Tag: EMC

FDA Issues Guidance on EMC of Electrically-Powered Medical Devices

by on Nov.18, 2015, under EMC, Medical

The U.S. me-300x240Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered products for premarket submissions. Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device, as well as the use of appropriate FDA-recognized standards.

EMC as defined by FDA includes immunity to electromagnetic disturbance (interference), and being free of excessive electromagnetic disturbances (emissions) that might interfere with other devices.

In premarket submissions, manufacturers of electrically-powered medical devices typically reference IEC 60601-1-2 (read about the new 4th edition here) or the equivalent U.S. version. In addition, there are device-specific consensus standards, or “particular” standards (e.g., IEC 60601-2-X, where X denotes a particular device standard). These particular standards may augment or supersede the requirements in the IEC 60601-1-2 standard. There are also other consensus standards for electrically-powered medical devices that include information on EMC (e.g., ISO 147083 for active implantable devices).

According to FDA’s guidance, a claim of EMC for a device should be accompanied by this information:

  • Summary of the testing that was performed to support EMC
  • The specifications of the standard that were met
  • The device-specific pass/fail criteria used
  • The specific functions of the device that were tested (including essential performance) and how these functions were monitored
  • The performance of the device during each test
  • An identification of and a justification for any of the standard’s allowances that were used
  • A description of and justification for any deviations from the specifications of the referenced standard
  • The device labeling and evidence of compliance with the reference standard’s labeling specifications
  • A detailed description of all changes or modifications that were made to the device in order to pass any of the EMC tests.

FDA will accept written or electronic comments and suggestions on this draft through mid-December.  Submit electronic comments to http://www.regulations.gov

FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Have questions about this guidance, or any other electro-medical device regulatory issue?  Ask Pat, our compliance expert.  Pat (and MET) have been skillfully performing medical product testing and certification for decades.

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Avionics RTCA DO-160 Testing Includes EMC and Environmental Components

by on Jul.21, 2015, under EMC, RTCA

aircraftWhen it comes to aircraft safety, the stakes are high.  There are tons of components on a commercial airliner.  One malfunction for any reason can be catastrophic.  That’s why equipment testing is crucial to ensure hardware meets quality and safety standards.

Here’s a summary of some of the most frequently performed aircraft equipment tests.

DO-160 is a standard maintained by the Radio Technical Commission for Aeronautics (RTCA) for testing avionics hardware. It applies to equipment in helicopters, general aviation aircraft and commercial airplanes.  DO-160 testing covers most everything that might cause an avionics component to falter or fail.  The most current version is DO-160G, which was approved in December 2010.

DO-160 applies to the United States, and there’s an identical set of standards for Europe, known as EUROCAE ED-14. (EUROCAE is the non-profit European Organisation for Civil Aviation Equipment.)

Electromagnetic Compatibility (EMC)
There are thousands of components in today’s jetliners. Each of these components must be resilient to electrostatic discharge, irregular voltage, magnetic fields and other unpredictable changes.

The RTCA/DO-160 standard covers these EMC test procedures:

Section 15 – Magnetic Effect
Section 16 – Power Input
Section 17 – Voltage Spike
Section 18 – Audio Frequency Conducted Susceptibility – Power Inputs
Section 19 – Induced Signal Susceptibility
Section 20 – Radio Frequency Susceptibility (Radiated and Conducted)
Section 22 – Lightning Induced Transient Susceptibility
Section 23 – Lightning Direct Effects
Section 25 – Electrostatic Discharge (ESD)

To do these tests, MET Labs utilizes three state-of-the-art RF anechoic EMC chambers with 1/3-phase 400Hz RF power filters with Power Factor Correction Coils (PFCCs) and RF filtered DC power.

Lightning strikes are a routine part of every commercial airplane’s experience. The Federal Aviation Administration (FAA) estimates that every airliner in the U.S. is hit by lightning once per year on average.  A single bolt of lightning may send a current of 200,000 amps through the airplane, and avionics electronics must be able to withstand the effects of this strike.  That’s why RTCA/DO-160 has a lightning requirement, and now the latest version of MIL-STD-461 (Revision G) has it too.

