Most electronic devices destined for sale in the U.S. fall under Part 15 (CFR 47) of the Federal Communications Commission (FCC) rules for limits to the unintentional and intentional emission of radiation. However, there are some exemptions that you may be able to take advantage of, depending on the nature of your product. You can find the bulk of this information in Section 15.103 of the rules.
The FCC says it is “strongly recommended” that you still attempt to comply with the rules, regardless of your product type. They have the power to halt sales of your device if the device has been found to cause harmful interference, so proceed with caution.
Here is a simplified description of product types that are FCC exempt from digital emissions testing:
- A digital device utilized exclusively in any transportation vehicle including motor vehicles and aircraft. Note: wireless devices are subject to other FCC rules.
- A digital device used exclusively as an electronic control or power system utilized by a public utility or in an industrial plant.
- A digital device used exclusively as industrial, commercial, or medical test equipment.
- A digital device utilized exclusively in an appliance, e.g., microwave oven, dishwasher, clothes dryer, air conditioner, etc.
- Specialized medical digital devices (generally used under the supervision of a licensed health care practitioner) whether used in a patient’s home or a health care facility.
- Digital devices that have a power consumption not exceeding 6 nW.
- Joystick controllers or similar devices, such as a mouse, used with digital devices but which contain only non-digital circuitry or a simple circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital conversion).
- Digital devices in which both the highest frequency generated and the highest frequency used are less than 1.705 MHz and which do not operate from the AC power lines. Digital devices that include battery eliminators, AC adaptors or battery chargers which permit operation while charging or that connect to the AC power lines indirectly do not fall under this exemption.
Although not noted in section 15.103, equipment authorization is also not required for:
- Personal use home-built devices (not kit-constructed) that are assembled in quantities of five or less
- Low-frequency devices that don’t generate timing signals or pulses at a rate in excess of 9,000 pulses (cycles) per second (i.e., 9 kHz)
Note that equipment is not exempt unless all of the devices in the equipment meet the criteria for exemption. For example, if you have a specialized medical digital device with a wireless transmitter, the wireless transmitter still has to be tested.
Please confirm with MET Labs whether you are indeed exempt as there are some caveats to this information.
And, of course, FCC-exempt devices might be required to undergo other types of testing, like product safety certification for U.S. OSHA compliance or EMC testing for CE marking in Europe. Contact MET for a full evaluation of your product line and its intended markets.
The U.S. Department of Defense (DoD) recently issued Change Notice 1 to MIL-STD-810G, Environmental Engineering Considerations and Laboratory Tests. This change notice incorporates more changes – climatic and dynamic – than any previous revision of -810.
A PDF of Notice 1 is available here. It’s a bulging 1,058 pages, over 280 pages more than the Revision G alone and more than twice as many pages as Revision F. Changes are marked by lines in the margins.
Major changes include:
- In Part 1, a significantly expanded section on the Life Cycle Environmental Profile (LCEP)
- In Part 2, all test methods – 500 through 528 – have been updated with a new note
- Only Method 528 can be called out in blanket fashion now
- A rewrite of mechanical shock
- Additional guidance in combining procedures
MIL-STD-810 is used by both the U.S. military and industry to assure that the environmental design and test limits of equipment match the requirements that equipment will face in actual use.
Whether a military product must be tested to Change Notice 1 is dependent on the DoD contract. The DoD uses the product’s life cycle environmental profile and its anticipated deployment region to determine which standard version to specify.
MET Labs is an elite 3rd Party Test Lab for Military and Commercial Aircraft equipment testing, and has top-flight experience working with every top defense contractor and commercial aircraft manufacturer and many of their suppliers. Contact us for a rapid-response quote for EMC or Environmental Simulation testing.
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.
The Radio Equipment Directive (RED) – 2014/53/EU – has been published in the Official Journal. This Directive is replacing the RTTE Directive (1999/5/EC).
You can read more about the changes in the new RED in a previous Compliance Today post.
May 22, 2014 – Publication in OJ
June 12, 2014 – Entry in force of RED
June 12, 2016 – Member states transposition period end date
June 12, 2016 – RTTE Directive 1999/5/EC repeal date
June 13, 2016 – Member states must apply the new RE Directive by this date
June 13, 2017 – Products compliant with the old Directive market placement end date
MET Labs is a leading provider of EMC and Wireless Testing services. Contact us today to test your radio equipment devices for Europe or any other major global market.
In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. There are a number of changes in the 4th edition, including new immunity and risk analysis requirements.
For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period (2017 recognition). The FDA does not currently require retesting of legacy products unless changes are made to the product that may affect its compliance.
Canada is planning to review the 4th Edition sometime in 2015 so it will not be accepted before 2015/2016. It’s typically 3 years before accepted standards are required for new submittals.
In Europe, CENELEC has voted affirmatively to accept the 4th edition but has not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 3rd Edition is expected in the 2017-2018 timeframe. There is no grandfathering in Europe.
Following are some of the key changes in the 4th edition.
Use environments are split into three areas:
- Professional Healthcare Facility Environment
- Home Healthcare Environment
- Special Environment (test levels specified in Annex E)
Small clinic, and Home use equipment need CISPR 11 Class B emission, IEC 61000-3-2 Class A harmonic distortion, and IEC 61000-3-3 voltage fluctuation and flicker. The home use equipment needs 10 V/m, 80 MHz to 1 GHz immunity.
For equipment that is installed in an aircraft or an ambulance, additional testing per ISO 7137 and CISPR 25 applies.
For an EUT with auto ranging power supply, most tests are required to be performed at one nominal voltage only. Only voltage interruptions need to be performed at maximum and minimum voltage if the rated voltage range is >25% of lowest rated input voltage.
Immunity test levels increase:
- The range of testing for radiated immunity harmonized up to 2.7GHz (up from 2.5GHz in the 3rd edition)
- Magnetic immunity at 30A/m
- Conducted immunity at 6V in ISM bands
- ESD at 8kV contact and 15kV air (up from 6kV and 8kV in the 3rd edition)
- Voltage dips and interruptions at additional phase angles
In addition to these Immunity changes:
- Immunity levels (Table 9) are harmonized with IEC 60601-1-11
- Immunity testing now follows the same port-by-port convention of the IEC 61000-6 series of Generic EMC standards
- Immunity to proximity fields from RF wireless communications equipment is now included, and is based on a minimum separation distance of 30cm
- There is a procedure for continuing to test a product that is damaged by an immunity test signal
And Risk Management is expanded:
- Manufacturers will be required to submit a test plan and the risk analysis document before testing
- Operating modes are based on risk analysis
- Reasonably foreseeable electromagnetic disturbances (Annex F) shall be taken into account in the risk management process
- The risk management process is used to determine whether subsystem testing is allowed
- The minimum separation distance are considered in the risk management process
- Reduced test levels (e.g. based on the intended use of the product) must be justified in the risk management file
Contact us for questions about these changes or for a free quote to test and certify medical equipment to any edition of 60601-1.
Most electrical product testing is to a published standard, but not always. MET Labs has a rich history of developing custom test plans that meet manufacturers’ specific needs.
One reason for developing a custom test plan is to check equipment performance against marketing claims made by the equipment manufacturer, or to check the performance of your product against a competitor’s product. Performance can include reliability, accuracy, safety, energy efficiency, or other factors.
A recent customer example comes from a large industrial solutions company that asked MET to test the performance of its noise isolation transformer against its own marketing claims. The transformers are sold to schools, hospitals and small offices (especially in high lightning strike areas) to protect against transient overvoltage, spikes/surges and other undesirable noise.
The company asked us to measure the capacitance and the common and normal mode noise attenuation between the primary and secondary of their transformers. We found that there was no established test procedure standard to refer to, so we developed one and had it approved by the customer.
Here is the basic setup we developed to measure the transformer’s capacitance: The transformer and test equipment was wired according to the accompanying diagram. At each test frequency, the signal generator was set to output Vrms (Vin), and the spectrum analyzer was set to measure Vrms (Vout). The following formula was used to calculate the capacitance:
C = [Kf((Vin/Vout)-1]^-1, where K=2π*50Ω and f=frequency in Hz.
The accuracy of this test method and our test equipment was checked by measuring a range of known capacitors prior to measuring the transformers under test.
Similarly, we developed test methods to measure common and normal mode noise attenuation.
What were the results? Customer test results are confidential so we can’t say, but the customer is satisfied and we are looking forward to the next non-‘standard’ testing challenge they have for us.
Have a challenging application? Tell us about it – we can help.
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.