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 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.
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.
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.
The FCC took 20 enforcement actions in 2013 against RF equipment manufacturers and vendors for violations of the FCC’s marketing rules and technical standards. These actions include enforcement of Rule Parts 2, 15, 18, 22, 24, 27, 90, and 95. Fish & Richardson P.C. summarizes FCC Equipment Manufacturer Violations from 2006-2013 here.
Four of the six largest violations (with Consent Decrees ranging from $100,000 to $280,000) involved the FCC’s hearing aid compatibility (HAC) rules. The HAC rules require handset manufacturers to report annually on their HAC compliance status, so manufacturers should expect that the FCC will continue to pursue HAC violations.
The FCC also continued its focus on Part 15 U-NII devices and digital devices. Violations involving equipment in the music industry, such as amplifiers and mixers, led to some of the year’s largest Consent Decree payments.
Effective September 13, 2013, the FCC raised the maximum penalty for most equipment violations from $112,500 to $122,500 per single violation.
The bottom line is that manufacturers and importers need to be careful about FCC compliance. Manufacturers with compliance issues can face delayed equipment approvals, contract disputes and lost sales opportunities, and even competitor or consumer lawsuits.
Body SAR will be required for Japan starting April 1, 2014. The limit is 2 W/kg for body and 4 W/kg for arms and legs. The SAR is calculated over any 10g of tissue (as compared to 1g of tissue for FCC). Body SAR will be exempt for radio devices that have less than 20mW output power. The test method, for the most part, is harmonized with IEC 62209-2. Read about SAR requirements in North America and Europe.
There is a second FCC Notice of Proposed Rulemaking (NPRM) coming out early next year proposing still-unknown new certification procedures for FCC. This is in addition to the first NPRM that issued in February 2013 and which included significant changes to the FCC equipment authorization process. FCC is calling it a “complete overhaul of the certification process.” It is expected these changes will take effect in late 2014.
Mexico and Israel MRAs
Mexico and Israel Mutual Recognition Agreements (MRAs) should be finalized late next year. When Phase I of the MRAs are implemented, U.S. manufacturers will be able to perform testing at a local U.S. lab for those countries. Later, when Phase II is implemented each country will be able to certify products for the other.
For questions about these changes or for an immediate test need, visit our Quote Center.
Register now for MET’s free EMC & Wireless Design & Testing Seminar in Baltimore next week.
Late last year, Version 1.8.1 of EN 300 328 was adopted and published in the EU’s Official Journal (OJ). This standard is the applicable standard for WiFi, Bluetooth, and other wideband transmitters operating in the 2.4GHz band.
Version 1.8.1 has an effective date of December 31, 2014, so declarations of conformity with the Radio and Telecommunication Terminal Equipment (R&TTE) Directive based on testing against EN 300 328, v1.7.1 would need to be re-evaluated before the end of 2014 for devices going into the EU market after this date. Devices already in the market will be grandfathered in.
However, at the same time as the v1.8.1 adoption, a note was added to v1.7.1 in the OJ, stating that part of the new v1.8.1 requirements – medium utilization factors – needed to be immediately implemented and tested.
The upshot: Radio modules tested and found compliant to v1.7.1 need to be retested due to the additional requirement – there is no longer a presumption of conformity with the R&TTE Directive. This has caused confusion and headache for manufacturers and some test labs.
In conclusion, wireless modules tested to the un-amended v1.7.1 need to be retested now to the latest version of the standard. By January 1, 2015, all wireless equipment in the 2.4GHz band needs to be tested to v1.8.1.
Contact us for an overview of changes specified in v1.8.1.
MET Labs recently completed a novel RF survey for a large federal government agency laboratory, to determine whether refrigerators and freezers on multiple floors in multiple buildings are receiving a sufficient-strength wireless signal with minimal noise.
Here are some of the project details, as well as surveyed information:
- Operating frequencies: 2.4 GHz ISM Band; 5 GHz UNII Bands; 5.8 GHz ISM Band
- Acceptable signal strength: -85dBm to -35dBm
- Minimum Signal-to-Noise Ratio: 20dB
- Access Point/Channels in Use Information
- Maximum Data Rate
- Retry Rate Distribution
- Loss Rate Distribution
- Operating Mode Information (Legacy/HT/Mixed HT)
- 20/40MHz Channel Information
- Tx/Rx MCS Index Information
MET used this test method:
- The calibrated 802.11a/b/g/n client radio was connected to a laptop running RF monitoring software.
- A passive and active survey was taken using the software and the radio was moved throughout the test site.
- In each lab and corridor within labs, measurements were taken of the strength of the received WLAN carriers.
- All the measurements were mapped to floor plans of the test site. Signal Strength, SNR, and other wireless signal properties were noted throughout and compared to the test requirements.
In situ RF surveys are a good way to ensure wireless-enabled equipment receives an uninterrupted signal that is free of excessive noise. For more information about conducting RF surveys, contact MET.
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.
To determine whether your product needs Specific Absorption Rate (SAR) testing, there are a few items to consider.
First, is the device operated within 20cm (7.87”) of the head or body? If no, then SAR does not apply. If yes, then SAR does apply, but testing may be excluded based on the device’s output power.
The maximum conducted output power is the average conducted power at the antenna port plus any production tolerance. When calculating output power, keep in mind the device’s duty-cycle. For SAR, the on and off time-averaged power is to be considered. So if not already accounted for, the duty cycle factor may be applied directly to the output power.
To determine whether the output power is below the threshold for testing, it depends on where the device is being certified for. Here are some common jurisdictions:
The Federal Communications Commission (FCC) utilizes a formula to determine SAR test exclusion in KDB 447498 D01v05 Section 4.3. For separation distances of <50mm if the following equation results in <3.0 then test exclusion for 1g SAR applies: (Output power, mW) / (separation distance, mm) x (sqrt(freq), GHz). Use 5mm for separation distances <5mm.
Industry Canada stipulates the exclusion threshold in RSS-102. For 3kHz – 1GHz it is 200mW, for 1GHz – 2.2GHz it is 100mW, for 2.2GHz – 3GHz it is 20mW and for 3GHz – 6GHz it is 10mW. Note that per Industry Canada, output power is always the higher of conducted or equivalent isotropically radiated power (EIRP).
In the EU, the threshold is given in IEC/EN 62479:2010. A simple formula is used: Pmax = SARmax * m.
For each jurisdiction, if the devices output power is less than the threshold, SAR testing is not required. However, in most cases, a statement showing why it is excluded and how it still meets the requirements must be submitted.
Sign up for one of our upcoming complimentary wireless product testing seminars in Silicon Valley, California: