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.
Environmental testing has nothing to do with an evaluation of the earth’s environment. Not the environmental testing we’re writing about here anyway.
Also known as environmental simulation, environmental testing involves putting your electronic product through environmental extremes and then determining what hardware failures occur. This process is crucial for pinpointing design flaws for ensuring the reliability and ruggedness of your equipment.
Environmental testing is split into two types: climatic and dynamic.
Climatic testing is performed in climatic test chambers. They range in size from desktop to hangar-sized. The McKinley Climatic Laboratory at Eglin Air Force Base in Florida is 55,000 square feet, and accommodates a hulking Lockheed C5 Galaxy transport aircraft.
Dynamic testing is performed on shakers and similar devices. It includes testing for shock, vibration, and earthquake/seismic. See a video of MET’s MIL-S-901D Hammer Shock rig being constructed and deployed.
Highly Accelerated Life Testing (HALT) is a form of environmental testing that combines climatic and dynamic components. It integrates vibration into the chamber environment, where temperature and humidity extremes can also be applied simultaneously. HALT is a faster, more effective version of the old environmental stress screening (ESS).
Testing should be conducted during the development of your hardware, so that all failures can be determined before the design is finalized. It is much better to fail during environmental testing than to fail in service, possibly causing user harm and often leading to warranty or recall expense.
With HALT, failure is a good thing, although it might not feel like it. It serves as a catalyst for redesign that improves the durability and ruggedness of the device, allowing you to lower your product’s infant mortality rate and reduce claims under your product warranty.
MET Labs owns and operates dozens of environmental test chambers and an impressive shock/vibe/seismic capacity in multiple locations across North America, as well as 24-hour HALT Testing on both coasts. Contact us for a free fast-response quotation.
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:
- 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.
Read about how Some Electronic Devices Are Exempt from FCC EMC Testing.
The European Union EMC Directive 2004/108/EU has been revised to the new Directive 2014/30/EU. After April 2016, the new directive will be required for all applicable electrical products being sold in the European Union.
Requirements listed in Annex I of the directive remain the same. But 4 key changes have been made:
- The directive now applies to distributers and importers, not just manufacturers
- Additional information is required in the technical file
- DoCs now need to be multilingual
- Notified Body requirements have been updated
In order to maintain EMC compliance, a few steps can be taken. First, be sure that all harmonized standards listed on the reports are current. Review your technical file and ensure that all operators’ information and technical instructions comply with Article 18. Your updated DoC should reference 2014/30/EU and clearly identify the product you wish to sell.
Also, read about the new Radio Equipment Directive for CE marking radio equipment.
Product safety compliance for equipment that falls into an established product category is straightforward. But what about new technologies – how are these products evaluated?
As a case example, let’s look at 3D printers. 3D printers aren’t new, but they are just now entering the mainstream, with many more manufacturers developing new small desktop versions for consumers or larger industrial versions for businesses. Also called additive manufacturing or rapid prototyping, 3D printing is the process of using specialized equipment to build a physical object from a three-dimensional digital model, typically by layering many successive thin layers of a material, such as plastic polymers or powdered metal or even food ingredients.
This post contains guidelines for selecting the appropriate safety standards for equipment associated with 3D printing and additive manufacturing, and can serve as an example for other new technology products that can’t be easily categorized.
The intent is to associate 3D printing and additive manufacturing equipment with relevant, existing safety standards for the various current uses of this technology, including commercial, consumer, food processing and medical equipment. Generally, existing standards that cover similar types of equipment used in similar operating environments may be used for equipment associated with additive manufacturing.
Here are the standards that cover 3D printing and additive manufacturing equipment for various potential uses:
International: IEC 60950-1 Safety of ITE or IEC 62368-1 Safety of AV & ICT Equipment
US: UL 60950-1 Safety of ITE or UL 62368-1 Safety of AV & ICT Equipment
EU: Low Voltage (LV), 2006/95/EC, 2014/35/EU
Food Preparation – Household
International: IEC 60335-2-14 Kitchen Machines
US: UL 982 Motor-Operated Household Food Preparing Machines
EU: Low Voltage (LV), 2006/95/EC, 2014/35/EU
Food Preparation – Commercial
International: IEC 60335-2-64 Safety of Commercial Electric Kitchen Machines
US: UL 763 Motor-Operated Commercial Food Preparing Machines
EU: Low Voltage (LV), 2006/95/EC, 2014/35/EU
International: IEC 60601-1 Medical Electrical Equipment
US: ANSI/AAMI ES60601-1 Medical Electrical Equipment
EU: Medical Devices (MDD), 93/42/EEC
When the equipment involves technologies, materials or methods of construction not specifically covered by the standard, the equipment should provide safeguards not less than that generally afforded by the applicable standard and the principles of hazard-based safety engineering, as found in standards like IEC 62368-1.
Of course, there are additional compliance requirements for electromagnetic compatibility (EMC) – FCC & Industry Canada in North America, the EMC Directive in the EU, and other EMC requirements around the world.
Contact MET, a leading 3rd party test laboratory, to determine what requirements apply to your equipment.