Component / component
shared term, no equivalence asserted
The rows below print this term in 4 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: 1 of 2 definitions in this view is quoted and 1 is withheld with the reason. No reading here says that two of them agree or differ.
Canada
- 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
- 1
EU
- Defined in
- EU Cyber Resilience Act
chapter-i/article-3(6): software or hardware intended for integration into an electronic information system; - Rows printing it in a normative sentence
- 11
- Rows printing it in a title
- 0
- Rows printing it in body
- 9
International
- 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
- 2
US
- Defined in
- 21 CFR Part 820 (QMSR)no clause given: text withheld (over the cap: its term and text are 28 words)
- Rows printing it in a normative sentence
- 6
- Rows printing it in a title
- 0
- Rows printing it in body
- 5
These forms are printed by the
tracked documents, each as a document defines it. The index’s key is
component (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
12 observed texts define 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
2 definitions in 2 current texts, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU Cyber Resilience Act
EUtext first observedchapter-i/article-3(6)component: software or hardware intended for integration into an electronic information system;
- 21 CFR Part 820 (QMSR)
UStext first observed- no clause given (no numbering read in this text) Component: text withheld (over the cap: its term and text are 28 words)
In normative sentences
88 sentences in 18 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.
- EMA CT computerised systems
EU2 sentences; text first observedfollows a withheld heading: 1 sentence (should) · id repeats in this text: 1 sentence (should) - EU AI Act
EU6 sentences; text first observedno clause anchor before this sentence: 4 sentences (should, may) ·chapter-i/article-3: 1 sentence (may, shall) ·chapter-iii/section-1/article-6/1: 1 sentence (shall) - EU Cyber Resilience Act
EU6 sentences; text first observedno clause anchor before this sentence: 3 sentences (should, may) ·chapter-i/article-3: 1 sentence (may) ·chapter-ii/article-13/6: 2 sentences (shall) - Regulation (EU) 2026/1744
EU5 sentences; text first observedno clause anchor before this sentence: 3 sentences (should) ·article-1: 1 sentence (shall, may) ·article-3: 1 sentence (shall) - EU GMP Annex 1
EU9 sentences; text first observedannex-1/11: 9 sentences (should, may) - EU GMP Annex 15
EU1 sentence; text first observed11.2: 1 sentence (should, may) - EU GMP Annex 6
EU1 sentence; text first observed40: 1 sentence (should) - EU IVDR
EU4 sentences; text first observedchapter-ii/article-20/1: 1 sentence (shall) ·chapter-ii/article-20/2: 1 sentence (shall) ·annex-vi/part-c/3.6: 1 sentence (shall) ·annex-vii/3.4.1: 1 sentence (may) - EU Machinery Regulation
EU15 sentences; text first observedno clause anchor before this sentence: 3 sentences (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-i/article-7/3: 1 sentence (shall) ·annex-iii/part-b/5: 10 sentences (shall) - EU MDR
EU6 sentences; text first observedchapter-ii/article-23/1: 1 sentence (shall) ·chapter-ii/article-23/2: 1 sentence (shall) ·annex-i/chapter-ii: 1 sentence (shall) ·annex-vi/part-c/3.6: 1 sentence (shall) ·annex-vi/part-c/6.4.5: 1 sentence (shall) ·annex-vii/3.4.1: 1 sentence (may) - EU NIS2 Directive
EU1 sentence; text first observedno clause anchor before this sentence: 1 sentence (should, may) - FDA AI guidance
US1 sentence; text first observed7: 1 sentence (should, may) - FDA device cybersecurity (2026)
US8 sentences; text first observed6: 8 sentences (should, may) - FDA electronic systems (clinical)
US2 sentences; text first observedno clause anchor before this sentence: 2 sentences (should, may, must) - ICH Q2(R2)
International1 sentence; text first observedid repeats in this text: 1 sentence (may) - NIST AI 600-1
US2 sentences; text first observed12: 2 sentences (may) - 21 CFR Part 11
US1 sentence; text first observedno numbering read: 1 sentence (shall) - 21 CFR Part 211
US17 sentences; text first observedno numbering read: 17 sentences (shall, 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
79 occurrences in 17 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.
- EMA CT computerised systems
EU1 occurrence; text first observed1 where the heading before it is withheld - EU AI Act
EU1 occurrence; text first observedannex-iv/1: 1 - EU Cyber Resilience Act
EU2 occurrences; text first observed2 where no heading is read before it - Regulation (EU) 2026/1744
EU3 occurrences; text first observedarticle-1/5: 1 · 2 where no heading is read before it - EU GMP Annex 1
EU3 occurrences; text first observedannex-1/11: 3 - EU GMP Annex 11 (draft)
EU1 occurrence; text first observed17.5: 1 - EU GMP Annex 14
EU4 occurrences; text first observed10: 4 - EU GMP Annex 2
EU1 occurrence; text first observed36: 1 - EU Machinery Regulation
EU4 occurrences; text first observedannex-iii/part-b/5: 2 ·chapter-i/article-7/2: 2 - FDA device cybersecurity (2026)
US4 occurrences; text first observed6: 4 - FDA electronic systems (clinical)
US1 occurrence; text first observed1 where no heading is read before it - Health Canada ML
Canada3 occurrences; text first observed3 where no numbering read in this text - ICH Q9(R1)
International3 occurrences; text first observed8: 3 - NIST AI 600-1
US37 occurrences; text first observed12: 36 ·3: 1 - NIST AI RMF
International1 occurrence; text first observed1 where no heading is read before it - NISTIR 8183
US9 occurrences; text first observed7: 9 - 21 CFR Part 211
US1 occurrence; text first observed1 where no numbering read in this text
Co-occurrence
189 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. 49 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).
- accreditation 1 clause:
eu-machinery-regulationchapter-i/article-3 - Act 3 clauses:
eu-digital-omnibus-aiarticle-3;fda-ai-guidance7;fda-device-cybersecurity-20266 - actively exploited vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - adverse event 2 clauses:
eu-gmp-annex-1410;eu-gmp-annex-236 - Agency 4 clauses:
eu-gmp-annex-1410;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112 - aggregate 1 clause:
nist-ai-600-112 - AI literacy 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1 - AI Office 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/5 - AI regulatory sandbox 1 clause:
eu-ai-actchapter-i/article-3 - AI system 7 clauses:
eu-ai-actannex-iv/1·chapter-i/article-3·chapter-iii/section-1/article-6/1;eu-digital-omnibus-aiarticle-1·article-1/5;nist-ai-600-112·3 - allow-list 1 clause:
fda-device-cybersecurity-20266 - Application 5 clauses:
eu-gmp-annex-11-draft17.5;eu-machinery-regulationannex-iii/part-b/5;fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - assurance level 1 clause:
eu-gmp-annex-1annex-1/11 - authorised representative 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - biometric categorisation system 1 clause:
eu-ai-actchapter-i/article-3 - biometric data 1 clause:
eu-ai-actchapter-i/article-3 - biometric identification 1 clause:
eu-ai-actchapter-i/article-3 - biometric verification 1 clause:
eu-ai-actchapter-i/article-3 - Carrier 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - CE marking 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - chains 5 clauses:
eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;ich-q9r18;nist-ai-600-112 - clinical benefit 1 clause:
eu-mdrannex-i/chapter-ii - clinical investigation 1 clause:
fda-ai-guidance7 - Closed system 2 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-236 - common specification 1 clause:
eu-ai-actchapter-i/article-3 - conformity assessment 10 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-6/1;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/5;eu-ivdrannex-vii/3.4.1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-vii/3.4.1;nist-ai-600-112 - conformity assessment body 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/5;eu-machinery-regulationchapter-i/article-3 - consumer 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;nist-ai-600-112;nistir-81837 - corrective action 2 clauses:
eu-gmp-annex-1annex-1/11;fda-device-cybersecurity-20266 - critical infrastructure 3 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112;nistir-81837 - CSIRT designated as coordinator 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - cyber threat 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;fda-device-cybersecurity-20266 - cybersecurity 6 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/5;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - cybersecurity risk 5 clauses:
eu-cyber-resilience-actchapter-i/article-3;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - danger zone 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 2 clauses:
eu-ai-actannex-iv/1·chapter-i/article-3 - device software function 1 clause:
fda-device-cybersecurity-20266 - distributor 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - downstream provider 1 clause:
eu-ai-actchapter-i/article-3 - Driver 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Dynamic test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - economic operator 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - electronic information system 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - Electronic record 1 clause:
eu-gmp-annex-11-draft17.5 - emotion recognition system 1 clause:
eu-ai-actchapter-i/article-3 - end-point 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-ii/article-13/6;eu-gmp-annex-236;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - essential health and safety requirements 3 clauses:
eu-digital-omnibus-aiarticle-3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - European standard 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - exploitable vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - floating-point operation 1 clause:
eu-ai-actchapter-i/article-3 - free and open-source software 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - general-purpose AI model 1 clause:
eu-ai-actchapter-i/article-3 - general-purpose AI system 1 clause:
eu-ai-actchapter-i/article-3 - guard 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 9 clauses:
eu-ai-actannex-iv/1;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/6;eu-gmp-annex-11-draft17.5;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - Harm 2 clauses:
fda-device-cybersecurity-20266;nist-ai-600-112 - harmonised standard 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Hazard / hazard 4 clauses:
eu-gmp-annex-1annex-1/11;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;ich-q9r18 - Hazard Identification 1 clause:
ich-q9r18 - high-impact capabilities 1 clause:
eu-ai-actchapter-i/article-3 - identity management 1 clause:
fda-device-cybersecurity-20266 - importer 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - incident 7 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - incident handling 1 clause:
nistir-81837 - indirect connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - informed consent 3 clauses:
eu-ai-actchapter-i/article-3;fda-device-cybersecurity-20266;nist-ai-600-112 - input data 3 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112·3 - instructions for use 6 clauses:
eu-ai-actannex-iv/1·chapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii - intended purpose 12 clauses:
eu-ai-actannex-iv/1·chapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1;eu-gmp-annex-1410;eu-ivdrchapter-ii/article-20/1·chapter-ii/article-20/2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-ii·chapter-ii/article-23/1·chapter-ii/article-23/2;nist-ai-600-112 - intended use 8 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nist-ai-600-112 - interchangeable equipment 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - international standard 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11 - label 3 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrannex-i/chapter-ii;nist-ai-600-112 - law enforcement 1 clause:
eu-ai-actchapter-i/article-3 - law enforcement authority 1 clause:
eu-ai-actchapter-i/article-3 - lay person 1 clause:
eu-mdrannex-i/chapter-ii - lifetime 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - lifting accessory 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Lifting operation 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - logical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - machinery 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - making available on the market 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - manufacturer 12 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/5;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - market surveillance 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - market surveillance authority 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - medical device 3 clauses:
eu-gmp-annex-1410;fda-ai-guidance7;fda-device-cybersecurity-20266 - Metadata 1 clause:
nist-ai-600-112 - micro, small and medium-sized enterprise 1 clause:
eu-digital-omnibus-aiarticle-1 - national accreditation body 1 clause:
eu-machinery-regulationchapter-i/article-3 - national competent authority 3 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-1410;eu-gmp-annex-236 - near miss 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - non-personal data 1 clause:
eu-ai-actchapter-i/article-3 - non-viable 2 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrannex-i/chapter-ii - notified body 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/5;eu-ivdrannex-vii/3.4.1;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-vii/3.4.1 - notifying authority 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/5 - open-source software steward 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - operator 9 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - particle 1 clause:
eu-gmp-annex-1annex-1/11 - partly completed machinery 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - performance 17 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17.5;eu-gmp-annex-236;eu-ivdrannex-vii/3.4.1·chapter-ii/article-20/1·chapter-ii/article-20/2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-vii/3.4.1·chapter-ii/article-23/1·chapter-ii/article-23/2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nist-ai-600-112;nistir-81837 - performance of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - personal data 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1;nist-ai-600-112 - physical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - placing on the market 5 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-6/1;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - post-market monitoring system 1 clause:
eu-ai-actchapter-i/article-3 - post-remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - Product Lifecycle 2 clauses:
fda-ai-guidance7;ich-q9r18 - product with digital elements 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/6 - professional user 1 clause:
eu-machinery-regulationchapter-i/article-3 - profiling 1 clause:
eu-ai-actchapter-i/article-3 - protective device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - provider 6 clauses:
eu-ai-actannex-iv/1·chapter-i/article-3;eu-digital-omnibus-aiarticle-1/5;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 4 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-6/1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Quality 7 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-gmp-annex-236;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nistir-81837 - Quality Risk Management 3 clauses:
eu-gmp-annex-1annex-1/11;fda-ai-guidance7;ich-q9r18 - Quality System 4 clauses:
eu-gmp-annex-1annex-1/11;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - real-time remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - real-world testing plan 1 clause:
eu-ai-actchapter-i/article-3 - reasonably foreseeable misuse 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266 - reasonably foreseeable use 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - recall 7 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-236;eu-machinery-regulationchapter-i/article-3;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - recall of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - remote data processing 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - removable mechanical transmission device 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - representative 10 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - reprocessing 1 clause:
eu-gmp-annex-1410 - Requirements 5 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;nistir-81837 - Risk / risk 18 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-6/1;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1·article-1/5·article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nist-ai-600-112·3;nistir-81837 - Risk Acceptance 1 clause:
ich-q9r18 - Risk Analysis 1 clause:
ich-q9r18 - Risk Assessment 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nistir-81837 - Risk Control 1 clause:
ich-q9r18 - Risk Evaluation 1 clause:
ich-q9r18 - Risk Management 7 clauses:
eu-gmp-annex-1annex-1/11;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nist-ai-600-112·3;nistir-81837 - Risk Reduction 1 clause:
ich-q9r18 - Risk Review 1 clause:
ich-q9r18 - ropes 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - safety component 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-6/1;eu-digital-omnibus-aiarticle-1·article-1/5·article-3;eu-machinery-regulationchapter-i/article-3·chapter-i/article-7/2·chapter-i/article-7/3 - safety function 4 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - sandbox plan 1 clause:
eu-ai-actchapter-i/article-3 - sensitive operational data 1 clause:
eu-ai-actchapter-i/article-3 - serious adverse event 2 clauses:
eu-gmp-annex-1410;eu-gmp-annex-236 - serious incident 1 clause:
eu-ai-actchapter-i/article-3 - significant cybersecurity risk 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;fda-device-cybersecurity-20266 - small mid-cap enterprise 1 clause:
eu-digital-omnibus-aiarticle-1 - SMC 1 clause:
eu-digital-omnibus-aiarticle-1 - SME 1 clause:
eu-digital-omnibus-aiarticle-1 - software 12 clauses:
eu-ai-actannex-iv/1;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/6;eu-gmp-annex-11-draft17.5;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nistir-81837 - software bill of materials 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - source code 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3;fda-device-cybersecurity-20266 - special categories of personal data 1 clause:
eu-ai-actchapter-i/article-3 - sponsor 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Stakeholder 1 clause:
nist-ai-600-112 - standard 10 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nist-ai-600-112 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 11 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nist-ai-600-112·3 - substantial modification 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - Supervisor 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5 - Supervisory function 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - support period 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - System / system 20 clauses:
eu-ai-actannex-iv/1·chapter-i/article-3·chapter-iii/section-1/article-6/1;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1·article-1/5;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17.5;eu-gmp-annex-1410;eu-gmp-annex-236;eu-gmp-annex-640;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nist-ai-600-112·3;nistir-81837 - systemic risk 1 clause:
eu-ai-actchapter-i/article-3 - technical specifications 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - Test coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - testing data 2 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-1annex-1/11 - testing in real-world conditions 1 clause:
eu-ai-actchapter-i/article-3 - training data 4 clauses:
eu-ai-actchapter-i/article-3;fda-ai-guidance7;nist-ai-600-112·3 - UDI 4 clauses:
