Eu approval of host devices with integrated wireless modules v5
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Eu approval of host devices with integrated wireless modules v5

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Technological advances and the increased allocation of electromagnetic spectrum for advanced communications have produced a wave of new electronic and digital devices...

Technological advances and the increased allocation of electromagnetic spectrum for advanced communications have produced a wave of new electronic and digital devices
that communicate wirelessly. As a result, product manufacturers are increasingly abandoning wired communications interfaces in favor of wireless technologies that offer greater user mobility without compromising transmission speed and accuracy. But obtaining worldwide regulatory approval for products with integrated wireless modules is a complex process.
In the European Union (EU), compliance with the essential requirements of the EU’s directive on Radio & Telecommunications Terminal Equipment (also known as the R&TTE Directive) is required for all wireless transmitters, including wireless modules integrated into end host devices. Ensuring compliance with the Directive’s essential requirements is the legal obligation of any party that seeks to import or sell such devices in the EU. However, unlike regulations in the United States that require manufacturers to obtain approval either from the FCC or an FCC-approved telecommunications certification body (TCB), the EU approval process for wireless modules offer manufacturers some flexibility in their chosen method for demonstrating compliance, including the ability to self-declare compliance with the applicable harmonized standards.

This white paper from UL is discusses the key regulatory compliance and approval issues facing manufacturers and importers of host devices with integrated wireless modules. This paper provides information on the regulations regarding the sale of host devices with integrated wireless modules in the EU and guidance on how to efficiently navigate the Union’s regulatory approval process.

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Eu approval of host devices with integrated wireless modules v5 Eu approval of host devices with integrated wireless modules v5 Document Transcript

  • EU Approval of HostDevices with IntegratedWireless Modules
  • EU Approval of Host Devices with Integrated Wireless ModulesEU Approval of Host Devices with IntegratedWireless ModulesTechnological advances and the increased allocation of electromagnetic spectrum foradvanced communications have produced a wave of new electronic and digital devicesthat communicate wirelessly. As a result, product manufacturers are increasinglyabandoning wired communications interfaces in favor of wireless technologies thatoffer greater user mobility without compromising transmission speed and accuracy.But obtaining worldwide regulatory approval for products with integrated wirelessmodules is a complex process.In the European Union (EU), compliance with the essential requirements of the EU’sdirective on Radio & Telecommunications Terminal Equipment (also known as theR&TTE Directive) is required for all wireless transmitters, including wireless modulesintegrated into end host devices. Ensuring compliance with the Directive’s essentialrequirements is the legal obligation of any party that seeks to import or sell suchdevices in the EU.However, unlike regulations in the United States that require manufacturers to obtainapproval either from the FCC or an FCC-approved telecommunications certificationbody (TCB), the EU approval process for wireless modules offer manufacturers someflexibility in their chosen method for demonstrating compliance, including the ability toself-declare compliance with the applicable harmonized standards.This white paper from UL is discusses the key regulatory compliance and approval issuesfacing manufacturers and importers of host devices with integrated wireless modules.This paper provides information on the regulations regarding the sale of host deviceswith integrated wireless modules in the EU and guidance on how to efficiently navigatethe Union’s regulatory approval process.page 2
  • EU Approval of Host Devices with Integrated Wireless ModulesBackground and telecommunications terminal which is responsible for ensuring andAs of Jan. 1, 2011, the EU consists of 17 equipment and the mutual recognition maintaining compliance as long as theindividual member “states,” constituting of their conformity,” also known as the device continues to be offered for salea single economic community of over 330 R&TTE Directive. In the majority of cases This white paper covers each of thesemillion consumers. EU regulations are for end host devices, the R&TTE Directive points in greater detail. Note thatintended to support the free movement mandates compliance with the following product approval requirements varyof approved products between EU essential requirements: on a case-by-case basis, and that themember states through the maintenance • Product safety, including RF exposure examples presented here are offeredof a unified product approval scheme • Electromagnetic compatibility only as guidance.and the elimination of country-spe-cific certifications. Since 1993 and the • Radio and telecommunication terminal equipment requirements The EU Certification Processpublication of the European CommissionGuide to the Implementation