Deepening the impact of lightning strikes is the increasing use of lighter composite materials in airframe construction, including that used in the Boeing 787 Dreamliner and Airbus A380.  Many composites don’t conduct lightning currents the way metal airframes do, leading to the possibility of higher voltages and currents affecting aircraft equipment.

MET performs Section 22 lightning testing up to level V, and has the unique capability to perform this testing at 3rd party sites, utilizing a portable Lightning Test System.


High intensity radiated fields (HIRF) testing is a form of EMC/EMI testing applicable to equipment that is subject to extreme electromagnetic environments.

Utilizing a 20,000 V/m Reverberation Chamber, MET performs HIRF testing to satisfy RTCA requirements, as well as FAA HIRF Rule & Advisory Circular 20-158.

Environmental Simulation
Airplanes operate in all sorts of environmental conditions: searing heat, driving rain and dust, shearing winds, and with a regular risk of icing.  They also have to withstand UV and solar radiation.

RTCA/DO-160 covers these environmental simulation test procedures:

Section 4 – Temperature and Altitude
Section 5 – Temperature Variation
Section 6 – Humidity
Section 7 – Operational Shocks and Crash Safety
Section 8 – Vibration
Section 9 – Explosion Proofness
Section 10 – Water Proofness
Section 11 – Fluids Susceptibility
Section 12 – Sand and Dust
Section 13 – Fungus Resistance
Section 14 – Salt Spray
Section 24 – Icing

From high school physics, we remember that acceleration is how fast your velocity is changing.  G-forces stress an airframe and many of its components, especially during take-off and landing.

There’s a variety of acceleration tests that are conducted on airframes and their components, including the use of machinery that spins components in a centrifuge.  MET’s new Centrifugal Static Acceleration Tester delivers 150 g’s for test equipment up to 35 pounds, or 40 g’s up to 200 pounds.

Modern aircraft operate at altitudes between 30,000 and 40,000 feet, and the air pressure at these altitudes is very low relative to the air pressure at sea level.

Airframes are pressurized to provide oxygen to the crew and passengers, but there is the potential for an “explosive decompression,” should the airframe fail.  Aircraft components need to withstand this rapid transition to outside air pressure.

MET can test avionics equipment from sea level to 100,000 feet, with various simulated atmospheric conditions, including pressure, temperature and humidity.

Airplane equipment has to undergo rigorous vibration stress testing to make certain it won’t fall apart in flight.  One of the main sources of vibration in an airframe is turbulence, and that places random vibrations forces on the aircraft. But airplane components must meet standards for both random and sine-wave vibration.

With a new Unholtz-Dickie K-Series Shaker, MET’s shock & vibe capacity is:

  • 17,000 lbf Sine
  • 16,000 lbf Random
  • 34,000 lbf Shock
  • 3 Inch pk-pk Stroke

At MET, we have the experience and equipment to perform DO-160 testing, as well as special test programs for commercial aircraft manufacturers like Boeing and Airbus, plus for satellite manufacturers.  Contact us for a free quote today.

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Electrical/Electronic Regulatory Requirements for Top 5 Middle East Economies

by on May.19, 2015, under EMC, Product Safety, Wireless

memapDriven by vast petroleum resources, many parts of the Middle East are growing rapidly.  Following are the region’s biggest economies (listed largest to smallest), and electrical/electronic regulatory compliance issues for each.

Boasting the largest economy in the Middle East, Turkey is being considered for European Union membership and the EU CE Mark is accepted as proof of compliance for EMC, Safety LVD, Medical, and Industrial.  Wireless and telecommunications products must meet country-specific requirements:

Authority: Information & Communications Technologies Authority (ICTA)
Local required, but no test samples
Standards: UE R&TTE ETSI
Documents: CE DoC, R&TTE test reports, LOA for local rep
Lead time: 4-6 weeks
Expiration: None

Saudi Arabia
With the 2nd largest Middle East economy, Saudi Arabia has special requirements for wireless and telecom products:

Authority: Communications and Information Technology Commission (CITC)
Local not required
Standards: FCC or EU
Documents: FCC Grant & test reports or CE DoC & R&TTE test reports
Lead time: 2-4 weeks
Expiration: 1 year/renewed annually

Saudi Arabia also has country-specific requirements for electronics/electrical products:

Authority: Saudi Standards, Metrology and Quality Organization (SASO)
Local not required
Standards: IEC
Documents: CB report or CE DoC & EU test reports
Lead time: 6-10 weeks
Expiration: 1 year/renewed annually

In Egypt, EMC, Health and Safety, Wireless and Telecom approvals are required for three categories: Wireless, Telecom and ITE.

Authority: National Telecommunication Regulatory Authority (NTRA)
Local not required
Standards: EU CE
Documents: CE DoC & EU test reports
Lead time: 8-10 weeks
Expiration: None

Israel has special requirements for wireless and telecom products:

Authority: Ministry of Communication (MOC)
Local required, but no test samples
Standards: UE R&TTE ETSI
Documents: CE DoC, R&TTE test reports, LOA for local rep
Lead time: 6-8 weeks
Expiration: 5 years/no renewal

Israel also has country-specific requirements for electronics/electrical products, including energy efficiency for some ITE products:

Authority: Standards Institute of Israel (SII)
Local required
Standards: SII
Documents: SII reports, construction files, user docs, LOA for local rep
Lead time: 6-8 weeks
Expiration: None

Note: MET Labs is hosting a North America Product Compliance Seminar in Israel next month.

United Arab Emirates
The UAE has special requirements for wireless and telecom products only:

Authority: Telecommunications Regulatory Authority (TRA)
Representation: Local required
Standards: EU CE
Documents: CE DoC & EU R&TTE test reports covering EMC/RF/Safety, LOA for local rep
Lead time: 6-10 weeks
Expiration: 3 years

MET Labs is deeply experienced helping product manufacturers access global markets through regulatory compliance assistance and global testing and certification.   Contact us today for a free quotation to perform testing and/or certification for any country or market.

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More Products Are Subject to FCC and R&TTE Wireless Module Compliance

by on Feb.23, 2015, under EMC, Wireless

SonyWireless 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.

European Union
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.

North America
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.

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EMC Testing Requires Robust Traceability in EMI Measurements

by on Feb.09, 2015, under EMC

systemnAs a leading 3rd party EMC Test Lab, MET Labs maintains a strict ISO/IEC 17025-2005 Quality System.  This system includes a set of requirements addressing the subject of traceability of measurement results.

Traceability means that the result of a measurement can be related to a national or international measurement standard, and that this relationship is documented. In addition, the measuring instrument must be calibrated by a measurement standard that is itself traceable.

Traceability is important because it allows the comparison of the accuracy of measurements worldwide according to a standardized procedure for estimating measurement uncertainty.

To guarantee traceability, MET uses measuring equipment that has been calibrated by an accredited calibration laboratory and meets international specifications:

  • CISPR 16-1-1 for a measuring receiver (EMI receiver or spectrum analyzer)
  • ANSI C63.5 for antennas

If no standard is available to calibrate a piece of test equipment (e.g. for spectrum analyzers or signal generators), MET uses the equipment manufacturer’s calibration process, per ISO/IEC 17025.

Since the calibration of measuring receivers has caused confusion in the EMC community, CISPR subcommittee A is in preparation of a normative annex to CISPR 16-1-1 (the future CISPR 16-1-6) to better outline the calibration requirements for measuring receivers.

In summary, EMC test results at MET Labs are subject to a strict Quality System that ensures accuracy, repeatability, and traceability.  Contact us today for a free quote for your next EMC testing need.

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FDA Adds 4th edition of IEC 60601-1-2 to EMC Consensus Standards List

by on Jan.12, 2015, under EMC, Medical

In July 2014, the FDA recognized the 4th edition of IEC 60601-1-2 as a standard that can be used to show EMC compliance for medical electrical devices and systems.

The complete standard is recognized with the following exception:

In Subclause 8.9, Table 8 on Page 39: The citation of Note b) under “Conducted disturbances induced by RF fields” (4th Row) is not recognized.

Starting on April 1, 2017 the FDA will no longer accept declarations of conformity in support of either IEC 60601-1-2 Edition 3:2007 or ANSI/AAMI/IEC 60601-1-2:2007.  This recognition affects all electrical medical devices, except for active implanted devices.

However, a new FDA publication “Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff” suggests using the 4th edition of IEC 60601-1-2 for Home Healthcare environments now (not 2017!) to cover test levels which may not be properly addressed in the 3rd edition.

Some of the changes to the 4th edition from the 3rd edition of IEC 60601-1-2 are:

  • With regards to electromagnetic environments, the “life supporting equipment” category has been removed
  • CISPR 15 has been removed as an option for lighting features, replaced by CISPR 11
  • ESD test levels were increased for both air and contact type discharges
  • RF susceptibility test levels are now specified based on the intended use environment
  • Transient tests on DC input power ports in accordance with ISO 7637-2 have been added
  • New conducted RF disturbances requirements are based on location of intended use
  • Test levels for power frequency magnetic fields increased tenfold, to 30 A/m
  • Testing is now at multiple phase angles for the half-cycle, 100% voltage dip

There are many other changes in the 4th edition, contact MET Labs to schedule a new product discovery or existing product ‘gap analysis.’

MET is a leading independent test lab for medical equipment approvals for product safety, EMC and performance.  Learn more about Medical Compliance Testing.

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Top 10 Compliance Today Blog Posts for Electrical Compliance Engineers in 2014

by on Jan.05, 2015, under EMC, Product Safety

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EU Inverters Mostly Non-Compliant to EMC Emissions Requirements in EN 55011 and EN 61000-6-3

by on Dec.29, 2014, under EMC

In the first half of 2014, the European Union’s EMC Administrative Cooperation Working Group (EMC ADCO) performed a cross-border EMC market surveillance campaign to assess the compliance of grid-connected solar panel inverters (and optimisers) intended to be used by consumers. Inverters allow electricity generated by solar photovoltaic (PV) modules to be fed into the mains electrical supply of a building, or directly into the public electricity grid.

The primary purpose of the campaign was to assess the compliance of inverter samples randomly taken from the market, with the provisions of the EMC Directive (EMCD).  EMC ADCO is not a regulatory body, so there were no penalties assessed as a result of non-compliance.

Fifty-five products were assessed between January 1, 2014 and the 30th June 2014. In general, the level of compliance with the administrative and technical requirements was considered very low.  Overall, only 9% of the Equipment Under Test (EUT) were assessed as compliant.

The results of the assessment of EUT showed:

  • Approximately a third (38%) were administratively compliant (related to CE mark use and Declarations of Conformity)
  • A third (33%) were technically compliant with an applicable harmonized standard

For emissions, 38% were compliant to EN 55011 Table 8 limits at mains terminals in the frequency range 9 kHz-150 kHz.  For the DC side (optional), 43% were compliant to EN 61000-6-3 emission requirements to the DC power port.  Immunity aspects were not assessed.

Fourteen European countries participated in the campaign.  The majority of EUT – 58 % – were of EU/EFTA origin.

EMC ADCO concluded: “The EUT represented a large sample of the products available on the market and it is clear that much remains to be done by manufacturers in terms of compliance.”

MET Labs is a leading 3rd party evaluator of inverters for Europe, North America, and Asia.  Contact us today for a free quote for inverter testing and certification for product safety and/or electromagnetic compatibility (including anti-islanding).

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How to Request FCC Confidentiality for Proprietary Product Information

by on Dec.08, 2014, under Wireless

On October 16, 2014 the FCC published 726920 D01 Confidentiality Request Procedures, a new document that details the steps required to ensure proprietary information about your device will be held confidential.

To be granted confidentiality, your application must include a reference to 0.457(d) and 0.459 of the FCC Rules, the reason why the information should be held from the public, specific confidential information by exhibit type, name, and description, an indication if the information is a “trade secret,” a signature, and the type of confidentiality requested.  Confidentiality Letters must specifically reference the documents you wish to withhold from the public.

The two types of confidentiality are long term and short term.

Under long term confidentiality, the following exhibits are held private without filing a request:

  • Software defined radio,  cognitive radio attachments submitted into the SDR software, security info exhibit type
  • Scanning receiver information included in one of the exhibits noted as “commonly held confidential” and scanning receiver internal photos

Under long term confidentiality, the following exhibits can be held private upon request:

  • Schematics
  • Block diagrams
  • Operational descriptions
  • Parts list/tune up info

Under short term confidentiality, exhibits held private are the same as long term confidentiality, plus:

  • External photos
  • Test set up photos
  • Internal photos
  • User manuals

Short term confidentiality can only last up to 180 days. If you request short term confidentiality but market your device before the 180 day period is over, you must notify your Telecommunication Certification Body (TCB) so your confidentiality request can be removed.

If you are seeking confidentiality for an exhibit not listed above, you are able to petition the FCC and all approvals are made on a case-by-case basis.

MET Labs is a leading provider of FCC Testing and FCC Certification. Contact us today for a free fast-response quotation.

Read about how Some Electronic Devices Are Exempt from FCC EMC Testing.

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EMI/EMC Testing Best Practices – Before & During Your Lab Visit

by on Aug.26, 2014, under EMC

Most electrical/electronic designs today are subject to electromagnetic interference/electromagnetic compatibility (EMI/EMC) testing.

Preparation before entering the test laboratory is vital.

Before Testing
The first step is to write a test plan. If you are working in the defense industry, a military test plan is usually a contract requirement. If not, you’ll still want one.  If you don’t know enough to create one, ask your lab to do it, or to recommend an independent consultant who can help.

A good test plan includes:

  • A configuration, mode of operation, and monitoring method, which represents a worst case scenario from an EMC perspective
  • Special software, test fixtures, and supporting equipment may be needed to exercise the equipment under test
  • A description of hardware to be tested, including peripherals & I/O configurations
  • An indication of which external power and data I/O ports need to be tested for each test method
  • Required tests
  • A definition of failure criteria
  • How to monitor, recognize & report failures
  • Special needs: Software, power, cooling, etc.

Then, get pricing and scheduling from a leading 3rd party test lab, like MET Labs.

You’ll have to determine what the lab will supply versus what you will supply.  You will need:

  • Equipment under test (EUT) & spares
  • Cables & connectors
  • Test fixture (for some programs)
  • Tool kit
  • EMI suppression supplies – ferrites, copper tape, etc.
  • The equipment’s design or compliance engineer or someone else familiar with the product to witness testing

In the Lab
Preliminary testing (pre-testing) is always a good idea.  Shortened versions of each test method can be performed to identify failures.  Design modifications can be made before final testing is scheduled.  A radiated emissions pre-test, often referred to as a pre-scan, is the most common pre-test performed.  Even if there is no plan to perform pre-testing for the other test methods, a radiated emissions pre-scan can identify failures and allow for design modifications, which will likely cause the equipment under test to perform better for the other test methods as well.

Then run the full program as specified in the test plan.  If you pass the first time, congratulations!  If not, don’t take it personally – it’s not unusual, especially with early-stage pre-compliance testing.  And practically anything can be overcome. 

If you fail a test, do some quick troubleshooting – you may be able to fix the problem right away.  Do the easy things first:

  • Verify that the EUT is still working properly. This is particularly important with immunity tests that might cause damage.
  • Unplug external cables to see if it improves results.  External cables, although not designed to do so, act as antennas to radiate emissions and receive RF interference.
  • Add ferrites to cables
  • Clean mating, conductive surfaces of paint and other materials.
  • Add an RF filter module at the power input to the equipment under test to limit RF emissions and protect from continuous conducted disturbances.
  • Add a MOVs or other transient limiting device at the power input to protect from transient disturbances.
  • To limit leakage, wrap the EUT in aluminum foil

For immunity, back off the test levels to determine the actual failure levels. If you are close, maybe a ferrite will fix things. If not, that’s good information to have – it will help you narrow the possible failure mechanisms.

Don’t be afraid to ask for suggestions.  Test engineers at an experienced lab like MET will have seen hundreds if not thousands of products, and know many debug and quick-fix solutions.

MET Labs is a full-service EMC testing lab with multiple convenient locations.  Contact us for a free quick-response quotation.

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