The European Commission is contemplating developing an “eCompliance System” and has published a “Preliminary Reflections on eCompliance” paper on how it would work. Following is a summary of this report that was distributed at the May 2014 meeting of the Group of Notified Bodies under the EMC Directive (EUANB) in Amsterdam.
As products become more complex while product cycles become shorter, the Commission believes it is necessary to explore how compliance with Union harmonisation legislation can be demonstrated/controlled electronically (“eCompliance” concept) instead of the traditional paper-based approach.
The primary objective is to maintain protection of the public interest, while reducing the administrative burden for manufacturers (especially SMEs), Notified Bodies, and authorities.
In an eCompliance context, the process of demonstrating compliance would become more interactive: manufacturers and other operators, Notified Bodies (if involved in the conformity assessment procedure) and authorities would share information and provide real-time feedback to each other.
This may lead to a situation where the border between conformity assessment (ex-ante control) and market surveillance (ex-post control) would not be so clearly defined – authorities may have the opportunity to monitor a product before it is placed on the market.
Various tools (e.g. e-labelling, digital market surveillance, electronic declarations of conformity, etc.) could function in all official Union languages and improve communication:
- Between authorities and manufacturers
- Between authorities and Accreditation/Notified Bodies and between Accreditation/Notified Bodies themselves
- Between authorities
Commercial secrets and confidentiality aspects would be protected by a system of access authorizations.
In order to avoid the proliferation of IT tools, the Commission would examine whether the eCompliance System should be part of the Information and Communication System on Market Surveillance (ICSMS).
Planning for an eCompliance System in Europe is still very preliminary, with many questions to be answered and stakeholders to be consulted. Subscribe to Compliance Today to be kept apprised on further developments in this area.
EN 61326-1: 2013 Replacing 2006 Version for EMC Directive Evaluation of Lab, Test & Measurement Equipment
For manufacturers selling scientific, test and measurement equipment in Europe, EMC emissions and immunity requirements defined in EN 61326-1 are changing. Effective August 14, 2015, the 2006 version of this standard will be withdrawn and can no longer be used to meet the essential requirements of the EMC Directive. From then on, EN 61326-1: 2013 will be in effect. The 2013 version is identical to IEC 61326-1, Ed. 2.0 (2012-07).
EN 61326-1 defines the immunity environments for different locations: Basic, Industrial, Controlled Electromagnetic (EM) and Portable Test and Measurement (in Annex A).
For immunity in ‘Basic’ environments, here are the changes in the 2013 version:
- 61000-4-2 – The ESD requirement for air discharge is now +/- 8kV, up from +/- 4kV
- 61000-4-8 – A power frequency H-field requirement of 3 A/m for both 50 & 60 Hz has been added. This only applies to “magnetically sensitive equipment.”
There are no significant changes in immunity for ‘Industrial’ environments.
For ‘Controlled EM’ environments, the “Measurement I/O” port category was eliminated.
For ‘Portable Test and Measurement Equipment,’ as in Basic environments, there is a new power frequency H-field requirement of 3 A/m specified in 61000-4-8.
There is also an important change in Performance Criteria. For Performance Criteria A and B, the 2013 version added new “permissible loss of performance” verbiage which allows for a pass despite immunity test failure, provided the manufacturer defines this in their product or user’s manual.
Performance Criterion C remains essentially the same: User intervention is still allowed to regain product functionality. So, as long as the function of a product can be recovered by the user and the product is not permanently damaged by testing, it complies with this criterion.
No changes were made to this section other than referencing the 2009 version of CISPR 11, including 2010 amendment. As with previous versions of this standard, AC power line harmonics and flicker are only required for products which must meet Class B (residential) limits.
MET Labs has over 30 years of experience testing and certifying for electromagnetic compatibility and product safety for Lab, Control, and Test & Measurement Equipment. See some of the leading test & measurement equipment manufacturers that trust MET to do their testing and certification, or contact us now for a quick-response quote.
The FCC released a First Report and Order (ET Docket No. 13-49) on April 1, 2014 allowing devices in the U-NII-1 band to operate with higher power. The R&O also allows this band to be used outdoors, whereas this has only been an indoor band previously. Some of the key points in the First R&O are:
- Devices operating in the U-NII-1 band will be allowed 30 dBm (1 W) conducted power, a PSD of 17 dBm/MHz and an allowance of a 6 dBi antenna. However, the maximum EIRP above 30 degrees elevation is limited to 21 dBm.
- The upper edge of the U-UNII-3 band has been extended by 25 MHz. Therefore, the band is now 5.725 – 5.850 GHz which is in line with the 15.247 DTS band. Both rule parts will be consolidated.
- Bin1 radar waveform will be updated to better account for actual Terminal Doppler Weather Radar (TDWR) waveforms.
For equipment that is already certified, a Class II Permissive Change may be performed to update the device to the new rules. A Class II PC is performed when there are changes to the radio, such as addition of new antenna or if a rule change allows for additional provisions.
The new rules will take effect 30 days after being published in the Federal Register. The publish date is expected soon.
The FCC has also updated the TCB Exclusion list. The exclusion list is now “empty.” Therefore, TCBs can now grant almost all applications, including equipment operating in the DFS bands and UWB equipment. However, TCBs will have to follow a Permit But Ask (PBA) procedure with the FCC to grant these devices. DFS equipment will still be independently tested by the FCC as before. But this is still expected to reduce the time to market for manufacturers.
The R&TTE Directive is getting a face lift. It will now be called simply the Radio Equipment (RE) Directive. Telecommunications equipment will be moved over to the EMC Directive. The RE Directive will be limited to wireless RF transmitter devices and receivers. The use of the exclamation mark (i.e. !) and the NB number (if applicable) will not be required adjacent to the CE mark.
EN 300 328 v1.8.1 will become effective end of the year and any new radio device placed on or after this date will need to meet the new standard. The previous version of the standard will cease to give presumption of conformity with the requirements for Article 3(2) of the Radio Equipment Directive.
On March 29, 2014, the European Commission published the recasts of eight CE marking directives. These directives have new reference numbers and are aligned with the rules and responsibilities for CE marking that were published earlier in Decision 768/2008/EU. Here are three that changed:
- EMC Directive is now 2014/30/EU (previously 2004/108/EC)
- Low Voltage Directive (LVD) is now 2014/35/EU (previously 2006/95/EC)
- ATEX Directive is now 2014/34/EU (previously 94/9/EC)
The new directives enter into force on April 19, 2014, and Member States have until April 20, 2016 to amend their national legislation, as the old directives will be repealed then.
Manufacturer CE Declarations of Conformity (DoC) can start referencing the new directive numbers when they enter into force later this month. By April 20, 2016 the new numbers are required for products that fall within the scope of these directives and which are made available for the first time.
The directive recast was undertaken to align with the European Commission New Legislative Framework (NLF).
Adopted in 2008, the NLF was designed to:
- Require traceability within the supply chain
- Improve market surveillance rules
- Boost the quality of conformity assessment through more stringent requirements imposed on conformity assessment bodies and testing laboratories
- Install tighter controls on the use of the ‘CE Mark’ to enhance its credibility
The new Radio Equipment Directive (RED) was adopted by the Members of the EU Parliament (MEPs) on March 13, 2014 by 550 votes to 12. It is now awaiting approval by the EU Council and then publication in the Official Journal (OJ) of the European Union. Member states will have two years to transpose the rules into their national laws and manufacturers will have an additional year to comply.
The RED will take the place of the R&TTE Directive. You can read more about this change in a previous post. The draft directive lays down harmonized rules for placing radio equipment, including cellular telephones, car-door openers and modems, on the market. The new rules aim to keep pace with the growing number and variety of radio equipment devices and ensure that they do not interfere with each other or human health.
On the same day as the vote, MEPs called for a renewed effort to develop a common charger for certain categories of radio equipment, in particular mobile phones, because it would simplify their use and reduce waste and costs.
MEPs also backed provisions in the directive that would give the authorities additional market surveillance tools to detect radio equipment products that fail to comply with the new safety rules. After an evaluation, the European Commission will identify those categories of equipment which will need to be registered before they can be put on the market. A similar database already operates in the U.S.
The next meetings of the RTTE Compliance Association (CA) and the European Union Association of Notified Bodies (EUANB) will take place May 19-20, 2014 in Amsterdam, The Netherlands. The details of the new RED will be the main subject of the meeting.
Do you supply IT or multimedia (MME) equipment into Europe? To comply with EMC Directive 2004/108/EC, new harmonized emission and immunity standards are being added to the EU’s Official Journal (OJ), making them available for demonstrating conformity with the essential requirements of the directive.
Note: Due to the convergence of technologies, the EMC standards for audio/studio equipment and broadcast receivers (and associated equipment) are being merged with information technology equipment into a single standard.
Emissions: EN55032 (CISPR32)
For emissions, EN55032 replaces EN55022 (IT equipment), EN55013 (broadcast receivers and associated equipment) and EN55103 (audio & studio equipment). EN55032 was approved in December 2012 and consists of CISPR32+A1+A2. It has officially been added to the OJ – meaning it can now be used by manufacturers – with a transition period until March 2017.
Apart from the power disturbance measurement, which is no longer permitted, all the other limit values and measurement procedures remain broadly unchanged.
Immunity: EN55035 (CISPR35)
For immunity, EN55035 will replace EN55024 (IT equipment), EN55020 (broadcast receivers) and EN55103 (audio & studio equipment). EN55035 has not yet been added to the OJ and cannot be used by manufacturers – it is expected to enter into force within the next year with a transition period until 2017.
Something to look forward to: Multiple measurements for multifunctional devices will no longer be necessary in EN55035.
MET Labs has tested thousands of products to support CE marking declarations of conformity. MET can test to the new EN55032 or any of the older, still-in-service standards. Contact us today to find out which is the best standard to use in a test program for your products.
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.