Glossary · Machinery law and conformity
Harmonized standard
Also known as: harmonised standard, hEN
German: Harmonisierte Norm
In EU product law, a harmonized standard is a European standard adopted on the basis of a request from the European Commission for the application of EU harmonization legislation. Once its reference is cited in the Official Journal of the European Union, applying it may support presumption of conformity with the requirements it covers.
- Standards
- EU
- Compliance
In one sentence
A harmonized standard is a European standard requested by the Commission and cited in the Official Journal, which may support presumption of conformity.
Example
EN ISO 12100 is a harmonized type-A standard under machinery law; a manufacturer of a palletizer applies it together with the type-B and type-C standards relevant to the machine.
Explained in context
Context cards connect this term with others to answer one question. Also in British English and German.
- CRA product categories: default, important and criticalWhich CRA products need a notified body, and how many products fall into the stricter categories?UKDeutsch
- The Radio Equipment Directive: when sector law absorbs aspect requirementsWhy does the cybersecurity part of the Radio Equipment Directive create parallel compliance paths?UKDeutsch
- Machinery Regulation and CRA: coupled through standards, not cross-referencesWhy can the Machinery Regulation and the Cyber Resilience Act not simply refer to each other?UKDeutsch
- EN 50742: safety-related security levels and IEC 62443 working togetherIs EN 50742 a sign that legislators misunderstand technicalities, and do its SRSLs contradict IEC 62443?UKDeutsch
- Module H under the CRA: BSI TR-03183-H builds full quality assurance on ISO/IEC 27001How can a manufacturer demonstrate CRA conformity through its processes rather than product by product, and what does BSI TR-03183-H add?UKDeutsch
- BSI guidance on the CRA: context-dependent, not contradictoryWhen two pieces of BSI guidance on the Cyber Resilience Act seem irreconcilable, is the guidance contradictory?UKDeutsch
How it applies
- Machinery standards: Type-A standards give basic concepts (ISO 12100), type-B standards cover safety aspects or devices (ISO 13849-1, guards, interlocks), and type-C standards give detailed requirements for a machine group. A type-C standard takes precedence where it deviates.
- Citation: Check that the edition you apply is the one cited for the legal act you rely on. Standards cited under the Machinery Directive are not automatically cited under the Machinery Regulation.
- Scope of the presumption: An informative annex, usually Annex ZA, maps the standard's clauses to the legal requirements. Only those are covered.
- Technical documentation: List the harmonized standards and editions in the technical file and the declaration of conformity.
Harmonized standard vs. AI Act harmonized standards
Machinery has an established body of harmonized standards. For the EU AI Act, harmonized standards are still being developed by CEN and CENELEC in JTC 21, so conformity assessment (AI Act) currently relies mostly on the provider's own justification. Once they are cited, Article 20(10) of the Machinery Regulation lets them serve machinery too until machinery-specific standards exist. In both cases, using a standard is voluntary and does not by itself make a product compliant; see presumption of conformity.