Late last year, Version 1.8.1 of EN 300 328 was adopted and published in the EU’s Official Journal (OJ). This standard is the applicable standard for WiFi, Bluetooth, and other wideband transmitters operating in the 2.4GHz band.
Version 1.8.1 has an effective date of December 31, 2014, so declarations of conformity with the Radio and Telecommunication Terminal Equipment (R&TTE) Directive based on testing against EN 300 328, v1.7.1 would need to be re-evaluated before the end of 2014 for devices going into the EU market after this date. Devices already in the market will be grandfathered in.
However, at the same time as the v1.8.1 adoption, a note was added to v1.7.1 in the OJ, stating that part of the new v1.8.1 requirements – medium utilization factors – needed to be immediately implemented and tested.
The upshot: Radio modules tested and found compliant to v1.7.1 need to be retested due to the additional requirement – there is no longer a presumption of conformity with the R&TTE Directive. This has caused confusion and headache for manufacturers and some test labs.
In conclusion, wireless modules tested to the un-amended v1.7.1 need to be retested now to the latest version of the standard. By January 1, 2015, all wireless equipment in the 2.4GHz band needs to be tested to v1.8.1.
Contact us for an overview of changes specified in v1.8.1.
To sell most types of electrical or electronic products in the European Union (EU), electromagnetic compatibility compliance with EMC Directive 2004/108/EC is required.
To meet the essential requirements of the EMC Directive, testing to a particular standard or standards is voluntary, although recommended, as they can provide a presumption of conformity. Harmonized standards are featured in The Official Journal of the European Union (OJ). Each standard governs a particular type of equipment, such as laboratory, IT, or household. The standards determine the strength and the limits for tests used to evaluate the product. Engineers should use generic standards only when there is no family standard covering the product.
If a product is redesigned or if the standard expires, manufacturers can perform a gap analysis to see if the product needs to be re-tested. If not, the manufacturer can prepare documentation with justifications, explaining why re-testing is not necessary.
The directive requires all possible product configurations be included in the EMC assessment, although a worst case representative model may be sufficient to cover simpler versions. If the difference is not design-related, such as a product color or shape, this model can be excluded from the list.
A company needs to prepare technical documentation or declaration of conformity (DoC) in accordance with Annex IV. The file should include a general description, environments where it can be used, warnings, manuals, and test reports.
The following standards are a good reference on how to prepare a DoC: EN ISO/IEC 17050-1:2005 and EN ISO/IEC 17050-2:2005. CENELEC has also published a specific guide for the DoC: CENELEC Guide 16.
The directive requires manufacturers or their authorized representatives to hold the technical documentation for at least 10 years after the last manufacturing date.
To ensure that products are tested to the correct standards and are in full compliance, manufacturers might want to submit their technical file and EMC report to a Notified Body (NB) for review. If everything is in order and complete, it issues a statement of opinion to be included in the technical file.
MET Labs has been designated a Conformity Assessment Body (CAB) in accordance with the US-EU mutual recognition agreement. For the EMC and R&TTE Directives, MET can prepare Technical Construction Files and perform other Notified and Competent Body functions.
If a manufacturer tries to place a non-compliant product on the EU market, it could face penalties that range from removing the product from the market to liability for a fine and/or imprisonment.
Like 60601-1 before it, CENELEC and IEC 61010-1: 2010 – along with CSA and UL 61010-1 Third Edition, 2012 – are moving to Third Edition. 61010-1 is the internationally harmonized safety standard for laboratory, process control, and test & measurement equipment. Products sold into the EU must comply with the 3rd edition of EN 61010-1 by October 2013.
The scope of the standard is expanded to cover the following types of equipment:
- Electrical test and measurement equipment
- Electrical laboratory equipment
- Electrical industrial process-control equipment
Note: Hand-held probe assemblies are no longer covered by IEC 61010-1; a new standard IEC 61010-031 has been created.
As of October 1, 2013, compliance with EN 61010 3rd Edition will be mandatory for products needing to comply with the EU low voltage directive for CE marking. The CB Scheme accepted IEC 61010-1 in August 2010. In North America, UL announced the effective date for 61010-1 third edition is January 1, 2018. CSA has not yet announced an effective date for the third edition.
Laboratory equipment requiring certification to a particular standard EN 61010-2-XXX must demonstrate conformity within three years of that particular standard’s date of ratification.
Following is a summary of the most significant changes in EN 61010-1, 3rd Edition.
- Introduces the requirement for red pushbuttons and indictors
- New allowance for products with permanent supply cords
- New test for transformers with a protective bonding screen
- New requirements for layered PWBs, molded and potted parts, and thin-film insulation
- With Annex K, covers the new requirements for insulation, including air clearance and creepage distances
- Test voltages are no longer based on clearance distances, thus interpolation is no longer needed
- Voltage tests on solid insulation are now 1 minute, up from 5 seconds
- New standard for impulse test is now EN 61180-1 (formerly EN 60060), and requires 5 impulses instead of 3
- Requirements for sharp edges were added
- Introduces the new requirements for moving parts, which include risk assessment requirements
- New requirements for gaps between moving parts, and limiting forces and pressures
- New requirement for load testing on parts supporting heavy loads
- New requirement for support feet and castors
- Introduces risk assessment as a means of identifying the levels of energy the equipment must resist during mechanical stress testing
- Added the IK rating as a means to identify the degree of protection required for the enclosure, referencing EN 62262
- Surface temperature limits were modified to align with EN 563
- Leakage and rupture at high pressure is checked by inspection
- Fluids now defined as including both liquids and gases
- Spillage test now includes aggressive substances (as for IVD equipment in EN 61010-2-101)
- Radiation requirements have been modified to include intended and unintended emission
- New requirements for reasonably foreseeable misuse and ergonomic aspects
Clause 17 (New)
- Added to deal with hazards and environments not covered by the standard, along with the new Annex J dealing with risk assessment
- Requires a review of the manufacturer’s risk assessment file as part of the overall evaluation of the product
Contact MET to determine how these changes affect your products.
Or attend a free 61010-1 webinar in July that will cover the standard and its changes in more detail.
The European Union Association of Notified Bodies (EUANB) met in December in Spain to discuss proposed revisions to the EMC Directive. The final revised Directive is expected to be issued in the next few months.
EUANB is the Notified Body Group for the EMC Directive and is composed of members who are a Notified Body (NB) in the EEA Countries or a Conformity Assessment Body (CAB) in a country where the EU has a mutual recognition agreement in place. MET Labs is an EMC Directive NB by virtue of a US-EU mutual recognition agreement (MRA).
The Commission has sent the revised document for discussion by the Council and EU Ministers, as well as by the EU Parliament. It is expected that the final revised EMC Directive will be published in the first quarter of 2013. There will then be a period during which each EU Member State will be transposing the Directive into national law. The latest available proposal contains a transition period of 2 years after the Directive has become operational.
In the revised EMC Directive, there are two modules made available to the manufacturer:
- Module A – Self certification, where the manufacturer determines compliance and issues its Declaration of Conformity (DoC)
- Modules B+C – Notified Body issues EU-Type Certificate (Module B), manufacturer then issues DoC (Module C)
A draft template for the EU‐Type Examination Certificate will be developed.
Much of the proposed changes center on a new role for Notified Bodies, as detailed following:
- The NB shall prepare an evaluation report explaining how compliance was determined.
- If documents are satisfactory, NB shall then issue an EU-Type Examination Certificate. An “opinion” is no longer being issued.
- If documents are not satisfactory, NB shall issue a letter of refusal.
- The manufacturer must choose a single NB and declare that no other NB has been used. This means that “NB Shopping” will not be allowed.
- The manufacturer specifies which parts of the Directive the NB is going to review, and the NB role is then limited to that aspect of the review.
- There is a new NB role that involves monitoring. Specifically, the NB must stay up‐to‐date with the “state of the art” and determine if the changes might impact the approved type. If so, they must contact the client manufacturer.
- The NB must inform the Notifying Authority (e.g. NIST for U.S. NBs) about issued or withdrawn certificates and periodically make available a list of the refused, suspended or otherwise restricted certificates to the Notifying Authority.
- There is a new requirement for information sharing with other NBs and with the Commission and market surveillance authorities.
- Record keeping – the NB shall keep the technical file and related documents for 10 years or until the EU‐Type Certificate is withdrawn.
The proposed date of the next meeting is Friday, May 3, 2013 in Amsterdam in conjunction with the R&TTECA meeting on May 2.
Questions about the proposed changes? Ask Pat, our regulatory compliance expert.
Credit: NIST provided much of the information provided in this post.
The Radio and Telecommunications Terminal Equipment Compliance Association (R&TTE CA) met in December in Malaga, Spain to discuss proposed revisions to the R&TTE Directive, which is being renamed the Radio Equipment (RE) Directive.
At the meeting, MET Laboratories was approved as a R&TTE Compliance Association member. (This is unrelated to R&TTE Notified Body status – a designation that MET already had).
The European Commission issued a formal proposal for revisions to the Directive on October 17, 2012. The final revised legal text of the Directive is expected to be issued within 18 months, and then there will likely be an 18-month period during which each EU Member State will be transposing the Directive into national law.
The Directive was revised to align it with the New Legislative Framework (NLF) and to improve specific technical elements.
Key revisions contained in the proposal are as follows:
New Legislative Framework
NLF alignment issues will be common for all Directives:
- New responsibilities for manufacturers, authorized representatives, importers, and distributors
- Mandatory single Declaration of Conformity (DoC) issued by the manufacturer
- Requirements for the Technical Construction File (TCF)
- Translation of the TCF upon request
- Safeguard clauses and formal non-compliances
- Common DoC template
Specific Technical Changes
The proposed Directive also includes technical changes, some of which follow:
- Change to Scope
- Definition of Radio Equipment
- Provision for software-defined radio
- New registration scheme for radio equipment
- Extra information in user manual
- Simplified DoC allowed
- Geographic information in package
- Notified Body will only be required if there is no harmonized standard under Article 3.2
- NB ID is only needed under the Quality Assurance Module
- No notification of Member States with placement on the market
- Alert mark is formally required
- CE mark no longer required in the Manual – only on product and packaging
- For evaluation of Safety/EMC aspects, manufacturer has the following choices: OEM declaration, NB involvement and OEM Certificate to Type, or Full Quality Assurance Module by NB
- For evaluation of Radio aspects using full harmonized standards, manufacturer has the same 3 options. If not using full harmonized standards, OEM declaration is not allowed.
The proposed date of the next meeting is Thursday, May 2, 2013 in Amsterdam.
Questions about the proposed changes? Ask Pat, our regulatory compliance expert.
For product safety compliance engineers, note our upcoming complimentary webinars on Using the CB Scheme for International Product Safety Certification and North American Product Safety Certification for EU Manufacturers.
Many thanks to NIST, which provided much of the information provided in this post.
On September 30, 2012, the previous version of ETSI EN 300 132-2 will be withdrawn, and ETSI EN 300 132-2 v2.4.6 (2011-12) will take effect. ETSI 300 132-2 covers the testing requirements for the DC power ports of telecommunications equipment. It is not a harmonized standard, but it is often required by EU carriers like Deutsche Telekom and British Telecom.
Here are the most significant additional requirements in this new revision:
4.2 Normal service voltage range at interface “A”
Test method now references EN 61000-4-29. The voltage variations now have dwell time and rise/fall time requirements.
4.3.2 Abnormal service voltage range at interface “A”
Same as 4.2 above but with abnormal service range defined in table 2.
4.3.3 voltage transients
Same 1.2/50 or 8/20 combo waveform @500V, but only one configuration now.
4.4 voltage changes due to regulation of the power supply
Defines voltage variation ranges; test method remains the same as before.
4.6 Maximum current drain
The EUT’s current drain cannot exceed 1.5 x Imax only in the range of -54V to -40.5V. For the range of -40.5V to 0V, it is allowed to exceed this amount. This is different from before when the current drain could never exceed 1.5 x Imax throughout the entire range.
4.7 Inrush current on connection of interface “A”
Same as before but with the following additional performance criteria:
- Below 0,1 ms, the inrush current is not defined
- Below 0,9 ms the It/Im ratio shall be lower than 48
- Above 1 ms the curve corresponds to the maximum tripping limit of majority of existing protective devices
4.8 Conducted immunity requirements of the telecommunications equipment at interface “A”: narrowband noise
Conducted immunity shall apply only to telecommunication equipment having analogue voice interface.
Additional Note 3: The test should be limited for equipment with an input not higher than 10A.
4.9 Conducted Emissions requirements of the telecommunications and datacom equipment at interface “A”
Conducted emissions requirements shall not be applicable at equipment installed in outdoor location such as shelters and street cabinets. Due to the nature of the emitted noise this could be influenced only other equipment directly connected at the interface “A” present in the outdoor location.
For telecommunications equipment fitted with analogue interfaces an evaluation of wideband noise amplitude in this frequency band can be calculated using method detailed in annex E.
For more information, read an IN Compliance article on ETSI EN 300 132 2 Compliance Testing by MET Engineer Zijun Tong.
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.
There was much relief when the European Union postponed the cessation of EN 55022:1998 to October 1, 2011. But now Information Technology Equipment manufacturers selling ITE products in the EU must face the music – EN 55022:2006 is upon us, as is Amendment A1:2007.
Here is a basic primer on the changes:
EN55022:2006 is based on CISPR 22 Edition 5, released in 2005. The major change in this edition was to remove the requirement for ferrite clamps to be used on cables exiting the test site.
Amendment A1 was issued by CISPR in 2005 also, and added requirements for testing above 1 GHz. The EN version was released in 2007.
Testing above 1 GHz is designed to simulate a free-space environment, so the ground plane needs to be covered with rf-absorbing material to suppress reflections. In addition, the specifications require a very low reflection from around the EUT.
The CISPR 22/EN 55022 limits are 4dB lower than the U.S. FCC limits for measurements below 3GHz and identical above 3GHz.
As with FCC rules, the upper frequency of the measurement range for the CISPR 22/EN 55022 measurements is a function of the highest frequency generated within the product.
Results from tests conducted per the older versions can likely continue to be used in October 2011 to help support your Declaration of Conformity to the EMC or R&TTE Directives. To see what tests may need to be repeated, we need to look at each of the different tests in turn:
AC power port conducted emissions, 0.15-30 MHz
Telecommunications ports conducted emissions
New ISN specification should produce a lower measurement, so there is not likely to be an impact here.
Radiated emissions, 30-1,000 MHz
Re-evaluation without the ferrite clamps is required, as it could cause an increase in the levels of radiated emissions, primarily for emissions radiated by the interface cables to the remote equipment.
Radiated emissions above 1GHz
This is a new requirement for equipment with internally-generated frequencies above 108 MHz.
For a more technical discussion of the new requirements of EN 55022:2006+A1:2007, watch this recorded webinar.