Compatible Electronics provides accredited CE marking testing for EMC, product safety, and radio equipment requirements — covering all key harmonized EN/IEC standards needed for EU market access from three California laboratory locations.
Scope effective 2025-06-05 through 2026-06-30 • View Full Accreditation Scope →
The CE mark enables the free movement of products into and within the European market. By affixing the CE mark, a manufacturer declares — on their sole responsibility — that the product conforms to all applicable EU Directive requirements. Not all products require the CE mark; only those subject to specific EU Directives must bear it.
Prior to placing a product on the European market, the manufacturer assesses it against all applicable Directives, verifies compliance with the relevant essential requirements, and maintains a technical documentation file for a minimum of 10 years, available to EU market surveillance authorities on request.
Depending on your product type, one or more of the following Directives will apply. Compatible Electronics supports testing for all three primary directives affecting electronic and electrical products.
Applies to all electrical and electronic equipment with potential to cause or be susceptible to electromagnetic disturbance. Repeals 2004/108/EC (April 2016).
Applies to products with intentional radio transmitters (Wi-Fi, Bluetooth, Zigbee, cellular, etc.). Includes EMC requirements under Article 3.1(b). Repeals R&TTE Directive 1999/5/EC (June 2016).
Applies to electrical equipment operating between 50–1000 V AC or 75–1500 V DC. Frequently required alongside the EMC Directive in the same CE marking project. Also see CE LVD Safety Testing.
Applies to medical devices placed on the EU market. Repeals MDD 93/42/EEC. EMC testing under IEC 60601-1-2 (Ed. 4.0/4.1) is required for medical electrical equipment under this regulation.
Compatible Electronics will guide your company through the CE testing and documentation process. The key steps are:
Determine which EU Directives apply to your product. Most electronic products require the EMC Directive; wireless products also require the RED; powered products in the specified voltage range additionally require the LVD. Medical devices fall under EU MDR 2017/745.
Each Directive specifies legal “essential requirements.” For the EMC Directive these are emissions limits and immunity levels. Harmonized standards — when applied in full — provide a presumption of conformity with these requirements. Manufacturers may also use other standards but must demonstrate conformity to essential requirements directly.
The EMC Directive permits manufacturer self-declaration using harmonized standards. Using an NVLAP accredited laboratory such as Compatible Electronics provides the strongest evidence base for your Declaration of Conformity and is required or expected by many retail customers, Notified Bodies, and EU supply chains.
Perform emissions and immunity testing to the applicable harmonized EN/IEC standards. Compatible Electronics conducts all testing in-house at three accredited California locations under NVLAP Lab Code 200527-0. Our scope covers EMC emissions, immunity, product safety, radio, and RF exposure — enabling a complete CE marking package from a single lab.
The technical file must include: product description and drawings, risk assessment, list of harmonized standards applied, accredited test reports, and the EU Declaration of Conformity. It must be retained for at least 10 years and be available to EU authorities on request. It may be in any EU language but must be kept in Europe.
Sign the EU Declaration of Conformity citing the applicable Directives and harmonized standards applied. Affix the CE mark to the product, packaging, or accompanying documentation. The mark must be visibly, legibly, and indelibly affixed. It may only appear on packaging or documents if it cannot be physically attached to the product itself.
The following standards are drawn from Compatible Electronics’ current NVLAP scope (effective 2025-06-05 through 2026-06-30, Lab Code 200527-0). Standards relevant to CE marking under the EMC Directive and RED are highlighted. The full scope also includes FCC, ISED, Korean, Australian, Taiwanese, Vietnamese, and Japanese market standards.
| Standard | Description | Locations |
|---|---|---|
| Multimedia / ITE Equipment | ||
| EN 55032 (2015)+A11(2020) | Electromagnetic compatibility of multimedia equipment — Emission Requirements | LF, B, NP |
| EN 55032 (2012-05) | Electromagnetic compatibility of multimedia equipment — Emission requirements (prior version, legacy products) | LF, B |
| EN 55022 (2010) | Information technology equipment — Radio disturbance characteristics (superseded ITE standard; legacy products) | LF, NP |
| ISM / Industrial / Scientific / Medical Equipment | ||
| EN 55011 (2007)+A2(2007) | ISM radio-frequency equipment — Electromagnetic disturbance characteristics | LF, B |
| EN 55011 (2009)+A1(2010) | ISM radio-frequency equipment — Electromagnetic disturbance characteristics | LF, NP |
| AS CISPR 11 (2017) | ISM equipment — Radio-frequency disturbance characteristics (CISPR 11:2015+AMD1:2016 MOD) | LF, B, NP |
| IEC/CISPR 11 Ed. 7.0 (2024-02) | ISM equipment — Radio-frequency disturbance characteristics (latest edition) | LF |
| Broadcast Receivers | ||
| EN 55013 (2013) | Sound and television broadcast receivers — Radio disturbance characteristics | NP |
| EN 55013 (2001)+A1(2003)+A2(2006) | Sound and television broadcast receivers — Radio disturbance characteristics (prior version) | LF, B |
| Household Appliances & Lighting | ||
| EN 55014-1 (2006)+A1(2009) | Electromagnetic compatibility — Household appliances, electric tools and similar apparatus — Part 1: Emission | B |
| EN 55015 (2013) / CISPR 15 Ed. 8.0 (2013) | Radio disturbance characteristics of electrical lighting and similar equipment | LF, NP |
| Professional Audio/Video | ||
| EN 55103-1 (2009) | Professional audio, video, audio-visual and entertainment lighting control apparatus — Part 1: Emission | NP |
| Gas Detection | ||
| EN 50270 (2015) / EN 50270:2015/AC:2016 | Electromagnetic compatibility — Electrical apparatus for detection and measurement of combustible gases, toxic gases or oxygen | B |
| Power Quality — Harmonic Current Emissions | ||
| EN 61000-3-2 (2014) | Limits for harmonic current emissions (input current ≤16 A per phase) | LF, B, NP |
| EN 61000-3-2 (2006)+A1(2009)+A2(2009) | Limits for harmonic current emissions (prior version) | LF, B |
| IEC 61000-3-2, Ed. 4.0 (2014-05) | Limits for harmonic current emissions (IEC version) | NP |
| Power Quality — Voltage Fluctuations & Flicker | ||
| EN 61000-3-3 (2013) / IEC 61000-3-3 Ed. 2.0 (2008) | Limitation of voltage changes, voltage fluctuations and flicker (≤16 A per phase) | LF, B, NP |
| EN 61000-3-3:2013/A2:2021/AC:2022-01 / IEC 61000-3-3 (2013)+AMD2(2021) | Voltage fluctuations and flicker (latest EN/IEC amendment) | LF |
| Generic Emission Standards | ||
| EN 61000-6-3 (2007)+A1(2011) / IEC 61000-6-3 (2006-06) | Generic emissions — Residential, commercial and light-industrial environments | LF, B, NP |
| EN 61000-6-4 (2007)+A1(2011) / IEC 61000-6-4 (2006-07)+A1(2010) | Generic emissions — Industrial environments | LF, B, NP |
| Measurement, Control & Laboratory Equipment | ||
| IEC 61326-1 (2005-12) / EN 61326-2-3 (2013) / IEC 61326-2-3 (2006) | Electrical equipment for measurement, control and laboratory use — EMC requirements | LF, B, NP |
| Low-Voltage Power Supplies | ||
| IEC/EN 61204-3 (2001) | Low-voltage power supplies, d.c. output — Part 3: Electromagnetic compatibility (EMC) | B, NP |
| Standard | Description | Locations |
|---|---|---|
| Multimedia / ITE Immunity | ||
| EN 55035 (2017)+A11(2020) | Electromagnetic compatibility of multimedia equipment — Immunity requirements (CISPR 35, modified) | LF, B, NP |
| EN 55035 (2017) | Electromagnetic compatibility of multimedia equipment — Immunity requirements | LF, B |
| EN 55024 (2010) / CISPR 24 (2010)+A1(2015) | Information technology equipment — Immunity characteristics | LF, B, NP |
| CISPR 35 (2016) | Electromagnetic compatibility of multimedia equipment — Immunity requirements | LF, B, NP |
| ESD Immunity — IEC 61000-4-2 | ||
| IEC 61000-4-2, Ed. 2.0 (2008-12) | Electrostatic discharge immunity test | LF, B, NP |
| IEC 61000-4-2, Ed. 1.2 (2001) | Electrostatic discharge immunity test (prior edition) | LF, B |
| Radiated RF Immunity — IEC 61000-4-3 | ||
| IEC 61000-4-3 Ed. 3.2 (2010-04) | Radiated, radio-frequency, electromagnetic field immunity test | LF, B |
| IEC 61000-4-3, Ed. 3.0 (2006-02) | Radiated, radio-frequency, electromagnetic field immunity test | LF, B |
| IEC 61000-4-3, Ed. 3.0 (2006-02)+A1(2007) | Radiated, radio-frequency, electromagnetic field immunity test | NP |
| EFT/Burst Immunity — IEC 61000-4-4 | ||
| IEC 61000-4-4, Ed. 3.0 (2012-04) | Electrical fast transient/burst immunity test | LF, B, NP |
| IEC 61000-4-4, Ed. 2.0 (2004-07) | Electrical fast transient/burst immunity test (prior edition) | LF, B |
| Surge Immunity — IEC 61000-4-5 | ||
| IEC 61000-4-5 Ed. 3.0 (May 2014) | Surge immunity test | LF, B, NP |
| IEC 61000-4-5 Ed. 3.1 (2017) | Surge immunity test (updated edition) | LF |
| IEC 61000-4-5, Ed. 1.1 (2001-04) / BS EN 61000-4-5 (2006) | Surge immunity test (prior editions) | LF, B, NP |
| Conducted RF Immunity — IEC 61000-4-6 | ||
| IEC 61000-4-6 Ed. 4.0 (2013) | Immunity to conducted disturbances induced by radio-frequency fields | LF, B, NP |
| IEC 61000-4-6, Ed. 2.2 (2006-05) | Immunity to conducted disturbances induced by radio-frequency fields (prior edition) | LF, B |
| Power Frequency Magnetic Field — IEC 61000-4-8 | ||
| IEC 61000-4-8 (2009) | Power frequency magnetic field immunity test | LF, B, NP |
| Voltage Dips & Interruptions — IEC 61000-4-11 | ||
| IEC 61000-4-11, Ed. 2 (2004-03) & EN 61000-4-11 | Voltage dips, short interruptions and voltage variations immunity tests | LF, B, NP |
| IEC 61000-4-11, Edition 3.0 (2020) | Voltage dips, short interruptions and voltage variations immunity tests (latest edition; ≤16 A per phase) | LF |
| Additional Immunity Tests | ||
| IEC 61000-4-9 (2016) | Impulse magnetic field immunity test | LF |
| IEC 61000-4-12 (2017) | Ring wave immunity test | LF |
| IEC 61000-4-13 Ed. 1.2 (2015) | Harmonics and interharmonics including mains signalling at a.c. power port, low frequency immunity tests | LF |
| Generic Immunity Standards | ||
| EN 61000-6-1 (2007) | Generic immunity — Residential, commercial and light-industrial environments | LF, B, NP |
| EN 61000-6-2 (2005) | Generic immunity — Industrial environments | LF, B, NP |
| Product-Specific Immunity | ||
| EN 61326-1 (2013) / EN 61326-1 (2006) | Measurement, control and laboratory equipment — EMC requirements — Part 1: General requirements | LF, B, NP |
| IEC 61326-2-6, Ed. 1.0 (2005-12) | In vitro diagnostic (IVD) medical equipment — EMC requirements | LF, B, NP |
| EN 50130-4 (2011) | Alarm systems — Immunity requirements for fire, intruder, hold up, CCTV, access control and social alarm systems | LF, B, NP |
| EN 55103-2 (2009) | Professional audio, video, audio-visual and entertainment lighting control apparatus — Part 2: Immunity | NP |
| EN 61547 (2009) / IEC 61547, Ed. 2.0 (2009) | Equipment for general lighting purposes — EMC immunity requirements | NP |
Compatible Electronics holds accreditation for ETSI EN 301 489 series EMC standards used as harmonized standards under the Radio Equipment Directive 2014/53/EU. These support CE marking for wireless devices alongside the RED essential requirement testing under Article 3.2.
| Standard | Description | Locations |
|---|---|---|
| ETSI EN 301 489-1 V2.2.3 (2019-11) | EMC standard for radio equipment — Part 1: Common technical requirements; Harmonised Standard for EMC | B |
| ETSI EN 301 489-1 V1.9.2 (2011-09) | EMC standard for radio equipment — Part 1: Common technical requirements (prior version) | LF, B |
| ETSI EN 301 489-3 V2.1.1 (2019-03) | Part 3: Short-Range Devices (SRD) operating 9 kHz–246 GHz; Harmonised Standard under Article 3.1(b) of RED | LF, B |
| ETSI EN 301 489-3 V1.6.1 (2013-08) | Part 3: Short-Range Devices (prior version) | LF, B |
| ETSI EN 301 489-4 V3.3.1 (2021-02) | Part 4: Fixed radio links and ancillary equipment | LF |
| ETSI EN 301 489-9 v1.4.1 (2007-11) | Part 9: Wireless microphones, RF audio link, cordless audio and in-ear monitoring devices | LF |
| ETSI EN 301 489-17 V3.2.4 (2020-09) | Part 17: Broadband Data Transmission Systems (Wi-Fi, RLAN); Harmonised Standard for EMC | B |
| ETSI EN 300 220-1/-2 V2.4.1 (2012-05) | Short Range Devices (SRD); 25 MHz–1000 MHz, up to 500 mW; Technical characteristics and Harmonised EN under R&TTE/RED | LF |
| ETSI EN 300 328 V2.2.2 (2019-07) | Wideband transmission systems; 2.4 GHz band; Harmonised Standard for access to radio spectrum | B |
| ETSI EN 300 330 V2.1.1 (2017-02) | SRD; 9 kHz–25 MHz and inductive loop systems 9 kHz–30 MHz; Harmonised Standard under Article 3.2 of RED | LF, B |
| ETSI EN 300 440 V2.1.1 (2017-03) | SRD; 1 GHz–40 GHz; Harmonised Standard under Article 3.2 of RED | LF, B |
| ETSI EN 300 386 V1.6.1 (2012-09) | Telecommunication network equipment — EMC requirements | LF, NP |
See also: ETSI RED Testing Services → and Full ETSI EN 301 489 Standards List →
Compatible Electronics’ NVLAP scope includes a broad range of product safety standards applicable to CE marking under the Low Voltage Directive and the EU MDR. This enables combined EMC + safety testing in a single visit for most product categories.
In addition to NVLAP accreditation for CE marking, Compatible Electronics participates in the FDA’s Accreditation Scheme for Conformity Assessment (ASCA). This enables streamlined FDA premarket submissions by providing accredited safety and EMC test reports directly recognized by the FDA.
| Standard (FDA#) | Description | Location |
|---|---|---|
| ANSI AAMI ES60601-1 (2005)/A2:2021 (FDA#19-46) | Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD incl. AMD2:2021) | LF |
| IEC 60601-1-2, Ed. 4.1 (2020-09) (FDA#19-36) | Medical electrical equipment — Part 1-2: Electromagnetic disturbances (see scope for specific exclusions) | LF, B, NP |
| IEC 60601-1-6, Ed. 3.1 (2013-10) (FDA#5-89) | Medical electrical equipment — Part 1-6: Usability | LF |
| IEC 60601-1-6, Ed. 3.2 (2020-07) (FDA#5-132) | Medical electrical equipment — Part 1-6: Usability (latest edition) | LF |
| IEC 60601-1-8, Ed. 2.1 (2012-11) (FDA#5-76) | Medical electrical equipment — Part 1-8: Alarm systems | LF |
| IEC 60601-1-8, Ed. 2.2 (2020-07) (FDA#5-131) | Medical electrical equipment — Part 1-8: Alarm systems (latest edition) | LF |
| IEC 60601-1-11, Ed. 2.0 (2015) (FDA#19-14) | Medical electrical equipment — Part 1-11: Home healthcare environment requirements | LF |
| IEC 60601-1-11, Ed. 2.1 (2020-07) (FDA#19-38) | Medical electrical equipment — Part 1-11: Home healthcare environment (latest edition; see scope for exclusion) | LF |
| IEC 61010-1, Ed. 3.1 (2017-01) (FDA#19-34) | Safety requirements for electrical equipment for measurement, control and laboratory use | LF |
Complete CE marking evidence package from one lab — emissions, immunity, product safety, and ETSI radio standards. Eliminates scheduling across multiple facilities.
ILAC MRA recognized test reports accepted by EU market surveillance authorities and Notified Bodies. Scope effective 2025-06-05 through 2026-06-30.
CE marking + FCC + ISED (Canada) + RCM (Australia) + BSMI (Taiwan) + KC (Korea) from one test session. Scope covers all major global markets simultaneously.
Guidance on Declaration of Conformity preparation, applicable Directive citations, and technical file structure. Lab does not act as Notified Body but provides complete test evidence for self-declaration.
Identify emissions and immunity failures before formal certification — saving time and rescheduling costs. Learn more →
Lake Forest/Silverado • Brea • Newbury Park. Fast turnaround scheduling available at all three. Select the location with the specific standard version and test capability you need.
The following legacy directives are superseded but may be relevant for legacy product documentation or for understanding the evolution of CE requirements. Original documents provided here for convenience; not maintained by Compatible Electronics.
This page is a regulatory reference covering EU Directive texts, harmonized standards lists, and the compatible Electronics accredited scope. If you are looking for detailed information on our testing services, real-world testing examples, and how to get started with a CE marking project, please visit our dedicated CE Marking EMC Testing Services page:
→ CE Marking EMC Testing Services — Standards, Examples & How to Get Started
Also see: International Compliance Testing → • Full Accreditation Scope → • Learning Center →
Contact Compatible Electronics today for CE marking testing, accredited test reports, and EU market access support.
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