standard
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 2 definitions in this view are quoted and 2 are withheld with the reason. No reading here says that two of them agree or differ.
EU
- Defined in
- EU Cybersecurity Act
title-i/article-2(19): text withheld (over the cap: its term and text are 17 words)EU NIS2 Directivechapter-i/article-6(16): text withheld (over the cap: its term and text are 28 words) - Rows printing it in a normative sentence
- 17
- Rows printing it in a title
- 0
- Rows printing it in body
- 10
International
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 3
- Rows printing it in a title
- 0
- Rows printing it in body
- 4
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 4
- Rows printing it in a title
- 0
- Rows printing it in body
- 8
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
standard (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
2 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 Cybersecurity Act
EUtext first observedtitle-i/article-2(19)standard: text withheld (over the cap: its term and text are 17 words)
- EU NIS2 Directive
EUtext first observedchapter-i/article-6(16)standard: text withheld (over the cap: its term and text are 28 words)
In normative sentences
103 sentences in 24 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
EU8 sentences; text first observedid repeats in this text: 1 sentence (should) · follows a withheld heading: 5 sentences (should) · id repeats in this text: 2 sentences (should) - EMA data quality framework
EU4 sentences; text first observed10: 4 sentences (may, should) - DI revision concept paper
International1 sentence; text first observedno numbering read: 1 sentence (must) - EU AI Act
EU15 sentences; text first observedno clause anchor before this sentence: 5 sentences (may, should) ·chapter-i/article-3: 1 sentence (may, shall) ·chapter-iii/section-5/article-41/1: 1 sentence (may, is expected) ·chapter-iii/section-5/article-41/4: 2 sentences (shall) ·chapter-iii/section-5/article-43/1: 1 sentence (shall) ·chapter-iv/article-50/2: 1 sentence (shall) ·chapter-v/section-2/article-53/4: 2 sentences (may, shall) ·chapter-v/section-3/article-55/2: 2 sentences (may, shall) - EU Cyber Resilience Act
EU7 sentences; text first observedno clause anchor before this sentence: 2 sentences (should, is expected) ·chapter-i/article-3: 1 sentence (may) ·chapter-iii/article-27/2: 1 sentence (shall, is expected) ·chapter-iii/article-27/6: 2 sentences (shall) ·annex-viii/part-iv/3.3: 1 sentence (shall) - EU Cybersecurity Act
EU2 sentences; text first observedtitle-iv/article-69/19: 1 sentence (shall) ·title-iv/article-69/20: 1 sentence (shall) - EU GMP Annex 1
EU1 sentence; text first observedannex-1/11: 1 sentence (should) - EU GMP Annex 11 (draft)
EU1 sentence; text first observed17: 1 sentence (should) - EU GMP Annex 12
EU1 sentence; text first observed5: 1 sentence (should) - EU GMP Annex 13
EU1 sentence; text first observed6.6: 1 sentence (should, may) - EU GMP Annex 14
EU1 sentence; text first observed10: 1 sentence (should) - EU GMP Annex 15
EU2 sentences; text first observed3.12: 1 sentence (should) ·5.20: 1 sentence (may) - EU GMP Annex 6
EU1 sentence; text first observed17: 1 sentence (should) - EU GMP Chapter 6
EU1 sentence; text first observedpart-1: 1 sentence (should) - EU IVDR
EU17 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·chapter-i/section-1/article-2: 1 sentence (shall, may) ·chapter-ii/article-5/5: 1 sentence (shall) ·chapter-iv/article-46: 1 sentence (shall) ·chapter-vi/article-60/1: 1 sentence (may) ·chapter-vi/article-61/1: 1 sentence (may, shall) ·chapter-vi/article-64/1: 1 sentence (may) ·chapter-vii/section-2/article-86: 1 sentence (may) ·chapter-viii/article-100/5: 1 sentence (shall) ·annex-ii/4: 1 sentence (shall) ·annex-vi/part-c/3.8: 1 sentence (shall) ·annex-vi/part-c/4.9: 1 sentence (shall) ·annex-vi/part-c/6.2.4: 1 sentence (shall) ·annex-vii/4.6: 1 sentence (shall) ·annex-ix/chapter-i/2.3: 2 sentences (shall) ·annex-xiii/part-a/1.2.2: 1 sentence (may) - EU Machinery Regulation
