GxPlex

hardware

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
EU Cyber Resilience Act
chapter-i/article-3 (5): text withheld (over the cap: its term and text are 18 words)
Rows printing it in a normative sentence
11
Rows printing it in a title
0
Rows printing it in body
5

International

Defined in
no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence
0
Rows printing it in a title
0
Rows printing it in body
3

US

Defined in
no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence
5
Rows printing it in a title
0
Rows printing it in body
4

This form is printed by the tracked documents, each as a document defines it. The index’s key is hardware (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.

In normative sentences

45 sentences in 16 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.

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

48 occurrences in 12 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.

Co-occurrence

156 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. 26 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).

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.

Annex 11 concept paper
First observedTextDefinedIn normative sentencesIn body
17bed942038f unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
6d68d146b07c (current)010
EMA CT computerised systems
First observedTextDefinedIn normative sentencesIn body
90f72782b398 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
ebaf707c409d (current)040
EU AI Act
First observedTextDefinedIn normative sentencesIn body
58dbc3006d27034
9d16077b1d3b (current)034
EU Cyber Resilience Act
First observedTextDefinedIn normative sentencesIn body
9206a43954eb (current)195
EU Cybersecurity Act
First observedTextDefinedIn normative sentencesIn body
1fe6027daa2c (current)030
EU GMP Annex 11
First observedTextDefinedIn normative sentencesIn body
797a882ba0ea000
53742d793b68 (current)013
ac0054416554000
749c40132375000
f110d5d47c11000
bf56cba791d8000
3db9896305a6000
EU GMP Annex 11 (draft)
First observedTextDefinedIn normative sentencesIn body
0e885238d69a unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
7a8b8a6e95d5 (current)017
EU IVDR
First observedTextDefinedIn normative sentencesIn body
903e40aaebe6 (current)040
EU Machinery Regulation
First observedTextDefinedIn normative sentencesIn body
1fc20ae2ffd8030
82fb682a6c54 (current)030
EU MDR
First observedTextDefinedIn normative sentencesIn body
14d00b77d5c8030
fab624c8e1dc (current)030
EU NIS2 Directive
First observedTextDefinedIn normative sentencesIn body
023dc18395dc (current)012
FDA device cybersecurity
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca (current)000
d34d8c706d880711
FDA device cybersecurity (2026)
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca000
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
d34d8c706d88 (current)0711
FDA electronic systems (clinical)
First observedTextDefinedIn normative sentencesIn body
06b24bf9ebcb unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
74c586849092 (current)012
FDA Part 11 scope
First observedTextDefinedIn normative sentencesIn body
a5590943862c (current)010
ICH Q13
First observedTextDefinedIn normative sentencesIn body
06273204f50b (current)001
ICH Q9(R1)
First observedTextDefinedIn normative sentencesIn body
57c484f5daed (current)001
NIST agent standards
First observedTextDefinedIn normative sentencesIn body
c0ab0e6263b3001
edcebd0e3a36001
9d19d28e1a57001
f2734caa33bb001
8727e7836a62001
e6bfd1f64b25000
67d33a19b1a7000
05c0bdbc196e000
8e07db344887000
84a3e0382b0e000
6f9c326c480f000
b413d56295e8000
e3d94d289c0b000
d800e5bf4d9b (current)000
NIST AI 600-1
First observedTextDefinedIn normative sentencesIn body
a5ad5867c187 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
caa03fc84948 (current)003
NIST AI RMF
First observedTextDefinedIn normative sentencesIn body
8afebcc0941a000
c240f2675bd3000
4c10dc03228b (current)002
NISTIR 8183
First observedTextDefinedIn normative sentencesIn body
92b7bfe588c4 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
fe392d207918 (current)027
21 CFR Part 11
First observedTextDefinedIn normative sentencesIn body
f0554d5c3fab010
6a4d277ca4f8010
95bf4a66f2d4010
98ed07f87cdd010
15f94377c4fc010
9269c75204ff010
4d93ac00b602010
825750c5633d010
39db0dd17f53010
244eba4196bb010
605180a389c7010
ed1c9acbb776010
bbbd805d0905 (current)010

Feed

/atom/term/hardware.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.

Rights envelope — how this record handles the text of each entry listed
Entrytext_retainedlicence_classquote_allowedsnapshot_available
EU Cyber Resilience Acttrueopentruetrue
21 CFR Part 11trueopentruetrue
EU MDRtrueopentruetrue
EU AI Acttrueopentruetrue
EU GMP Annex 22trueopentruetrue
FDA device cybersecuritytrueopentruetrue
FDA device cybersecurity (2026)trueopentruetrue
EU IVDRtrueopentruetrue
EU GMP Annex 11trueopentruetrue
EU Machinery Regulationtrueopentruetrue
21 CFR Part 820 (QMSR)trueopentruetrue
EU Cybersecurity Acttrueopentruetrue
EU NIS2 Directivetrueopentruetrue
ICH Q9(R1)trueopentruetrue
FDA electronic systems (clinical)trueopentruetrue
Regulation (EU) 2026/1744trueopentruetrue
ICH Q13trueopentruetrue
EU GMP Chapter 4trueopentruetrue

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: