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PD CEN/CLC/TR 17894:2024 Artificial Intelligence. Artificial Intelligence Conformity Assessment, 2025
- undefined
- European foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Framework of conformity assessment and objects of conformity assessment [Go to Page]
- 4.1 General
- 4.2 International accreditation and conformity assessment framework [Go to Page]
- 4.2.1 General
- Figure 1 — Accreditation Standardization System - classification of evaluation methods in level structure [Go to Page]
- 4.2.2 Level 5
- 4.2.3 Level 4
- 4.2.4 Level 3
- 4.2.5 Level 2
- 4.2.6 Level 1
- 4.3 Conformity assessment modules [Go to Page]
- 4.3.1 Conformity assessment modules of Decision No 768/2008/EC
- Table 1 — Conformity Assessment Modules described in Annex II of EU Decision No 768/2008/EC (see [25]) [Go to Page]
- 4.3.2 Conformity assessment modules of the EU AI Act
- Figure 2 — Decision No 768/2008/EC (see [24]) conformity assessment procedures available in the EU AI Act (AIA), see [8], in consideration of access to source code, training, validation, and test data sets and test provisions. [Go to Page]
- 4.3.3 Conformity assessment modules following the EU AI Act Annex II Section A
- 4.3.4 Conformity assessment modules under sectorial legislation [Go to Page]
- 4.3.4.1 Conformity assessment modules of the Machinery Regulation
- Figure 3 — Decision No 768/2008/EC (see [24]) conformity assessment procedures available in Machinery Regulation 2023/1230 [Go to Page]
- 4.3.4.2 Conformity assessment modules of the Medical Device Regulations
- Figure 4 — Decision No 768/2008/EC (see [24]) conformity assessment procedures available in the Medical Device Regulations
- Figure 5 — Illustration of how conformity assessment procedures available in the Medical Device Regulations depend on placement on the market, regulatory class, and whether the device is custom-made, is a well-established technology (WET) or subject t... [Go to Page]
- 4.3.4.3 Conformity assessment modules of the Personal Equipment Directive
- Figure 6 — Decision No 768/2008/EC (see [24]) conformity assessment procedures available in Personal Protective Equipment Directive (EU) 2016/425 [Go to Page]
- 4.3.4.4 Conformity assessment modules of the Radio Equipment Directive
- Figure 7 — Decision No 768/2008/EC (see [24]) conformity assessment procedures available in Radio Equipment Directive 2014/53/EU [Go to Page]
- 4.4 Considerations on the interplay of conformity assessment under EU AI Act and sectorial legislation [Go to Page]
- 4.4.1 General
- 4.4.2 Interplay between notified body requirements under EU AI Act and its Annex II Section A legislation
- 4.4.3 Possible interplay between conformity assessment in the Machinery Regulation and the EU AI Act
- 4.4.4 Possible interplay between conformity assessment in the medical devices sectorial legislation and the EU AI Act
- 4.4.5 Conformity assessment in the automotive sectorial legislation
- 4.4.6 Conformity assessment of representative AI system (aka ‘sampling’)
- Figure 8 — A surgical robot uses an AI system to position and operate the surgical instruments during surgery
- 5 Mapping of horizontal and vertical standard items to the level system and assignment to conformity assessment activities [Go to Page]
- 5.1 Mapping of AI horizontal standard items to conformity assessment activities [Go to Page]
- 5.1.1 General
- 5.1.2 Management system certification according to EN ISO/IEC 17021-1
- 5.1.3 Inspection according to EN ISO/IEC 17020
- 5.1.4 Testing according to EN ISO/IEC 17025
- 5.1.5 Verification and Validation according to EN ISO/IEC 17029
- 5.1.6 Product, process or service certification according to EN ISO/IEC 17065
- 6 Supporting compliance to EU AI Act [Go to Page]
- 6.1 Analysis of conformity assessment elements in EU AI Act [Go to Page]
- 6.1.1 Conformity assessment requirements for high-risk AI systems according to EU C(2023)3215 – Standardization request M/593
- 6.1.2 Interdependencies of EU AI Act provisions
- Figure 9 — Examples of relationships between provisions of the EU AI Act (see [8]) [Go to Page]
- 6.1.3 Article 17 “quality management system” in the EU AI Act [Go to Page]
- 6.1.3.1 Role of the article 17 “quality management system” in the EU AI Act for organizations developing, deploying or using AI systems
- 6.2 EN ISO/IEC 17065 certification approach related to EU AI Act [Go to Page]
- 6.2.1 General
- 6.2.2 Potential certification process according to EN ISO/IEC 17065
- Figure 10 — Functional Approach for an AI system certification according to EN ISO/IEC 17065 [Go to Page]
- 6.2.3 Accreditation of certification bodies according to EN ISO/IEC 17065 within the field of AI
- 6.3 Role of testing for conformity assessments [Go to Page]
- 6.3.1 General
- 6.3.2 Testing of general purpose AI models and general purpose AI models with systemic risk
- 6.4 Measurement, measures and metrics
- Figure 11 — European legal references and international standards on data quality for AI
- 7 Existing horizontal certifications possibly relevant for the AI area [Go to Page]
- 7.1 General
- 7.2 Data related certifications: the example of GDPR-CARPA national level certification
- Figure 12 — GDPR-CARPA criteria of certification [Go to Page]
- 7.3 Cybersecurity related certification
- 8 Observations and identified gaps [Go to Page]
- 8.1 General
- 8.2 Challenges of terms and definitions operationalisation for AI conformity assessment [Go to Page]
- 8.2.1 General
- 8.2.2 Identified differences of terms definition
- Annex A (informative) Tools to support operationalisation of AI conformity assessment
- Bibliography [Go to Page]
