DEVELOPING THE CERTIFICATION PROCESSES FOR A COMMUNICATION ELECTRONICS UNIT ON THE EXAMPLE OF COMODULE OÜ

Transcription

1 Geili Pais DEVELOPING THE CERTIFICATION PROCESSES FOR A COMMUNICATION ELECTRONICS UNIT ON THE EXAMPLE OF COMODULE OÜ GRADUATION THESIS Faculty of Mechanical Engineering Engineering materials and marketing Tallinn 2017

2 Mina, Geili Pais, tõendan, et lõputöö on minu kirjutatud. Töö koostamisel kasutatud teiste autorite, sh juhendaja teostele on viidatud õiguspäraselt. Kõik isiklikud ja varalised autoriõigused käesoleva lõputöö osas kuuluvad autorile ainuisikuliselt ning need on kaitstud autoriõiguse seadusega. Lõputöö autor Geili Pais. Nimi, allkiri ja allkirjastamise kuupäev Üliõpilase kood Õpperühm TT-81 Lõputöö vastab sellele püstitatud kehtivatele nõuetele ja tingimustele. Juhendajad Meelis Bergmann Nimi, allkiri ja allkirjastamise kuupäev Kristjan Maruste Nimi, allkiri ja allkirjastamise kuupäev Kaitsmisele lubatud..20.a. Mehaanikateaduskonna dekaan Vello Vainola.. allkiri

3 TABLE OF CONTENTS LIST OF ABBREVIATIONS... 5 INTRODUCTION COMPANY OVERVIEW History Product Resources Competitors CERTIFICATION Certification purpose Different certificates CE marking FCC mark UL Mark CSA Processes Liabilities Certification authorities Certification price Enforcement Market Surveillance Marking requirements CE CERTIFICATION OF THE COMMUNICATION HARDWARE CE marking process Identifying the applicable directives Product specific standards and requirements

4 Conformity assessment procedure Selection of a suitable notified body Technical documentation Marking CERTIFICATION MANAGEMENT Expiration and updated requirements Changes in the product design SUMMARY KOKKUVÕTE REFERENCES APPENDIXES Appendix 1. Quote for CE and FCC Appendix 2. Overview of different conformity assessment modules Appendix 3. Declaration of Conformity

5 LIST OF ABBREVIATIONS OEM original equipment manufacturer; HTGF High Tech Gruenderfongs; EEA European Economic Area; CE European Conformity (Conformité Européene); FCC Federal Communications Comission; TCB Telecommunication Certification Body; NRTL Nationally Recognized Testing Laboratory; DoC Declaration of Conformity; UL Underwriters Laboratories; CSA Canadian Standards Association; OSHA Occupational Safety & Health Act; SMTC supervised manufacturer's testing for certification; CPC category program for certification; MSA Market Surveillance Authority; OJEU Official Journal of the European Union; LVD Low Voltage Directive; EMCD Electromagnetic Compatibility Directive; R&TTED Radio & Telecommunications Terminal Equipment Directive; RED Radio Equipment Directive; GPSD General Product Safety Directive; NANDO New Approach Notified and Designated Organisations; PCB Printed Circuit Board; TUAS Tallinn University of Applied Sciences; TUT Tallinn University of Technology. 5

6 INTRODUCTION The purpose of this graduation thesis is to map the need for certification, different alternatives and obligations and to develop the certification process of COMODULE s communication electronics unit. The aim is to compile an extensive guide to COMODULE s certification process and to initiate a certification process which would ensure the product s compliance to applicable requirements and would therefore demonstrate that the product is safe to use. Product certification is an internationally recognized warranty that ensures the safety of the product. Certification demonstrates that the manufacturer, after successfully conducting conformity assessment, declares that the product complies with applicable requirements and is safe to use. The need for this graduation thesis lies mainly in the fact that COMODULE has verified the market demand for its product and is ready to increase the sales. The demand for a certified product comes primarily from COMODULE s customers who wish to integrate COMODULE s electronics unit into their product-families, but who want the product to be pre-certified and declared safe. Developing the certification process together with compiling an instruction for the certification process of COMODULE s communication hardware, is necessary to administrate further actions related to product certification. The guide allows to speed up subsequent certification processes and provides a comprehensive overview to all related parties. This graduation thesis is composed of four chapters. The first section is introductory and describes COMODULE OÜ and the communication hardware that is the subject matter of the thesis. Chapter two combines theoretical information about certification process and conjointly forms the content of the certification process guide. The third chapter describes the CE certification process and how it was carried out with COMODULE s communication hardware. The final chapter demonstrates the ongoing certification management, the need for recertification and necessities in case of changes in the product design. 6

7 COMPANY OVERVIEW COMODULE is a start-up company that offers connected vehicles technology for electric vehicle manufacturers and transportation sharing operators. COMODULE focuses on bringing connectivity technology and data analytics to light electric vehicles and the solution consists of a communication electronics unit, a smart-device application and an online data-analytics platform. [1] The research and development office is located in Tallinn and business development office in Berlin. COMODULE is a tier 1 supplier which means that the direct target lies in the original equipment manufacturer (OEM) segment. COMODULE s main customers are bicycle and scooter manufacturers and fleet managers. [2] 1.1. History COMODULE was founded in The four founders came together in a Tallinn University of Applied Sciences (TUAS) and Tallinn University of Technology (TUT) project Formula Student. After founding COMODULE, the founders applied to several business accelerators around the world. They took part in the accelerator StartUpBootCamp Berlin Smart Transportation and Energy which became COMODULE s first investor. The acceleration program included three months of extensive mentoring and the focus was on the business model development, improvement of presentation skills and creating materials for investor pitches. During the accelerator program, COMODULE also raised angel investment from Estonian-German investor syndicate, which includes investors from both Estonian and German companies. The funding helped COMODULE to finalize the proof of concept and validate the market. After the 3-months accelerator program, COMODULE raised further investment from the biggest German venture capital fund High Tech Gruenderfongs (HTGF). [1] 7

8 1.2. Product COMODULE s end-to-end connectivity solution includes three core elements: the communication hardware, an online data-analytics platform and a smart device application. The communication electronics unit is the connectivity platform s key-element which is integrated into the vehicle during the manufacturing process. The communication electronics unit is designed to forward the data gathered from the vehicle (for example energy consumption, speed etc) and it receives commands from the user interface (for example locking the motor, switching lights etc). The data interchange is done over Bluetooth. The hardware also includes GSM/GPS microchips, which allow the vehicle to be connected with COMODULE s data-analytics platform. They also offer the opportunity to position the vehicle in case it has been stolen. The hardware can be integrated into almost all light electric vehicles and the technical design is in continuous development. [1] The second part of COMODULE s connectivity solution lies in the web-based data analytics platform, which visualizes the data gathered from the vehicle. The visualization can be used to inspect the vehicle s technical data and the results can be used to improve product development. The platform allows real time vehicle tracking and it eases dealing with vehicle maintenance and warranty issues. All the information from the vehicles is stored in COMODULE s server and database where the data is encrypted for safety reasons. [1] The third element in COMODULE s product family is the smart device user interface which allows the user to interact with the vehicle. The application can be used on smartphones and smartwatches and its purpose is to improve the general user experience. The application includes different features for the user, for example maximum driving range, easy navigation, vehicle positioning etc. 8

9 Visual representation of COMODULE s solution (Figure 1): 1.3. Resources Figure 1. COMODULE connectivity solution [1] COMODULE s physical resources consist mainly of the research and development office together with necessary equipment (work stations, tools, office apparatus etc) in Tallinn and a small officespace in Berlin. COMODULE curently employs 15 specialists of whom 14 work daily in the Estonian office and one in Berlin. The personnel consists of people who differ by gender, nationalities, age goups and fields of expertise. 9

10 The general structure and the command line of the company is as follows (Figure 2): 1.4. Competitors Figure 2. Structure of COMODULE OÜ [1] COMODULEs solution is rather unique as there are no other full stack technology providers on the market. There are different sharing and fleet management projects, but none of them offer a holistic approach. The difference between COMODULE and other providers solutions is as follows (Figure 3): Figure 3. COMODULE s solution compared to state of the art solutions [1] 10

11 2. CERTIFICATION The aim of this chapter is to gather necessary information about the certification process which, as a compilation, would form a guide to COMODULE s certification process. The chapter includes general overview about different certification options, as well as the description of different regulations, conformity assessment procedures, liabilities etc. Further management of the certification, including information about re-certification and changes in product design, are covered in the fourth chapter Certification purpose Product certification indicates that the product complies with product-specific requirements. All different certifications have different purpose or area of expertise, but the main aim usually lies in ensuring the product s safety for end-consumers. Certification is also often used as a marketing argument as it is the best approach for companies to guarantee the safety of their products. There are both, mandatory and optional certification options, depending mainly on the characteristic of the product and the region it is sold or distributed. When starting a certification process, it is necessary to define the need and the expected output of the certification. The scope of this thesis covers the essential safety certification for the European market. As COMODULE s target market is not limited to Europe, a further certification process for North- America (and any other possible market which will be considered necessary) needs to be carried out before placing the product on the market. The outcome of this certification process is CE product certification that declares product s safety to European market. In the future, the purpose of the process might lie, for example, in a quality insurance verification or in any other possible needs. Before starting a new certification process, it is important to consider all related costs, human and time resources to re-evaluate whether it would be reasonable to carry out the certification process in- 11

12 house or by outsourcing. Though the whole process of certification can be outsourced, many companies often decide to complete as much as possible on their own. This is mainly due to the high price which can be overwhelming especially for small start-ups Different certificates There are numerous certificates around the world and they differ mainly due to the aim, region where they are applicable and the field which products need the certification. Though most certificates overlap in some parts, there is no one general certification regulation for the whole world. This means that manufacturers need to certify their products according to the regulation of the region where they are selling their products. As COMODULE is active mainly in Europe and North America, there is no need to comply with the certificates for other regions at the moment. The applicable certificates in Europe and North-America are CE, FCC, CSA and UL, which will be described in following sub-chapters CE marking CE marking is a certification for products which are sold or distributed in the European Economic Area (EEA) and it has been mandatory for various product categories since The original term was EC mark but it was officially replaced by CE marking which comes from a French phrase Conformité Européene and it stands for European Conformity. The CE marking is often referred to as the passport to European market as it allows the free circulation of products within EEA. [3], [4] The CE marking assures that the product complies with high safety, health, and environmental protection requirements prescribed by the European Union. The requirements to what the products need to comply are defined in Product Directives which contain "essential requirements" and/or "performance levels" and "Harmonized Standards" [5] There are 21 different Product Directives which define the general product categories which are required to conform to the directives [6]: Machinery Directive 2006/42/EC Low Voltage Directive 2014/35/EU EMC Directive 2014/30/EU 12

13 Medical Devices Directive 93/42/EEC Personal Protective Equipment Directive 89/686/EEC Construction Products Regulation Regulation (EU) No 305/2011 Pressure Equipment Directive 2014/68/EU REACH Regulation (EC) No 1907/2006 RoHS Restriction of Hazardous Substances Directive 2011/65/EU Waste Electrical and Electronic Equipment Directive 2012/19/EU ATEX Directive 2014/34/EU Toy Directive 2009/48/EC Radio and Telecommunication Terminal Equipment Directive 1999/5/EC or Radio Equipment Directive 2014/53/EU Recreational Craft Directive 94/25/EC Active Implantable Medical Devices Directive 90/385/EEC Explosive for Civil Use Directive 93/15/EEC Noise Emission in the Environment Directive 2000/14/EC Gas Appliances Directive 2009/142/EC Lifts Directive 2014/33/EL Pyrotechnic Directive 2007/23/EC Measuring Instruments Directive 2004/22/EC The directives that apply to COMODULE s communication hardware, are as follows: Low Voltage Directive 2014/35/EU EMC Directive 2014/30/EU Radio and Telecommunication Terminal Equipment Directive 1999/5/EC or Radio Equipment Directive 2014/53/EU A further description of the directives and COMODULE s compliance to them will be covered in the third chapter. Each directive lays out the main essential requirements for all product groups and refers to European Harmonised Standards. A harmonised standard contains all the necessary information for the product manufacturer about the technical specifications and requirements that need to be complied with. Harmonised standards are more specific and narrower than the directives. 13

14 All products which need CE Marking are considered to have either minimal risk or greater risk. The risk-level designates whether the CE Marking can be acquired by self-certification or if it needs to be acquired from a notified body. If the product is considered low-risk, the manufacturer has the option to go through the certification process by itself. Self-certification means that the manufacturer tests the product and affixes the CE Marking to the product on its own. If the product s risk-level is considered to be greater, the manufacturer must use a third party to do the testing. [7] The third-party certification needs to be done by a Notified Body which is an official organisation designated by the EU country who is authorized to carry out the product certification process. A further explanation of the Notified Bodies will be given in the third chapter. [8] FCC mark The Federal Communications Commission (FCC) mark is a certification for electronic products which affirms that the product complies with the FCC s regulations on electromagnetic interference. The aim of the FCC certification is protecting the electromagnetic spectrum through limiting the electromagnetic radiation [9]. FCC authorization is mandatory for all electronic products sold in the United States of America irrespective of whether the emission or reception of electromagnetic radiation is intentional, unintentional or incidental. Unlike CE marking, FCC certification deals strictly with electromagnetic interference and not with the safety of the consumer or user of the product. [9] There are three authorization methods for FCC certification: Certification, Declaration of Conformity, Verification. Certification is the most complex and formal FCC certification model which is mandatory for devices with high risk (i.e. mobile phones, radio transmitters, wireless telemetry transmitters etc.). The process is issued by an accredited Telecommunication Certification Body (TCB) and the equipment testing is done by a Nationally Recognized Testing Laboratory (NRTL). The TCB analyses the test reports and technical documentation presented by the responsible party (manufacturer or importer) and evaluates whether the device complies with the necessary regulations and thus if it is safe to use. The technical information together with some descriptive material is released in FCC s public database. [10] 14

15 Declaration of Conformity (DoC) is a semi-formal process which does not require filing an application with the Commission nor TCB. However, it is still necessary to use an accredited testing laboratory to guarantee the device s compliance to relevant standards. The information is not stored in any public database but the responsible party is required to present the test reports, product documentation and other necessary information if the Commission asks for it. Declaration of Conformity is usually needed for personal computers, microwave ovens, radio receivers etc. [10] Verification is the most informal of all FCC s authorization methods as it doesn t require the responsible party to use a third-party testing laboratory. The manufacturer or importer still needs to provide all the necessary testing reports and product documentation, but the testing can be done by the responsible party itself. The information is not published in a database, but it s still compulsory to provide it upon request. Verification is the suitable option for very low-risk devices such as TV and FM receivers. [10] UL Mark Opposing to CE and FCC, which are governed on a high legislative level, UL isn t a governmental regulation. There isn t any general legislative regulation for electronic devices sold and distributed in the USA but there are different private organizations who are handling the safety certifications. Though it s not legally required to be certified by a Nationally Recognized Testing Laboratory, it is almost impossible to sell electronics without any safety approvals. This is mainly influenced by insurance companies who will not cover the products which have not been certified either by UL or another NRTL. This means that using an uncertified product will void the insurance. The UL Mark is the most accepted and thus the most popular certification option in the USA. UL stands for Underwriters Laboratories which is the largest product safety testing organization in North America. Similar to CE, the UL Mark also guarantees only the safety of the product and it doesn t include performance or quality standards. The UL certification is divided into three main methods: UL Listed UL Recognized UL Classified 15

16 The UL listing authorizes the manufacturer to test its products on its own and without any third-party involvement. The responsible party is also authorized to apply the UL listed mark to the product by themselves but the products are covered by a follow-up program to ensure proper testing and safety measures. The UL recognition mark ensures that a component of a bigger product complies with applicable standards. It is usually in the interest of product companies who use outsourced components rather than end-consumers as the components are intended to be integrated into the product during the manufacturing and they usually don t have independent value separate from the product. The process of acquiring the UL recognition mark is similar to UL listing as UL authorizes the manufacturer to test the component, but still does routine follow-ups to determine continued compliance The UL classification is more complex certification method as it s the only one of the three which requires the products to be tested in a NRTL. This has the highest quality level of UL certification and it is used for products with higher risk-level. [11] CSA Canadian Standards Association (CSA) is a nationally recognized testing laboratory which indicates that the product complies with Canadian or U.S. standards. The CSA certification is relatively similar to the UL Mark, thus according to the Occupational Safety & Health Act (OSHA), the CSA-US certification is considered as an alternative to the UL Mark. [12] The purpose of CSA certification is to ensure the safety of products in the following categories [13]: gas equipment heaters and boilers, vehicle fuel systems etc.; construction products and materials building materials, plumbing products etc.; life sciences public and occupational safety etc.; electrical and electronics wiring, electromagnetic compatibility etc.; communications telecommunication and information technology etc.; energy renewable energy, fire safety etc. COMODULE s hardware belongs to the electrical and electronics and the communications product groups. 16

17 The biggest difference between CSA and other certification options lies in the opportunity to choose whether the manufacturer wants to conduct the whole certification process on its own or with a thirdparty involvement. The options differ from an entire certification package to full self-certification as follows [14]: model certification manufacturer provides product samples and carries out the whole certification process; witnessed manufacturer's testing for certification manufacturer tests its products on its own, but with the presence of a CSA technical representative who conducts reports from the results; supervised manufacturer's testing for certification (SMTC) manufacturer carries out all tests and compiles the testing reports, afterwards CSA validates the data and organizes spot-checks; category program for certification (CPC) manufacturer conducts testing and documenting the data, CSA issues the certificate of compliance. To ensure the quality of the certification, CSA has set requirements which need to be fulfilled in order to be qualified for the SMTC and CPC models. To qualify for the SMTC, CSA will audit the manufacturer s testing equipment and the testing process. If the manufacturer meets the necessary requirements, CSA will allow the use of SMTC, but will conduct routine audits of the testing facility. In order to use the CPC method, the manufacturer is required to retrieve a certificate of qualification from CSA. The manufacturer needs to demonstrate the following aspects [14]: thorough knowledge and understanding of the applicable standards and product requirements; capability to design, manufacture and test products according to the standards; access to appropriate testing resources. Although all aforementioned certificates are suitable and necessary for COMODULE s hardware, the capacity of this thesis is not ample enough to cover all the regarding information. Therefore, from now on, the thesis will include information mostly about the CE certification as it is COMODULE s primary target to obtain CE marking. The FCC, UL and CSA certifications will be taken into consideration during the development of general certification process and referred to where necessary. 17

18 2.3. Processes The certification process for different certificates follows mainly the same route. The first step is to identify the applicable directives and standards. The directives and standards lay out all the necessary product-specific requirements that the product needs to comply to. This means that all the applicable requirements need to be worked through and followed very precisely. Directives and standards also state which conformity model or method needs to be used, i.e. whether a third-party involvement is mandatory or not. If a third-party involvement is mandatory, the selection of a notified body is necessary as a next step. The next step, after choosing the appropriate route for conformity (and if necessary the selection of a notified body) is testing the product in order to verify if it complies with the requirements. Testing can be done by the manufacturer or by an authorized body (notified body for CE). Test reports should show whether the product is safe to use or not. If the initial testing shows that the product does not comply with the requirements, the manufacturer must make improvements to the product s technical design, otherwise it is not allowed to be sold nor distributed on European markets. [15] Next phase is compiling the technical documentation. The specific information needed in the technical documentation is stated in the applicable directives and standards. In most cases the general list of necessary information which should be included is as follows [16]: description of the apparatus, usually accompanied by block diagram; wiring and circuit diagrams; general Arrangement drawing; list of standards applied; records of risk assessments and assessments to standards; description of control philosophy/logic; datasheets for critical sub-assemblies; part list; copies of any markings and labels; copy of instructions (user, maintenance, installation); test reports; quality control & commissioning procedures; declaration of Conformity. 18

19 Last stage of certification process is issuing the Declaration of Conformity and other technical documentation. After that the respective certification mark is affixed and the product is ready to be sold or distributed. Further information about the product specific process that applies to COMODULE s certification will be provided in the third chapter Liabilities Though all aforementioned certifications measure and guarantee the safety of the products, the liability of a defective product remains on the manufacturer or importer. The liability cannot be transferred to a third party irrelevant of the certification method and whether an authorized testing laboratory has approved the safety of the product. This means that even if the responsible party covers all necessary safety measures, they are still responsible for their product s malfunction. For example, the European Commission s official position on the manufacturer s liability is as follows: By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility (and irrespectively of whether a third-party has been involved in the conformity assessment process), conformity with all the legal requirements to achieve CE marking [17, p. 147]. In case of an accident caused by a defective product, the burden of proof usually lies on the injured person. The person does not have to prove the negligence or carelessness of the responsible party but the person must demonstrate the harm done, a defect in the product and a causal relationship between the injury and the defect. There are also different aspects which reduce or discard manufacturer s liability. The European Commission s guide on the implementation of EU products rules brings out some of the possibilities [17]: they did not put the product into circulation; the defect appeared after the product was put into circulation; the product was not manufactured by them to be sold or distributed for profit; the product was not manufactured or distributed by them for any purpose within the usual transactions and practices of their business; the defect is due to compliance of the product with mandatory regulations issued by public authorities; 19

20 the defect of a component was caused during the manufacture of a final product. This means that the manufacturer must be aware of its porduct s conditions, applicable requirements and other necessary information at all times as the liability always lies on the manufacturer Certification authorities Depending on the risk-level of the product, different certification methods require a third-party involvement in the testing process. The third-party must be authorized by the certification issuer to carry through the conformity assessment procedure according to applicable standards. CE marking is issued by European Commission which has accredited different notified bodies to assess the product s compliance to the requirements. All member states have their own notified bodies for particular product areas in order to divide the work-load, but the states do not have the obligation to provide notified bodies for all different product groups. This kind of decentralized system has had plenty of negative feedback from different entities, which state that not having a unified authorized body for all CE marking processes, has caused a difference in the quality of the notified bodies work. It has been said that the varying levels of expertise cause differences in test results. This means that situations might arise, where a product passes a safety testing with one notified body even if another notified body has declared the product to be unsafe for customer use. [18], [19] The demonstration of Estonian certification authorities and the description of choosing the suitable notified body will be covered in the third chapter of this thesis Certification price The price of a certification ranges from one thousand euros to tens or even hundreds of thousands of euros. The price differs as much mainly due to different product-specific requirements. For example, the number and difficulty of tests a product must go through to comply with the regulations etc. The price also depends on the certification body used and on the amount of work done by the responsible party itself. For example, the responsible party can save a remarkable amount by identifying the applicable directives and product-specific standards, compiling necessary product documentation and a Declaration of Conformity etc. A sample of a full offer to fulfil all COMODULE s certification needs can be seen in appendix 1. 20

21 2.7. Enforcement There is no unified regulation about the ways of legislation enforcement regarding CE certification, but in general it is governed by Market Surveillance Authorities (MSAs). More comprehensive overview of the Market Surveillance Authorities and their tasks will be given in the next subchapter. There are different methods and sanctions that can be used if it is found that the manufacturer has not carried out necessary certification procedures or if the product does not comply with necessary requirements. In general, the penalty depends on the degree of the violation. If it is a formality (e.g. mistakes or incomplete information in the technical documentation), the sanction is usually rather light. These kinds of breaches often involve a probation period during which the manufacturer has the chance to correct its mistakes. A low-degree violation can also include fines for the responsible party. If the infringement is considered to be more significant, the following sanctions are also stricter. A high-degree violation may include the obligation to remove the product from the market or criminal penalties. Member states must secure that the CE marking regulations are followed and implemented. In order to avoid the misunderstanding and misuse of the CE marking, member states are obligated to provide national regulation for suitable measures. According to the Blue Guide, which describes the implementation of EU product rules, the means of preventing and eliminating the mistreatment of CE certification must be effective, proportionate to the seriousness of the offence and dissuasive and may be increased if the relevant economic operator has previously committed a similar infringement [17, p. 108] Market Surveillance As mentioned previously, the market surveillance is carried out by public authorities nominated by each member state Market Surveillance Authorities and they conduct the market surveillance depending on the scope of the body. The purpose of market surveillance is to secure that products on the European market comply with the applicable requirements in order to protect public interests (e.g. health and safety). However, it is also necessary to enable free movement of products and not to overly burden the manufacturers. In 21

22 addition, market surveillance has a positive influence on the economic operators as it helps to remove unfair advantage. It is member states responsibility to ensure sufficient market surveillance and thus they are obliged to coordinate and conduct the monitoring of products on the market. Market Surveillance ought to disable the circulation of unsafe products and therefore it should act as a persuasive deterrent. The Market Surveillance Authorities check the conformity according to the legislation applicable at the time of placing the product on the market. This guarantees that if the regulations change after the product has already been made available on the market, the manufacturer is not responsible for noncompliance to the new legislation. There are many means to ensure efficient market surveillance, such as statistics, risk assessment procedures etc. The measures of monitoring the products according to the Blue Guide, include, but are not limited to: regular visits to commercial, industrial and storage premises; regular visits to, if appropriate, work places and other premises where products are put into service; organising random and spot checks; taking samples of products, and subjecting them to examination and testing; requiring upon reasoned request, all necessary information. The main reasons that bring products and their compliance to MSA s attention, are as follows: accidents; complaints; custom authorities control; information from other manufacturers. If there are enough adequate reasons to assume that the product might present a risk, MSAs analyze and evaluate the product s conformity to applicable regulations. [20] 2.9. Marking requirements CE marking is the distinguishable consequence of the CE marking process and it demonstrates that the manufacturer has declared the product to be in conformity with European Union legislation. The 22

23 CE mark can be affixed to the product only if the manufacturer has conducted a conformity assessment procedure according to applicable legislation and the product complies with necessary requirements. [17] Acoording to the Blue Guide, the CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and/ or to the accompanying documents. The visibility condition means that the marking must be approachable without difficulty for all parties. This does not require the marking to be visible before opening the package of the product. The legibility requirement means that the minimum height of the marking is 5mm and its proportions must be respected at all times. The indelibly clause means that it cannot be removed under normal circumstances without leaving noticeable traces (for example some product standards provide for a rub test with water and petroleum spirits) [17, p. 60]. The CE mark is generally affixed on the product itself, but in cases it is impossible or not reasonable due to technical of economic conditions, it can be affixed to the packaging and/or to the accompanying document (if the EU legislation provides for such documents). If the involvement of a notified body is necessary in the production phase according to relevant directives and standards, the identification number of the notified body needs to be included in the CE marking. Marking of the COMODUDULE s communication hardware is described in the third chapter of this thesis. 23

24 3. CE CERTIFICATION OF THE COMMUNICATION HARDWARE 3.1. CE marking process Identifying the applicable directives As mentioned before, there are 21 product groups which are defined by European Directives. As the product groups are relatively inexact, it is rather easy to find the correct categories that may apply to COMODULE s hardware. In general, there are three main characteristics that need to be analysed in order to evaluate the safety of the device: the maximum voltage; the electromagnetic emission; the emission and reception of radio waves. The respective product groups into which COMODULE s communication hardware belongs are as follows: Low Voltage Directive 2014/35/EU; EMC Directive 2014/30/EU; Radio and Telecommunication Terminal Equipment Directive 1999/5/EC or Radio Equipment Directive 2014/53/EU. It is important to decode the objectives of the directives in order to understand whether the directives of suitable product groups apply to specific product. There are two different safety regulations for low voltage devices [21]: General Product Safety Directive (GPSD) 2001/95/EC for devices with a voltage below 50 V for alternating current or 75 V for direct current Low Voltage Directive (LVD) 2014/35/EU for devices with a voltage between 50 and 1000 V for alternating current and between 75 and 1000 V for direct current 24

25 The objective of the Low Voltage Directive (LVD) is to ensure that electrical equipment within certain voltage limits provides a high level of protection for European citizens, and benefits fully from the Single Market [22, p. 39]. Products that need to comply with the directive include different consumer and professional products, e.g. cables, power supply units, fuses etc. COMODULE s communication hardware s voltage range falls under the scope of the LVD. Regarding the way different electric devices influence each-other, European Commission has created the Electromagnetic Compatibility (EMC) Directive. The purpose of the directive is to limit the electromagnetic emission of different electric appliances in order to guarantee that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance [23]. As all electric devices affect other near-by electric appliances with electromagnetic emission, it is mandatory for all electric products to comply with the regulation, hence it is also compulsory for COMODULE s communication hardware. Compliance to the directive ensures that the device does not interfere with radio and telecommunication nor any other near-by equipment. [23] The third product group covers the equipment that uses radio frequency spectrum and products which are connected to public telecommunication networks. As COMODULE s communication hardware supports GSM/GPS technology and emits and receives radio waves, it is subject to the Radio and Telecommunication Terminal Equipment (R&TTE) Directive. Although the R&TTE Directive (entered into force in 1999) is currently valid, it is being revised by a new Radio Equipment Directive (RED) which was adopted in A transitional period has been appointed during which the manufacturer can choose which directive to comply with. The period ends on June 12, As any further certification needs to be in compliance with the new RED, there is no reason to start COMODULE s hardware certification according to the old R&TTE Directive, hence the new RED will be applied. The purpose of the directive is to guarantee efficient use of the radio spectrum, as well as electromagnetic compatibility, to avoid interference with terrestrial and orbital communications [24] Product specific standards and requirements Most directives refer to essential and product specific requirements. The essential requirements according to EMCD are as follows: 25

26 Equipment shall be so designed and manufactured, having regard to the state of the art, as to ensure that: (a) the electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended; (b) it has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use [23, p. 97]. LVD adds that (a) the essential characteristics, the recognition and observance of which will ensure that electrical equipment will be used safely and in applications for which it was made, shall be marked on the electrical equipment, or, if this is not possible, on an accompanying document; (b) the electrical equipment, together with its component parts, shall be made in such a way as to ensure that it can be safely and properly assembled and connected; (c) the electrical equipment shall be so designed and manufactured as to ensure that protection against the hazards set out in points 2 and 3 is assured, providing that the equipment is used in applications for which it was made and is adequately maintained. [22] Product specific requirements are outlined in the applicable directives and in the Harmonized Standards which the directives refer to. The aforementioned directives which apply to COMODULE s communication hardware determine the essential standards and requirements as follows: Radiated Spurious emission for GSM (900/10180 MHz), 2 frequency bands according to EN Global System for Mobile communications (GSM); Harmonized EN for mobile stations in the GSM 900 and GSM 1800 bands covering essential requirements of article 3.2 of the Radio Equipment Directive (2014/53/EU); EN for GPS - Short Range Devices (SRD); Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Harmonised Standard covering the essential requirements of article 3.2 of Radio Equipment Directive 2014/53/EU; EN v1.9.1 for Bluetooth Low Energy complete scope - Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the Radio Equipment Directive (2014/53/EU); EMC testing combined for GPS, GSM and BTLE according to EN /-3/-7/-17 - Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; 26

27 Electrical safety Testing according to EN 60950; SAR (specific absorption rate) test for BTLE + 2G + GPS product body position Testing for product conformity of the Peak Spatial-Average Specific Absorption Rate (SAR) in the human body emitted by wireless equipment according to Radio Equipment Directive (2014/53/EU); EN :2010 Safety of information technology equipment Conformity assessment procedure European Union has combined a set of conformity assessment procedures which include different routes for conformity from the least to the most rigorous module respective of the degree of risk involved. The purpose of specifically defined modules is to ensure inter-sectoral unity, prevent ad hoc solutions and to decrease manufacturer s burden as much as possible. All conformity procedure modules are described in the European Parliament s Decision 768/2008/EC of July 9, [25] Aforementioned decision defines 8 different conformity procedure modules of which some have variants [25]: module A internal production control; module A1 internal production control plus supervised product testing; module A2 internal production control plus supervised product checks at random intervals; module B EC type-examination; module C conformity to type based on internal production control; module C1 Conformity to type based on internal production control plus supervised product testing; module C2 conformity to type based on internal production control plus supervised product checks at random intervals; module D conformity to type based on quality assurance of the production process; module D1 quality assurance of the production process; module E conformity to type based on product quality assurance; module E1 quality assurance of final product inspection and testing; module F conformity to type based on product verification; module F1 conformity based on product verification; 27

28 module G conformity based on unit verification; module H conformity based on full quality assurance; module H1 conformity based on full quality assurance plus design examination. The level of severity of the modules depends on the degree of risk involved, whereas module A is the mildest and module H1 is the most rigid. It is important to keep in mind that the directives state the mildest module suitable for conformity assessment. Consequently, the manufacturer can decide whether to use the module recommended in the directive or one from a higher-level, but a lower-level module cannot be applied. [17] The requirements to recognize which modules are suitable for specific products are mostly provided in the applicable directives. Therefore, it is necessary to determine which conformity procedures are recommended in the respective directives in order to find the suitable route for conformity. The Low Voltage Directive defines the suitable module rather plainly: The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer. There is no conformity assessment procedure in this Directive which requires the intervention of a notified body [22, p. 357]. This means that module A can be used throughout the conformity assessment in the scope of the LVD. The EMC Directive evaluates the level of risk regarding the electromagnetic emission higher than the LVD and therefore states that the conformity assessment procedure requires the intervention of a Notified Body. Consequently, the EMC Directive lays out two modules which need to be used for conformity assessment [29]: internal production control (module A); EU type examination that is followed by Conformity to type based on internal production (modules B and C). The Radio Equipment Directive also indicates that some conformity assessment procedures set out in the directive include a third-party involvement. The compliance with the essential requirements can be demonstrated by using module A or modules B and C together. [24] Therefore, there are two different conformity assessment procedures that apply to COMODULE s communication hardware certification with respect to applicable requirements: 28

29 Module A is an internal production control module which covers both design and production. Module A does not include involvement of a third-party which means that the manufacturer himself carries out all necessary procedures and ensures the conformity to respective legislation. Module B is the first part of a two-element procedure which covers only design and is always followed by other modules. Module B includes an examination of the technical design by a notified body. Module C is one of the options that can be combined with module B. It covers only production and it does not include a third-party assessment. Consequently, COMODULE ought to use both internal design and production control regarding LVD, only internal production control for EMCD and RED and a third-party involvement regarding the design in the area of EMCD and RED. If the design and/or nature of COMODULE s product changes or if the legislation is modified, it is necessary to re-evaluate applicable directives, regulations and requirements. It is also important to consider the need to change the conformity assessment procedure according to the regulations and it might be inevitable to change the route to conformity. For that reason, a longer overview of the conformity assessment modules can be found in appendix 2 [17, p. 71] Selection of a suitable notified body As mentioned above, COMODULE needs to involve a notified body to examine the technical design and to attest the compliance to the essential requirements. There are a few non-governmental notified bodies in Estonia that are active in the field of testing electronical devices, such as Inspecta Estonia OÜ, Bureau Veritas Eesti OÜ and Testlink OÜ. Unfortunately, none of those notified bodies have the capability to test COMODULE s hardware regarding all necessary requirements. Therefore, it is necessary to find a notified body outside Estonia. As COMODULE is also active in Berlin, it is reasonable to use a notified body from Germany if possible. According to the NANDO (New Approach Notified and Designated Organisations) Information System, there are approximately 100 different notified bodies in Germany. [26] To find a suitable notified body for COMODULE s product certification, it is necessary to verify which of the authorities have the capability to test COMODULE s communication hardware regarding all necessary requirements. As COMODULE has previously been in contact with a German notified body 29

30 7layers GmbH, it was known that 7layers has the capability to test COMODULE s product and thus it was the first choice Technical documentation CE marking process includes compiling the technical documentation (often referred to as technical file ) which combines all information that is crucial to evaluate the product s compliance to relevant requirements. Drawing up the technical documentation is the responsibility of the manufacturer and most directives state that it needs to be available for at least ten years from the last manufacturing date. [27] There are not any definitive lists of the content that needs to be covered in the technical documentation, but nearly all directives provide at least some kind of instructions on what should be included. In general, it validates that the testing was carried out accurately and that the conformity of the product has been established. [27] COMODULE s technical documentation consists mainly of three parts: product overview; testing reports; Declaration of Conformity. The technical information of the communication hardware has been compiled beforehand and the testing reports will be provided by the notified body who carries out the testing. Therefore, only Declaration of Conformity will be covered by this thesis. The Declaration of Conformity must include sufficient information about the manufacturer which could be used to trace back to the manufacturer. It may also contain information about the applicable directives and standards, short product overview, reference to the notified body etc. As COMODULE s conformity assessment procedure is not finished by the time of publishing the thesis, COMODULE cannot yet declare the conformity of its product. Therefore, a template of the Declaration of Conformity was created (see appendix 3), but the signature will be added once the conformity assessment has been carried out successfully. 30

31 Marking The CE marking is usually affixed onto the product, but in exeptional cases it is also allowed to be affixed onto the packaging or the accompaning documentation of the product. In COMODULE s case, there is no need to affix the marking anywhere besides the product itself. The CE marking will be printed during the manufacturing of the PCB on the backside of the communication hardware. Though the hardware is relatively small, the CE marking will satisfy the minimum measurements required by the legislation. This means that the measurements of the marking will be 5x7mm. The required design and proportions of the CE marking (Figure 4): Figure 4. CE mark [17] As mentioned beforehand, the identification number of the notified body needs to be added to the CE marking only in cases where the conformity assessment method requires third-party involvement in the production phase. The LVD allows the manufacturer to use entirely internal production control which does not require a notified body engagement. The RE and EMC directives require following module B together with a production control module chosen by the manufacturer. COMODULE has chosen following module C for the production phase, which includes only internal control. As thirdparty involvement is required only by module B, which covers only design, affixing the identification number of the notified body togehter with the CE marking is not necessary [17]. In the future, if there is a need to change the conformity assessment method (for example due to modifications in the directives or shanges in the product design), it is important to re-evaluate the need to add the notifeid body s identification number to the marking. 31