{"meta":{"dataset_id":"praxikon:sys:registry:dataset:ai-act-implementation-graph","dataset_version":"2.1.0","schema_version":"1.4.0","lang":"en","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-14T00:00:00.000Z","count":12,"filters":{"id":null,"type":"standard","role":null,"duty_holder":null,"topic":null},"identifiers":{"canonical_namespace":"praxikon","canonical_form":"praxikon:<jurisdiction>:<regulation>:<type>:<slug>","legacy_namespace":"raip","legacy_resolution":"permanent","resolved":{"id":null,"role":null,"duty_holder":null}}},"data":[{"id":"praxikon:eu:ai-act:standard:standard-en-18286-quality-management-system","legacy_id":"raip:standard:standard-en-18286-quality-management-system","type":"standard","slug":"standard-en-18286-quality-management-system","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"ee0b79f8c9aae4f696785a3ea1ca801363acd98f156c62c5a3d8ef85e20ac5b6","label":"EN 18286:2026: quality management system for EU AI Act regulatory purposes","summary":"The first completed European standard under the AI Act standardisation request: the quality management system that Article 17 requires from providers of high-risk AI systems.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-17-quality-management"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"standard-en-18286-quality-management-system-scope","operator":"all","description":"Relevant to providers of high-risk AI systems, who must have a quality management system in place by 2 December 2027 (Annex III standalone) or 2 August 2028 (Annex I embedded in regulated products)."}],"exceptions":[{"id":"standard-en-18286-quality-management-system-exception","operator":"not","description":"According to that same coverage statement the standard does not cover Article 17(2) to (4) or Article 72; those obligations must be substantiated independently."}],"statements":[{"kind":"official_fact","text":"EN 18286:2026 (Artificial intelligence: Quality management system for EU AI Act regulatory purposes) was drafted by CEN/CLC/JTC 21 under standardisation request M/613 and approved by CEN-CENELEC on 12 July 2026. It is the first JTC 21 deliverable to reach publication. According to a published coverage statement accompanying the standard, not yet confirmed by a second independent source, it addresses Article 17(1) points (a) to (m) and Article 11(1) first sentence, and expressly not Article 17(2) to (4) or Article 72. The standard is NOT currently cited in the Official Journal. The Article 40 presumption of conformity only attaches after that citation.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN 18286:2026, CEN/CLC/JTC 21 under standardisation request M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This is the first time the AI Act quality requirements exist as an auditable normative text, which is worth more than its legal status suggests. The common trap runs the other way: people read \"first harmonised standard\" and assume compliance now carries evidentiary weight. As long as the reference is not in the Official Journal, EN 18286 is simply a well-structured document with no legal presumption. You still carry the burden of showing your system meets Article 17. Conversely, anyone building on this structure now will not have to rebuild after citation.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN 18286:2026, CEN/CLC/JTC 21 under standardisation request M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Use the clause structure of EN 18286 as the table of contents for your quality dossier: separate the organisational clauses (governance, leadership, planning, support, management review) from the per-system clauses (lifecycle, operations, post-market monitoring, incident handling). Record which internal document evidences each clause. Note explicitly that Article 17(2) to (4) and Article 72 fall outside the standard and must be substantiated separately.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN 18286:2026, CEN/CLC/JTC 21 under standardisation request M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 17 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-en-iso-iec-42001-ai-management-system","legacy_id":"raip:standard:standard-en-iso-iec-42001-ai-management-system","type":"standard","slug":"standard-en-iso-iec-42001-ai-management-system","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"5ee10b85a24a9bf7b3568085d9b7505cba98678fa0ec51d64f233cedb479aae9","label":"EN ISO/IEC 42001: artificial intelligence management system","summary":"The certifiable organisation-level AI management system, a European standard since 2026, but not a harmonised standard under the AI Act.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-17-quality-management"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"standard-en-iso-iec-42001-ai-management-system-scope","operator":"all","description":"Usable by both providers and deployers seeking to structure AI governance organisation-wide."}],"exceptions":[{"id":"standard-en-iso-iec-42001-ai-management-system-exception","operator":"not","description":"Certification against ISO/IEC 42001 replaces no AI Act obligation and does not shift the burden of proof."}],"statements":[{"kind":"official_fact","text":"ISO/IEC 42001:2023 is the first certifiable international standard for an AI management system, published on 18 December 2023 and structured on the plan-do-check-act cycle. The text was adopted unchanged as EN ISO/IEC 42001:2026, approved by CEN on 13 March 2026, with national implementation by the member standards bodies. This adoption is not a deliverable under standardisation request M/613: the standard is not cited in the Official Journal and therefore confers no presumption of conformity under Article 40. For Article 17, the designated deliverable under M/613 is EN 18286:2026; that standard is likewise not cited in the Official Journal.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN ISO/IEC 42001:2026, European adoption via CEN-CENELEC","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This is the most expensive misconception in the whole standards layer: an ISO/IEC 42001 certificate is not AI Act conformity. The certificate shows you have a governance structure, not that a specific high-risk system meets the regulation. Documented gaps against Article 17 include the absence of a per-system regulatory compliance strategy, of predetermined change management for continuously learning systems, of the Article 73 serious incident reporting timelines, and of a structured fundamental rights assessment. Vendors saying \"ISO 42001 certified, therefore AI Act ready\" are selling you a certificate, not your dossier.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN ISO/IEC 42001:2026, European adoption via CEN-CENELEC","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Use ISO/IEC 42001 as the organisational layer (policy, roles, management review, internal audit) and put the per-system layer on top: a dedicated dossier per high-risk system along the clauses of EN 18286. Deliberately close the gaps named above: per-system compliance strategy, predetermined change management, incident reporting process with the Article 73 timelines, and fundamental rights assessment. In procurement, ask not for the certificate but for the statement of applicability and the audit report.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN ISO/IEC 42001:2026, European adoption via CEN-CENELEC","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 17 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-iso-iec-12792-transparency-taxonomy","legacy_id":"raip:standard:standard-iso-iec-12792-transparency-taxonomy","type":"standard","slug":"standard-iso-iec-12792-transparency-taxonomy","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"f05c734a543acf72052d1f7a806928e4df6af5ae0509212b9892215750dfc967","label":"ISO/IEC 12792: transparency taxonomy of AI systems","summary":"The international taxonomy of transparency information elements, usable as a checklist for the Article 13 instructions for use.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-13-instructions"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"ISO/IEC 12792:2025 (Information technology: Artificial intelligence: Transparency taxonomy of AI systems) was published in November 2025 by ISO/IEC JTC 1/SC 42. It specifies a taxonomy of information elements to help stakeholders identify and address transparency needs, and describes the semantics of those elements and their relevance to different stakeholders' objectives. The text was adopted as a European standard as EN ISO/IEC 12792:2025. It is not cited in the Official Journal and therefore confers no presumption of conformity under Article 40. For Article 13 the designated deliverable is prEN 18229-3.","citations":[{"source_id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","source_locator":"ISO/IEC 12792:2025, ISO/IEC JTC 1/SC 42","source_url":"https://www.iso.org/committee/6794475.html","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 13","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The value lies in the completeness check: the taxonomy shows which information elements you can forget, and that is exactly where instructions for use fall short in practice. What it is not: a template that satisfies Article 13. The regulation itself determines what the instructions for use must contain, including the provider's details, characteristics and limitations, accuracy metrics, oversight measures and expected lifetime. Also watch the confusion with Article 50: those transparency obligations have applied since 2 August 2026 and fall on providers of AI systems that interact directly with natural persons or generate synthetic content, and on deployers of emotion recognition, biometric categorisation and deepfakes. They apply regardless of high-risk classification. For systems already placed on the market before 2 August 2026, the machine-readable marking under Article 50(2) has a transition until 2 December 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","source_locator":"ISO/IEC 12792:2025, ISO/IEC JTC 1/SC 42","source_url":"https://www.iso.org/committee/6794475.html","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 13","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Structure your instructions for use as a numbered list following the elements of Article 13(3) one for one, and use the ISO/IEC 12792 taxonomy alongside it as a checklist for missing elements. Keep Article 50 transparency information separate, since it addresses the end user rather than the deployer.","citations":[{"source_id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","source_locator":"ISO/IEC 12792:2025, ISO/IEC JTC 1/SC 42","source_url":"https://www.iso.org/committee/6794475.html","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 13","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 13 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-iso-iec-23894-ai-risk-management-guidance","legacy_id":"raip:standard:standard-iso-iec-23894-ai-risk-management-guidance","type":"standard","slug":"standard-iso-iec-23894-ai-risk-management-guidance","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"97f89403e72d95ecd362a023a4bb4ee38d74bde7f30f7997125dfeb6f0e72c63","label":"ISO/IEC 23894: guidance on risk management for AI","summary":"The international guidance for AI-specific risk management, usable as an interim structure while prEN 18228 remains in draft.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-9-risk-management"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"ISO/IEC 23894:2023 (Information technology: Artificial intelligence: Guidance on risk management) was published in February 2023 and is the first international standard dealing specifically with risk management for AI. It is non-prescriptive and built on the ISO 31000 structure. The text was adopted by CEN-CENELEC as EN ISO/IEC 23894:2024. It is not cited in the Official Journal and therefore confers no presumption of conformity under Article 40 of the AI Act. The deliverable intended to do so for Article 9 is prEN 18228.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN ISO/IEC 23894:2024, European adoption via CEN-CENELEC","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"ISO/IEC 23894 gives you the vocabulary and process flow of AI risk management, and that is usable today. Where it falls short: it is guidance, not a requirements set, and it is written from organisational risk while Article 9 starts from risk to the health, safety and fundamental rights of others. A risk register built entirely along ISO/IEC 23894 therefore does not automatically cover Article 9. Use it as scaffolding, not as evidence.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN ISO/IEC 23894:2024, European adoption via CEN-CENELEC","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Adopt the ISO/IEC 23894 process flow (context, identification, analysis, evaluation, treatment, monitoring, recording) and add two AI Act-specific fields per risk: who outside your organisation can be affected, and what residual risk you deem acceptable on what justification. That lets you connect the register to the final EN 18228 without rebuilding it.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"EN ISO/IEC 23894:2024, European adoption via CEN-CENELEC","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 9 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-iso-iec-24029-robustness-neural-networks","legacy_id":"raip:standard:standard-iso-iec-24029-robustness-neural-networks","type":"standard","slug":"standard-iso-iec-24029-robustness-neural-networks","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"90a88e1eab0ea2115fc69dcffb95fd81f4beda2674e8a39e98349b2cddc54e5e","label":"ISO/IEC 24029 series: assessment of the robustness of neural networks","summary":"The international series making neural network robustness testable, usable as methodology under Article 15 while prEN 18229-2 remains in draft.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-15-accuracy-robustness"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"standard-iso-iec-24029-robustness-neural-networks-scope","operator":"all","description":"Particularly relevant to high-risk systems based on neural networks."}],"exceptions":[],"statements":[{"kind":"official_fact","text":"ISO/IEC TR 24029-1:2021 (Assessment of the robustness of neural networks, Part 1: Overview) is a technical report mapping the topic and available assessment methods. ISO/IEC 24029-2:2023 (Part 2: Methodology for the use of formal methods) describes the application of formal methods in assessing robustness. The series is aimed at AI developers and users assessing robustness across the lifecycle. Neither part is cited in the Official Journal, so no presumption of conformity under Article 40 arises. For Article 15 the designated deliverable is prEN 18229-2, which as at June 2026 was still in drafting.","citations":[{"source_id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","source_locator":"ISO/IEC TR 24029-1:2021 and ISO/IEC 24029-2:2023, ISO/IEC JTC 1/SC 42","source_url":"https://www.iso.org/committee/6794475.html","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 15","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Part 1 is a technical report and therefore not a requirements set: it gives an overview, not a benchmark. Part 2 is the sharper text substantively, but formal methods are only feasible for relatively bounded models. For large generative models you hit the limits quickly, leaving empirical testing. The trap is making a robustness claim measured only on the average test set: Article 15 is specifically about behaviour under errors, faults and unexpected input.","citations":[{"source_id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","source_locator":"ISO/IEC TR 24029-1:2021 and ISO/IEC 24029-2:2023, ISO/IEC JTC 1/SC 42","source_url":"https://www.iso.org/committee/6794475.html","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 15","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Choose deliberately per system between formal verification (for bounded models) and empirical stress testing, and record the choice and its justification. Test explicitly on out-of-distribution input, missing fields and edge cases, and document the performance degradation observed. Add those results to the technical documentation and to the instructions for use where they define the limits of use.","citations":[{"source_id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","source_locator":"ISO/IEC TR 24029-1:2021 and ISO/IEC 24029-2:2023, ISO/IEC JTC 1/SC 42","source_url":"https://www.iso.org/committee/6794475.html","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 15","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 15 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-iso-iec-5259-data-quality-machine-learning","legacy_id":"raip:standard:standard-iso-iec-5259-data-quality-machine-learning","type":"standard","slug":"standard-iso-iec-5259-data-quality-machine-learning","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"9fcb6844fee38f7cddc5546b1fc8835cbf284965148c69abc788b201cb2c685e","label":"ISO/IEC 5259 series: data quality for analytics and machine learning","summary":"The five-part international series on data quality, in practice the most usable structure for the Article 10 data governance dossier.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-10-data-governance"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"The ISO/IEC 5259 series (Artificial intelligence: Data quality for analytics and machine learning) comprises five parts: part 1 (overview, terminology and examples), part 2 (data quality measures), part 3 (data quality management requirements and guidelines) and part 4 (data quality process framework), all published in 2024, plus part 5 (data quality governance framework), published in February 2025. CEN-CENELEC has adopted parts as European standards, including EN ISO/IEC 5259-4:2025 and EN ISO/IEC 5259-3:2025. No part is cited in the Official Journal, so no presumption of conformity under Article 40 arises. The deliverable intended to do so for Article 10 is prEN 18284.","citations":[{"source_id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","source_locator":"ISO/IEC 5259 series, ISO/IEC JTC 1/SC 42","source_url":"https://www.iso.org/committee/6794475.html","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This is currently the most concrete help available for Article 10, because part 2 actually makes data quality measurable rather than merely discussing it. What it is not: coverage of Article 10. The regulation asks for things the series does not address, such as examination for possible bias with a view to fundamental rights and representativeness for the specific intended user population in the EU. A dataset scoring well on every 5259 measure can still structurally under-represent a population group.","citations":[{"source_id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","source_locator":"ISO/IEC 5259 series, ISO/IEC JTC 1/SC 42","source_url":"https://www.iso.org/committee/6794475.html","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Use part 2 to fix a small number of hard quality measures per dataset and part 4 to describe the process that maintains them. Add two AI Act fields the series does not cover: representativeness for the intended user population, and the outcome of the bias examination with the measures taken. Retain the measurement results per dataset version, not only for the latest version.","citations":[{"source_id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","source_locator":"ISO/IEC 5259 series, ISO/IEC JTC 1/SC 42","source_url":"https://www.iso.org/committee/6794475.html","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 10 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-pren-18228-ai-risk-management","legacy_id":"raip:standard:standard-pren-18228-ai-risk-management","type":"standard","slug":"standard-pren-18228-ai-risk-management","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"efc0d590e74fcc9850050e3c063c288082c701a96530ffc6c49dcaaea71ea1b4","label":"prEN 18228: AI risk management for high-risk systems","summary":"The draft European standard filling in the Article 9 risk management system, built on a product-safety logic rather than an enterprise-risk logic.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-9-risk-management"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"standard-pren-18228-ai-risk-management-scope","operator":"all","description":"Relevant to providers preparing for the high-risk obligations applying from 2 December 2027 (Annex III) or 2 August 2028 (Annex I)."}],"exceptions":[],"statements":[{"kind":"official_fact","text":"prEN 18228 (AI risk management) is the JTC 21 deliverable under M/613 intended to confer presumption of conformity with Article 9 of the AI Act: the risk management system that providers of high-risk AI systems must establish, implement, document and maintain across the full lifecycle. The public Enquiry ran until 30 July 2026. The standard has not yet been published as an EN and is not cited in the Official Journal. The prEN designation means it is a draft text.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18228 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"The distinguishing feature is the perspective. prEN 18228 is written from product safety: it concerns risks to the health, safety and fundamental rights of third parties, not risks to your organisation. Anyone filling an Article 9 dossier with an existing ISO 31000 or ERM register makes exactly the mistake this standard exposes: that register looks inward, Article 9 looks outward. And a draft standard is not yet evidence: you can adopt the method, but you cannot prove anything with it towards a supervisory authority today.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18228 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Build your Article 9 risk register now with an outward view: for each foreseeable use and foreseeable misuse, name the person or group who can be affected, the measure that reduces the risk, and the residual risk that remains. Keep the structure separate from your ERM register so the final EN 18228 can be mapped over it later without rewriting the content.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18228 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 9 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-pren-18229-1-logging","legacy_id":"raip:standard:standard-pren-18229-1-logging","type":"standard","slug":"standard-pren-18229-1-logging","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"163333159c9f358bd74a4ac8364a7f497d5deb28d366166b00650b93b87f5a13","label":"prEN 18229-1: AI trustworthiness framework part 1, logging","summary":"The draft European standard for the automatic event recording that Article 12 requires of high-risk AI systems.