Wireless 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.
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.
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.
In the past, design flaws in smart meter units have been known to cause serious fire hazards and spotty performance. This has caused a lot of concern for utilities and manufacturers of smart meters. To prevent problems like this, a new voluntary safety standard – UL 2735 – has been created for electric utility meters.
In the past, meters were tested to UL/CSA 61010-1, as was other Measurement, Control, and Laboratory Equipment. Meter manufacturers are increasingly migrating from UL 61010-1 to UL 2735.
UL 2735 covers:
- Meters rated up to 600V which measure, monitor, record, transmit, or receive electrical energy generation or consumption information
- Socket mounted plug-in (Type S) utility meters, and non-socket mounted, bottom connected (Type A) utility meters
- Meters provided with one or two-way communication capabilities by means of carrier signals, telephone, cable, or wireless communication
- Meters that provide signals, directly or wirelessly, for the control of electrical loads or electrical power generation equipment
These construction and performance requirements are included in UL 2735:
- Compliance with relevant component standards
- Used within their recognized ratings
- Includes plastics, PCBs, MOVs, wire, and transformers
- Accessibility of hazardous live parts
- Electrical spacings over-surface and through-air
- Isolation of current transformer secondary
- Endurance of load control switch
- Single component fault
- Polymeric enclosure flammability
- Battery protection, charging, placement and replacement
- Single component fault
- Enclosure environmental considerations
- Enclosure strength and rigidity
- Access panels
- Insulation resistance
- HV line surges
- Fast transient/burst
- RF interference
- RF conducted/radiated emissions
- Temperature rise
- Temporary overload
- Electrostatic discharge
- Environmental suitability
- Electrical ratings
- Installation instructions
- ANSI C12.10 nameplate
- Permanence and legibility
UL 2735 is not yet part of the NRTL Program, however MET Labs is already accomplished in testing to it. Learn more about MET’s highly-regarded testing of meter safety, reliability, and accuracy for manufacturers or utilities.
As 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.
Foreign manufacturers of products that require U.S. Military Standard (MIL-STD) testing need to comply with the Arms Export Control Act and the International Traffic in Arms Regulations (ITAR).
Obtaining ITAR licensing and development of technical agreements can be a lengthy process. Fortunately, clients in the United Kingdom and Australia can simplify the process and bypass ITAR licensing requirements using exemption programs available through Defense Trade Cooperation Treaties to which the United States, United Kingdom, and Australia are signatories.
Once recognized under these treaties, clients are part of the UK or Australian Approved Communities (AC) and are listed under the DDTC’s Treaty Reference System (TRS). TRS is a resource operated by The Directorate of Defense Trade Controls that helps U.S. Exporters confirm whether or not UK or Australian organizations are exempt from ITAR licensing requirements.
More information can be found at the DDTC’s website for Defense Trade Cooperation Treaties. Exemption programs for United Kingdom and Australia are also described in the ITAR regulation under 22 CFR 126.16 – 126.17.
When an RF product is revised due to obsolete parts, cost cutting, or product improvements, how does the engineer know what the FCC requirements are for the altered product? Will it require a new FCC filing and ID number or will a Permissive Change be allowed?
To allow products to be modified without requiring a new filing, the FCC has defined three Permissive Change options listed in Title 47 Part 2.1043, KDB 178919 D01 Permissive Change Policy v05r04.
Class I Permissive Change
This class includes modifications which do not degrade the characteristics accepted by the FCC when certification is granted. No filing with the Commission is required for a Class I Change.
Class II Permissive Change
This class includes modifications which degrade the performance characteristics as reported to the FCC at initial certification. In this case, the grantee must supply the Commission with results of tests of characteristics affected by the change.
Class III Permissive Change
This class includes software modifications of a software-defined radio transmitter that change the frequency range, modulation type or maximum output power (either radiated or conducted) outside the parameters previously approved.
In this case, the grantee must supply the FCC with a description of the changes and test results showing that the equipment complies with applicable rules with the new software loaded, including compliance with applicable RF exposure requirements.
Class III changes are permitted only for equipment on which no Class II changes have been made from the originally approved device.
For any of these changes, modified equipment cannot be marketed under the existing grant of certification prior to acknowledgment by the Commission that the change is acceptable.
In summary, changes to a modular radio or product will result in either a Permissive Change or a new FCC filing and ID number. The degree of change will determine both the process and the amount of supporting data required to illustrate compliance.
With few exceptions, a new FCC ID and a new equipment authorization application will be required in the event of changes to the basic frequency (including clock and data rates), frequency multiplication stages, basic modulator circuit, or maximum power or field strength ratings.
In the last three months of 2014, the Consumer Product Safety Commission and Health Canada maintained their torrid pace of recall announcements. Here is a list of electrical/electronic products that were recalled in the 4th quarter of 2014, per the Consumer Product Safety Commission:
- UL-Listed Keurig MINI Plus Brewing Systems
- AP Specialties Power Bank Chargers
- Olympus Digital Audio Recorders
- Goal Zero Battery Packs
- Daikin Air Purifiers
- Horizon Hobby HobbyZone Super Cub S Radio Controlled Aircraft
- UL-Listed Schneider Electric PowerPact J Frame Circuit Breakers
- Giggles International Animated Monkey Toy
- CSA-Listed Lenovo Computer Power Cords
- Tankless Water Heaters
- Ventamatic Draft Misting Fans
- Tectron International USB Chargers
- Visonic Amber Personal Emergency Response Pendants and Kits
- Meijer Halloween Projector Flashlight
Recalls are expensive. Keurig took a $10M charge in December when 7 million of its UL-listed single-serve brewers were recalled.
Beyond the recall cost, there is the risk of regulatory penalties to watch out for. In 2014, CPSC levied over $12M in civil penalties, a record.
Avoid the steep cost and hassle of recalls. MET Labs is the experienced alternative to UL for product safety certification. The first OSHA Nationally Recognized Testing Laboratory (NRTL), MET has 55 years of product safety testing experience, and a stellar track record of clients that have avoided costly recalls.
Beyond safety recalls, electronics manufacturers are increasingly engaging in reliability testing to prevent product returns and warranty claims. HALT testing is the quick and sure way to prove product reliability. HALT testing helps you discover defects in your product design, guarantees a much lower product infant mortality rate, and reduces development costs.
Contact MET to ensure the safety and reliability of your product before it’s on the market.
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.
Just like last year, the Compliance Today blog for electrical product manufacturer compliance engineers saw a significant increase in readers and subscribers for 2014. Following were the most popular posts, by pageviews.
- IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes
- EN 61326-1: 2013 Replacing 2006 Version for EMC Directive Evaluation of Lab, Test & Measurement Equipment
- EN55032 Replacing EN55022 and Others for CE Marking of Multimedia Equipment
- New Radio Equipment Directive Adopted by EU, Awaits Publication in OJ
- CE Marking Directives Recast to Align with New Legislative Framework
- IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets
- Some Electronic Devices Are Exempt from FCC EMC Testing
- Top 20 Non-Compliance Findings for Panel & Motor-Operated Equipment
- EMI/EMC Testing Best Practices – Before & During Your Lab Visit
- Radio Equipment Directive (RED) Replacing R&TTE Directive, is Published in OJ
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Want more in-depth information on one of these topics? Check to see if we are planning a seminar or webinar on it.
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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).
Changes in the new edition are extensive. They include:
- Air conditioners installed in panels need to comply with UL 1995 and clause 26.3
- When protectors (fuse, breaker, etc.) are in a DC circuit above 32 volts, they must be evaluated to appropriate product standard and have a rating equal to or greater than the operating circuit voltage
- Type 4 or 4X enclosure/compartment that is ventilated must now also comply with clause 62.4
- New requirements for control panels intended to control fountains
- New requirements to address power factor correction circuits/capacitors that do not need to be specifically described
- New requirements to address components provided that are configured as autotransformer- and resistor-type reduced-voltage motor controllers
- New requirements for control panels intended to control irrigation equipment
MET Labs’ Industrial Control Panel Certification Program delivers a responsive cost-effective product safety certification for manufacturers who custom-build or mass-produce ICPs.
Contact us today for a quote to the 2nd edition of 508A, or for a ‘gap analysis’ of an already-certified panel.