CE harmonised standards

Author Hugues Orgitello Last updated 25 May 2026

CE · Pillar

CE marking does not mandate the application of standards. It mandates compliance with the essential requirements of the directives. Harmonised standards are a shortcut: applying them correctly creates a presumption of conformity, the authority must then prove otherwise to challenge you. This page details the mechanism, reliable sources, and the structuring standards for electronic products in 2026.

The "new approach" logic

Since 1985, the EU has separated two layers:

Directives set essential requirements: safety, health, consumer protection, environment. They are deliberately generic ("equipment shall not cause electromagnetic disturbances such that...") to remain valid against technological evolution.
Harmonised standards, drafted by European standardisation bodies (CEN, CENELEC, ETSI) on Commission mandate, translate these requirements into measurable technical specifications.

Applying a harmonised standard is never mandatory; it is a choice. The manufacturer may demonstrate conformity by other means, but will then have to build the technical case itself, without benefiting from the presumption.

Three European Standards Organisations (ESO)

Organisation	Domain	Standard type
CEN	European Committee for Standardization	General standards, non-electrical safety
CENELEC	European Committee for Electrotechnical Standardization	Electrical and electronic standards (EN 6xxxx)
ETSI	European Telecommunications Standards Institute	Radio and telecom standards (EN 3xxxx)

Harmonised standards carry the EN (European Norm) prefix followed by a number indicating origin and category. An EN standard generally re-publishes an international standard (CISPR, IEC, ITU) with possible European amendments.

The mandate and harmonisation process

The cycle is as follows:

The Commission identifies a need for standards to implement a directive.
It mandates an ESO to draft or adapt the standard.
The ESO drafts the standard via its technical committees (with public consultation).
The standard is published by the ESO as EN xxxxx.
The Commission evaluates whether the standard effectively meets the essential requirements.
If yes, it publishes the reference in the Official Journal of the European Union (OJEU, C series).
From this publication, correct application of the standard creates the presumption of conformity.

A standard may exist, be cited by CEN/CENELEC/ETSI, without being harmonised. Always verify OJEU publication to confirm presumption.

Where to find the harmonised standards in force

References are published in the Official Journal of the European Union, C series, as Commission communications. Three reliable sources:

EUR-Lex, search by directive (e.g. "2014/30/EU harmonised standards"). This is the authoritative source.
The Single Market & Standards portal of the European Commission, consolidated lists by directive, regularly updated. More readable than EUR-Lex for quick consultation.
CEN-CENELEC, for electrical and general standards; ETSI for radio and telecoms standards.

A standard cited by a brand, a consulting firm, or a manufacturer is not an official reference. Always cross-check with the latest OJEU publication, especially for new projects and after each portfolio review.

Lifecycle of a harmonised standard

A harmonised standard passes through several phases over time:

Initial publication in the OJEU → presumption of conformity begins.
Coexistence period (noted doc, date of cessation, in the OJEU communication), typically 24 to 36 months during which both old and new versions create presumption.
Date of cessation of presumption of conformity ("doc") → the withdrawn version no longer grants presumption; only the updated version confers it.
Amended evolution (A1, A2...): the amendment is treated as a separate publication in the OJEU.

The classic trap: a test performed against a standard version that has since been withdrawn. The test remains technically valid but no longer carries presumption, technical equivalence with the current version must be justified, which often means redoing the tests.

Chronological example: EN 62368-1 (audio/video/IT safety)

2014: Initial publication of EN 62368-1:2014.
2018: EN 62368-1:2018 published as replacement.
20 December 2020: Official doc: EN 60065 (audio/video) and EN 60950-1 (IT) withdrawn in favour of EN 62368-1 for all covered products. Manufacturers still on old standards must transition.
2020-2024: EN 62368-1 remains the reference standard with A11 amendments (European Annex Z).
2024-2025: Publication of EN 62368-1:2023 (edition 4) at CENELEC. Harmonised reference at OJEU expected 2026.

Following this kind of chronology is essential to anticipate transitions.

How to read an OJEU publication

A Commission communication in the OJEU C series always follows the same structure:

Standard reference            | Replaced standard reference      | Date of cessation
EN 55032:2015/A11:2020        | EN 55032:2015                    | -
EN 55035:2017/A11:2020        | EN 55032:2017                    | -
EN 62368-1:2020/A11:2020      | EN 60950-1:2006 + EN 60065:2014  | 20/12/2020

Reading:

The first column gives the exact reference (edition + amendments) to cite in the DoC.
The second column lists standards the new version replaces.
The third column gives the date of cessation of presumption of the old version.

Key standards for electronic products

Electromagnetic compatibility: EMC Directive

Standard	Coverage	Notes
EN 55032	Conducted and radiated emissions for multimedia (audio, video, IT)	Re-publishes CISPR 32
EN 55035	Multimedia immunity	Re-publishes CISPR 35
EN 55011	Industrial, scientific and medical equipment emissions	ISM 50 Hz - 1 GHz
EN 55014-1 / -2	Household appliances (emissions / immunity)	Portable tools, household appliances
EN 55015	Lighting equipment	Lamps, luminaires
EN 61000-3-2	Harmonic current emission limits (≤ 16 A per phase)	Classification A, B, C, D
EN 61000-3-3	Voltage variations / flicker limits	P_st, P_lt
EN 61000-3-11	Limits for equipment > 16 A and special conditions	Conditional connection
EN 61000-3-12	Harmonics for 16-75 A equipment
EN 61000-6-1	Generic immunity, residential/commercial/light industrial	Default generics
EN 61000-6-2	Generic immunity, industrial environment
EN 61000-6-3	Generic emissions, residential/commercial/light industrial
EN 61000-6-4	Generic emissions, industrial environment
EN 61000-4-x	Immunity test methods (-2 ESD, -3 RF, -4 EFT, -5 surge, -6 conducted RF, -8 magnetic, -11 dips)	Referenced by product standards

Electrical safety: LVD

Standard	Coverage
EN 62368-1	Audio/video, IT and communication equipment safety, replaces former EN 60065 and EN 60950-1
EN 61010-1	Safety of measurement, control and laboratory equipment, generic base for EN 61010-2-XX
EN 60335-1	Safety of household appliances, generic base for parts 60335-2-XX (washing machine, refrigerator, etc.)
EN 60601-1	Safety of medical electrical devices
EN 60598-1	Safety of luminaires
EN 62841-1	Safety of portable electric tools
EN 60204-1	Machinery safety, electrical equipment

Radio equipment: RED

The RED directive covers three main articles (3.1, 3.2, 3.3), each with its standards.

Article 3.1(a): Health and safety

EN 50360: SAR method for phones (head)
EN 50566: SAR method for worn equipment
EN 62209-1: Generalised SAR (phones)
EN 62209-2: SAR for devices ≤ 100 g
EN 62311: General EMF exposure ≤ 300 GHz

Article 3.1(b): Radio electromagnetic compatibility

EN 301 489 series with a generic part and specific parts:

Part	Coverage
EN 301 489-1	Common requirements for all radio equipment
EN 301 489-3	SRD ≤ 1 GHz (LoRa, Sigfox 868 MHz, remote controls, alarms)
EN 301 489-4	Fixed radio links
EN 301 489-5	PMR trunking (Tetra)
EN 301 489-9	Wireless microphones
EN 301 489-15	Amateur equipment
EN 301 489-17	Wi-Fi 2.4/5/6 GHz and Bluetooth
EN 301 489-19	GNSS receivers (GPS, Galileo)
EN 301 489-31	Active medical implants
EN 301 489-50	Cellular base stations
EN 301 489-52	Cellular user equipment (mobile phones, cellular modules)
EN 301 489-53	UWB

Article 3.2: Efficient use of spectrum

Standard	Band	Coverage
EN 300 328	2.4 GHz	Wi-Fi, Bluetooth, BLE, ZigBee, Thread
EN 301 893	5 GHz	Wi-Fi 5/6 (5150–5350 / 5470–5725 MHz)
EN 303 687	6 GHz	Wi-Fi 6E / Wi-Fi 7 (5945–6425 MHz)
EN 300 220	Sub-GHz	SRD 25 MHz – 1 GHz (LoRa, Sigfox, Z-Wave, remote controls)
EN 300 113	VHF/UHF	Analogue and digital PMR
EN 301 511	GSM	GSM 900/1800 cellular modules
EN 301 908	UMTS/LTE/5G	Multiple parts, user equipment and base stations
EN 302 065	UWB	Ultra Wide Band
EN 303 098	RFID 13.56 MHz	NFC, readers
EN 300 422	Wireless microphones
EN 300 718	DTM	Avalanche transceivers 457 kHz

Article 3.3: Specific requirements (cybersecurity since August 2025)

Standards harmonised in 2024 for Delegated Regulation (EU) 2022/30:

Standard	Coverage
EN 18031-1	Article 3.3(d): protection of network functionalities
EN 18031-2	Article 3.3(e): protection of personal data
EN 18031-3	Article 3.3(f): protection against fraud

RoHS: Restriction of Hazardous Substances

RoHS conformity relies on:

IEC 63000, conformity documentation methodology, supplier declarations, materials segregation.
EN 62321 (series): test methods for dosing restricted substances (lead, cadmium, mercury, hexavalent chromium, brominated flame retardants PBB/PBDE, phthalates DEHP/BBP/DBP/DIBP).

Ecodesign and energy

EN 50564, standby electrical power measurement
EN 62301, standby consumption measurement
EN 50563, external power supplies (chargers)
EN 50643, networked household appliances

What if no harmonised standard covers your case?

Three common situations:

The product is novel, no dedicated standard yet published. Solution: apply a generic standard (e.g. EN 61000-6-x for EMC) with a documented rationale, complemented by a product-specific risk analysis.
The standard exists but is not harmonised in the OJEU sense (e.g. a recent CISPR standard not yet cited). It may be applied but does not grant presumption; the case must be well-substantiated.
No relevant standard exists, the case of genuinely innovative products. The manufacturer must demonstrate conformity through its own analysis, its own tests, and cross-referencing with the state of the art. This is the most demanding case in terms of technical file.

In these three cases, the manufacturer may apply an international standard (CISPR, IEC, ITU) in the absence of EN, provided it demonstrates that it adequately covers the essential requirements.

Technical standards vs. harmonised standards

A subtle distinction that comes up in audit:

A standard is a technical specification adopted by a recognised body (ISO, IEC, CEN, CENELEC, ETSI, ANSI, JIS...).
A harmonised standard is a standard whose reference has been published in the OJEU by the Commission. That publication triggers the presumption.

A standard can be technical without being harmonised. Conversely, a standard may be harmonised for one directive and not for another. Always check the list for the directive in question.

Special case of amended standards (A1, A2, A11)

A harmonised standard evolves via numbered amendments:

A1, A2, A3..., international amendments (IEC, CISPR).
A11, A12, A13...: European Annex Z amendments specific to the harmonised version. They add or modify requirements to meet the European directive without changing the international standard.

For example, EN 55032:2015/A11:2020 takes CISPR 32:2015 and adds a European Annex Z harmonised in 2020. A DoC omitting the A11 amendment would be incomplete and lose presumption.

How to reference standards in the EU DoC

The DoC must list the exact references of the applied standards, with edition year and amendments:

EN 55032:2015/A11:2020
EN 55035:2017/A11:2020
EN IEC 61000-3-2:2019/A1:2021
EN 61000-3-3:2013/A1:2019/A2:2021
EN 62368-1:2020/A11:2020
EN 300 328 V2.2.2 (2019-07)
EN 301 489-1 V2.2.3 (2019-11)
EN 301 489-17 V3.2.4 (2020-09)
EN IEC 63000:2018

Note: ETSI standards use a different notation (V_x.y.z + date in parentheses). Always respect the format published in the OJEU when editing the DoC.

An imprecise reference ("EN 55032" with no year) is a classic ground for rejection in market surveillance audits. A reference to a version withdrawn more than 24 months ago without equivalence justification with the version in force is equally so.

Tracking evolutions: process to stay current

Three recommended practices to maintain product portfolio consistency:

Bi-annual OJEU watch for each applicable directive. Identify added standards and those approaching doc.
Internal dashboard per product listing standards cited in the DoC and their status (in force / coexistence / withdrawn).
Predefined transition procedure: for each production product, which migration schedule to the new standard, which retests required, which documentation impact.

Without this discipline the portfolio drifts: 3 years after launch, several products cite obsolete standards on their DoC, and a single audit can lead to a multi-reference recall.

Key takeaways

The obligation rests on the essential requirements of the directives, not on the standards.
Harmonised standards create a presumption of conformity; applying them correctly protects you.
Presumption is time-bounded: tracking OJEU publications is essential.
Without a harmonised standard, the manufacturer must build the technical case alone, feasible but demanding.
The exact reference (version + amendments) must appear in the DoC without approximation.

For practical implementation, see Certification procedure and Required tests.

Sources & references

Article 17 of Regulation (EU) No 1025/2012, harmonised standards , EUR-Lex eur-lex.europa.eu/eli/reg/2012/1025/oj
EU Single Market, harmonised standards portal , European Commission single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en
CEN-CENELEC standards database , CEN-CENELEC www.cencenelec.eu/european-standardization/european-standards/
ETSI portal , ETSI www.etsi.org/standards