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-12-logging"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"standard-pren-18229-1-logging-scope","operator":"all","description":"Providers build in the logging capability (Article 12) and keep the logs under their control (Article 19); deployers retain the logs generated by the system (Article 26(6))."}],"exceptions":[],"statements":[{"kind":"official_fact","text":"prEN 18229-1 (AI trustworthiness framework, Part 1: Logging) is the JTC 21 deliverable under M/613 for Article 12 of the AI Act: high-risk AI systems must technically allow for the automatic recording of events over their lifetime. As at June 2026 the deliverable was at the Enquiry stage. It has not yet been published as an EN and is not cited in the Official Journal.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18229-1 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12; Article 19; Article 26(6); Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Logging is the obligation that is cheapest to get right now and most expensive to repair later, because a system that does not log cannot start logging retroactively. Mind the split of roles: the provider must build in the logging capability, the deployer must retain the logs. Buying a system without checking whether it logs means buying a hole in your own dossier. This standard is still a draft text and therefore carries no evidentiary weight yet.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18229-1 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12; Article 19; Article 26(6); Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Put the logging requirement in your procurement terms and in the acceptance test: which events are recorded, with what timestamp, how long they are retained, and how you export them to a supervisory authority. Document those answers per system now, so the final EN 18229-1 only needs to be mapped against what you already record.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18229-1 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 12; Article 19; Article 26(6); Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 12 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-pren-18229-2-accuracy-robustness","legacy_id":"raip:standard:standard-pren-18229-2-accuracy-robustness","type":"standard","slug":"standard-pren-18229-2-accuracy-robustness","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"0e893c917fe9435350acafd09346a9557045fb27dfdea30ab46091cf9cdb7e23","label":"prEN 18229-2: AI trustworthiness framework part 2, accuracy and robustness","summary":"The draft European standard meant to make the appropriate level of accuracy and robustness under Article 15 measurable.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-15-accuracy-robustness"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[],"exceptions":[],"statements":[{"kind":"official_fact","text":"prEN 18229-2 (AI trustworthiness framework, Part 2: Accuracy and robustness) is the JTC 21 deliverable under M/613 for Article 15 of the AI Act, which requires high-risk AI systems to achieve an appropriate level of accuracy, robustness and cybersecurity and to declare accuracy metrics in the instructions for use. As at June 2026 the deliverable was at the drafting stage. It has not yet been published as an EN and is not cited in the Official Journal.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18229-2 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 15; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Article 15 leaves open what \"appropriate\" means, and that open norm is precisely what this deliverable would fill in. Until it is finished, you must justify yourself which accuracy level fits your application and why. The common trap is putting a single percentage in the instructions for use without stating on which population and under which conditions it was measured: that is not a metric, it is a marketing figure. A supervisory authority will ask about the measurement setup.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18229-2 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 15; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Record a test protocol per high-risk system: which metric, which test population, which subgroups measured separately, and what performance degradation under out-of-distribution conditions is acceptable. Use the ISO/IEC 24029 series for robustness methodology and retain the raw test results, not only the summary.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18229-2 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 15; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 15 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-pren-18229-3-transparency-human-oversight","legacy_id":"raip:standard:standard-pren-18229-3-transparency-human-oversight","type":"standard","slug":"standard-pren-18229-3-transparency-human-oversight","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"7ec718d0ce2778b5802f6a916ccbf5c3cb159bdee9050681b3b4bf9697ba111c","label":"prEN 18229-3: AI trustworthiness framework part 3, transparency and human oversight","summary":"The draft European standard for the transparency and oversight requirements of Articles 13 and 14 for high-risk AI systems.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:deployer","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-14-human-oversight"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"standard-pren-18229-3-transparency-human-oversight-scope","operator":"all","description":"Providers design in the oversight measures under Article 14; under Article 26(2) deployers assign natural persons with the necessary competence, training and authority and give them the mandate they need."}],"exceptions":[],"statements":[{"kind":"official_fact","text":"prEN 18229-3 (AI trustworthiness framework, Part 3: Transparency and human oversight) is the JTC 21 deliverable under M/613 addressing Articles 13 and 14 of the AI Act: transparency and provision of information to deployers, and the design for effective human oversight of high-risk AI systems. As at June 2026 the deliverable was at the drafting stage. It has not yet been published as an EN and is not cited in the Official Journal. This deliverable concerns Article 14 (high-risk) and not the Article 50 transparency obligations, which apply since 2 August 2026.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18229-3 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 13 and 14; Article 26(2); Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Human oversight is the obligation that most often exists on paper and fails in practice. Article 14 requires the designated person to be able to genuinely understand, override and reverse the output. A staff member with thirty seconds per case and no mandate to deviate is not human oversight, only a signature. The common mistake is waiting for this standard while the bottleneck is not technical but organisational: mandate, time and escalation route.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18229-3 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 13 and 14; Article 26(2); Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Describe per high-risk system who exercises oversight, what information that person sees at the decision moment, how much time is allotted, what mandate exists to deviate, and how a deviation is recorded. Those four answers are the core of your Article 14 evidence and will not change with the final normative text.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18229-3 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 13 and 14; Article 26(2); Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 14 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-pren-18284-dataset-quality-governance","legacy_id":"raip:standard:standard-pren-18284-dataset-quality-governance","type":"standard","slug":"standard-pren-18284-dataset-quality-governance","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"e0b691537e172f662c412c1a0b09f589f84d1aec77e74ec3cde19a5648db4282","label":"prEN 18284: quality and governance of datasets in AI","summary":"The draft European standard operationalising the Article 10 data governance requirements for training, validation and testing data.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:article-10-data-governance"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"standard-pren-18284-dataset-quality-governance-scope","operator":"all","description":"Applies to providers of high-risk AI systems that are trained on data."}],"exceptions":[],"statements":[{"kind":"official_fact","text":"prEN 18284 (Artificial intelligence: Quality and governance of datasets in AI) is the JTC 21 deliverable under M/613 for Article 10 of the AI Act, which sets requirements for the training, validation and testing datasets of high-risk AI systems. As at June 2026 the deliverable was at the drafting stage. It has not yet been published as an EN and is not cited in the Official Journal.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18284 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"Article 10 is where most organisations actually fail, because they never recorded the provenance and processing history of their data. prEN 18284 will turn that recording into a normative requirement. The common mistake is waiting for the standard before starting data lineage: that documentation is almost impossible to reconstruct retroactively. What you do not record now cannot be proven two years from now.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18284 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Start a dataset passport per high-risk system now: provenance, collection method, processing steps, representativeness for the intended user population, known gaps and the bias examination performed. Use the ISO/IEC 5259 series as an interim structure and keep the fields generic so they can be renamed to the terminology of the final EN 18284.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18284 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 10; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 10 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}},{"id":"praxikon:eu:ai-act:standard:standard-pren-18285-conformity-assessment-framework","legacy_id":"raip:standard:standard-pren-18285-conformity-assessment-framework","type":"standard","slug":"standard-pren-18285-conformity-assessment-framework","version":"1.0.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-08-08T00:00:00.000Z","valid_until":null,"payload_hash_sha256":"6912ad1f00cd9830b1995fd9ea6e88df0aeb116adb20a4655378cb061d173ff0","label":"prEN 18285: conformity assessment framework for AI systems","summary":"The draft European standard operationalising the conformity assessment procedure of Article 43 and Annex VII.","topics":["standards"],"actor_ids":["praxikon:eu:ai-act:actor:authorised-representative","praxikon:eu:ai-act:actor:provider"],"duty_holder_ids":[],"affected_actor_ids":[],"oversight_actor_ids":[],"evidence_owner_ids":[],"duty_holder_uncertainty_status":null,"interpretation_status":null,"interpretation_note":null,"obligation_ids":["praxikon:eu:ai-act:obligation:conformity-ce-registration"],"change_ids":[],"action_ids":[],"evidence_ids":[],"control_ids":[],"template_ids":[],"conditions":[{"id":"standard-pren-18285-conformity-assessment-framework-scope","operator":"all","description":"The Article 43 conformity assessment rests on the provider. The authorised representative established in the Union keeps the EU declaration of conformity and the technical documentation available to the supervisory authority and cooperates with it under Article 22."}],"exceptions":[],"statements":[{"kind":"official_fact","text":"prEN 18285 (Conformity assessment framework) is the JTC 21 deliverable under M/613 covering the conformity assessment of high-risk AI systems under Article 43 and Annex VII of the AI Act. As at June 2026 the deliverable was at the drafting stage. It has not yet been published as an EN and is not cited in the Official Journal. Standardisation request M/613 was amended by Implementing Decision C(2025)3871 of 23 June 2025 and expires on 28 February 2027.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18285 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43 and Annex VII; Article 22; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"}},{"kind":"editorial_interpretation","text":"This is the deliverable that determines how heavily the rest weighs. For most Annex III systems the provider may self-assess (internal control), but that does not mean nothing is required: it means you must be able to show the complete dossier yourself. The trap is thinking self-assessment is light. The notified body is absent, the burden of proof is not. While prEN 18285 remains in draft, there is no recognised blueprint for that self-assessment and you must justify the structure yourself.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18285 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43 and Annex VII; Article 22; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}},{"kind":"recommended_action","text":"Determine per system which assessment route applies (internal control or notified body) and build your dossier as one an external party would have to be able to read, even where you self-assess. Plan backwards from 2 December 2027 for standalone Annex III systems and 2 August 2028 for systems embedded in regulated products.","citations":[{"source_id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","source_locator":"prEN 18285 (draft standard), CEN/CLC/JTC 21 under M/613","source_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null},{"source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 43 and Annex VII; Article 22; Article 40","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"editorial"}}],"legal_status":"guidance","deadline_at":null,"links":[{"relation":"official_source","href":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","label":"Article 43 on EUR-Lex"}],"review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"source_review":{"level":"source_verified","last_checked_at":"2026-08-08T00:00:00.000Z","next_review_due_at":"2027-02-04T00:00:00.000Z","date_basis":"first_publication"}}],"included":{"sources":[{"id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","title":{"nl":"CEN-CENELEC JTC 21: Europese normen onder normalisatieverzoek M/613","en":"CEN-CENELEC JTC 21: European standards under standardisation request M/613"},"publisher":{"nl":"CEN-CENELEC JTC 21","en":"CEN-CENELEC JTC 21"},"canonical_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null,"source_version":"work-programme-checked-2026-08-08","verified_at":"2026-08-08T00:00:00.000Z","fingerprint_basis":"canonical_url|source_version|verified_at","source_record_hash_sha256":"952a677040f5a8facb59fc7e89676b9127e1c9e4a36e191112c7f7c1dcd45a94","review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"legacy_id":"raip:source:cen-cenelec-jtc21"},{"id":"praxikon:eu:ai-act:source:iso-iec-jtc1-sc42","title":{"nl":"ISO/IEC JTC 1/SC 42: internationale normen voor artificiele intelligentie","en":"ISO/IEC JTC 1/SC 42: international standards for artificial intelligence"},"publisher":{"nl":"ISO/IEC JTC 1/SC 42","en":"ISO/IEC JTC 1/SC 42"},"canonical_url":"https://www.iso.org/committee/6794475.html","eli":null,"source_version":"catalogue-checked-2026-08-08","verified_at":"2026-08-08T00:00:00.000Z","fingerprint_basis":"canonical_url|source_version|verified_at","source_record_hash_sha256":"50d723c8c721474cf3cb49fddecdfe4cbd517a9f6c6f83ddc529a9c7c5f94503","review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"legacy_id":"raip:source:iso-iec-jtc1-sc42"},{"id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","title":{"nl":"EU AI-verordening 2024/1689","en":"EU Artificial Intelligence Act 2024/1689"},"publisher":{"nl":"Europees Parlement en Raad","en":"European Parliament and Council"},"canonical_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_version":"original-oj-2024-07-12","verified_at":"2026-08-08T00:00:00.000Z","fingerprint_basis":"canonical_url|source_version|verified_at","source_record_hash_sha256":"bf0fca3e1fb47ce58924f6e736d572bb5db3812c3276c0b2891fbf328c42a5c6","review":{"reviewed_at":"2026-08-08T00:00:00.000Z","reviewer":"Praxikon release validation","review_method":"source_link_and_rule_validation","legal_status":"source_checked"},"legacy_id":"raip:source:reg-eu-2024-1689"}]},"links":{"self":"https://www.praxikon.com/api/v1/entities?lang=en&type=standard","alternate":"https://www.praxikon.com/api/v1/entities?lang=en&type=standard&format=jsonld","licence":"https://www.praxikon.com/nl/legal/terms"}}