eu-ivdrannex-vi/part-c/3.6;eu-mdrannex-vi/part-c/3.6·annex-vi/part-c/6.4.5;fda-device-cybersecurity-20266 - Union harmonisation legislation 7 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-6/1;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1·article-1/5;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - user 11 clauses:
eu-ai-actannex-iv/1;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17.5;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nistir-81837 - validation data 1 clause:
eu-ai-actchapter-i/article-3 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 5 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/6;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - webbing 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - widespread infringement 1 clause:
eu-ai-actchapter-i/article-3 - withdrawal 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1410;eu-machinery-regulationchapter-i/article-3 - withdrawal of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - Working coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - written 9 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;nist-ai-600-112·3
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 |
|---|---|---|---|---|
90f72782b398 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
ebaf707c409d (current) | 0 | 2 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 0 | 6 | 1 | |
9d16077b1d3b (current) | 0 | 6 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 1 | 6 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92eb86f25281 (current) | 0 | 5 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2f3d52a59156 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
1d99797d3b8b (current) | 0 | 9 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
0e885238d69a unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
7a8b8a6e95d5 (current) | 0 | 0 | 1 |
| 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 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
50a728365a3b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
db59da980bed (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
053f731102ad unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c1a1d8a7fee4 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
10131cf8966a unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
1787513e049d (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 4 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 15 | 4 | |
82fb682a6c54 (current) | 0 | 15 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 0 | 6 | 0 | |
fab624c8e1dc (current) | 0 | 6 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
023dc18395dc (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
61d4603ff66e | 0 | 0 | 0 | |
088a7a37c55d | 0 | 0 | 0 | |
630bd27c7b42 | 0 | 0 | 0 | |
5c61f4c6351d (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 8 | 4 |
| 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 | 8 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06b24bf9ebcb unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
74c586849092 (current) | 0 | 2 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2988351a1019 | 0 | 0 | 3 | |
f34e637e74cb (current) | 0 | 0 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
bb656b9e84a8 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
57c484f5daed (current) | 0 | 0 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5ad5867c187 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
caa03fc84948 (current) | 0 | 2 | 37 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 0 | |
c240f2675bd3 | 0 | 0 | 0 | |
4c10dc03228b (current) | 0 | 0 | 1 |
| 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 | 0 | 9 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f0554d5c3fab | 0 | 1 | 0 | |
6a4d277ca4f8 | 0 | 1 | 0 | |
95bf4a66f2d4 | 0 | 1 | 0 | |
98ed07f87cdd | 0 | 1 | 0 | |
15f94377c4fc | 0 | 1 | 0 | |
9269c75204ff | 0 | 1 | 0 | |
4d93ac00b602 | 0 | 1 | 0 | |
825750c5633d | 0 | 1 | 0 | |
39db0dd17f53 | 0 | 1 | 0 | |
244eba4196bb | 0 | 1 | 0 | |
605180a389c7 | 0 | 1 | 0 | |
ed1c9acbb776 | 0 | 1 | 0 | |
bbbd805d0905 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
393b48f902b8 | 0 | 17 | 1 | |
5997ebbb6661 | 0 | 17 | 1 | |
9d7b6d9aa4e1 | 0 | 17 | 1 | |
18e04a0c925a | 0 | 17 | 1 | |
1e7f13684129 | 0 | 17 | 1 | |
f24b92ecdf42 | 0 | 17 | 1 | |
b670ac9656b7 | 0 | 17 | 1 | |
bc527e48bcd8 | 0 | 17 | 1 | |
4edb9480421c | 0 | 17 | 1 | |
cd3e1c0c936b | 0 | 17 | 1 | |
75605421c92f (current) | 0 | 17 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8b8ac787c687 | 1 | 0 | 0 | |
fa65ecef3a81 | 1 | 0 | 0 | |
8ee8e1aad0a5 | 1 | 0 | 0 | |
f3605b69e136 | 1 | 0 | 0 | |
baa155d883e3 | 1 | 0 | 0 | |
ac6e97a3c75d | 1 | 0 | 0 | |
bb66b9cbb2c4 | 1 | 0 | 0 | |
0e1bbcb2d14d | 1 | 0 | 0 | |
0eb9eade1868 | 1 | 0 | 0 | |
94a77d5625e8 | 1 | 0 | 0 | |
ca64082d7f23 (current) | 1 | 0 | 0 |
Feed
/atom/term/component.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 |
|---|---|---|---|---|
| EU Cyber Resilience Act | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU MDR | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU GMP Annex 22 | 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 NIS2 Directive | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| FDA electronic systems (clinical) | true | open | true | true |
| Regulation (EU) 2026/1744 | true | open | true | true |
| ICH Q13 | true | open | true | true |
| EU GMP Chapter 4 | 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: