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:
In the U.S., wireless module approvals fall into one of three categories:
- Full modular approval – A radio module to be approved for use in any host and sold to anyone
- Limited modular approval – A radio module to be approved for restricted use
- Split modular approval – A radio module where the transmitter firmware is held on a host
FCC Full Modular Approval
Full approval is defined in FCC Part 15.212. The module will have the FCC ID; any host incorporating the module will show that the module is contained within it: Contains FCC ID: XXXYYYYY.
There are 8 criteria for full approval:
- Transmitter must have its own shield
- Must have buffered modulation/data inputs
- Must have power supply regulation
- Must meet Part 15 antenna requirements
- Must be tested in stand-alone configuration
- Must be labelled with the FCC ID
- Must meet its own FCC rule part
- Must meet RF exposure requirements
The module host must still comply with its own requirements (e.g. Part 15B, Verification or DoC).
FCC Limited Modular Approval
FCC limited approval is for modules that don’t meet all eight criteria for full approval. Limited approval is possible when the host or end environment is known:
- The module will be certified for a range or series of devices, similar in construction
- The module will be certified for use by the grantee or an authorized OEM
- The module will be tested in a representative host
FCC Split Modular Approval
Split approval can only be certified by the FCC, and is included on the TCB Exclusion List.
For module approvals, Knowledge Database (KDB) 996369 is key. Other important KDBs include:
- KDB 784748 contains labelling requirements
- KDB 447498 contains RF exposure, MPE and SAR test guidance
- KDB 616217 contains SAR host guidance
Canada IC modular approvals are to RSS-GEN section 3.2, with requirements and labelling similar to FCC. Unlike FCC, unlicensed modules use the same eight criteria as licensed modules.
For limited modular approval, guidance comes from RSS-GEN section 3.2.3, and is also similar to FCC.
MET is an FCC TCB and an Industry Canada CB.
Europe R&TTE Directive
In the EU, there is no certification or modular approval, but rather Declaration of Conformity (DoC).
A module placed on the market should be fully assessed to the R&TTE Directive (Radio, EMC and Safety), either as an independent radio or as a radio component intended for use within a host.
There are not eight criteria, so the manufacturer must assess to all possible installation environments. By CE Marking a module, you are stating that it will comply in its intended use and environment.
For integrating modules into a host, the host company is ultimately responsible for compliance, unlike with the FCC and IC. However, previous testing may be taken into consideration by the module integrator. If module testing is trusted for the DoC of host, the module’s Technical Construction File (TCF) becomes part of the host’s TCF.
For the R&TTE Directive, these guidance documents exist:
- ETSI TR 102 070-1 – Application of EMC standards
- ETSI TR 102 070-2 – Application of Radio standards
- R&TTECA, TGN 01 – Requirements for a Final Product that Integrates an R&TTE Directive Assessed Module
Read about the proposed changes to the R&TTE Directive.
“Modular approvals” do not appear in Japanese radio law. However, in July 2012, MIC announced that a module could be certified as a radio device, even if it used soldered connections, if it was the type: WLAN, Bluetooth, Zigbee, etc. In other words, a FCC 15.247 type of device. It is not modular approval, but it does allow soldered modules to be certified as radios.
In February 2013, MIC announced that modular approvals will be integrated into Japanese radio law. Requirements are being developed now. Currently, there is no timeline or estimated implementation date.
For questions or for a modular approval quote, visit our Quote Center.
We will be at CTIA Wireless next month. Request to meet with us.
The U.S. Federal Communications Commission (FCC) has proposed important changes to its equipment testing and authorization program under Part 15 and Part 68 of its rules. The FCC says the changes will streamline the approval process and expedite the introduction of new devices to the market.
In a Notice of Proposed Rulemaking issued last month, the FCC proposed a number of changes to its existing equipment authorization program. The key proposed changes include:
TCB Accreditation – Telecommunications certification bodies (TCBs) – like MET Labs – will be accredited in accordance with the requirements of ISO/IEC 17011 and ISO/IEC 17065. These standards replace ISO/IEC Guides 58, 61 and 65.
Testing Laboratories Accreditation – Laboratories that test equipment subject to certification or approval under any of its rules must be accredited to ISO/IEC 17025.
TCB Authority – The FCC will no longer directly issue any grants of equipment authorization. Instead, TCBs will authorize and deny all products subject to certification.
Post-Market Surveillance – For post-market surveillance, the FCC will specify the number and types of samples that a TCB must test.
Assessing TCB Performance – NIST will assess TCB performance. The Commission also outlined a process to address TCB non-performance issues.
Measurement Procedures – ANSI C63.10-2009 will be the procedure used to determine the compliance of intentional radiators, and ANSI C63.4-2009 will be the procedure for assessing unintentional radiators.
We understand these proposed changes are likely to go through without significant modification, but first there is a comment period to elicit feedback. Comments on the Commission’s proposed rule changes are due by late March here.
Read the complete text of the FCC’s Notice of Proposed Rulemaking regarding important changes to its equipment testing and authorization program under Part 15 and Part 68.
MET Labs is an accredited testing laboratory and TCB. Contact us for FCC Testing or Certification assistance.
At the recent Telecommunication Certification Body Council Workshop in Baltimore, Kwok Chan and Mark Neumann of the Federal Communications Commission (FCC) Office of Engineering and Technology outlined testing and certification requirements for Consumer Wireless Charging Devices.
Wireless charging devices are generally used to charge batteries in portable electronic devices via magnetic induction. Chargers can deliver up to 5W of power, enough to charge most wireless handsets, and work at distances up to 10mm.
These products have been around since the 1990s, but only have become practical in recent years, so FCC thought it was worthwhile to cover how these devices fall into the existing regulatory compliance framework. Following are main points from the presentation.
Chargers and clients are generally approved separately; however, they should satisfy compliance in both standalone mode and as a system.
Wireless charging devices can be approved under Part 15 or Part 18 or both rule parts.
Part 15 authorization required if:
- Primary charging frequency includes information not related to power management
- A secondary frequency is used for communications
Part 18 authorization for the charger and clients:
- Load and power management must be integral to wireless charging operation and frequency
- May not communicate any information not related to power management and control
- Proximity of the charger and client device(s) must satisfy Part 18 requirement that the RF energy is locally generated and used
- Other communications are authorized separately under Part 15
Electromagnetic Compatibility (EMC) considerations:
- Charger must be evaluated with appropriate client(s) in place
- The worst case transmitting conditions for the system as a whole must be evaluated for each applicable configuration: Bluetooth, WWan, WLan, etc.
Radio Frequency Exposure
Single client low power devices generally do not present exposure concerns for nearby users, but multi-client devices or short-distance power transfer can result in widely varied fields and potential exposure concerns.
For most small consumer chargers, exposure conditions identified in §2.1091(d)(4) may apply.
Specific Absorption Rate (SAR) and Maximum Permissible Exposure (MPE) limits do not cover wireless chargers operating below 100 kHz and 300 kHz, respectively.
The presentation concluded with two points:
- A KDB Inquiry should be submitted for guidance for wireless charger applications
- Wireless Chargers remain on the Permit But Ask (PBA) list
Sign up for a Wireless Testing & Certification Seminar in Austin, Texas in December.
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.
This week, MET Labs, Federal Signal Technologies, Concurrent Technology Corporation, and OmniAir Consortium, Inc. are performing a 4th round of regression testing on Dedicated Short Range Communications (DSRC) Vehicle Awareness Devices. The testing is being performed at Southwest Research Institute in San Antonio, Texas. The Vehicle Awareness Device specification produced by the U.S. DOT has undergone updates – the latest as recent as last week – and device manufacturers have now incorporated these new requirements into their products in time for this week’s testing.
A last round of regression testing has been scheduled for December and this testing will be performed at MET Labs in Baltimore. For testing that requires vehicles moving at certain speeds and for measurements requiring an open field, testing will be performed at New Jersey Motorsports Park in Millville, New Jersey. In addition to using the racetrack, MET Labs has also received permission from the city of Millville to use an open adjacent field.
The December regression testing is for device manufacturers to fine tune their devices before they move into official Qualification testing in the first quarter of 2012. Qualification testing will be performed at MET Labs. Devices that comply with the specification based on the Qualification testing will be picked for the U.S. DOT Safety Pilot Model Deployment. The pilot will commence in late 2012 in Ann Arbor, Michigan and will include at least 2,500 vehicles fitted with these DSRC radios. The purpose of this safety pilot is to ascertain how effective these devices are in mitigating accidents involving vehicle-to-vehicle collisions.
Read about previous testing for this program.
Read about other types of automotive testing.