Integrating Radio Modules: Europe: Page 5
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1 Packet Includes: Basic EMC Conformity Assessment: Europe: Page 1 Integrating Radio Modules: Europe: Page 5 FCC Testing Requirements for your Product: Page 10
2 LS RESEARCH Basic EMC Conformity Assessment: Europe Understanding the requirements for the EMC Directive in the New Approach By: Ryan Urness 2012 LS Research s Compliance Testing Division commonly answers questions regarding how to select the appropriate methods of demonstrating a product s EMC conformity in several international markets.
3 BASIC EMC CONFORMITY ASSESSMENT: EUROPE UNDERSTANDING THE REQUIREMENTS FOR THE EMC DIRECTIVE IN THE NEW APPROACH BY RYAN M. URNESS, LABORATORY MANAGER INTRODUCTION LS Research s Compliance Testing Division commonly answers questions regarding how to select the appropriate methods of demonstrating a product s EMC conformity in several international markets. The scope of this article is specific to European methods of EMC conformity assessment, under what the European Union refers as the New Approach methods. This article is not meant to be purposed as a comprehensive guide, rather it s meant to clarify terminology and provide some explanation to the process used when selecting test standards which are appropriate for demonstrating compliance to the essential requirements of the EMC Directive 2004/108/EC. Joint efforts between multiple European standards organizations, the European Commission, and the European Free Trade Association established what is referred to as the New Approach for product approvals. It wasorganized as a means of simplifying the path to product certification, and streamlining the process by which the technical requirements could be established and maintained and keep with the pace of new technologiesand market growth[1]. EMC Directive 2004/108/EC is part of the New Approach Directives, and a requirement for CE Marking. CE MARKING It is important to understand CE marking and how it relates to EMC conformity. Directive 93/68/EEC establishes the scope, structure, and application for CE Marking, which is the official terminology as specified by the EU (in lieu of the term CE Mark ); and signifies a Declaration of Conformity by the manufacturer[2]. the New Approach Directives; however, it is up to the manufacturer to determine which Directives are applicable. Currently, there are 32 countries which participate in the New Approach, perform market surveillance, and require CE marking[3]. Though manufacturers may receive assistance from third party consultants or experts when determining which directives (and subsequent standards) are best suited for a conformity assessment; it is ultimately the responsibility of the manufacturer to construct the Declaration of Conformity and provide a subsequent record supporting these declarations, if requested by market surveillance authorities. Consequently, it is important that once a directive is determined as applicable to the product being considered for conformity assessment(such as the EMC Directive, for example, in this article); the applicable standards for testing arethen identified. UNDERSTANDING TEST STANDARDS In order to better understand how to identify appropriate standards, a basic understanding of the classifications and hierarchy of the standardsis necessary. Article 6 of 2004/108/EC paragraph 2 identifies using the Official Journal of the European Union (OJEU)[4] to identify all relevant harmonized standards, which upon application would satisfy the essential requirements of Annex 1 of the EMC Directive[5]. The image in Figure 1 is a simple outline of our classifications of standards: basic standards, generic standards, product family standards, and product standards. By CE Marking a product, the manufacturer is declaring conformity with the essential requirements of all relevant European health, safety, and environmental protection legislation; as outlined in
4 Basic standards provide test methodology and arrangement, and may even outline references or guidance; however, they do not specify requirements. As a result, basic standards do not appear in the OJEU, as declarations of conformity to a Basic standard are unnecessary[6]. Generic standards are based on the applicable product environments such as Residential or Industrial, rather than product type; and are to be utilized when no applicable product family standardsare available. The limits and requirements are general, and no consideration for product specific criterion is applied[6]. Product Family and Product Specific standards are detailed in scope of performance criterion and requirements to a product or product family. Product Family and Dedicated Product standards have precedence over the requirements specified in the Generic Standards; however, any applicable requirement not addressed in a Product Family standard may still need to meet said requirements as specified in the Generic Standards [6]. Often, a Product Family standard may reference a basic standard, and in cases where the referenced basic standard is dated, the requirements as detailedmust be satisfied, even ifa newer edition is specified in the OJEU [7]. It is also important to note that compliance to the harmonized standards is not compulsory. There is a alternative for demonstrating compliance beyond using the harmonized standards contained in the OJEU. This process is outlined in Annex III of 2004/108/EC, and consists of constructing technical documentation submitted to a Notified Body (as defined in Article 12 of 2004/108/EC) for a conformity assessment. Although, all member states come to an agreement that compliance with the relevant harmonized standards in the OJEU shall demonstrate a presumption of conformity to the essential requirements of the EMC Directive; and according to Article 4, shall not impede or restrict the free movement of equipment therein[5]. CONCLUSION In closing, proper conformity assessment for a product according to the requirements put forth by the European Union and member states would include identifying all of the applicable directives outlined in the New Approach. When applicable, the EMC Directive 2004/108/EC requires that the essential requirements of Annex 1 are observed, either through compliance to the generic, product family, or product specific standards specified in the Official Journal of the European Union; or via an assessment of a manufacturer s technical file by a notified body which demonstrates an equivalency. In the event that the harmonized standards of the OJEU are utilized for the Declaration of Conformity, member states agree to a presumption of compliance. Understanding the different types of standards and relationships between them is an essential component in understanding which requirements will be applicable for conformity to the EMC Directive, and only upon demonstrating compliance with ALL the applicable directives of the New Approach can a product be subject to CE marking. LS Research has an accredited test facility, and has provided guidance in design services and European conformity assessment for over 30 years. LS Research is recognized as a Conformity Assessment Body in accordance with the US-EU MRA, and as such can provide Notified Body services to any of our customers for both the EMC (2004/108/EC) and R&TTE (1995/5/EC) Directives ABOUT THE AUTHOR: Ryan Urness is Laboratory Manager for LS Research, andhas 16 years in qualification, reliability, and compliance testing in the fields of dynamics, environmental, electronics, and EMC. Ryan holds a bachelor s degree in Organizational Management and Engineering Studies, and is an inarte certified laboratory auditor. Mr. Urness can be reached at rurness@lsr.com or
5 WORKS CITED [1] Eurpean Commission, "Guide to the Implementation of Directives based on the New Approach and the Global Approach," [Online]. Available: [Accessed 03 April 2012]. [2] European Union, 22 July [Online]. Available: [Accessed 03 April 2012]. [3] Export.gov, "CE Marking," 28 August [Online]. Available: [Accessed 03 April 2012]. [4] European Comission, "Official Journal of the European Union," 30 September [Online]. Available: [Accessed 04 April 2012]. [5] European Union, "Directive 2004/108/EC," 15 December [Online]. Available: [Accessed 03 April 2012]. [6] CENELEC, "CENELEC Guide 24," Decemeber [Online]. Available: ftp://ftp.cencenelec.eu/cenelec/guides/clc/24_cenelecguide24.pdf. [Accessed 03 April 2012]. [7] CENELEC, "CENELEC Guide 25," December [Online]. Available: ftp://ftp.cencenelec.eu/cenelec/guides/clc/24_cenelecguide24.pdf. [Accessed 03 April 2012].
6 LS RESEARCH Integrating Radio Modules: Europe Understanding the Requirements of the 1999/5/EC R&TTE Directive By: Thomas T. Smith 2012 LS Research is commonly answering question regarding the requirements for radio products in Europe. Obviously there are a variety of answers and requirements depending on each product; however the European Union (EU) has established a basic set of guidelines in the form of the 1999/5/EC R&TTE Directive.
7 INTEGRATING RADIO MODULES: EUROPE UNDERSTANDING THE REQUIREMENTS OF THE 1999/5/EC R&TTE DIRECTIVE BY THOMAS T. SMITH, MANAGER EMC TEST SERVICES INTRODUCTION LS Research is commonly answering question regarding the requirements for radio products in Europe. Obviously there are a variety of answers and requirements depending on each product; however the European Union (EU) has established a basic set of guidelines in the form of the 1999/5/EC R&TTE Directive. The scope of this article is to discuss the current version of the R&TTE Directive and how it applies to the integration of an assessed radio module. This article in no way meant to steer the manufacturer or integrator of the radio module in one direction or another, but rather provide the manufacturer with information which can be used to make an informed decision. For the purpose of this article, a few assumptions to consider are: 1). Discussion focus around using harmonised standards which minimizes the requirement for Statement of Opinions by a Notified Body. 2). Products being discussed contain a single radio module. Most of the core discussions are relevant to all radio products however there may be additional requirements placed on the products as a result of any deviations. DEFINITIONS The R&TTE Directive covers all radio equipment and all equipment intended to be connected to public telecommunications networks [1]. It establishes a regulatory framework for the placing on the market, free movement, and putting into service. Before discussing the specifics of the R&TTE Directive, basic definitions help to provide some context. Telecommunication Terminal Equipment- a product enabling communication, or a relevant component thereof, which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunication networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services). [2] Radio equipment- a product or relevant component thereof, capable of communication by means of emission and/or reception of radio waves, utilizing the spectrum allocated to terrestrial/space radiocommunication. Radio waves are electromagnetic waves of frequencies from 9kHz to 3000GHz propagated in space without artificial guide. [2] Technical Construction File (TCF)- a file describing the apparatus and which provides information and explanations how the applicable essential requirements have been implemented. [2] REQUIREMENTS OF THE R&TTE DIRECTIVE The R&TTE Directive, like other European Directives, does not contain test limits, those requirements are identified in one of 3 standard types (Generic, Product Family and Product Specific). The current revisions for the applicable standards can be found in the Official Journal of the European Union for the R&TTE Directive. Article 3.1a and 3.1b of the R&TTE Directive dictates the essential requirements for Health/Safety and EMC respectively. Article 3.2 identifies the Radio Spectrum requirements. APPROACH TO COMPLIANCE In order to market and sell product in the European markets, manufacturers need to demonstrate
8 compliance using a Declaration of Conformity. Unlike the United States, there is no certification process through a regulating body. Instead, manufacturers have the sole responsibility of ensuring their products are compliant to the applicable directives and standards. This responsibility for manufacturers provides more flexibility; however it increases their risk as the system of checks and balances is minimized. Meeting the rules is the responsibility of the manufacturer or the company that brings the radio device on the market. As a result, in the case of a module, there may be multiple companies responsible for ensuring the module compliance. If the module manufacturer declares compliance to the R&TTE Directive, they need to provide evidence that the radio equipment has been assessed by constructing a Declaration of Conformity (DoC) and TCF. However if another company then integrates that radio equipment into a product, the new product must also be compliant to the requirements of the R&TTE Directive. MODULAR CONSIDERATIONS Unlike the FCC, which has specific guidelines and requirements for Modular Approval, the European Union does not have rules in place specifically for modular approval. As a result, radio modules need to be assessed to the same compliance requirements as radios integrated in a product. However the assessment does not necessarily equate into more testing. In general, the aim should be to avoid repeat assessment of the module in the final product where this can be justified on the basis of technical analysis and information provided by the module manufacturer [3]. However, in many cases, it will not have been practical to perform a meaningful assessment of the requirements on the module alone, and a complete assessment is required after integration [3]. This should be made clear in the information concerning the installation and intended purpose of the module provided by the module manufacturer, in accordance with Article 6 of 1999/5/EC [3]. A final product integrating an assessed radio module with an integral antenna, or supplied with a specific antenna and installed in conformance with the radio module manufacturer s installation instructions, requires no further evaluation under Article 3.2 of the R&TTE Directive and does not require further involvement of an R&TTE Directive Notified Body for the final product. [3] The above statement assumes that the integrator is able to leverage all existing data from Article 3.1a, 3.b and 3.2. Module manufacturers may not be able to fully assess the module to all requirements for Article 3.1a and 3.1b; therefore, the module integrators need to review the DoC carefully, and if possible, request supporting documentation from the manufacturer in order make an informed decision. The supporting documentation may include test reports, DoC, and installation guidelines. At this point, the integrator is responsible for 1) evaluating the data to ensure proper assessment by the module manufacturer 2) evaluating the relevancy of leveraging the existing data into their own product declaration. A specific example where an integrator may attempt to leverage existing compliance documents would be if a module has been assessed to the R&TTE Directive with an integrated antenna, but the integrator wants to use an external antenna. The module manufacturer s documentation does not indicate that the module was assessed with an external antenna. At this point, it would not be appropriate for the integrator to leverage the existing assessment for compliance, as there is no test data to support the new antenna. Instead, the integrator would most likely need to perform an assessment that would include testing for Article 3.1a, 3.1b and 3.2 with the new antenna. ETSI has provided two technical report documents (ETSI TR and ETSI TR ) that help
9 define and guide manufacturers on the EMC requirements based on their type of integration. All assessments need to be fully supported by the TCF and DoC, he or his authorized representative established within the Community must keep it for a period ending at least 10 years after the last product has been manufactured at the disposal of the relevant nation al authorities of any Member State for inspection purposes [2]. experience in compliance testing related to EMC and Wireless Products. Tom holds a bachelor s degree in Biomedical Engineering, and is an active member of IEEE. Mr. Smith can be reached at tsmith@lsr.com or CONCLUSION As stated previously, the intent of this article is not to steer integrators or manufacturers in one direction but rather to emphasize the important of understanding the various approaches and responsibilities the manufacturers face when going to market in Europe. Manufacturers have the sole responsibility of identifying and ensuring their products are compliant to the applicable directives and standards. Therefore special attention is required for proper assessment that provides adequate supporting documentation while limiting cost and time to market. If a manufacturer is unsure of the proper approach it is acceptable for them to work with a Notified Body in order to gain confidence in the approach. However the Notified Body s Statement of Opinion does not alleviate the responsibility of the manufacturer when placing the end product into the European market. LS Research has an accredited test facility, and has provided guidance in design services and European conformity assessment for over 30 years. LS Research is recognized as a Conformity Assessment Body in accordance with the US-EU MRA, and as such can provide Notified Body services to any of our customers for both the EMC (2004/108/EC) and R&TTE (1995/5/EC) Directives ABOUT THE AUTHOR Thomas T. Smith is the Manager of EMC Test Services at LS Research and has over 12 years of
10 WORKS CITED [1] ETSI, "What is the R&TTE Directive," [Online]. Available: [Accessed 6 June 2012]. [2] European Commission, "Directive 1999/5/EC," 9 March [Online]. Available: [Accessed 2 May 2012]. [3] R&TTE Compliance Association, "Technical Guidance Note on Requirements for a Final Product that Integrates an R&TTE Directive Assessed Module," 27 December [Online]. Available: [Accessed 12 May 2012].
11 LS RESEARCH FCC Testing Requirements for your Product By: Tom Smith 2011 We are often asked: What are the FCC s testing requirements for my product?
12 FCC Testing Requirements for Your Product Tom Smith We are often asked: What are the FCC s testing requirements for my product? The FCC has defined three categories of equipment approval for Part 15 devices: Verification, Declaration of Conformity (DoC) and Certification. All products that fall within these three categories require testing. Each category presents its own challenges. Verification testing is the method of approval for products such as Class B external switching power supplies and Class A or B digital devices that are not PC-related. Verification testing ensures that the manufacturer s product meets the FCC s technical requirements. The manufacturer must also ensure that subsequent manufactured equipment continues to meet the requirements and is the same as the original unit tested. Verification testing can be performed at a non-accredited laboratory. Products stating conformance with FCC rules using a Declaration of Conformity (DoC) must be tested at an ISO Guide accredited laboratory. In the U.S., such laboratories are audited by NVLAP and A2LA. As with the verification process, the manufacturer must maintain a file containing all test results and product documentation. devices, ZigBee radios, WLAN, and most other intentional radiators. After testing is completed, a formal filing is presented to a Telecommunication Certification Body (TCB) or directly to the FCC. The documentation filing for Certification is more indepth than for the DoC. The submitted documentation file includes block diagrams, theory of operation, schematics, a formal test report, and other documents, depending on the type of equipment tested. After reviewing the filing, the FCC or TCB will issue a Grant of Authorization; each product is then identified by an FCC ID number. Portions of this number are specific not only to the product but also to the manufacturer. In summary, most devices require testing (in most cases by an accredited laboratory) and some form of documentation to support the test results. Intentional radiators require the most documentation and must be certified by the FCC before the Grant of Authorization is provided to allow sale of the product. In all cases, product conformance (providing and maintaining compliance of the product) is the manufacturer s responsibility. Along with the documentation file, the manufacturer creates the Declaration of Conformity stating that all information in the documentation packet is accurate and up to date. A representative of the manufacturer signs the DoC, and it is placed in the documentation file. Unlike the Certification process, though, the DoC does not require formal filing of the documentation with the FCC or any other certification body. Product Certification is the most detailed and formal process imposed by the FCC. Testing is required and must be performed by an accredited laboratory. Products that require Certification include Bluetooth Property of LS Research and not intended for further publication without the express written permission of the company. Page 1 of 1
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