Wireless modules are increasingly being integrated into everyday products, like refrigerators, cars, and consumer medical devices. Therefore, more manufacturers need to be aware of the regulatory requirements of wireless transmitters.
In the European Union, it is mandatory that radio equipment meets the requirements for the Radio and Telecommunications Terminal Equipment Directive (R&TTE) 1999/5/EC (replaced in June 2016 by the Radio Equipment Directive 2014/53/EC).
The manufacturer of the wireless-enabled product is responsible for its overall compliance. Module manufacturers must provide clear instructions of integration to any host product manufacturer.
Since the R&TTE Directive does not make specific reference to wireless modules, there are no strict rules to follow, but there are a few general guidelines to keep in mind:
- When an R&TTE compliant module is integrated into a final host product, no further radio compliance testing is required, provided the module is integrated in accordance with its manufacturer’s instructions
- The final host product must always meet the other essential safety and EMC requirements of the directive
- The most common method of demonstrating compliance and a presumption of conformity with R&TTE is by using harmonized standards
The R&TTE Compliance Association has issued guidance on the use of wireless modules: Technical Guidance Note 01 on the R&TTED compliance requirements for a Radio Module and the Final Product that integrates a Radio Module, May 2013.
In the U.S. and Canada, the approval process is straightforward, unless there are multiple modules integrated together.
The Federal Communications Commission’s (FCC) rules on module integration are explained in CFR 47 Part 15.212, with further detail in the guidance document KDB 996369. The Industry Canada rules for modules are similar to those of the FCC and are spelled out in RSS-GEN Section 3.
In order for a wireless module to meet the requirements of FCC Part 15, it must comply with the requirements for shielded circuitry, a unique antenna connector, stand-alone configuration, and RF exposure limits. Once these guidelines are met, FCC modular approval is granted through a TCB like MET Labs, and the product may be operated under certain conditions of use. If the conditions of the grant are met, further testing is not required for the intentional radiator part of the host equipment.
Where multiple modules are integrated together, the rules can become more complex. This is particularly true if the host device is to be used in a portable application within 20cm of the human head or body and RF exposure becomes a major issue. Then SAR testing is required.
Where the conditions of the modular grant cannot be adhered to when integrated into the final host, additional testing and certification is usually required.
To learn more about wireless compliance, attend our upcoming EMC & Wireless Design and Testing Seminar in Santa Clara, CA. If you have an upcoming need for wireless equipment testing or compliance assistance, contact us today.
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.
Here at MET Labs, we’ve been product safety testing electrical/electronic equipment in the field for over 55 years. Naturally, we see the same failures over and over again. We hope this list of Top 20 Field Failures for Panel & Motor-Operated Equipment will help inspectors identify and contractors fix the most commonly observed non-compliances.
1. Supplementary Protector Usage – Supplementary Protectors are used incorrectly as branch circuit protection. When used incorrectly, these components are known to fail – welding closed and causing fires/short circuits. These can either be replaced by UL 489 listed circuit breakers or branch circuit fuses (suitable for the circuit rating).
2. Risk of Electrical Shock – Covers over live electrical parts are not secured properly. A tool or key is required to access areas that pose a risk of electrical shock.
3. Dedicated Ground – The main incoming grounding conductor is not terminated at its own dedicated point (e.g. there were two wires in the grounding terminal). The secondary ground must be moved to another grounding terminal.
4. Motor Overload Protection – Overload charts are not provided in the panel to verify the rating of the overload protection.
5. Protection of Power Supplies – The manufacturer’s instructions for overcurrent protection are not followed.
6. Strain Relief – An internal terminal strain relief device is not provided.
7. Working Space – Control panels are located too close to the wall and are not able to be serviced properly. The panel doors must be able to open at least 90 degrees.
8. Emergency Stop – Emergency stops are not provided at control and operator stations where shutdown would be required. These E-stops are required to override all other functions and operations in all modes (unless it creates another hazard).
9. Protection of Motor Drives – Motor drives are improperly protected per the manufacturer’s installation instructions. These frequency drives require specific size and type primary fuses or listed circuit breakers depending upon the size of the drive.
10. Power Transformer Protection – Power Transformers are not properly protected on the primary or secondary, based on the appropriate tables in the related standards.
11. Control Transformer Protection – Control Transformers are not properly protected. In some cases, only primary protection was found when secondary protection was also needed.
12. Termination of Wiring – Some wires are not terminated or were improperly terminated. Improper multiple terminations is a common issue and could create overheating at the terminal.
13. Conductor Ampacities Based on Termination Ratings – Conductor sizing is done improperly. Conductors are sized based on conductor ampacity without consideration to termination ratings.
14. Wire Bending Space for Main Connections – Control panels don’t have adequate wire bending space for the main connections, risking snapping the termination completely off.
15. Component Information – Components are not marked as certified (MET, CSA, UL, FM, ETL, VDE, JIS, etc.). Some components have CE marking, which is not acceptable.
16. Flexible Cords – Flexible cords are used improperly per NEC Article 400, which restricts the use of flexible cords for specific applications.
17. Multiple Power Sources – Panels that are fed with more than one source of power are not marked with a cautionary marking to protect the individual servicing the panel. This marking is required: “Caution, more than one disconnect, disconnect all before servicing.”
18. Area Classification – The environment where the product is installed is inappropriate. For example, a product intended for Ordinary Locations cannot be installed in a Class 1 Division 2 location.
19. Panel Only Certification – A control panel is certified but the load served by the panel is not.
20. Equipment Markings – Marking labels are not suitable for the surface material and temperature applied or text is not of adequate size and of good contrast.
What electrical equipment field failures do you see most often? Please leave a comment.
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.
