About the Author: Shane Rismeyer is an EMC Engineer for LSR’s Compliance Division. He received his BS in Biomedical Engineering from MSOE, is a member of IEEE, and is involved with the Milwaukee Chapter of the EMC Society. You may contact Shane via email at email@example.com.
With the release of a new medical standard (as with any) there comes a certain amount of apprehension and concern about how current and future products will fit into a new testing scheme. In the medical field this is especially true, as there are additional factors that come into play when seeking approval, as compared to typical consumer products. The fourth edition of IEC 60601-1-2 brings with it a revamped product classification system for both emissions and immunity.
Gone is the old system based on whether or not a product is life supporting, replaced by a classification system based on intended use environment. The new organizational model is better suited for the diverse range of products found in today’s medical field. In order to reduce the susceptibility of these products the fourth edition has increased, added to or changed many of the stress levels for the immunity tests. One of the major focuses addresses the increased proliferation of wireless devices across multiple frequency bands. With these changes in the immunity suite, this will result in a rather distinct difference in tests when compared to the third edition. This is an important point to remember when considering upcoming compliance testing.
At this post, the fourth edition is still several years away from being requisite, and not published in the Official Journal associated with the Medical Directive. For further information regarding these changes or questions regarding the approvals process, you may contact LSR through our website at www.lsr.com, connect with us on LinkedIn, or find our latest news and information on Twitter by following @lsresearch.
On February 15, 2013, the FCC released a Notice of Proposed Rulemaking to amend FCC Parts 0, 1, 2, 15, and 68. The PDF document can be found here (ET Docket No. 13-44 RM-11652).
The changes proposed by the FCC will affect the TCB Program, Test Laboratory Accreditation and Validation, and recognized Measurement Procedures; and have an implementation transition period of one year after publication of the rules in the Federal Register.
The TCB Program:
The telecommunications certification body (TCB) program, which has been implemented since June of 2000, is well established; and the FCC is proposing to no longer directly issue any grants of equipment authorization for wireless products or modules, but instead allow TCBs to authorize all wireless products subject to certification. This would include eliminating the current KDB TCB Exclusion List of device types which still require the Commission for certification, but also implementing a "pre-approval" process for specific product types which would require TCB to receive the Commissions concurrence prior to granting an equipment authorization. This transfers the authority for granting certification to the TCB, while still allowing the Commission oversight and control of these special product types; at least until such time that the Commission determines oversight is no longer requisite.
In addition, the FCC is proposing changes to the post-market surveillance rules to clarify the authority of TCBs when requesting samples from grantees, and procedures for when the Commission requests a TCB perform surveillance on a specific device, as well as procedures in the event a non-compliance is discovered.
The Commission is also seeking input regarding logistics, counterbalancing influences, and minimizing the expense of these post market surveillance efforts. Suggestions such as sample request methods that limit solicitation duplication, cross-checking efforts amongst TCBs, and how the burden of expense for these efforts are distributed are currently under proposal.
A clarification of the role NIST will have in the designation of domestic TCBs, along with clarification of the process with which a laboratory must follow to demonstrate competence as a TCB. With the proposal of added authority for all equipment authorization for TCBs, the Commission is also proposing new corrective programs when deficiencies are discovered with a TCB, and under current rules there is no recourse other than withdrawal of the TCBs designation or recognition. These efforts would be designed specifically for performance issues that the Commissions recognizes can be resolved with simple corrective actions by the TCB.
Test Laboratory Accreditation and Verification:
One of the most significant changes being proposed has to do with a change to the Commission's requirements for Test Laboratories, the acceptance of data based upon accreditation, and the requirements for measurement sites.
Currently there are three authorization procedures: Certification, Declaration of Conformity (DoC), and Verification. Certification is a grant of equipment authorization issued by the Commission or TCB based on the submittal of an application and test data; a Declaration of Conformity is a statement of conformance to the requirements with the appropriate technical standards but isn't requisite for a grant of equipment authorization from the Commission or TCBs, just a statement supplied with the product; and a verification requires no application for a grant of equipment authorization, nor a statement of compliance, just performance of measurements which ensure the equipment complies with appropriate technical standards.
Under current Commission rules, only DoC procedures requires laboratory accreditation to the requirements of ISO/IEC 17025; however, under this proposal, accreditation will be required for laboratories performing certification as well, with the most significant effect being that any testing performed in countries without a US MRA may not be accepted for Part 15 or Part 18 certification.
Additionally, the proposal will update the test site validation requirements to those specified in ANSI C63.4-2009 for emissions below 1GHz, and the Site VSWR requirements specified in CISPR 16-1-4 for emissions in the range of 1GHz to 40GHz.
The Commission is also proposing To incorporate ANSI C63.4-2009 and ANSI C63.10-2009 for determining the compliance of unintentional and intentional radiators respectively. However, the Commission will not acknowledge the use of rod antennas below 30MHz, artificial hand for handhold devices, or absorber clamps for radio noise power measurements due to insufficient evidence that they produce accurate, repeatable measurements. Additionally, it will not observe relaxation of limits for emissions of a transient nature resulting from findings which demonstrate that brief durations in emissions still produce nuisance interference.
As of the publishing of this blog, the FCC will continue to review comments regarding the proposed rulemaking for another 4-5 weeks, with responses to comments following 30 days later.
Over the years I've presented at several wireless seminars. My favorite question to ask is always, 'How many of you have submitted your designs for FCC testing?' and most hands fly up. I then follow up with another question, 'How many of you have passed compliance on your first try?' and unfortunatley, most hands go down just as fast.
The Federal Code Of Regulation (CFR) FCC Part 15 is a common testing standard for most electronic equipment. FCC Part 15 covers the regulations under which an intentional, unintentional, or incidental radiator that can be operated without an individual license. FCC Part 15 covers as well the technical specifications, administrative requirements and other conditions relating to the marketing of FCC Part 15 devices. Depending on the type of the equipment, verification, declaration of conformity, or certification is the process for FCC Part 15 compliance.
FCC Part 15 Subpart C is for intentional radiators. An Intentional radiator is any device that is designed to produce a radio signal on purpose. The FCC has made provisions for unlicensed transmitters throughout the radio spectrum. The various types of intentional radiators covered by Subpart C include cordless telephones, remote control and alarm transmitters and spread-spectrum systems for wideband data transmission which include WiFi, Bluetooth and ZigBee devices. The FCC Part 15 Subpart C rules for operation of radio transmitters for the most part are very detailed regarding fundamental field strength, power and/or power density, frequency accuracy, and permitted harmonic and spurious emissions.
With the advent of single chip or system on chip (SoC) transceivers it has become much easier and cost effective to add a low power wireless device to any product. Most semiconductor manufacturers such as TI, Semtech, SiLabs and Analog Devices provide full featured reference designs and in some case even the CAD files that lower the overall development risk and time to market. Regardless of the wireless technology platform, all products that include an integrated radio are subject to intentional radiator testing. And even if a reference design is carefully replicated in the end product, there is a chance that the final design may fail one or more portions of the compliance testing. Antennas, cables, RF shields, power supplies, passive component selection, PCB trace routing and stack may all influence radiated emissions.
I’d like to pose the following questions to learn about your success and/or failures related to FCC testing:
How many PCB spins are typically required to achieve compliance?
How many visits to the compliance lab are usually required for success?
How do you prepare to assure you have the greatest chance of success?
Do you prescan the device early on in the development phase or just wait and test when the design is completed?
What common, reoccurring failures do you observe? Transmitter harmonics, emissions off the antenna, emissions off the PCB?
What tricks do you use to isolate or fix problems?
How much does your PCB layout impact the emissions?
How does adding a power amplifier (100 mW, 500 mW) to the transmitter impact your chances of compliance success?
North America (FCC, Industry Canada):
The FCC Office of Engineering and Technology (OET) laboratory division released an update to KDB Publication Number 447498 on January 29th, 2013; which updates the RF Exposure requirements for Mobile and Portable devices, located in Title 47 CFR Part 1 Section 1.1307, Part 2 Section 2.1091, and Part 2 Section 2.1093. The KDB Publication can be found here.
The attachments to the KDB 447498 D01, and 447498 D02 are the general RF Exposure Guidance document and the SAR procedures for a dongle transmitter respectively. Additional attention should be observed for equipment types outlined in KDB 628591, the exclusion list for telecommunication certification bodies (TCBs). The exclusions of evaluation for these equipment types includes specific absorption rates (SAR) RF exposure evaluations. The TCB Exclusion List KDB Publication can be found here.
Industry Canada released Notice 2012-DRS1203 in response to the revision of the FCC RF Exposure KDB procedure, and the applicability of those requirements to Industry Canada. In addition, there is further guidance on the applicability of other procedures when seeking certification for the Canadian market. A copy of the Notice from the Certification and Engineering Bureau can be found here.
The Ministry of Economy (Secretaria de Economia) of Mexico published new requirements for equipment related to telecommunications standards NOM-121-STC1-2009 and NOM-151-SCT1-1999; or specifically equipment utilizing Spread Spectrum techniques such as Bluetooth modules, Bluetooth Low Energy, WiFi modules (802.11 b/g/n), and Zigbee products.
The following agreements were made as of January 11, 2013:
All imported equipment related to NOM-121 is now required to present verification of compliance at customs by either presenting a Certificate of Compliance issued by an accredited certification body of Mexico such as NYCE, or a Homologation Certificate issued from COFETEL.
NYCE has pledged that the certification process shall not exceed a period of 10 days from submission of the application, and will send the issued certificates to the Ministry of Economy to be entered into the system, which will prevent delays when customs is reviewing compliance.
The name of the importer does not need to match the name of the recipient of the certification (with either case, NYCE or COFETEL)
Equipment with COFETEL Homologation Certifications have additional requisites specific to labeling
The European Union Association of Notified Bodies released a reference document reviewing the EMC Testing requirements for products that integrate radio modules. LSR has written several articles regarding this process, such has our September 25, 2012 Blog on what to do after you've integrated a Wifi module into your product, and our news article on integrating radio modules for Europe published July 2, 2012.
The EUANB Reference document points out that the relevant requirements against the various applicable directives of non-radio based equipement may not harmonize to the requirements of the R&TTE directive placed upon a radio based module.
Prior to leveraging a modular device's conformity document to demonstrate compliance once itegrated into a product, an assessment of the test methods and requrements must be performed against the outlined product requirements and the performed modular radio testing. Instances which the conformity requirements of the product and module are not harmonized, the more stringent requirements shall take precedence, and the equipement shall be monitored for appropriate operation.
If it's time to go wireless, don't forget the basics of RF Design. You may be excited about your new wireless project: innovative design, environmentally friendly, consumer demand, and the list could go on. Whether your budget is substantial or minimal, it is important to keep in mind the following questions in order for your project to go ahead without a hitch.
1. Where will your product be based? U.S., Asia, Europe, Canada?
Knowing where the product will be sold will help you during the design and certification process. Different regulatory bodies control frequency spectrum, allowable output power, and testing requirements. For instance, in the US (per FCC regulations), you can operate a product in the 902-918 MHz ISM band, while in Europe (per ETSI regulations), the same band is not allowed, however the Short Range Device (SRD) band of 863 to 870 MHz is license free and may provide similar performance. The 2.4 GHz ISM band is the most widely used frequency as it is a license free band in more than 95% of the world. When designing your product, you must understand if you are designing per FCC rules (US), ETSI (Europe), C-Tick (Australia), or IC (Industry Canada). For more information on the administrative preparation needed for testing watch our video.
2. Who will be using your product and how will it be used?
Understanding how the product will be used will affect the type of radio selection and antenna design or selection. For instance, if it is a handheld product, you may want to consider a radio that does not operate in the 2.4 GHz band, for superior range performance, as the human body radially absorbs RF energy at 2.4 GHz. Additionally, you will want to optimize the antenna for use on the human body and consider if SAR (Specific Absorption Rate) or RF exposure testing is required.
3. How large is the production of your product, and within what time frame is your product desired?
The FCC allows for modular approval which can be very advantageous to OEM's who are using the same radio design across multiple sku's or platforms. By meeting the FCC's 8 Key Requirements for Module Approval, you can certify the module once and reference the FCC ID number across all products. This can drastically save you time and money.
4. Does your product need to be plugged-in, use solar power, or operate on batteries?
Understanding the power supply and operating conditions is critical when selecting a radio. Most popular radio technologies are relatively lower power, however there are significant differences between radios designed for ultra-low power sensor applications vs. radios designed for sending pictures or streaming videos.
5. What is your time frame and budget?
When it comes to wireless design and development, you have multiple options on how to make your product wireless. Certified off-the-shelf rf modules are arguably the fastest and easiest way to market. Discrete design, another option, may provide you with the most aggressive product costs and optimized design for your application, however this type of implementation involves weeks to months of engineering efforts, plus certification costs and time.
Of course, all these factors have an impact on cost and risk. With a little due diligence up front, you can avoid many pitfalls along the way. Take a time to make sure all interested parties are in agreement with the work ahead.
There are numerous steps to take when filing your product with the FCC. Administrative action can be taken before the FCC Testing is started in order to reduce the document filing and submittal period. The video below reviews the administrative preparations needed prior to starting a certification program, including:
Purchase Grantee Code
Generate FCC ID#
The FCC Office of Engineering and Technology (OET) laboratory division periodically releases lists of updates to the OET Knowledge Database (KDB); the following are some of the latest KDB updates, with a brief review of the subject and content of the KDB publications.
The OET KDB is a useful resource which is used as a reference and research tool, and serves as a repository for answers to both common, and not-so-common, questions regarding the the complex process of Equipment Authorization and FCC Certification.
The OET KDB search can be visited at: https://apps.fcc.gov/oetcf/kdb/index.cfm; which also has a link to an RSS Feed for those looking to keep abreast of the most recent changes.
KDB number 178919 - Permissive Change Policy
This publication provides as attachment, 178919 D01, which outlines the general policy and specifications for a permissive change to a Grant of Equipment Authorization. Categories for the permissive changes and policies addressed in this document include: antenna design changes, PCB or hardware changes, changes to the enclosure, software changes, and other basic miscellaneous revisions. Permissive changes are classified as Class I or Class II; Class I permissive changes require re-evaluation upon the type change, but not re-submittal for a new Grant of Equipment Authorization. A Class II permissive change requires submittal for an updated Grant of Equipment Authorization for equipment operating under an existing FCC ID number. The policy was updated on 10/24/12 to allow TCBs to approve third part software upgrades under the "Permit but Ask" policy of the FCC. Additionally, RF exposure considerations have been updated to reference the published RF Exposure KDB procedures.
KDB number 852134 - Authorized Individual Policy (Form 731)
This KDB document reviews the role of an authorized agent of form 731, and the guidelines which are to be followed when during the filing of an Application for Equipment Authorization, or amending an existing Grant of Equipment Authorization. Attachment D01 of this publication was last updated on 12/3/12; with an adjustment to the procedure for submitting a request for the Grantee Code number if an applicant is not the authorized contact in the Grantee Code Database.
KDB number 204515 - Grantee Code
- This publication outlines the guidelines for acquiring a Grantee Code, modifying the information in the Grantee Code Database, and transferring control of a Grantee Code. The guide was published on 12/3/12 in response to a submitted KDB inquiry.
KDB number 726920 - Confidentiality
This publication reviews confidentiality of information submitted during the Equipment Authorization. There are four attachments associated with this publication. 726920 D01 is a table outlining the applicability of confidentiality to various exhibits submitted during an Equipment Authorization and whether long-term or short-term confidentiality is available. 726920 D02 details the procedure for requesting confidentiality during an Application for Equipment Authorization. 726920 D03 provides specific details when the application is processed by the FCC, and 726920 D04 provides details when the application is processed by a TCB. The KDB publication date was 12/3/12
KDB number 558074 - DTS Measurement Guidance
This publication's attachment, 558074 D01, provides guidance on the procedures for compliance measurements on Digital Transmission Systems operating under Title 47 CFR Part 15, Subpart C, section 15.247. The guidance was updated as clarification to existing procedures and to expand measurement options to accommodate contemporary digital modulation schemes. The guidance document supersedes any previous revisions of this publication, but does not invalidate the measurement methodology document ANSI C63.10. Publication date was 10/4/12.
KDB number 789033 - UNII Test Procedures
This publication outlines the general test procedures and guidance for testing UNII type devices. The attachment, 789033 D01, replaces and supersedes guidance in Public Notice DA 02-2138 from August 2002; and is the general test procedures for testing UNII devices to Title 47 CFR Part 15 Subpart E section 15.407. The procedures for evaluating DFS functionality and MIMO devices are not applicable to this guidance document, and can be found in FCC order, ET Docket No.03-122 and KDB Publication 662911 respectively. 789033 D01 was revised on 9/26/12 with clarifications to duty cycle and power spectral density; a modification allowing testing single channels for each modulation mode for overall test time reduction purposes; an addition allowing 15.209 limits to satisfy peak emission limits under certain circumstances, and a replacement guidance procedure for array gain for spurious emissions (reference KDB Pub. 662911).
RF Exposure / SAR:KDB number 447498 - Mobile and Portable RF Exposure
KDB number 690783 - Guidance for TCBs listing SAR on Grants of Equipment Authorization.
KDB number 865664 - RF Exposure on GHz devices
"Let's Say..." is a monthly blog where LSR's staff provide explanation, expertise, and insight on hypothetical scenarios regarding different product's EMC/EMI regulatory compliance. This month we discuss considerations for a manufacturer who's implemented a WiFi Module, and is concerned about their product's FCC and CE compliance.
The effect of integrating a WiFi module on a product's compliance to the applicable technical standards in the US will greatly depend on the type of product which has been modified, the module selected, and the compliance status of the each prior to the integration.
The FCC Office of Engineering and Technology (OET) Equipment Authorization (EA) procedures include product verification, declaration of conformity (DoC), and/or certification; the type, industry, and implementation of the product will determine which authorization is appropriate and applicable. WiFi modules are intentional radiators requiring certification, and are subject to the requirements of Title 47 CFR Part 15 for unlicensed transmitters.
When considering a WiFi module, there is a tangible cost benefit to implementing a modular design which already has a Grant of Authorization with modular approval from the FCC. The certification costs related to a module are significant; and depending on the antenna design and WLAN protocols utilized, the approval process can exceed 8 to 12 weeks. By integrating one which already has modular approval, the certification for FCC compliance is complete and the product may only need an updated declaration of conformity (DoC) or verification.
Considerations of integrating a this type of module in a product for CE marking differ from those in the US. The European Union (EU) does not consider the modular approval program of the United States and Canada; however, this may not equate to a test program requiring a complete recertification of the specific module, dependent upon the integration of the module itself.
For consideration of compliance for distribution in the countries who participate in the European Union, the product must demonstrate compliance to all applicable directives of the EU's "New Approach" method of harmonisation. Upon integrating a WiFi module into a product, said product is not only required to demonstrate compliance to the EMC directive; but is also now required to demonstrate compliance to the Radio and Telecommunications Terminal Equipment (R&TTE) directive. This being said, there is advantage to sourcing a module that has demonstrated compliance with the R&TTE in it's modular configuration.
Demonstrating compliance to the applicable directives of the EU is a process of self-declaration; requires that evidence of compliance, supported by data obtained from an approved assessment body, clearly demonstrates that the product conforms to all the applicable requirements therein. The product can however, under certain circumstances, leverage the test data of the specific module to demonstrate its compliance to the R&TTE, as long as it can be demonstrated that there is no appreciable difference between the module's performance when integrated into the product and it's performance in a modular configuration.
In conclusion, there are several considerations to evaluate when integrating a WiFi module into a product, not the least of which is how this integration will effect the product's regulatory compliance requirements. Clearly there is cost and conformity advantage in choosing a pre-certified WiFi module, and with special consideration to how the module is integrated, the impact of that integration for demonstrating compliance can be significantly reduced.
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