EU11 sentences; text first observedno clause anchor before this sentence: 3 sentences (should, is expected) ·chapter-i/article-3: 1 sentence (may) ·chapter-iii/article-20/3: 1 sentence (shall, is expected) ·chapter-iii/article-20/7: 2 sentences (shall) ·annex-iii/part-b/5: 2 sentences (shall) ·annex-ix/3.3: 1 sentence (shall) ·annex-x/4: 1 sentence (shall) - EU MDR
EU12 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·chapter-i/article-2: 1 sentence (shall, may) ·chapter-iv/article-50: 1 sentence (shall) ·chapter-vi/article-68/1: 1 sentence (may) ·chapter-vii/section-2/article-91: 1 sentence (may) ·annex-ii/4: 1 sentence (shall) ·annex-vi/part-c/3.8: 1 sentence (shall) ·annex-vi/part-c/4.9: 1 sentence (shall) ·annex-vi/part-c/6.5.4: 1 sentence (shall) ·annex-vii/4.6: 1 sentence (shall) ·annex-ix/chapter-i/2.3: 1 sentence (shall) ·annex-xi/part-b: 1 sentence (shall) - EU NIS2 Directive
EU1 sentence; text first observedchapter-i/article-6: 1 sentence (may) - FDA device cybersecurity (2026)
US4 sentences; text first observed6: 4 sentences (should, may) - FDA electronic systems (clinical)
US2 sentences; text first observedno clause anchor before this sentence: 2 sentences (should, may) - ICH Q2(R2)
International6 sentences; text first observedannex-2/2.3: 1 sentence (should) ·annex-2/3.3.2.4: 1 sentence (should) · id repeats in this text: 4 sentences (may, should) - NIST AI 600-1
US1 sentence; text first observed12: 1 sentence (may) - NIST AI RMF
International1 sentence; text first observed6: 1 sentence (may) - 21 CFR Part 211
US2 sentences; text first observedno numbering read: 2 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
69 occurrences in 22 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 - EMA data quality framework
EU23 occurrences; text first observed10: 23 - EU Cyber Resilience Act
EU1 occurrence; text first observed1 where no heading is read before it - EU Cybersecurity Act
EU1 occurrence; text first observedtitle-i/article-2: 1 - EU GMP Annex 1
EU4 occurrences; text first observedannex-1/11: 4 - EU GMP Annex 15
EU1 occurrence; text first observed12: 1 - EU IVDR
EU2 occurrences; text first observedannex-vi/part-c/1: 1 ·annex-xiii/part-a/1.2.2: 1 - EU Machinery Regulation
EU1 occurrence; text first observedannex-v/part-b/6: 1 - EU MDR
EU1 occurrence; text first observedannex-vi/part-c/1: 1 - EU NIS2 Directive
EU1 occurrence; text first observed1 where no heading is read before it - FDA AI guidance
US3 occurrences; text first observed7: 3 - FDA device cybersecurity (2026)
US4 occurrences; text first observed6: 4 - FDA electronic systems (clinical)
US3 occurrences; text first observed3 where no heading is read before it - FDA ETP
US1 occurrence; text first observed1 where no numbering read in this text - FDA Part 11 scope
US1 occurrence; text first observed1 where no numbering read in this text - ICH Q13
International1 occurrence; text first observed1 where the heading before it is withheld - ICH Q14
International4 occurrences; text first observed13.2: 4 - ICH Q2(R2)
International11 occurrences; text first observedannex-2/3.2.3.3: 6 ·annex-2/4: 2 · 3 where the heading before it is withheld - ICH Q9(R1)
International1 occurrence; text first observed8: 1 - NIST agent standards
US1 occurrence; text first observed1 where no numbering read in this text - NIST AI 600-1
US2 occurrences; text first observed12: 2 - 21 CFR Part 820 (QMSR)
US1 occurrence; text first observed1 where no numbering read in this text
Co-occurrence
280 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. 43 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).
- accessory for a medical device 1 clause:
eu-mdrchapter-i/article-2 - accessory for an in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - accreditation 5 clauses:
eu-cybersecurity-acttitle-i/article-2·title-iv/article-69/19·title-iv/article-69/20;eu-ivdrchapter-ii/article-5/5;eu-machinery-regulationchapter-i/article-3 - Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - active device 1 clause:
eu-mdrchapter-i/article-2 - actively exploited vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - adverse event 4 clauses:
ema-data-quality-framework10;eu-gmp-annex-1410;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Agency 5 clauses:
ema-data-quality-framework10;eu-gmp-annex-1410;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112 - agglomerate 1 clause:
eu-mdrchapter-i/article-2 - aggregate 2 clauses:
eu-mdrchapter-i/article-2;nist-ai-600-112 - AI literacy 1 clause:
eu-ai-actchapter-i/article-3 - AI Office 1 clause:
eu-ai-actchapter-i/article-3 - AI regulatory sandbox 1 clause:
eu-ai-actchapter-i/article-3 - AI system 5 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1·chapter-iv/article-50/2;nist-ai-600-112;nist-ai-rmf6 - allow-list 1 clause:
fda-device-cybersecurity-20266 - analytical performance 2 clauses:
eu-ivdrannex-xiii/part-a/1.2.2·chapter-i/section-1/article-2 - Application 6 clauses:
eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-vi/part-c/6.5.4·annex-xi/part-b;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-rmf6 - assurance level 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11 - authorised representative 9 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrannex-xi/part-b·chapter-i/article-2 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - benefit-risk determination 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - 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 - calibrator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Carrier 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - CE marking 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - CE marking of conformity 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - chains 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;ich-q9r18;nist-ai-600-112 - clinical benefit 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical data 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical evaluation 2 clauses:
eu-mdrannex-vii/4.6·chapter-i/article-2 - clinical evidence 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical investigation 3 clauses:
eu-mdrchapter-i/article-2·chapter-vi/article-68/1;fda-ai-guidance7 - clinical investigation plan 2 clauses:
eu-mdrchapter-i/article-2·chapter-vi/article-68/1 - clinical performance 4 clauses:
eu-ivdrannex-xiii/part-a/1.2.2·chapter-i/section-1/article-2·chapter-vi/article-64/1;eu-mdrchapter-i/article-2 - Closed system 1 clause:
eu-gmp-annex-1annex-1/11 - cloud computing service 1 clause:
eu-nis2chapter-i/article-6 - common specification 3 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationannex-v/part-b/6·annex-x/4 - companion diagnostic 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Component / component 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 - conformity assessment 15 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2·title-iv/article-69/19·title-iv/article-69/20;eu-ivdrannex-vii/4.6·chapter-i/section-1/article-2·chapter-iv/article-46;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-vii/4.6·chapter-i/article-2·chapter-iv/article-50;nist-ai-600-112 - conformity assessment body 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - conformity self-assessment 1 clause:
eu-cybersecurity-acttitle-i/article-2 - consumer 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;nist-ai-600-112 - content delivery network 1 clause:
eu-nis2chapter-i/article-6 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 4 clauses:
eu-gmp-annex-1annex-1/11;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266 - critical infrastructure 2 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112 - CSIRT designated as coordinator 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - custom-made device 1 clause:
eu-mdrchapter-i/article-2 - cyber threat 4 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266 - cybersecurity 9 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-iii/article-27/2·chapter-iii/article-27/6;eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6 - cybersecurity risk 6 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6 - danger zone 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - data centre service 1 clause:
eu-nis2chapter-i/article-6 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iv/article-50/2 - derivative 2 clauses:
eu-mdrannex-xi/part-b·chapter-i/article-2 - device deficiency 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - device for near-patient testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device software function 1 clause:
fda-device-cybersecurity-20266 - diagnostic sensitivity 1 clause:
eu-ivdrchapter-i/section-1/article-2 - diagnostic specificity 1 clause:
eu-ivdrchapter-i/section-1/article-2 - digital service 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - digital service provider 1 clause:
eu-cybersecurity-acttitle-i/article-2 - distributor 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - DNS 1 clause:
eu-nis2chapter-i/article-6 - DNS service provider 1 clause:
eu-nis2chapter-i/article-6 - domain name system 1 clause:
eu-nis2chapter-i/article-6 - 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 4 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - electronic communications service 1 clause:
eu-nis2chapter-i/article-6 - electronic information system 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - 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 7 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-ivdrchapter-ii/article-5/5;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - entity providing domain name registration services 1 clause:
eu-nis2chapter-i/article-6 - essential health and safety requirements 6 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·annex-x/4·chapter-i/article-3·chapter-iii/article-20/3·chapter-iii/article-20/7 - ethics committee 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - European cybersecurity certificate 1 clause:
eu-cybersecurity-acttitle-i/article-2 - European cybersecurity certification scheme 1 clause:
eu-cybersecurity-acttitle-i/article-2 - European standard 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - exploitable vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - falsified device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - field safety corrective action 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - field safety notice 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - 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 - fully refurbishing 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - general-purpose AI model 1 clause:
eu-ai-actchapter-i/article-3 - general-purpose AI system 1 clause:
eu-ai-actchapter-i/article-3 - generic device group 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - 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 5 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;nist-ai-600-112 - Harm 2 clauses:
fda-device-cybersecurity-20266;nist-ai-600-112 - harmonised standard 22 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-41/1·chapter-iii/section-5/article-41/4·chapter-iii/section-5/article-43/1·chapter-v/section-2/article-53/4·chapter-v/section-3/article-55/2;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3·chapter-iii/article-27/2·chapter-iii/article-27/6;eu-ivdrannex-ii/4·annex-ix/chapter-i/2.3·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·annex-x/4·chapter-i/article-3·chapter-iii/article-20/3·chapter-iii/article-20/7;eu-mdrannex-ii/4·annex-ix/chapter-i/2.3·chapter-i/article-2 - 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 - health institution 3 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-5/5;eu-mdrchapter-i/article-2 - high-impact capabilities 1 clause:
eu-ai-actchapter-i/article-3 - ICT process 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - ICT product 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - ICT service 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - identity management 1 clause:
fda-device-cybersecurity-20266 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - incident 12 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-2/article-86;eu-mdrchapter-i/article-2·chapter-vii/section-2/article-91;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112 - incident handling 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - indirect connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - informed consent 9 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-mdrchapter-i/article-2·chapter-vi/article-68/1;fda-device-cybersecurity-20266;nist-ai-600-112 - input data 5 clauses:
eu-ai-actchapter-i/article-3·chapter-iv/article-50/2;ich-q1413.2;ich-q2r2annex-2/4;nist-ai-600-112 - instructions for use 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - intended purpose 17 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-ivdrannex-ii/4·annex-ix/chapter-i/2.3·annex-vi/part-c/1·chapter-i/section-1/article-2·chapter-ii/article-5/5;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-ii/4·annex-ix/chapter-i/2.3·annex-vi/part-c/1·chapter-i/article-2;ich-q1413.2;ich-q2r2annex-2/4;nist-ai-600-112 - intended use 10 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-chapter-6part-1;eu-machinery-regulationannex-iii/part-b/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q2r2annex-2/2.3;ich-q9r18;nist-ai-600-112 - interchangeable equipment 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - international standard 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-125 - internet exchange point 1 clause:
eu-nis2chapter-i/article-6 - interventional clinical performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - invasive device 1 clause:
eu-mdrchapter-i/article-2 - investigational device 1 clause:
eu-mdrchapter-i/article-2 - investigator 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-mdrchapter-i/article-2·chapter-vi/article-68/1 - kit 1 clause:
eu-ivdrchapter-i/section-1/article-2 - label 9 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-136.6;eu-gmp-annex-617;eu-gmp-chapter-6part-1;eu-ivdrannex-vi/part-c/4.9·chapter-i/section-1/article-2;eu-mdrannex-vi/part-c/4.9·chapter-i/article-2;nist-ai-600-112 - large-scale cybersecurity incident 1 clause:
eu-nis2chapter-i/article-6 - law enforcement 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1 - law enforcement authority 1 clause:
eu-ai-actchapter-i/article-3 - lay person 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - lifetime 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - 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 - likelihood ratio 1 clause:
eu-ivdrchapter-i/section-1/article-2 - logical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - machinery 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·annex-x/4·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 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - managed security service provider 1 clause:
eu-nis2chapter-i/article-6 - managed service provider 1 clause:
eu-nis2chapter-i/article-6 - manufacturer 28 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-chapter-6part-1;eu-ivdrannex-ix/chapter-i/2.3·annex-vi/part-c/1·annex-vi/part-c/3.8·annex-vi/part-c/4.9·annex-vii/4.6·annex-xiii/part-a/1.2.2·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·annex-x/4·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·annex-vi/part-c/1·annex-vi/part-c/3.8·annex-vi/part-c/4.9·annex-vii/4.6·annex-xi/part-b·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266 - market surveillance 9 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-2/article-86;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-xi/part-b·chapter-i/article-2·chapter-vii/section-2/article-91 - market surveillance authority 4 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - medical device 5 clauses:
eu-gmp-annex-1410;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266 - Metadata 2 clauses:
ema-data-quality-framework10;nist-ai-600-112 - nanomaterial 1 clause:
eu-mdrchapter-i/article-2 - national accreditation body 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-machinery-regulationchapter-i/article-3 - national competent authority 2 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-1410 - national cybersecurity certification scheme 1 clause:
eu-cybersecurity-acttitle-i/article-2 - national cybersecurity strategy 1 clause:
eu-nis2chapter-i/article-6 - national strategy on the security of network and information systems 1 clause:
eu-cybersecurity-acttitle-i/article-2 - near miss 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-nis2chapter-i/article-6 - negative predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - network and information system 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - non-personal data 1 clause:
eu-ai-actchapter-i/article-3 - non-viable 2 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrchapter-i/article-2 - notified body 14 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrannex-ix/chapter-i/2.3·annex-vii/4.6·chapter-i/section-1/article-2;eu-machinery-regulationannex-ix/3.3·annex-x/4·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·annex-vii/4.6·annex-xi/part-b·chapter-i/article-2 - notifying authority 2 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3 - online marketplace 1 clause:
eu-nis2chapter-i/article-6 - online search engine 1 clause:
eu-nis2chapter-i/article-6 - open-source software steward 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - operator 12 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-153.12;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6 - operator of essential services 1 clause:
eu-cybersecurity-acttitle-i/article-2 - particle 4 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-1512;eu-mdrchapter-i/article-2;ich-q1413.2 - partly completed machinery 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - performance 24 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1512;eu-gmp-chapter-6part-1;eu-ivdrannex-ii/4·annex-vii/4.6·annex-xiii/part-a/1.2.2·chapter-i/section-1/article-2·chapter-ii/article-5/5·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-ii/4·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q2r2annex-2/4;ich-q9r18;nist-ai-600-112;nist-ai-rmf6 - performance evaluation 2 clauses:
eu-ivdrannex-vii/4.6·chapter-i/section-1/article-2 - performance of a device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - performance of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - performance study 5 clauses:
eu-ivdrannex-xiii/part-a/1.2.2·chapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1 - performance study plan 2 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-64/1 - personal data 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;nist-ai-600-112 - physical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - placing on the market 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - positive predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - post-market monitoring system 1 clause:
eu-ai-actchapter-i/article-3 - post-market surveillance 5 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-2/article-86;eu-mdrannex-xi/part-b·chapter-i/article-2·chapter-vii/section-2/article-91 - post-remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - procedure pack 1 clause:
eu-mdrchapter-i/article-2 - Product Lifecycle 3 clauses:
fda-ai-guidance7;ich-q1413.2;ich-q9r18 - product with digital elements 2 clauses:
eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3 - professional user 2 clauses:
eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - profiling 1 clause:
eu-ai-actchapter-i/article-3 - protective device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - provider 8 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-11-draft17;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112 - public administration entity 1 clause:
eu-nis2chapter-i/article-6 - public electronic communications network 1 clause:
eu-nis2chapter-i/article-6 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 5 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - qualified trust service 1 clause:
eu-nis2chapter-i/article-6 - qualified trust service provider 1 clause:
eu-nis2chapter-i/article-6 - Quality 10 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-chapter-6part-1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r18 - Quality Risk Management 5 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;fda-ai-guidance7;ich-q1413.2;ich-q9r18 - Quality System 7 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;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 8 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2;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 23 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-chapter-6part-1;eu-ivdrannex-ix/chapter-i/2.3·chapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·annex-xi/part-b·chapter-i/article-2·chapter-vi/article-68/1;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;nist-ai-600-112 - reprocessing 3 clauses:
eu-gmp-annex-1410;eu-gmp-chapter-6part-1;eu-mdrchapter-i/article-2 - Requirements 6 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266 - research organisation 1 clause:
eu-nis2chapter-i/article-6 - Risk / risk 24 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1·chapter-v/section-3/article-55/2;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-chapter-6part-1;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2·chapter-vi/article-68/1;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r18;nist-ai-600-112;nist-ai-rmf6 - Risk Acceptance 1 clause:
ich-q9r18 - Risk Analysis 1 clause:
ich-q9r18 - Risk Assessment 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - Risk Control 1 clause:
ich-q9r18 - Risk Evaluation 1 clause:
ich-q9r18 - Risk Management 8 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r18;nist-ai-600-112;nist-ai-rmf6 - 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 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - safety function 3 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - sandbox plan 1 clause:
eu-ai-actchapter-i/article-3 - scientific validity of an analyte 1 clause:
eu-ivdrchapter-i/section-1/article-2 - security of network and information systems 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - sensitive operational data 1 clause:
eu-ai-actchapter-i/article-3 - serious adverse event 3 clauses:
eu-gmp-annex-1410;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious incident 3 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious public health threat 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - significant cyber threat 1 clause:
eu-nis2chapter-i/article-6 - significant cybersecurity risk 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;fda-device-cybersecurity-20266 - single-use device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - SME 2 clauses:
eu-gmp-annex-11-draft17;nist-ai-rmf6 - social networking services platform 1 clause:
eu-nis2chapter-i/article-6 - software 16 clauses:
ema-data-quality-framework10;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;eu-ivdrannex-vi/part-c/1·annex-vi/part-c/6.2.4·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-vi/part-c/1·annex-vi/part-c/6.5.4·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;nist-ai-600-112;nist-ai-rmf6 - 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 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266 - Stakeholder 1 clause:
nist-ai-600-112 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 23 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-chapter-6part-1;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-xi/part-b·chapter-i/article-2·chapter-vi/article-68/1;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r18;nist-ai-600-112;nist-ai-rmf6 - 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 33 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1·chapter-iv/article-50/2;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-chapter-6part-1;eu-ivdrannex-ix/chapter-i/2.3·annex-vi/part-c/6.2.4·annex-vii/4.6·chapter-i/section-1/article-2·chapter-viii/article-100/5;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·annex-vi/part-c/6.5.4·annex-vii/4.6·annex-xi/part-b·chapter-i/article-2;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q2r2annex-2/4;ich-q9r18;nist-ai-600-112;nist-ai-rmf6 - systemic risk 2 clauses:
eu-ai-actchapter-i/article-3·chapter-v/section-3/article-55/2 - technical specification 3 clauses:
eu-cyber-resilience-actannex-viii/part-iv/3.3;eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - technical specifications 3 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationannex-v/part-b/6·chapter-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 - TLD name registry 1 clause:
eu-nis2chapter-i/article-6 - top-level domain name registry 1 clause:
eu-nis2chapter-i/article-6 - training data 3 clauses:
eu-ai-actchapter-i/article-3;fda-ai-guidance7;nist-ai-600-112 - Trend 1 clause:
eu-gmp-chapter-6part-1 - trust service 1 clause:
eu-nis2chapter-i/article-6 - trust service provider 1 clause:
eu-nis2chapter-i/article-6 - UDI 9 clauses:
eu-ivdrannex-vi/part-c/1·annex-vi/part-c/3.8·annex-vi/part-c/6.2.4·chapter-i/section-1/article-2;eu-mdrannex-vi/part-c/1·annex-vi/part-c/3.8·annex-vi/part-c/6.5.4·chapter-i/article-2;fda-device-cybersecurity-20266 - Union harmonisation legislation 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - Unique Device Identifier 4 clauses:
eu-ivdrannex-vi/part-c/1·chapter-i/section-1/article-2;eu-mdrannex-vi/part-c/1·chapter-i/article-2 - Unit Operation 1 clause:
ich-q1413.2 - user 14 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1512;eu-ivdrannex-vi/part-c/6.2.4·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-vi/part-c/6.5.4·chapter-i/article-2;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6 - validation data 2 clauses:
eu-ai-actchapter-i/article-3;ich-q1413.2 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 5 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112 - 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 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1410;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - 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 11 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-chapter-6part-1;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2;nist-ai-600-112
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 | 8 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
e2ad4536a9bd unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
4d30b7bae7dd (current) | 0 | 4 | 23 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
208b17ec5cbe | 0 | 1 | 0 | |
4f4cdfc13143 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 0 | 15 | 0 | |
9d16077b1d3b (current) | 0 | 15 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 7 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fe6027daa2c (current) | 1 | 2 | 1 |
| 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 | 1 | 4 |
| 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 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
791686510e26 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
b3718fa9a670 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
48f21f2e4f1b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c4635c9c95ba (current) | 0 | 1 | 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 | 1 | 0 |
| 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 | 2 | 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 |
|---|---|---|---|---|
2ebf88652dc3 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
6ec505fc00ef (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 17 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 11 | 1 | |
82fb682a6c54 (current) | 0 | 11 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 0 | 12 | 1 | |
fab624c8e1dc (current) | 0 | 12 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
023dc18395dc (current) | 1 | 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 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 4 | 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 | 4 | 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 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6b01e1d72618 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5590943862c (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06273204f50b (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
5e9388123e17 (current) | 0 | 0 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
bb656b9e84a8 (current) | 0 | 6 | 11 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
57c484f5daed (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c0ab0e6263b3 | 0 | 0 | 0 | |
edcebd0e3a36 | 0 | 0 | 0 | |
9d19d28e1a57 | 0 | 0 | 0 | |
f2734caa33bb | 0 | 0 | 0 | |
8727e7836a62 | 0 | 0 | 0 | |
e6bfd1f64b25 | 0 | 0 | 1 | |
67d33a19b1a7 | 0 | 0 | 1 | |
05c0bdbc196e | 0 | 0 | 1 | |
8e07db344887 | 0 | 0 | 1 | |
84a3e0382b0e | 0 | 0 | 1 | |
6f9c326c480f | 0 | 0 | 1 | |
b413d56295e8 | 0 | 0 | 1 | |
e3d94d289c0b | 0 | 0 | 1 | |
d800e5bf4d9b (current) | 0 | 0 | 1 |
| 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 | 1 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 0 | |
c240f2675bd3 | 0 | 0 | 0 | |
4c10dc03228b (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
393b48f902b8 | 0 | 2 | 0 | |
5997ebbb6661 | 0 | 2 | 0 | |
9d7b6d9aa4e1 | 0 | 2 | 0 | |
18e04a0c925a | 0 | 2 | 0 | |
1e7f13684129 | 0 | 2 | 0 | |
f24b92ecdf42 | 0 | 2 | 0 | |
b670ac9656b7 | 0 | 2 | 0 | |
bc527e48bcd8 | 0 | 2 | 0 | |
4edb9480421c | 0 | 2 | 0 | |
cd3e1c0c936b | 0 | 2 | 0 | |
75605421c92f (current) | 0 | 2 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8b8ac787c687 | 0 | 0 | 1 | |
fa65ecef3a81 | 0 | 0 | 1 | |
8ee8e1aad0a5 | 0 | 0 | 1 | |
f3605b69e136 | 0 | 0 | 1 | |
baa155d883e3 | 0 | 0 | 1 | |
ac6e97a3c75d | 0 | 0 | 1 | |
bb66b9cbb2c4 | 0 | 0 | 1 | |
0e1bbcb2d14d | 0 | 0 | 1 | |
0eb9eade1868 | 0 | 0 | 1 | |
94a77d5625e8 | 0 | 0 | 1 | |
ca64082d7f23 (current) | 0 | 0 | 1 |
Feed
/atom/term/standard.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 Cybersecurity Act | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| EU MDR | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU Cyber Resilience Act | 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 |
| 21 CFR Part 820 (QMSR) | 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: