Earlier this year, the European Commission released the latest references for the harmonized standards used to demonstrate conformity with the EU EMC Directive 2004/108/EC and the new R&TTE Directive 1999/5/EC requirements started on January 1, 2015. (R&TTE is replaced in June 2016 by the Radio Equipment Directive (RED) 2014/53/EC).
Placed on many categories of products, CE Marking is mandatory for machinery, electrical and electronic equipment, medical devices, hazardous location equipment, and other products. So if you are looking to sell an electronics product in the EU, you will need to apply a CE mark.
Here’s a Top 12 list of interesting facts about CE marking:
- The CE mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985
- CE stands for Conformité Européenne (French), which means European conformity
- CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product’s compliance with relevant requirements
- With a CE mark, your product can be sold in the EU and in Iceland, Liechtenstein, and Norway
- There are six steps to CE marking: 1. Identify the relevant directives and standards, 2. Verify the product’s specific requirements, 3. Identify whether an independent conformity assessment (Notified Body) is necessary, 4. Test product, 5. Create technical documentation, and 6. Add CE mark to the product
- CE marking is not evidence of compliance – your technical documentation/technical file is
- The manufacturer or authorized representative must keep technical documentation for a number of years (the number is dependent on the product type) after the last product has been placed on the market
- Each EU country is responsible to enforce CE marking, by banning products and levying fines for non-compliance
- Unsafe products are shared in the EU via RAPEX – a rapid alert system on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers
- There is a very similar logo where the CE stands for Chinese Export or China Export – this has nothing to do with European conformity
- The size of the CE mark must be at least 5 mm high. If the appearance or size of a product do not allow for the CE marking to be affixed on the product itself, the marking has to be affixed to its packaging or accompanying documents
- Pre-testing early in the product development process can reduce cost and time to market
MET Labs has tested thousands of products to support CE Marking Declarations of Conformity (DoC) for product safety, electromagnetic compatibility, and energy efficiency. Contact us today to tap the experience and skill of the MET engineering team.
Just like last year, the Compliance Today blog for electrical product manufacturer compliance engineers saw a significant increase in readers and subscribers for 2014. Following were the most popular posts, by pageviews.
- IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes
- EN 61326-1: 2013 Replacing 2006 Version for EMC Directive Evaluation of Lab, Test & Measurement Equipment
- EN55032 Replacing EN55022 and Others for CE Marking of Multimedia Equipment
- New Radio Equipment Directive Adopted by EU, Awaits Publication in OJ
- CE Marking Directives Recast to Align with New Legislative Framework
- IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets
- Some Electronic Devices Are Exempt from FCC EMC Testing
- Top 20 Non-Compliance Findings for Panel & Motor-Operated Equipment
- EMI/EMC Testing Best Practices – Before & During Your Lab Visit
- Radio Equipment Directive (RED) Replacing R&TTE Directive, is Published in OJ
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Want more in-depth information on one of these topics? Check to see if we are planning a seminar or webinar on it.
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The European Union EMC Directive 2004/108/EU has been revised to the new Directive 2014/30/EU. After April 2016, the new directive will be required for all applicable electrical products being sold in the European Union.
Requirements listed in Annex I of the directive remain the same. But 4 key changes have been made:
- The directive now applies to distributers and importers, not just manufacturers
- Additional information is required in the technical file
- DoCs now need to be multilingual
- Notified Body requirements have been updated
In order to maintain EMC compliance, a few steps can be taken. First, be sure that all harmonized standards listed on the reports are current. Review your technical file and ensure that all operators’ information and technical instructions comply with Article 18. Your updated DoC should reference 2014/30/EU and clearly identify the product you wish to sell.
Also, read about the new Radio Equipment Directive for CE marking radio equipment.
The European Commission has been busy updating lists of European harmonized standards for various product directives. Here are the updates to the Official Journal (OJ) of the European Union, looking back from the most recent:
May 4, 2012 – Updates to the ATEX Directive (94/9/EC), the European CE directive that applies to equipment used in potentially explosive atmospheres.
The list introduces two new European harmonized standards:
- EN 13617-2:2012 Petrol filling stations – Part 2: Safety requirements for construction and performance of safe breaks for use on metering pumps and dispensers. Replaces the 2004 version with the same number and must be applied by September 30, 2012.
- EN 60079-11:2012 Explosive atmospheres – Part 11: Equipment protection by intrinsic safety ‘i’ (IEC 60079-11:2011). Replaces EN 60079-11:2007 + EN 60079-27:2008 + EN 61241-11:2006 and must be applied by August 4, 2014.
For explanation of the new EN 60079 standard and other updates, register for this July 17 seminar: Hazardous Location Product Safety Compliance for North America (UL & CSA), EU (ATEX) & World (IECEx)
April 11, 2012 – Updates to the Radio and Telecommunication Terminal (R&TTE) Directive (1999/5/EC) and the EMC Directive (2004/108/EC).
February 29, 2012 – Updates to the Machinery Directive (2006/42/EC).
These updated lists are important for manufacturers of relevant CE-marked products that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, you’ll need to reevaluate your products against the updated or new standards and update your Declaration of Conformity.
Request pricing and lead time for CE Mark testing.
The recent delay in the high-profile new product launch of the Raspberry Pi has reminded electronics manufacturers of a simple truth: Compliance sometimes means exceeding regulatory requirements due to buyer demands.
The iPhone-size Pi is a $25 mini PC that is intended to teach students about programming. Its maker, the UK-based Raspberry Pi Foundation, had been operating under the assumption that this type of engineering sample product could be sold in the UK without a CE mark. After all, the rival ARM-based Beagleboard development kit is sold under the same terms without a CE mark, as are the majority of similar prototyping platforms.
The rub here is that the Pi has proved wildly popular, making its distributors nervous about lawsuits. Distribution partners element14/PremierFarnell and RS Components insisted that the device receive a CE mark to indicate compliance with electronic emissions guidelines. Their judgment was seconded by the UK Department for Business, Innovation and Skills (BIS), which said the Pi did in fact need to carry the CE marking.
Last week, to everyone’s relief, the Pi passed EMC testing without requiring any hardware modifications. The testing was conducted at Panasonic’s facility in South Wales.
The device passed radiated and conducted emissions and immunity tests in a variety of configurations, as well as electrostatic discharge (ESD) testing. In the lab for all of last week, the Pi is now also reportedly compliant with requirements for United States’ FCC, Australia’s C-Tick, and Canada’s Technical Acceptance Certificate.
Find out more about testing requirements and cost and lead time for CE Marking.
Last week, MET Labs attended the FCC Telecommunication Certification Body (TCB) Council TCB Workshop in Baltimore. Here was the agenda.
One of the workshop’s more interesting presentations was on the R&TTE Directive. Following is a summary of the key points.
The Radio and Telecommunication Terminal Equipment Directive applies in Europe and the European Economic Area.
There is no certification for the R&TTE Directive 1999/5/EC. Meeting the requirements is the responsibility of the manufacturer or whoever puts the device on the market.
- Products must have CE mark to show compliance
- Declaration of Conformity (DoC) must be created for each device
- Technical Construction File (TCF) is necessary to demonstrate compliance
The CE mark must be visible on the label, user manual, and packaging, and must include the Notified Body and Alert Symbol, if applicable.
The DoC must be available in each language, and must be traceable to a signatory.
The TCF must be kept for at least 10 years after the final version of each device has been made.
R&TTE Directive does not give test limits. It instructs the manufacturer that the device must comply with certain performance requirements:
- Article 3.1a – Health (RF exposure; boundary calculations; acoustic safety; typical operation)
- Article 3.1a – Safety (EN 60950 for IT equipment; EN 60065 for Audio/Video equipment)
- Article 3.1b – EMC Performance (EN 301 489 series for radio; EN 55022 & EN 55024 for TTE)
- Article 3.2 – Radio Spectrum (output power; frequency tolerance; spurious emissions; receiver performance tests; tests at extreme voltage/temperature)
R&TTE Directive divides products into two classes:
- Class 1 – No restrictions on putting the device into service
- Class 2 – Restrictions exist for use of the device, and Country Notifications may be necessary
Ideally, all devices fall within an existing harmonized (harmonised) test standard. If you test to a harmonized standard and pass, there is a presumption of conformity to the essential technical requirements.
Harmonized standards are listed by the European Commission in its Official Journal (OJ).
When a standard is superseded, the device should meet the new version of the standard to stay compliant. There is an overlap period.
A Notified Body opinion is required if harmonized standards are not fully applied in these situations:
- Device has new technology with no applicable standards yet
- New standards are not yet harmonized
- Family of products, where the standard has not been applied to some models
- Test procedures or processes of the harmonized standard were not followed
If the technology is new and no harmonized standards exist, the manufacturer works with a Notified Body – like MET Laboratories – to determine a test plan, or parts of another standard to use. Alternatively, use a new version of a standard which has not yet become harmonized.
For most Radio and Telecommunication Terminal devices, the R&TTE Directive alone is sufficient – the EMC and Safety (Low Voltage) Directives do not apply.
R&TTE Directive was written in 1999. The new version of the directive is being written now, with these goals in mind:
- Improve traceability to DoC signatory
- Improve compliance rates
- Improve process for dealing with non-compliant products
- Maintain equipment quality
- Maintain trade
The next TCB event is a FCC/TCB Conference Call on December 13. The call is restricted to TCB personnel, but Associate Members can receive the call minutes.
Find out more about compliance with the R&TTE Directive.
The Common Production Mark was approved April 7, 2011 in Decision No. 605 by the 26th Congress of the Customs Union Commission. The Customs Union is made up of Russia, Kazakhstan and Belarus, and was created on January 20, 2005.
The Common Production Mark will be used for marking of products in the Customs Union (CU) and Eurasian Economic Community (EAEC or EurAsEC). EAEC countries include the CU countries, plus Kyrgyzstan and Tajikistan.
Products eligible for the Mark must be on the Common List of Products, and pass all conformity assessment procedures defined by the technical regulations.
The Mark is analogous with the European Union’s CE mark for product safety.
Read more about product safety compliance in Russia and CIS countries.