Tag: CE

EU Updates ATEX, Medical, R&TTE & Machinery Directives for CE Marking

by admin on May.21, 2012, under EMC, Europe, Product Safety

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 27, 2012 – Updates to the Medical Devices Directive (93/42/EC), In Vitro Diagnostics Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). 

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.

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CE Compliance Testing Delays Launch of Raspberry Pi Mini PC

by admin on Apr.10, 2012, under EMC, Europe

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.

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TCB Workshop Includes R&TTE Directive Overview

by admin on Nov.03, 2011, under Telecom, Wireless

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.

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Russia & Customs Union Countries Adopt Common Production Mark for Product Safety

by admin on Jun.17, 2011, under Product Safety, Russia

This Compliance Today blog post is supplied by MET Labs Russian partner Elmas Group

common production markThe 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.

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