Risk Assessment
shared term, no equivalence asserted
The rows below print this term in 3 jurisdictions, set side by side by each row’s own jurisdiction field, in code-unit order of that field. Each definition is kept apart under its own text, and quoted where the term and its text together sit under the quote cap: 0 of 1 definition in this view are quoted and 1 is withheld with the reason. No reading here says that two of them agree or differ.
EU
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 1
- Rows printing it in a title
- 0
- Rows printing it in body
- 5
International
- Defined in
- ICH Q9(R1)no clause given: text withheld (over the cap: its term and text are 41 words)
- Rows printing it in a normative sentence
- 0
- Rows printing it in a title
- 0
- Rows printing it in body
- 1
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 2
- Rows printing it in a title
- 0
- Rows printing it in body
- 3
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
risk assessment (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
1 observed text defines it.
Counts below are over each row’s current text, the
81 of 126 current
texts the derivation read; a title is read for every one of the 132 tracked rows.
Defined
1 definition in 1 current text, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- ICH Q9(R1)
Internationaltext first observed- no clause given (its definitions section's heading carries no number the clause anchors placed) Risk Assessment: text withheld (over the cap: its term and text are 41 words)
In normative sentences
3 sentences in 3 current texts
printing one of the forms in the heading and one of the sentence derivation’s listed verbs (shall, should, must, is expected, may). A sentence is a row of printed words; nothing here calls it a requirement. A defining occurrence that lies inside such a sentence is counted here and under Defined; only In body leaves out both.
Each sentence is given by the clause the sentence derivation places it under and the verbs it prints, grouped by clause, each clause followed by its count of sentences; its words are not quoted here, and are served by their offsets at /api/v1/modal-sentences.json.
- EU GMP Chapter 4 (draft)
EU1 sentence; text first observedno numbering read: 1 sentence (should) - FDA device cybersecurity (2026)
US1 sentence; text first observed6: 1 sentence (should) - NISTIR 8183
US1 sentence; text first observed7: 1 sentence (may)
In titles
0 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.
No tracked row’s title prints it.
In body
12 occurrences in 9 current texts outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.
- EU GMP Annex 11
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Annex 14
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Chapter 2
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Chapter 4
EU1 occurrence; text first observed1 where no numbering read in this text - EU GMP Chapter 4 (draft)
EU1 occurrence; text first observed1 where no numbering read in this text - FDA AI guidance
US1 occurrence; text first observed7: 1 - FDA device cybersecurity (2026)
US1 occurrence; text first observed2: 1 - ICH Q9(R1)
International2 occurrences; text first observed8: 2 - NISTIR 8183
US3 occurrences; text first observed7: 3
Co-occurrence
58 other terms of the index share at least one clause of a current text with this one: a clause a definition sits in, the clause of a sentence above, or the clause a body occurrence is counted under. Terms in order of their key; each with the count of clauses shared and the clauses, by row. 7 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).
- Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Agency 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - allow-list 1 clause:
fda-device-cybersecurity-20266 - Application 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - chains 1 clause:
ich-q9r18 - clinical investigation 1 clause:
fda-ai-guidance7 - Component / component 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nistir-81837 - consumer 1 clause:
nistir-81837 - corrective action 1 clause:
fda-device-cybersecurity-20266 - critical infrastructure 1 clause:
nistir-81837 - cyber threat 1 clause:
fda-device-cybersecurity-20266 - cybersecurity 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - cybersecurity risk 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - device software function 1 clause:
fda-device-cybersecurity-20266 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - hardware 2 clauses:
fda-device-cybersecurity-20266;nistir-81837 - Harm 1 clause:
fda-device-cybersecurity-20266 - Hazard / hazard 1 clause:
ich-q9r18 - Hazard Identification 1 clause:
ich-q9r18 - identity management 1 clause:
fda-device-cybersecurity-20266 - incident 2 clauses:
fda-device-cybersecurity-20266;nistir-81837 - incident handling 1 clause:
nistir-81837 - informed consent 1 clause:
fda-device-cybersecurity-20266 - intended use 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - manufacturer 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - medical device 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - operator 2 clauses:
fda-device-cybersecurity-20266;nistir-81837 - performance 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nistir-81837 - Product Lifecycle 2 clauses:
fda-ai-guidance7;ich-q9r18 - provider 2 clauses:
fda-device-cybersecurity-20266;nistir-81837 - Quality 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nistir-81837 - Quality Risk Management 2 clauses:
fda-ai-guidance7;ich-q9r18 - Quality System 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - reasonably foreseeable misuse 1 clause:
fda-device-cybersecurity-20266 - recall 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - representative 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - Requirements 2 clauses:
fda-device-cybersecurity-20266;nistir-81837 - Risk / risk 5 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20262·6;ich-q9r18;nistir-81837 - Risk Acceptance 1 clause:
ich-q9r18 - Risk Analysis 1 clause:
ich-q9r18 - Risk Control 1 clause:
ich-q9r18 - Risk Evaluation 1 clause:
ich-q9r18 - Risk Management 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nistir-81837 - Risk Reduction 1 clause:
ich-q9r18 - Risk Review 1 clause:
ich-q9r18 - significant cybersecurity risk 1 clause:
fda-device-cybersecurity-20266 - software 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - source code 1 clause:
fda-device-cybersecurity-20266 - sponsor 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - standard 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - subject 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - System / system 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nistir-81837 - training data 1 clause:
fda-ai-guidance7 - UDI 1 clause:
fda-device-cybersecurity-20266 - user 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - vulnerability 2 clauses:
fda-device-cybersecurity-20266;nistir-81837
History
Every text of each row holding the term in any text the store holds under the current version, in the order the texts were first observed. A row’s current text is marked.
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 0 | 0 | |
53742d793b68 (current) | 0 | 0 | 1 | |
ac0054416554 | 0 | 0 | 0 | |
749c40132375 | 0 | 0 | 0 | |
f110d5d47c11 | 0 | 0 | 0 | |
bf56cba791d8 | 0 | 0 | 0 | |
3db9896305a6 | 0 | 0 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6eabc41e8879 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
ea32c21545ee (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6d54bcfeb8e7 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
313242556edd (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
ef49f58a80fe unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
b9143ae11461 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
85a680107f4d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
8f04120f403b (current) | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
61d4603ff66e | 0 | 0 | 0 | |
088a7a37c55d | 0 | 0 | 0 | |
630bd27c7b42 | 0 | 0 | 0 | |
5c61f4c6351d (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca | 0 | 0 | 0 | |
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
d34d8c706d88 (current) | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
57c484f5daed (current) | 1 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92b7bfe588c4 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
fe392d207918 (current) | 0 | 1 | 3 |
Feed
/atom/term/risk-assessment.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.
How this page is derived
From the terms-index derivation’s current version, first derived on
, read from
state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and
term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on
the derivation methods page, which lists every version of each with
the day it was first derived: a change there is a change of method, never a change in a text.
Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| ICH Q9(R1) | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| FDA device cybersecurity | true | open | true | true |
| FDA device cybersecurity (2026) | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| EU MDR | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| ICH Q13 | true | open | true | true |
One row for each entry whose own characters this page prints: a text defining a form printed here, or a definition quoted. A row named or linked without its characters printed, or whose title only or sentence clauses only are given, has no row.
Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.
Last updated: