R&TTE CA R&TTE Compliance Association TGN 01

Transcription

1 R&TTE CA R&TTE Compliance Association TGN 01 Version May 2013 Technical Guidance Note on the R&TTED compliance requirements for a Radio Module and the Final Product that integrates a Radio Module 1. Introduction Under the R&TTE Directive, the definitions of "radio equipment include the notion of a relevant component (Articles 2 (b) & (c)), which must be assessed against the essential requirements of the R&TTE Directive. 1 Therefore, a radio module when making available on the Community market 2 must comply with the essential requirements of the R&TTE Directive 1999/5/EC. Although this seems clear, there is apparent confusion on the assessment requirements for a radio module device. Examples of different types of radio modules are stated below; but not limited to: 1. Any component (IC, hybrid circuit, plug-in unit, etc.), which together with an antenna, constitutes the transmitter RF circuit of a Radio communications device, which has well defined RF parameters and which can clearly be identified. 2. A plug-in unit can be characterised as a radio equipment module intended to be used with or within a host, combined or multi-radio equipment, using their control function and power supply, such as an internal mini PCI module or a USB Dongle. NOTE: It is the responsibility of the manufacturer to declare if a product is a module, based on the Directive text and taking into account the R&TTE Guide and any other official EU document. Additionally, there is an issue under the R&TTE Directive regarding the compliance, documentation and labelling requirements of a product that integrates a R&TTE-D assessed module (hereafter called the final product ). In this context, an assessed module is one that is CE marked and accompanied by all the information required by Article 6 of the Directive including the Declaration of Conformity and information about its proper installation and intended purpose. Such a module is manufactured with the intention of being integrated in a designated type of product(s). This Guidance Note has been constructed so a harmonised approach is used by all Notified Bodies regarding the understanding, assessment, documentation and labelling of all three scenarios above. 2. Conformity Assessment to the Essential Requirements of the Directive for a radio module device There are three typical scenarios considered by this TGN: a. A Radio Module not placed on the market but integrated in a product by a (number of) different manufacturer(s) who places the final product on the market. b. An assessed Radio Module placed on the market and installed in a product by the end user. c. An assessed Radio Module placed on the market and integrated in a product by a different manufacturer who places the final product on the market. 1 "apparatus" means any equipment that is either radio equipment or telecommunications terminal equipment or both; "radio equipment" means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radio communication. 2 EC 765/2008 states making available on the market shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge.

2 Page 2 of 7 With regard to radio modules, an assessment must be considered of the combined equipment; either by the economic operator responsible for the module (scenario b ) or the economic operator responsible for the final installation (scenario a ). Similarly, the manufacturer of a host device (such as a laptop, tablet, computer, etc.) which is placed onto the market without a radio module but contains provisions or connections for user installation of a radio module must consider this intended use of their device Scenario a. A module falling into the category of scenario a is not placed on the market and, therefore the R&TTE Directive does not apply. In this case, the module does not require the CE Mark for the R&TTE Directive and the integrator (host product manufacturer) is responsible for the assessment and marking of the end product which will include the module. Example: Completely Solder-Down RF modules such as RF Integrated Circuits that will only be soldered into a final product during its production phase, do not require an upfront assessment and CE marking as well as the preparation of a DoC. The technical characteristics of the module need to be covered by the assessment of the final product. If a module manufacturer or person placing a module onto the market wishes to CE Mark this type of module, perhaps for marketing purposes, then they must assume scenario b or c Scenario b. A module for installation by the user must be fully assessed to all aspects of the R&TTE Directive. This will require testing to all applicable aspects of article 3. Testing the module on a test jig may be suitable for some aspects of the module (such as Article 3.2 conducted antenna port measurements). However, some of the tests are host dependent (such as radiated emissions, EMC, SAR / EMF, etc.); therefore it is normally required to test the module in the range of host platforms. It is the responsibility of the economic operator placing the module on the market to assess the module for its intended environment and if that environment is not clearly known then, the economic operator responsible for compliance needs to incorporate a range of environments into their assessment TCF. For example, it would not be sufficient to test a module stand-alone on a jig and consider the EMC tests to be not applicable due to cable length, etc. and then declare that the module would be compliant for use in a laptop or tablet. In such a case, testing should be performed in a range of typical hosts. Note: If the manufacturer does not know what the use of or where the device will be used in a host product because they have done inadequate marketing / market research then they really cannot really know what the module is going to be used for For this reason the use of the module needs to be clearly specified within the user manual or operating instructions to remove all possibility of liability once integrated in to the host product This is also applicable to scenario C. In addition, one should consider the wide range of input voltage and temperature environments which may be considered by the user. Other aspects should be considered, such as:

3 - antenna configuration - software modifications, - safety aspects - type of installation - type of operation and use, - should a voltage regulator be included into the module, - are variations in power supply quality between host devices considered. Page 3 of 7 Another example is where the product can be installed into a series of laptops where the only difference between the laptops is the processor speed, installed memory, hard drive size. This should be typically be considered (from the R&TTE Directive) a single series. However if there are also changes to the antenna position, antenna types, etc. then they are different devices and need to be re-evaluated. Note that the internal working temperature or internal supply voltage variations of the host may not be known, so the economic operator placing the module on the market is responsible for anticipating and assessing for every possible installation condition. With regard to typical host platforms and environmental conditions, it becomes necessary for the module s installation instructions to clearly identify any environments or installation conditions which have not been assessed and are therefore not to be implemented by the user installer. Note that the module manufacturer should only put sensible restrictions for typical use into their instructions, if the module is for user installation. For example, it might be reasonable to state: Not for ATEX environment or Not for use in vehicles because it is likely that the user installer would follow this guidance Scenario c. Scenario c is in fact a combination of Scenario a and b. A Radio Module for installation only by an equipment manufacturer (OEM) will be a component if it is provided directly to the installer without being placed on the market; therefore scenario a applies. A Radio Module which is placed on the market and an OEM installs it must be assessed to the requirements of the R&TTE Directive for CE Marking and therefore the assessment process of scenario b applies; where the module must be assessed to all aspects of the R&TTE Directive. A partial assessment of the R&TTE Directive requirements is not possible when applying the CE Mark. For example, a manufacturer choosing to test the radio parameters (article 3.2) but leave the EMC and Safety aspects (article 3.1) to the installer is following scenario a and the module should not be CE Marked, nor placed on the market as a radio device. If the module is placed on the market specifically for one type of host and professional installation, then this must be clearly explained and controlled in the module s installation instructions. It was proposed at the meeting that for economic operators to CE mark radio modules (both connector-type and solder-down modules) but, indicate on the DoC that compliance to certain aspects of the essential requirements is to be assessed when the module is integrated into a host. This is not an ideal solution, but a creative one under the current regulations the module suppliers won t encounter unexpected/unjustified delays due to the lack of CE mark; the

4 Page 4 of 7 integrators will be adequately informed that the modules haven t been assessed in their hosts for certain aspects of the essential requirements. E.g., the module is assessed for the conducted aspects of Article 3.2 but is not assessed for the radiated aspects of Article 3.2 and also Article 3.1(a) and 3.1(b). 3. Conformity Assessment to the Essential Requirements of the Directive The concerns related to the integration of modules assessed against the requirements of the R&TTE Directive into final products are given here: 3.1. Issue: Under the R&TTE directive Article 10, the conformity assessment procedure used is at the choice of the manufacturer. It is clearly the responsibility of the manufacturer to perform the conformity assessment procedures. In the case where a terminal equipment module or radio module is integrated (scenario c in section 1), the person integrating the module becomes the manufacturer of the final product and is therefore responsible for demonstrating compliance of the final product with the essential requirements of the R&TTE Directive. This approach is logical because integrating modules into products can affect the compliance of the final product with the essential requirements Guidance: 1. 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. However, in many cases, it will not have been practical to perform a meaningful assessment of the requirements on the module alone and so complete assessment is required after integration. This should be made clear in the information provided by the module manufacturer concerning the installation and intended purpose of the module in Accordance with Article 6 of 1999/5/EC. 2. In all cases assessment of the final product (which integrates the R&TTE-D assessed module) must be made against the Essential requirements of the R&TTE Directive Articles 3.1(a) and (b), safety and EMC respectively, and any relevant Article 3.3 requirements. Assessment may include technical analysis, design evaluation and testing. ETSI Technical Report ETSI TR , Guide to the application of harmonised standards to multi-radio and combined radio and non-radio equipment; Part 1: Electromagnetic Compatibility gives guidance about final products and modules which may have been separately assessed for EMC compliance before integration. It also gives advice about assessment where the harmonised standard applicable to the finished product is different from that relevant to the integrated module. Although the report is set in the context of harmonised standards the principles may be found of more general applicability in assessment of the final product. The concept of primary product and primary function defined in the ETSI report may also be found helpful in assessment of safety. However, note the following extract from the Guidelines on the application of Directive 2006/95/EC: However, other electrical components which are intended to be incorporated into other electrical equipment and for which a risk assessment can be undertaken, such as transformers and electrical motors, are covered as such by the Directive and must be CE marked. A further assessment of the safety aspects related to the way in which such components are incorporated is in general also necessary.

5 Page 5 of 7 3. In the case where the product is already radio equipment, even without the addition of a radio module, then assessment of the final product must also be done against Article Except as provided for in 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 may require no further evaluation under Article 3.2 of the R&TTE Directive and may not require further involvement of an R&TTE Directive Notified Body for the final product. In all other cases, or if the manufacturer of the final product is in doubt, then the final product integrating the radio module must be assessed against Article 3.2 of the R&TTE Directive. For modules with an RF Pin or trace, these could not be reasonably installed by a user and must therefore come under scenario a or c.. ETSI Technical Report ETSI TR , Guide to the application of harmonised standards to multi-radio and combined radio and non-radio equipment; Part 2: Effective use of the radio frequency spectrum illustrates the application of the above guidance in different scenarios for various product combinations. It also includes advice on other scenarios (eg where the modules have not been assessed), embedded radio equipment and multi-radio equipment where the above guidance will not normally apply. The report is drafted in the particular context of harmonised standards but the circumstances demanding (or not) further assessment applies equally in the case where harmonised standards do not exist or are not applied in full (ie notified body assessment as the basis of an opinion). 5. In the case where integration of a module requires assessment involving the submission of a TCF to a Notified Body and the module manufacturer has not made his technical documentation (*) available to the final product manufacturer, the module manufacturer will be asked to make the module documentation available directly to the Notified Body. Not having the module documentation may prevent the Notified Body from delivering an opinion on the TCF to the final product manufacturer. Accordingly, the final product manufacturer must ensure that their module manufacturer is aware of this need and is willing to provide the relevant documentation direct to the Notified Body. It is not required that the final product manufacturer's TCF include the module manufacturer s proprietary documentation. (However, note that if a market surveillance authority wishes to inspect the TCF, they will most likely request to see the module technical information). In any event the final product manufacturer should ensure that the build status of the module integrated is known. This could take the form of a model and issue number, or a list of drawing numbers with issue numbers and date. Note: Assessment means following all the conformity assessment procedures of the R&TTE Directive but with a view to avoiding repetition of the assessment of the integrated module in so far as this can be justified on the basis of technical analysis. 4. Technical Documentation 4.1. Issue: Under the R&TTE directive Annex II, 2 "The manufacturer must establish the technical documentation described in point 4 and he or his authorised 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 national authorities of any Member State for inspection purposes."

6 Page 6 of 7 In the case of a manufacturer integrating an assessed module into a product, they may not have all the information required to enable them to hold all the documentation on the module as required under Annex 2(4). All the technical documentation for the module would reside with the module manufacturer or his authorised representative. However, it is the responsibility of the final equipment's manufacturer, his authorised representative or person first placing the product on the community market to declare that the final product meets with the essential requirements of the R&TTE Directive. It is also their responsibility to provide all relevant technical documentation to the relevant national authorities of any Member States for inspection purposes Guidance: The final product manufacturer, his authorised representative or person first placing the final product on the community market, must ensure that the module manufacturer is aware that all documentation pertaining to the module must be supplied, on demand, either directly or via the final product manufacturer themselves, to the relevant national authority of any Member States as required by the R&TTE Directive. 5. Notification 5.1. Issue: The R&TTE directive Article 6 (4) states: "Notification shall be given no less than four weeks in advance of the start of placing on the market and shall provide information about the radio characteristics of the equipment (in particular frequency bands, channel spacing, type of modulation and RF-power) and the identification number of the notified body referred to in Annex IV or V." Therefore the Notified Body/Bodies number must be included in a Notification if the Notified Body/Bodies has/have been involved in the assessment procedure of the final product. In the case of radio equipment using frequency bands whose use is not harmonised throughout the Community, the manufacturer or his authorised representative established within the Community or the person responsible for placing the equipment on the market shall notify the national authority responsible in the relevant Member State for spectrum management of the intention to place such equipment on its national market. From the above statement, the manufacturer of the final product is the person responsible for making the notification Guidance: 1. In the case where a Notified Body/Bodies has/have assessed the final product this will be the Notified Body number(s) given on the notification to the Spectrum Management Agencies. 2. In the case where a Notified Body has not assessed the final product but just the radio module, the Notification can be made to Spectrum Management Agencies using the Notified Body number(s) on the radio module.

7 Page 7 of 7 6. Marking 6.1. Issue: Under the R&TTE directive Article 12 (1) "Apparatus complying with all relevant essential requirements shall bear the CE marking referred to in Annex VII. It shall be affixed under the responsibility of the manufacturer, his authorized representative within the Community or the person responsible for placing the apparatus on the market. Where the procedures identified in Annex III, IV or V are used, the marking shall be accompanied by the identification number of the notified body referred to in Article 11(1). Radio equipment shall in addition be accompanied by the equipment class identifier where such identifier has been assigned. Any other marking may be affixed to the equipment provided that the visibility and legibility of the CE marking is not thereby reduced." Therefore the question arises as to which Notified Body/Bodies number(s) must be included in the CE marking of the final product Guidance: The final product must carry CE marking to show compliance with all the directives that are applicable to it. The numbers of all the NBs involved in every aspect of the conformity assessment (including any involved in the assessment of the module) must be shown next to the CE Marking with any additional marking such as the Alert Symbol alongside. The technical documentation of the final product will show the role of each NB. Disclaimer This guidance document does not replace the text of the R&TTE Directive and is for guidance only. In legal disputes the text of the Directive or its implementation in National legislation takes precedence.