Harmonized Standard
A Harmonized Standard is a technical specification adopted by a recognized European Standardization Organization (CEN, CENELEC, or ETSI) in accordance with Regulation (EU) No 1025/2012 and published in the Official Journal of the European Union (OJEU).
When applied correctly, it provides a presumption of conformity with the essential requirements of relevant EU legislation, such as the:
Legal Basis and Recognition
Harmonized standards are developed by:
ETSI – European Telecommunications Standards Institute
CEN – European Committee for Standardization
CENELEC – European Committee for Electrotechnical Standardization
They are published under the framework of the New Legislative Framework (NLF) and are officially listed in the OJEU.
Role in Conformity Assessment
When a harmonized standard is fully applied, manufacturers can:
Use Module A (Internal Production Control) for self-certification
Avoid mandatory involvement of a Notified Body
Reference the applied standards in the EU Declaration of Conformity (DoC)
This simplifies the compliance process and facilitates faster market access within the EU.
Presumption of Conformity
If a product is manufactured in accordance with a harmonized standard cited in the OJEU, it is presumed to comply with the relevant essential requirements of EU legislation.
This presumption only applies if the standard fully covers the product’s relevant aspects.
Common Harmonized Standards by Application
The following harmonized standards are frequently applied in the context of CE marking and radio equipment compliance:
| Standard | Details |
|---|---|
| EN 300 328 |
Focus Area: Spectrum efficiency and RF parameters in the 2.4 GHz band Application: Wi-Fi, Bluetooth, Zigbee, SRD |
| EN 301 489-1 |
Focus Area: Electromagnetic compatibility for radio devices Application: EMC testing under RED and EMCD |
| IEC/EN 62368-1 |
Focus Area: Product safety for AV and ICT equipment Application: RED, LVD, general CE safety compliance |
| Standard | Focus Area | Application |
|---|---|---|
| EN 300 328 | Spectrum efficiency and RF parameters in the 2.4 GHz band | Wi-Fi, Bluetooth, Zigbee, SRD |
| EN 301 489-1 | Electromagnetic compatibility for radio devices | EMC testing under RED and EMCD |
| IEC/EN 62368-1 | Product safety for AV and ICT equipment | RED, LVD, general CE safety compliance |
Limitations and Exceptions
Applying harmonized standards is voluntary, not mandatory.
They do not replace the need to meet all essential legal requirements.
Not all product types have harmonized standards.
In cases of novel technologies or partial applicability, manufacturers may need third-party assessment by a Notified Body.