of directives The R&TTE Directive provides three Depending on the final intendedbased on the New Approach and the separate paths for demonstrating application of the end host device,Global Approach (Blue Guide), products compliance with its essential there may be other European directivesthat bear the CE Mark (Conformité requirements, as follows: to consider. For example, there are aEuropéene) are presumed to be compliant • Harmonized standards route number of directives applicable towith all applicable EU specifications medical devices that may impose • Technical construction fileand requirements. additional requirements on end host • Full quality assuranceMany EU directives are based on the devices with integrated wireless modulesconcept of “self declaration,” or more operating in that context. Harmonized Standards Routespecifically on the completion of a EC Annex III of the R&TTE DirectiveDeclaration of Conformity (DoC), from Key Factors describes the certification processwhich a manufacturer or importer placing When considering the sale of end host using harmonized standards. Whena product on the EU market declares that devices with integrated wireless modules following the harmonized standardsit meets all applicable test specifications within the EU, manufacturers must route, manufacturers and importersand is legally compliant with the consider a number of key factors essential should always apply the latest versionessential requirements of any relevant for gaining regulatory approval under the of the applicable harmonized standards,EU directives. Self-declaration allows a R&TTE Directive. These factors include: since compliance with the latest versionparty to label and sell a product without • The most appropriate approach to is required when the final productperforming any external, third-party product certification, e.g., harmonized is placed on the market. Updatedtesting or verification. standards (Annex III), technical lists of standards that can be usedIn the case of end host devices with construction file (Annex IV) or full to demonstrate compliance with theintegrated wireless modules, Annex 1 of quality assurance (Annex V) essential requirements of the Directivethe Blue Guide (“Community legislation • The module manufacturer’s are published periodically in the Officialreferred to in the Guide”) specifies instructions (if these are not followed, Journal of the European Communities.that product approval is achieved by additional testing may be required todemonstrating compliance with the Under the harmonized standards route, a confirm compliance)essential requirements of “the Directive manufacturer or importer takes complete99/5/EC of the European Parliament and • The named party placing the end host responsibility for ensuring that a productof the Council relating to radio equipment device on the market within the EU, meets the necessary EU requirementspage 3
  • EU Approval of Host Devices with Integrated Wireless Modulesas detailed in the applicable harmonized satisfactorily demonstrates wireless module intended for use in astandards. How and where compliance compliance with the essential domestic or commercial environmenttesting is performed is at the discretion requirements of the Directive, thereby is typically categorized as informationof the party placing the end host potentially reducing cost and lead technology (IT) equipment, andproduct on the market. However, the time. Or, if no appropriate harmonized is expected to comply with themanufacturer or importer must retain standards can be identified, the NB requirements found in the latest versionall relevant documentation regarding a can assist in the selection of standards of EN 60950 – Information Technologyproduct’s technical specifications and that can be used to demonstrate Equipment. However, depending on thecompliance testing results in case future compliance with the essential environment in which a device is intendedquestions are raised regarding for use, other safety standards may be requirements of the Directivethe product’s conformance. more appropriate. 3. Even when the harmonized standardsTechnical Construction File With regard to RF exposure, the route is utilized to demonstrate environment into which an end hostThe preparation of a technical compliance, the preparation of a TCF device will be placed is extremelyconstruction file (TCF) is required for by an NB can be an effective marketing important. As determined by reviewingdemonstrating compliance to the tool, since the CE mark applied to the the appropriate standard published inessential requirements the R&TTE approved product is accompanied by Official Journal of the European Union (forDirective. For those cases where no the NB’s reference number example, EN 62311:2008) and dependingharmonized standard(s) can be fully or on the transmitter frequency and power Full Quality Assurancepartly applied from the Official Journal, range, specific absorption rate (SAR)a manufacturer seeking to demonstrate In practice, this approach is utilized only testing may be required if a device iscompliance through the use of TCF must by large manufacturers that have internal intended for use while placed on theengage a Notified Body (NB) or other testing capabilities backed by a fully human head or body. If a device is notindependent third party authorized to integrated quality assurance system. intended for use on the human body, aassess compliance to relevant directives. These facilities and systems are not maximum permissible exposure (MPE)In addition to providing assistance common for manufacturers of end host calculation is required to determine a safein the selection of appropriate test devices with integrated wireless modules. operating distance for users.standards, a NB can provide guidance in Therefore, the full quality assurance path If an end host device is also intended forthe compilation of the TCF, and prepare is not covered in further detail here. sale outside of the EU, the manufactureran official Notified Body Opinion (either should consider testing a product forpositive or negative) regarding the EU Testing Requirements compliance with the safety requirementscompliance of a device. As previously noted, the R&TTE Directive under the IECEE’s CB Scheme. The CBThe use of a NB or other independent requires compliance with the essential Scheme is a system that supports thethird party in the preparation of a TCF requirements in three main areas: mutual acceptance of test reports andoffers a variety of benefits: product safety, including RF exposure; certificates by participating members, and electromagnetic compatibility; and currently provides market access to more 1. The manufacturer is confident radio and telecommunications terminal than 50 countries worldwide. For products that a product has been tested for equipment-specific requirements. destined for sale in North America, the compliance with the provisions of the manufacturer can also choose testing appropriate standards Product Safety consistent with the requirements of 2. The NB may be able to use Regarding matters of product safety, a number of available safety marks non-harmonized test data that an end host device with an integrated (including the UL Mark issued by UL).page 4
  • EU Approval of Host Devices with Integrated Wireless ModulesElectromagnetic CompatibilityThe preparation of a technical construction file (TCF) is required for demonstrating compliance to the essential requirementsthe R&TTE Directive. For those cases where no harmonized standard(s) can be fully or partly applied from the Official Journal, amanufacturer seeking to demonstrate compliance through the use of TCF must engage a Notified Body (NB) or other independentthird party authorized to assess compliance to relevant directives. In addition to providing assistance in the selection of appropriatetest standards, a NB can provide guidance in the compilation of the TCF, and prepare an official Notified Body Opinion(either positive or negative) regarding the compliance of a device.To meet the R&TTE Directive’s essential requirements regarding electromagnetic compatibility (EMC), an end host device isrequired to demonstrate compliance with one of the EN 301 489 series of standards published in Official Journal – Electromagneticcompatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services.Each of these wireless technology collateral standards make reference to the common technical requirements specified inEN 301 489-1.The most common list of technologies and the applicable standards in this series are identified in the table below.TYPE FREQUENCY ARTICLE 3.2 (RADIO) ARTICLE 3.1B (EMC)GSM 900/1800MHz 3GPP TS51.010-1 (EN 301 511) EN 301 489-1 ref EN 301 489-7UMTS 900/2100MHz EN 301 908-1 and EN 301 489-1 ref EN 301 908-X EN 301 489-23/24SRD (Inc RFID) 9kHz to 25MHz EN 302 291 and/or EN 301 489-1 ref EN 300 330-2 EN 301 489-3SRD 25MHz to 1GHz EN 300 220-2 EN 301 489-1 ref EN 301 489-3SRD 1GHz to 40GHz EN 300 440-2 EN 301 489-1 ref EN 301 489-3WLAN (802.11b/g) 2.4GHz to 2.4835GHz EN 300 328 EN 301 489-1 ref EN 301 489-17WLAN (802.11a) 5.2GHz to 5.8GHz EN 301 893 EN 301 489-1 ref EN 301 489-17Bluetooth 2.4GHz to 2.4835GHz EN 300 328 EN 301 489-1 ref EN 301 489-17Table 1: EMC and RF Standards for Common Wireless TechnologiesTo meet EMC requirements, an end host device must meet both the emissions and immunity conditions defined in applicabletest standards. For multi-technology end host devices, assessment with each applicable test standard is required to determineoverall compliance. For example, if a device contains WiFi and GSM technology, compliance with both EN 301 489-17 andEN 301 489-7 is required.page 5
  • EU Approval of Host Devices with Integrated Wireless ModulesRadio prepare and sign a DoC attesting to a product’s conformity with all relevantWhether a wireless technology module directives and standards. The DoC musthas previously been tested and approved be available with the end host device atto the applicable EU requirements the point of sale, typically as part of theis a key factor in determining the product documentation or user manual.radio performance tests required to A DoC must include:demonstrate compliance with theprovisions of the R&TTE Directive. A • Manufacturers’ details (company“pre-approved” integrated wireless name, address, etc.)module dramatically reduces the amount • Product characteristicsof testing required and will typicallyrequire only radiated emissions testing. • European standards (to whichHowever, it is important to make sure that conformity is attested)the pre-approved module is integrated • NB identification numberinto an end host device in a manner (if applicable)consistent with a module manufacturer’sinstallation instructions. Otherwise, • Legally binding signature on behalfadditional testing may be required. of the organizationIf a wireless module has not been Additionally, the R&TTE Directivepreviously approved, the full suite of stipulates that a manufacturer shallradio performance tests is required, as identify any restrictions that apply todefined in the applicable standard. For placing an end host device into service,a device using a non-approved GSM e.g., due to licensing or no harmonizedmodule, several hundred hours of frequency bands applicable to a device.testing may be required, which can In such situations, a manufacturerbe an expensive proposition! must attach an Alert Symbol next to the CE mark. Additional guidance canLabeling and Declarations be found on the website of the EU’sThe CE Mark is affixed to an end host Communications Office website, www.device by a manufacturer or importer, ero.dk (click on the “Deliverables” taband must be done in manner that is at the top of the page, and then on thevisible, legible and indelible. If a Notified “R&TTE equipment sub classes” tab).Body Opinion has been issued, then the For most GSM end host devices, theNB’s accreditation reference number Alert Symbol is not typically requiredshould also be used as part of the unless there are other radio technologiesCE Mark label. used within the product.In order to use the CE Mark, themanufacturer or importer mustpage 6
  • EU Approval of Host Devices with Integrated Wireless ModulesOther Certification installed in a manner consistent with the radio characteristics (including theConsiderations module manufacturer’s requirements, antenna), the module used or the minimum additional testing is usually enclosure will almost always requireFounded in 1999, the Global Certification required for product approval. additional testing. Manufacturers andForum (GCF) provides cellular network importers are urged to consult with an NBoperators with confidence in the effective Once the manufacturer or importer has or test service providerand trouble-free interworking of new an EU-compliant product, the following for further guidance on what additionalcellular mobile terminal devices. With considerations apply: testing might be required to maintain thethe PCS Type Certification Review Board Updates to the Module original end host device approval.(PTCRB) setting the requirements forNorth America, the GCF has effectively When a manufacturer makes changes to Updates to Harmonized Standardsprovided the foundation for mobile an approved module, consideration must European test standards are periodicallycellular terminal device approvals in the be given to the impact on certification, updated, or are superseded by newEU, and is a prerequisite for European even if the changes consist only of versions. The Official Journal periodicallynetwork operator acceptance. firmware updates. All planned changes publishes updated standards lists for should be reviewed by an NB or test the R&TTE Directive that note the “dateUnlike the North American market, the service provider. When module changes of cessation of conformity,” providingchallenge in Europe and other parts of the may affect the RF performance of the end manufacturers with advanced noticeworld is that mobile devices can handover host device, the NB may suggest some of the need to retest their productsbetween many different network form of “delta testing,” i.e., partial retests, consistent with the requirements of aoperators when users travel between to affirm ongoing compliance. revised or new standard.countries and regions. Therefore, theaim of the GCF is to provide a seamless Similarly, manufacturers should seek End host devices can claim compliance guidance when an approved module only as long as the underlying standardsmobile communications experience becomes obsolete and a replacement are active and valid at the time whenfor users of cellular devices. However, module is being considered for inclusion those products are placed on theunless specifically stipulated by a in an end host device. Unless the RF market. Once the date of cessation ofnetwork operator, there is currently no characteristics are identical, the TCF conformity has passed, the manufacturerrequirement for GCF approval of end host will need to be updated to demonstrate of a previously approved product mustdevices with integrated wireless modules. ongoing compliance. demonstrate compliance with the revised or replacement version of a standard.Maintaining Compliance Updates to an End Host Product Depending on the changes to theUsing a wireless communication Changes to the end host device should standard, retesting may be required.technology module in an end host device also comply with the original CE approvalhas many advantages. If a module is restrictions. Changes that impact thepage 7
  • EU Approval of Host Devices with Integrated Wireless ModulesSummaryGiven the complexity of obtaining approvals for end host devices with integratedwireless modules, many manufacturers opt to retain the services of a NB or otherqualified testing laboratory. NBs are typically experienced in regulatory requirementsand anticipated changes, and can provide expert guidance at a reasonable cost. Thispath to product approval is often the most efficient and cost-effective means to achievecompliance with the R&TTE’s essential requirements.For information about the “EU Approval of Host Devices with Integrated WirelessModules” white paper, please contact Chris Guy, Head of Global Approvals,at chris.guy@ul.com.Copyright©2011 Underwriters Laboratories Inc. All rights reserved.No part of this document may be copied or distributed without the prior written consent of Underwriters Laboratories Inc. 6/11page 8