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.
Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical
devices. The guidance is recommended, but not mandatory.
FDA said its recommendations cover devices that are implanted or worn on the body, and others intended for use in locations such as hospitals and clinical laboratories.
The guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including electromagnetic compatibility (EMC).
The use and deployment of RF wireless technology in and around medical devices is an increasing concern because the electromagnetic environments where medical devices are used might contain many sources of RF energy, and the RF wireless emissions from one product or device could potentially affect the function of another, the agency said.
FDA says these issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products.
FDA recommends that EMC be an integral part of the development, design, testing, and performance for RF wireless medical devices. Beyond FCC requirements, FDA recommends using risk analysis to identify any potential issues associated with EMC and determining risk acceptability criteria based on information about the device and its intended use, including foreseeable misuse, sources of environmental EMD (e.g., radio transmitters, computer RF wireless equipment), and the potential for RF emissions to affect other devices.
IEC 60601-1-2 is a FDA-recognized consensus standard for EMC, but it does not adequately address whether the wireless communications will operate properly in the presence of in-band EMD (e.g., other RF emissions overlapping the frequency band utilized by the medical device wireless signals). Therefore, the medical device’s wireless communication(s) should be actively transmitting while testing for susceptibility during all EMC immunity testing.
EMC considerations for active implantable medical devices are covered under documents such as the ISO 14708-1 standard (see Appendix B).
FDA worked closely with the Federal Communications Commission (FCC) to develop this guidance.
MET Labs teamed with FDA on a voluntary Program to Test Medical Devices for RFID Interference. Find out more about the Program.
MET’s Annual Global Compliance Seminar in September will include a session on Electrical Medical Equipment Approvals for EU. Register here.
China is fast becoming the largest consumer market in the world, and for many products, China Compulsory Certification (CCC) is necessary for manufacturers to tap this market.
There are three main certification bodies (CBs) for electronic equipment:
- China Quality Certification Center (CQC) – issues all electronic equipment CCC certificates
- China Information Security Certification Center (ISCCC) – issues ITE CCC certificates
- China Electronics Standardization Institute (CESI) – issues A/V CCC certificates
An application is submitted to one of the certification bodies mentioned above. Once the application is accepted, the manufacturer has samples tested at an accredited lab in China. When the product passes, the test report is issued by the test lab and reviewed by the certification body. If the CB is satisfied with the test report and the manufacturer passes an initial factory inspection, the report will be approved and the CCC certificate will be released.
The CCC certificate is generally valid for five years and requires follow-up inspections that verify quality control and product consistency.
CCC certification is to Chinese national standards called Guobiao or GB standards. Usually the GB standard is harmonized to an IEC standard. For example for ITE, GB4943 is harmonized to IEC60950 for product safety; GB17625 (updated to GB17625.1-2012 on July 1, 2013) is harmonized to IEC61000-3-2 and GB9254 is harmonized to IEC/CISPR 22 for electromagnetic compatibility. There are some minor national deviations like ratings, altitude or tropical zone requirements. (Read more about recent changes to GB8898 Audio, Video and Similar Electronic Apparatus – Safety Requirements and GB4943.1 Safety of Information Technology Equipment.)
Generally, if you can pass the IEC standard, you should be OK to pass the CCC test. Manufacturers can save time and reduce cost by transferring a CB report to a CCC report.
MET Labs has experience helping manufacturers obtain CCC certification. MET’s China operations are based in Shenzhen, Guangdong Province. Contact MET China or MET U.S. for more information about CCC certification.
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.
The Compliance Today blog for electrical product manufacturer compliance engineers saw a significant jump in readers and subscribers in 2012. Following were the most popular 2012 posts, by pageviews.
- RTCA/DO-160G is Latest Version for Testing of Airborne Equipment, But Not the Only Choice
- UL1604 to Be Replaced by ANSI/ISA 12.12.01-2000 for Hazardous Locations Certification
- 2011 National Electrical Code (NEC) Updates Standard for the Safe Installation of Electrical Equipment
- Health Canada Provides Guidance on IEC 60601-1 3rd Edition Transition
- Product Safety Compliance Engineers Use These Resources
- IECEE Suspends Brazil NCBs and CBTLs from CB Scheme
- Electromagnetic Compatibility Compliance Engineers Use These EMC Resources
- China CCC Product Safety Compliance for A/V & IT Equipment is Changing
- For IT Equipment in Canada, ICES-003 Issue 5 Required by August 2013
- Military EMC Testing Standard MIL-STD-461G is Coming
If you want to receive an email of each post when it publishes (about once a week), subscribe on the right side of this page.
Want more in-depth information on one of these topics? Check to see if we are planning a seminar or webinar on it.
Need electrical product testing? Fill out an RFQ.
We received so much positive feedback on our blog posts for EMC Compliance Links and Product Safety Compliance Links, that we decided to dedicate a post to spotlight the top blogs for electrical product developers.
With a few exceptions, these blogs are from independent sources, like industry associations, publishers or consultants. What are we missing? Leave a comment with a link to it.
Aerospace & Defense Blog Military and aerospace electronics news and information.
ANSI International standards and accreditation activities.
Buzzblog Intelligence and insight for Network and IT Executives.
CertAssist Consulting Product Safety information, especially regarding 60950-1 and 61010-1.
Circuit Advisor Circuit design and troubleshooting.
Compliance Today Electrical testing and certification news and information.
DfR Solutions Forum Reliability design and testing.
Digital Dialogue From the Consumer Electronics Association, sponsor of the Consumer Electronics Show. (Side note: You can meet with MET at CES next week)
EDN Network 59(!) blogs for the electronics community on various topics.
EE Life Blog Electrical engineering topics from EE Times.
EleBlog Frequently updated blog on the electrical industry.
Electronics Weekly Blogs 15 blogs, including Certification & Test and Directive Decoder.
EMC Zone Issues affecting engineers working in the EMC industry.
Emergo Group Global medical device regulatory updates.
EPN Automotive Electronics Blog Automotive electronics issues from a European perspective.
EPN Industrial Automation Blog Industrial automation and controls topics from a European perspective.
EPN Renewable Energy Blog Info on electronic components and technologies related to solar power, wind power, and other renewable energy sources from a European perspective.
EPN RF & Wireless Blog Updates on RF/microwave and wireless technology, systems, standards and events from a European perspective.
IEEE Spectrum 5 blogs on nanotech, robots, risk analysis, general tech, and energy.
IEEE Standards Insight Promotes technology standards and their development.
Instruments for Industry Information to help RF EMI and EMC test engineers, from an amplifier manufacturer.
Medical Electronics Design A resource for medical electronics OEMs.
Microwave Journal A handful of blogs concentrating on microwave and RF technology.
NEMA Currents Information on electrical grid, safety, energy efficiency, smart grid, and regulation.
Nick’s Fire, Electrical Safety & Security Blog Common sense security, fire & electrical safety.
OnSafety Official blog of the U.S. Consumer Product Safety Commission.
Pradeep’s Point A resource for semiconductors, solar PV, telecom, electronics, infocom, components, nanotech, and IT.
Product Safety Blog Product safety legal issues from Miles & Stockbridge.
Regulatory News Blog Telecom regulatory news.
Reliability Blog Electronics reliability engineering.
RFID Journal Blog RFID industry news and information.
Smart Grid Sherpa Information on smart grid technologies, from DNV KEMA.
Test and Certification Blog Product test and certification from an EU perspective.
Test & Measurement World 14 blogs, including The EMC Blog and Eye on Standards.
WeMakeItSafer Product safety regulations and recall information.
What are your favorite electrical product development blogs? Please leave a comment with a link to it.
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In the event of a power failure on the electric grid, it is required that any independent power-producing inverters attached to the grid turn off in a short period of time. This prevents the DC-to-AC inverters from continuing to feed power into small sections of the grid, known as “islands.” Powered islands present a risk to workers who may expect the area to be unpowered, and they may also damage grid-tied equipment.
A single inverter operating independently can easily detect the presence or lack of a grid source. However, if there are two inverters in a given island, things become considerably more complex. It is possible that the signal from one can be interpreted as a grid feed from the other, and vice versa, so both units continue operation.
Since 1999, the standard for anti-islanding protection in the United States has been UL 1741, harmonized with IEEE 1547.
The requirement for a unit under test is to detect an island condition and cease to energize the area electric power
system (EPS) within two seconds of the formation of an island. This disconnection time is measured from the point that the switch is opened up disconnecting the grid but leaving the islanding circuit connected and the point that the unit ceases exportation of current to the grid.
The island load is adjusted to ensure a power quality factor (Q) of 1.0 (+/- 0.05) and the “central” balanced load condition. In addition, the output current flowing to the grid through the switch (S3) is limited to a maximum value of 2% of the rated output current and the Q=1.0 balanced load condition of the unit under test.
In addition to testing at the balanced load condition of Q=1.0, The test is to be repeated with the reactive load (either capacitive or inductive) adjusted in 1% increments from 95% to 105% of the initial balanced load component value. If the unit’s shutdown times are still increasing at the 95% or 105% points, additional 1% increments shall be taken until trip times begin decreasing.
The anti-islanding test is repeated for 3 output power levels: 33%, 66%, and 100% of the rated output power of the unit under test.
The test is considered complete when one of two situations occur:
- When disconnect times illustrate a pattern of decreasing times with respect to a balanced load condition yielding the longest disconnect time
- When the resultant tank circuit frequency is such that it is past the frequency trip point of the unit under test such that the unit under test is tripping offline due to a frequency fault
UL 1741 has other performance requirements as well, including power quality, interconnect integrity, and operating voltage and frequency parameters. For information about testing inverters to any of these requirements, contact us.
Calibration and test labs both stand to save time and money when calibrating/verifying chambers, due to an update to CISPR 16-1-4.
CISPR 16-1-4 Amd.1 Ed. 3.1 (2012) has replaced Ed. 2.0 (2007) for radio disturbance and immunity measuring apparatus – antennas and test sites for radiated disturbance measurements. The publish date was July 11, 2012.
The major addition that this amendment introduces is an alternative site validation method to Normalized Site Attenuation (NSA) called Reference Site Method (RSM). Here is how it works:
- Perform a site validation using a pair of transmitting/receiving broadband antennas (biconical and log periodic to cover 30MHz-1GHz) at a reference test site – this site represents an ideal test location
- Using the same pair of antennas, perform a site validation at the chamber that is being verified
- Compare the site validation readings between the two locations, with deviation not to exceed +/- 4dB
Since the same antennas have consistency between validations, antenna factors and uncertainties do not need to be taken into account. This is in contrast to the NSA method where the validation measurement of the site is being compared to a setup that does not use the same antenna pairs, so those additional factors need to be accounted for to equate the two different setups.
Otherwise, there were only minor definition updates and edits in this edition.
Background: CISPR is an international special committee on radio interference within the International Electrotechnical Commission (IEC). CISPR prepares standards that offer protection of radio reception from interference sources such as the electricity supply system, industrial, scientific and electro-medical RF, broadcasting receivers, and IT equipment (ITE).
A draft of Revision G of MIL-STD-461 has not been released yet, but MET Labs has obtained information about proposed changes to the Military EMC test. As covered in this previous post, one of the primary changes is the incorporation of indirect lightning testing heavily leveraged off of Section 22 of RTCA/DO-160G. There is no lightning requirement in MIL-STD-461F, which was released in 2007.
There is one test that is very likely to be added to MIL-STD-461G: CS117
There are two additional tests that are being considered, but are much less likely to be included: RS106 & RS108
Information about the CS117 test:
- Derived from DO-160 Section 22 lightning induced transient susceptibility
- Includes Multiple Burst/Single Stroke same as DO-160
- Idea is not to change waveforms; services (Army, Navy, Air Force) would need to control the application
- Cable injection only – no pin injection testing
- Limited applicability (aircraft electronics) based upon specific program contact call out
Information about the RS106 test:
- Similar to RS105 (EMP free field test for equipment)
- Limited applicability – mainly for external stores (missiles, pods, ground equipment, etc.)
Information about the RS108 test:
- Similar to RTCA/DO-160 Section 23 Lightning Direct Effects
- Limited applicability (antennas or other external located items) based upon specific program contact call out
The rollout of MIL-STD-461G is currently scheduled for an initial draft in June 2013, a final draft in September 2013, and release in Fall 2014.
Want to know more about upcoming changes to MIL-STD-461? Consider attending one of these events:
In two days, MET is hosting a MIL-STD Testing Seminar in Santa Clara, California.
Next week, attend this Lightning Testing Webinar.
In August, Pittsburgh is hosting the EMC Symposium, where MET Labs is exhibiting in booth #1024.
Or contact us with questions or a quote request.
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.