Early Consideration of EMC & Product Safety Compliance in Product Development Saves Time and Headaches
When developing a new electrical product, early consideration of electromagnetic compatibility (EMC) and product safety compliance issues will pay major dividends later.
If compliance is not engineered in from the start, expect to endure this pain:
- A major delay as the product is redesigned, jeopardizing time to market and product viability
- Significant extra costs for rework and increased product cost
- Team dissension and rock-bottom morale
What’s the best way to integrate compliance into a new product? First, get buy in from senior management, then:
- Buy and read the relevant safety and EMC standards and train your design engineers in the basics of compliance
- Have your compliance engineers work side by side with the designers, providing deeper expertise when needed, and information about the latest changes to standards and regulations
- Perform early design reviews and early testing on the first prototypes to lower the risk during final compliance testing
Don’t have a compliance engineering team? We can help. In addition to testing and certification, MET Labs offers compliance assistance, with controls in place to prevent a conflict of interest, as required by our accreditation agencies.
In recent years, software has been king in Silicon Valley. Now the pendulum is swinging back, and hardware is taking center stage again, says Bloomberg Businessweek.
The strongest evidence is the tablet war, which has been dominated by Apple’s iPad. Now, however, all the big players are piling in. Within two weeks of each other, Microsoft unveiled its new Surface tablet, and Google announced a partnership with Asustek Computer to build the Nexus 7.
Amazon has been making Kindles since 2007. Barnes & Noble has its Nook e-reader. Oracle purchased server maker Sun Microsystems in 2009 to house its databases.
Fueling the trend for small companies is Kickstarter and other crowd-funding sites. That’s how the iPhone-enabled gTar guitar got its start.
The high tech hardware boom extends beyond personal electronic devices. In the symbolic return of hardware and its manufacture stateside, MET Labs-tested all electric cars from Tesla Motors are produced in a Fremont factory not far from where an Apple manufacturing plant was shuttered in the early 1990s.
Tesla is not the only big name producing locally; Google is manufacturing its new Nexus Q entertainment device in the Bay Area.
We are encouraged by this return to prominence of hardware, not only for the increased business for 3rd party test labs like MET Labs, but also for the return of balance to the U.S. tech industry that will ensure its future health.
Have a question about electronic hardware regulatory compliance? Ask Pat, our compliance expert.
Or contact us to get a tour of one of our Bay Area labs.
For Medical Electrical Equipment product safety compliance in Canada, Health Canada currently recognizes both the second edition of IEC 60601-1, published in 1988, and the third edition, published in 2005. In October, 2008, Health Canada published a notice indicating that until June 1, 2012, conformity to the second edition of IEC 60601-1 and its related collateral and particular standards would be accepted. After June 1, 2012, conformity to the third edition would be required.
New editions of particular standards (specific to a particular device type and designated as IEC 60601-2-X) harmonized with the third edition of IEC 60601-1 have, in many cases, not yet been published, or have been published only recently, making a full transition to the entire family by the June 1, 2012 deadline impossible.
To address this, on March 22, Health Canada issued Additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada’s List of Recognized Standards. It states:
- If there is not a particular standard that is directly applicable to the device as of June 1, 2012, it should conform to IEC 60601-1 3rd edition and its applicable collateral standards (that is, IEC 60601-1-X).
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1 3rd edition and its applicable collateral standards in addition to this particular standard.
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply. During this transition, Health Canada will accept conformity to both editions and related collateral standards.
These transition rules will not be applied retroactively. If the manufacturer currently holds a license for a device that was tested according to IEC 60601-1 2nd edition, you do not need to submit additional data, unless there is a significant change to the product as defined in the Guidance for the Interpretation of Significant Change of a Medical Device.
Keep in mind that provincial or territorial electrical safety requirements are separate and distinct from the requirements of the Health Canada regulations. For further information regarding these requirements, contact the applicable regulatory authorities. A listing of some of these authorities is available here.
The Health Canada website should be consulted for the most current List of Recognized Standards.
For the 3rd edition implementation schedule for the United States, see this Compliance Today post.
Later this month, MET is hosting a free Medical Equipment Regulatory Compliance Seminar in Texas. It features presentations on 60601-1 for product safety and EMC compliance, as well as CE marking.
The U.S. Federal Communications Commission (FCC) has issued draft revisions to six Knowledge Database (KDB) publications for RF exposure and SAR compliance.
KDB Publication 447498 – General RF Exposure Policies for Equipment Authorization
KDB Publication 941225 – SAR Evaluation Considerations for LTE Devices
KDB Publication 865664 – SAR Measurement Requirements, Compliance Reporting and Documentation for 100 MHz – 6 GHz
KDB Publication 616217 – SAR Evaluation Considerations for Laptop, Notebook, Netbook and Tablet Computers
KDB Publication 648474 – SAR Evaluation Considerations for Handsets with Multiple Transmitters and Antennas
KDB Publication 643646 – RF Exposure Evaluation Considerations for Occupational Push-to-Talk Two-Way Radios
The public may post a comment on these proposed revisions through June 1, 2012.
Other RF Exposure KDBs
Remaining RF exposure KDB publications that do not have draft revisions are:
- KDB Publication 248227 – Additional SAR Measurement Procedures that Specifically Address 802.11 a/b/g Devices
- KDB Publication 615223 – SAR Requirements and Procedures for 802.16e/WiMax Devices
- KDB Publication 450824 – SAR Probe Calibration and System Verification Considerations for Measurements from 150 MHz to 3 GHz
- KDB Publication 680106 – Rules Regulating Short Distance Wireless Inductive Coupled Charging Pads or Charging Devices
Questions about SAR compliance? A SAR testing expert will be available next week at 2012 International CTIA Wireless at the MET Labs exhibit.
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.