instrument.
The text of this document is published under a restrictive licence. It is cited and linked, never excerpted; change is reported by hash.
Each format carries the permalink and the date this consensus standard was observed. The observation date is part of the citation: the underlying source may have changed since.
GxPlex. ISO 81001-1 — Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts [consensus standard record]. Observed 18 September 2026. https://gxplex.com/r/iso-81001-1 Primary source: https://www.iso.org/obp/ui/#iso:std:iso:81001:-1:ed-1:v1:en
@misc{gxplexriso810011,
author = {{GxPlex}},
title = {{ISO 81001-1 — Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts}},
year = {2026},
note = {consensus standard record, observed 18 September 2026},
howpublished = {\url{https://gxplex.com/r/iso-81001-1}},
urldate = {2026-09-18},
url = {https://www.iso.org/obp/ui/#iso:std:iso:81001:-1:ed-1:v1:en}
} GxPlex. (2026). ISO 81001-1 — Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts [consensus standard record]. Retrieved 18 September 2026, from https://gxplex.com/r/iso-81001-1
{
"@context": "https://schema.org",
"@type": "Dataset",
"name": "ISO 81001-1 — Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts",
"publisher": "GxPlex",
"url": "https://gxplex.com/r/iso-81001-1",
"temporalCoverage": "2026-09-18",
"observation": {
"url": "https://gxplex.com/observations/iso-81001-1#obs-2026-09-18-1",
"observedDate": "2026-09-18"
},
"isBasedOn": "https://www.iso.org/obp/ui/#iso:std:iso:81001:-1:ed-1:v1:en"
} observation.url addresses the single observation this
citation rests on.
Every observation of this document is addressed and separately citable at the observation series.
Observed on 85 occasion(s) since 2026-08-08. None produced a content hash — see the note below.
~××××~×~~~~××~××~~××~~×××××~××~×××~×~~×××~~×~×××××~×××××~~××~××××××~×××~~×~~×~~~~····
All 85 marks, one per observation, oldest first. · unchanged · ! content changed ·
~ fetched but rendered client-side, no hash ·
× could not be fetched, no hash.
41 of 42 days from 2026-08-08 to 2026-09-18 hold an observation. 1 day holds none: 2026-09-14. A day with no observation is a day this record did not reach; it is not a statement about the publisher, and it is not counted as unchanged.
Each mark links to the single observation it stands for, at
that observation’s own address. The whole series, with every address, is at /observations/iso-81001-1.
Any two of its retained observations can be set side by side at /compare/iso-81001-1.
The same evidence as a packet, with its refusals and its
integrity reference, is at /packet/iso-81001-1.
Every observation in this series is published, untruncated, at /api/v1/observations.json.
This source has never produced a content hash. Either it refuses automated requests, or its content is assembled in the browser and is not present in the HTML. No hash is recorded for a document that could not be read — an invented one would corrupt every finding computed from this series. See crawlability.
2026-09-18·1. /observations/iso-81001-1 — every record of this row, with its address. /api/v1/series.jsonl — the same records for every row, one line each.
Each observation is addressed by this row’s identifier, the date it was observed, and its sequence within that date — the same key /api/v1/series.jsonl publishes as `sequence`, counted in the order the store recorded them. Counts and dates over a stated window. No figure here is a mark out of a hundred, no cell is ordered against another, and none of it is a statement about the publisher: a day this record did not reach is a fact about this record’s reach.
blocked ×49. Of those, 0 produced a digest: a
page that answers and is assembled in the browser answers
without one. withheld. What that record returned is in Observation history above.
What sits around this entry, counted. Every figure below is drawn from a value already rendered elsewhere on this page; where a count has a list, the count is here and the list stays in the section holding its evidence.
| Window | Observations of the document | Of those, carrying a digest | Of those, carrying a change | Direct document | Official signals dated inside it |
|---|---|---|---|---|---|
| 30 calendar days | 18 | 0 | 0 | no digest in window | 0 of 0 |
| 90 calendar days | 40 | 0 | 0 | no digest in window | 0 of 0 |
| 365 calendar days | 40 | 0 | 0 | no digest in window | 0 of 0 |
A window is marked changed where at least one observation of the document inside it recorded a change against the previous one; unchanged where the window holds at least one such observation, at least one of them carries a digest of the retrieved bytes, and none recorded a change; undigested where the window holds observations and none of them carries a digest, so no observation in it could be compared with another; and unmeasured where the window holds no observation at all. The word is shorthand for the three counts printed beside it and adds nothing to them. It is a statement about the window and never about the document outside it, which is why a window reaching back before the first observation says so underneath. A mark is derived from the observations a window holds and never from the days it spans; which days inside this entry’s own window hold none is stated by the coverage sentence in Observation history above.
The first observation of the document this entry names is . These windows reach back before it — 90 calendar days · 365 calendar days — so part of the span each names was never watched, and a window with no change inside it says nothing about the days before that first observation.
no digest in window — this window holds observations of the document and not one of them carries a digest of the retrieved bytes, so no observation in it could be compared with another and no change was measurable either way — what this record does and does not digest for this entry is stated by the hash term in the coverage contract above
No word is attached to the signal count beside it, and none will be. Any word for the size of a count needs either a threshold this record would have authored or a comparison against other entries that would rank the sources against one another; the count and its window are the whole claim. The document column beside it carries a word only because the rule reaching it is printed underneath and can be checked against the counts it stands for.
The last column holds no member on this entry. The zero it holds is named under “Around it” below.
topic.health-software. Next holds the publisher-dated facts this record already carries that fall after the day this record calls today — a stated effective date, a consultation close. Nothing is projected and no step is inferred from a lifecycle: where a publisher has stated no further date, the cell says so, and what is absent is a statement rather than a future.
The words this document uses about itself, matched verbatim against its own title. Not a statement of scope, and not a judgment about which organisations or products fall under it: each value quotes the span it was read from and links to where that span was read.
Listed primary first, then the further addresses this record holds for this entry, then the route it was found by, then dated third-party copies. Repeated URLs appear once, at their first position.
A field and some words a reader may keep beside this entry while reading it. This record never sees the note: nothing is sent anywhere, nothing is stored on this device, and it is gone when the page is reloaded. Nothing below is selected until a reader selects it — no default is offered here, and this record states no view about which of the four words belongs on this entry.
Those four words are a reader's own vocabulary, not this record's description of the document. A judgement of consequence, a decision to keep watching, a decision to look further and a decision to raise are refused in this record's own voice by the wall it publishes under, and that refusal is why the choice sits with a reader rather than being made here.
The copy control puts the note on this device's clipboard as Markdown,
carrying this entry's identifier and the four published addresses of its
evidence packet at /packet/iso-81001-1, so a note and
the packet it belongs beside can be filed together. The note is not merged
into the packet's own bytes: merging needs either a request this control
does not make, or a copy of a published surface inside every entry page,
and neither is taken.