Understanding & Pursuing European Conformity Marking (CE Marking) TÜV Rheinland Singapore Pte. Ltd.

Transcription

1 Understanding & Pursuing European Conformity Marking (CE Marking) TÜV Rheinland Singapore Pte. Ltd. This presentation is copyright of TÜV Rheinland Singapore Pte. Ltd.

2 Agenda Introduction to CE Marking Framework and guidelines of CE Marking How and where to obtain CE Marking for my products / Conformity Assessment (self-declaration or third-party certification) Ecodesign Directive 2

3 Introduction to CE Marking Why has the CE-marking been introduced.....aren't there enough different marks & standards already? VDE 3

4 Introduction to CE Marking...because there are so many marks already! Every country's technical culture and technical practice is reflected in its standards and legal provisions and these vary greatly from country to country. Consequently, each European country has its own complex body of legislation - consisting of laws, regulations, technical rules drawn up by private standardization committees and inspection and licensing procedures. These requirements often form an obstacle to free trade. In order to achieve the free circulation of goods, EU authorities developed a new approach to technical legislation, its mechanism and procedures. 4

5 Agenda Introduction to CE Marking Framework and guidelines of CE Marking How and where to obtain CE Marking on my products / Conformity Assessment (self-declaration or third-party certification) Ecodesign Directive 5

6 Framework and guidelines of CE Marking 6

7 Framework and guidelines of CE Marking 1. General Principle of European Directive Within the Community, the free movement of electrical equipment should follow when this equipment complies with certain safety requirements recognized in all member States. Without Prejudice to any other form of proof, the proof of compliance with these requirements may be established by reference to harmonised standards which incorporate these conditions. These harmonised standards should be established by common agreement by bodies to be notified by each Member State to the other Member States and to the Commission and should be published as widely as possible. Such harmonisation should, for the purposes of trade, eliminate the inconveniences resulting from differences between national standards. 7

8 Framework and guidelines of CE Marking 1. Harmonized standard The Member States shall take all appropriate measures to ensure that electrical equipment may be placed on the market only if, having been constructed in accordance with Good Engineering Practice in safety matters in force in the community, it does not endanger the safety of persons, domestic animals or property when properly installed and maintained and used in applications for which it was made. The Member States shall take all appropriate measures to ensure that, in particular, electrical equipment which complies with the safety provisions of harmonised standards shall be regarded by their competent administrative authorities as complying with the provisions mentioned above, for the purposes of placing on the market and free movement as referred to in Articles 2 and 3 respectively. 8

9 Framework and guidelines of CE Marking 2. Rule before putting into service and/or placed on the market Before being placed on the market, the electrical equipment must have affixed to it the CE marking attesting to its conformity to the provisions of Directive, including the conformity assessment procedure. The CE conformity marking shall be affixed by the manufacturer or his authorised representative established within the Community to the electrical equipment or, failing that, to the packaging, the introduction sheet or the guarantee certificate so as to be visible, easily legible and indelible. Where electrical equipment is subject to other Directives concerning other aspects which also provide for the affixing of the CE marking, the latter shall indicate that the equipment in question is also presumed to conform to the provisions of those other Directives. 9

10 Framework and guidelines of CE Marking 3. The conformity assessment procedure Internal production control is the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the electrical equipment satisfies the requirements of this Directive that apply to it. The manufacturer or his authorised representative established within the Community must affix the CE marking to each product and draw up a written declaration of conformity. The manufacturer must establish the technical documentation and he or his authorized representative established within the Community must keep it on Community territory at the disposal of the relevant national authorities for inspection purposes for a period ending at least 10 years after the last product has been manufactured. 10

11 Framework and guidelines of CE Marking Which products are included by the CE-marking and where can I get it? Basically all products which are sold in Europe are included The manufacturer puts the CE-mark on their product by themselves but they must prove that their product complies with all relevant EC-Directives 11

12 Framework and guidelines of CE Marking Directive Title EU Ref Entry into force End of validity Appliances burning 2009/142/EC 16/Dec/ gaseous fuels Cableway installations 2000/9/EC 03/May/ designed to carry persons Construction products 89/106/EEC 27/Dec/ /Jun/2013 Electromagnetic 2004/108/EC 20/Jun/ compatibility Equipment and protective 94/9/EC 09/May/ systems in potentially explosive atmospheres Explosives for civil uses 93/15/EEC 15/Apr/ In vitro diagnostic medical 98/79/EC 07/Dec/ devices Lifts 95/16/EC 27/Sep/ Low Voltage Equipment 2006/95/EC 16/Jan/ Machinery safety 2006/42/EC 29/Dec/ Measuring instruments 2004/22/EC 30/Apr/

13 Framework and guidelines of CE Marking Directive Title EU Ref Entry into force End of validity New hot-water boilers fired 2004/8/EC 21/Feb/ with liquid or gaseous fluids (efficiency requirements Non-automatic weighing 90/384/EEC 05/June/ instruments Personal protective 89/686/EEC 19/Jan/ equipment Pressure equipment 97/23/EC 29/July/ Pyrotechnic articles 2007/23/EC 04/Jun/ Radio and 1999/5/EC 07/Apr/ telecommunications terminal equipment Recreational craft 2003/44/EC 26/Aug/ Simple pressure vessels 2009/105/EC 28/Oct/ Toys safety 2009/48/EC 27/July/

14 Agenda Introduction to CE Marking Framework and guidelines of CE Marking How and where to obtain CE Marking for my products / Conformity Assessment (self-declaration or third-party certification) Ecodesign Directive 14

15 Proof How can I prove that my product complies with the CE-Directives? Each directive lists essential requirements which have to be fulfilled in order to meet relevant directives. These standards can be national standards, harmonized standards or international standards. Exp 1: CD Stereo System Directive 1 : LVD 2006/95/EC Harmonized Standard : EN Directive 2 : EMC 2004/108/EC Harmonized Standard : EN 55013, EN EN , EN Directive 3 : 2009/125/EC (ErP) Harmonized standard : Commission Regulation 1275/2008 Exp 2: Refrigerator for household use Directive 1 : LVD 2006/95/EC Harmonized Standard : EN , EN Directive 2 : EMC 2004/108/EC Harmonized Standard : EN , EN EN , EN Directive 3 : 2009/125/EC (ErP) Harmonized standard : Commission Regulation 643/

16 Proof Who can prove the compliance? For Appliances with low risk requirements, the manufacturer can do the testing by himself. For appliances with high risk which are regulated as model(s) of EC-Type examination in the directive, third party testing as well as a quality management system might be required. Why is third party testing so important? The market requires independent testing. If the manufacturer is located outside the EU, the importer is responsible for the product. According to the product liability law, he will be responsible for any hazard caused by the product. Third party testing means independent testing! Third party labs accredited and will be performed in accordance with the actual harmonized standard! 16

17 Proof Is the CE mark sufficient? The Compliance to the CE mark is a self declaration by the manufacturer or his authorized representative established within the Community to the electrical equipment or failing that to the packaging, the introduction sheet or the guarantee certificate so as to be visible, easily legible and indelible that the product is in compliance with relative Directive. However, in order to avoid liability issues during a possible law suite, an assessment of the product at a third party laboratory is highly recommended. 17

18 Steps to European Conformity Example :Printer for office use Step 1 Identify all applicable directives and standards Directive 1: LVD 2006/95/EC Standard :EN Directive 2: EMC 2004/108/EC Standard : EN 55022, EN 55024, EN , EN Directive 3: ErP 2009/125/EC Standard : EN 62301, Commission Regulation 1275/2008 Directive 4, 5, etc. 18

19 Steps to European Conformity Example :Printer for office use Step 2 Assess equipment according to the "Essential Requirements and "Harmonized standards" TÜV Rheinland provides you with a complete test report as well as a detailed photo-documentation Documentation required: Rating label Manual Block diagram Schematic Diagram Operational/Technical Description Draft for Declaration of Conformity to the CE Directives Samples 19

20 Steps to European Conformity Example :Printer for office use Step 3 Prepare the Technical Construction File TCF The TCF consists of: Declaration of Conformity The name and address of the manufacturer and identification of the products European agent s name and address, if applicable List of harmonized standards followed Description of the product (model, name, etc. ) Operating instructions Test report(s) Design details, description of operation, components list, circuits and diagrams 20

21 Steps to European Conformity Example :Printer for office use Step 4 Prepare and sign the Declaration of Conformity Declaration of Conformity (DoC) lists: The directives applied The applied standards Product model and type designation Manufactures address EU representative if applicable 21

22 Steps to European Conformity Example :Printer for office use Step 5 Affix the CE marking Issuance: The CE mark may be reduced or enlarged but has to have the same proportions as shown below, the minimum vertical dimension is 5 mm 22

23 Recommended Contents of Technical Construction File (TCF) : TCF Declaration of Conformity including: - The name and address of the manufacturer - The product Identification - European agent s name and address (if applicable) - List of harmonized standards followed - The person responsible for the declaration Design & Technical Construction User instructions and photos Test Results & Calculations Test report(s) 23

24 Recommended Contents of Technical Construction File (TCF) : TCF Plan and description of product and production process Quality Assurance System Quality Manual Supporting Quality Inspections Controls 24

25 Declaration of Conformity 60 EU Declaration of Conformity Identification of the products according to the Low Voltage Directive 2006/95/EC and the Machinery Directive Annex 1 of 2006/42/EC The name and address of the manufacturer For the following equipment: Product : Type Designation/Trademark : Manufacturer s Name : Manufacturer s Address : is herewith confirmed to comply with the requirements set out in the Council Directive 2006/95/EC for electrical equipment used within certain voltage limits. And the Machinery Directive Annex 1 of 2006/42/EC For the evaluation of the compliance with this Directives, the following standards was applied : Declaration of Conformity List of harmonized standards followed Responsible for making this declaration is the : Manufacturer Authorized representative established within the EU Authorized representative established within the EU (if applicable): Company Name : Company Address : Person responsible for making this declaration Name, Surname : Position/Title : European agent s name and address 25

26 How about documents in foreign languages??? Regulation The complete technical documentation must be written of official language accepted in the country in which the equipment will be installed. A manufacturer must be able to deliver the technical documents of their product within 48h in the official language, if a serious incident happens. The user manual must be translated into the native language of the country where the product will be sold. 26

27 User manual Purpose The user has to know how to use the equipment in a safe way User manual and rating label shall License holder and Type must be mentioned Small pictures for easy understanding are very useful provide all necessary information for the user All information for using, cleaning and repairing must be given 27

28 Circuit diagram All components must be marked 28

29 Construction drawing The construction must be clear from the drawing The different components shall be visible and marked 29

30 Photo documentation Details The photo-documentation should show all Report number: Appliance: Model: details of the product It is essential, that the product is produced in exactly the same way as shown in the pictures All modifications have to be re-tested and photographed as well Pic 1 TÜV Rheinland prepares a digital photo documentation which can conveniently be stored for later reference Pic 2 30

31 Measurement results and calculations Enter Type of test here T/C absolute Temperature (C) Details 120 Temperature records and all measured values should be noted and filed. It is particular important to be able to reconstruct the original testing conditions. Applied voltages, thermocouple locations, Temperature Ambient Pri Windings Sec Winding Core Pri Wire Sec Wire Capacitor PCB Top Encl. Bottom Encl. Side Encl. environment humidity and ambient temperature are only a few examples of important data to be stored together with the results Time Cold Resistance Pri (Ohm): Cold Resistance Sec (Ohm) : At Voltage (V): Fuse-Break after(min) : I/P (V):243.8 O/P (Ohm): 7.96 Ch 12 Side Encl Fail Ch 11 Bottom Encl Pass Ch 10 Top Encl Fail Ch 9 PCB N/A Ch 8 Capacitor N/A Ch 7 Sec Wire Pass Ch 6 Pri Wire Pass Ch 3 Pri Windings Pass Ch 2 Ambient 26.2 Enter Type of test here Winding Temperature rise (K),PASSED Ch 2 Sec Pass (interpolated) Ch 1 Pri Pass 31

32 Test report(s) Details The test report lists each clause of the followed standard. Clauses which are not applicable for the test object are marked with "N" (Not applicable) Clauses which could not be met by the test object are marked with "F" (Fail) Test clauses which have been passed are marked with "P"(Pass) Comments in the test report explain how the requirements have been met 4.1 (0) SCOPE P 4.1 (0.2) More sections applicable... : No Rated voltage not exceeding 250 V 230V P 4.4 (2) CLASSIFICATION P 4.4 (2.2) Type of protection... : Class I 4.4 (2.3) Degree of protection... : IP (2.4) Suitable for flammable surfaces... : Yes 4.5 (3) MARKING P 4.5 (3.2) Mandatory markings P Position of the marking On inside surface of lampshade P Format of symbols/text 4.5 (3.3) Additional information P Language of instructions German P 4.5 (3.3.1) Combination luminaires N 4.5 (3.3.2) Nominal frequency in Hz 50Hz P Operating temperature 25 C P P 32

33 Agenda Introduction to CE Marking Framework and guidelines of CE Marking How and where to obtain CE Marking on my products / Conformity Assessment (self-declaration or third-party certification) Ecodesign Directive 33

34 EU Mandatory Energy Efficiency Requirements ECODESIGN Directive (Calls for Regulations) Regulation 1 Regulation 2 Regulation 3 Regulation X Standard A Standard B Standard C Standard D Standard E Standard F 34

35 Ecodesign Directive Name: Introduction European Ecodesign directive 2005/32/EC (EuP-Directive), recast through the 2009/125/EC (ErP-Directive) Scope: Design of products related to energy (exceptions vehicles for transport) What does it do? The Ecodesign Directive creates a framework for the Regulations of binding requirements. Why was the Ecodesign Directive implemented? EU want to reduce CO2-Emmissions. Less energy consumption less CO2 Why is the Ecodesign Directive targeting the design of a product? A good portion of the environmental impact of a product is predetermined by its design and construction. Because of that, this Directive aims at the improvement of the environmental sustainability of energy related products in the stage of their design. 35

36 Ecodesign Directive Introduction 2009/125/EC Ecodesign for energy-related products Energy-related product means any good that has an impact on energy consumption during use which is placed on the market and/or put into service, and includes parts intended to be incorporated into energy-related products covered by this Directive which are placed on the market and/or put into service as individual parts for end-users and of which the environmental performance can be assessed independently Scheme compliance to the Directive and it s regulations for products in scope is mandatory under the CE-Scheme 36

37 Ecodesign Directive Process The first step in considering whether and which eco-design requirements should be set for a particular product is a preparatory study, recommending ways to improve the environmental performance of the product. Preparatory study The preparatory study is done by an external institute / group and shall provide the necessary information to prepare for the next phases as below: Impact Assesment Consultation of the Ecodesign Forum Adoption phase Carried out by the commission The Commission launched an invitation to tender for the preparatory studies on 7 July The tender was subdivided into 14 lots Adoption by the Commision (Regulation) 37

38 Ecodesign Directive Regulations that were official published for Ecodesign requirements until today: Regulation No 1275/2008: Standby and off mode electric power consumption of electrical and electronic household and office equipment Regulation No 278/2009: No-load condition electric power consumption and average (and 859/2009) active efficiency of external power supplies Regulation No 244/2009: Non-directional household lamps Regulation No 245/2009: Fluorescent lamps without integrated ballast, for high intensity discharge lamps, and for ballasts and luminaires able to operate such lamps Regulation No 107/2009: Simple set-top boxes Regulation No 640/2009: Electric motors Regulation No 641/2009: Glandless standalone circulators and glandless circulators integrated in products Regulation No 642/2009: Televisions Regulation No 643/2009: Household refrigerating appliances 38

39 Ecodesign Directive Product with external Power Supply Regulation No 1275/2008 standby and off mode electric power Consumption of electrical and electr. household and office equipment Regulation No 278/2009 no-load condition electric power consumption and average active eff. of external power supplies Both Regulations apply, unless Power Supply output is: < 6V and 550 ma* In that case, product is out of scope of the Regulation No. 1275/2008 *(Low voltage external power supply. Values on Name plate. See No. 278/2009, Article 8 ) 39

40 Ecodesign Directive Regulation No 1275/2008: Standby and off mode electric power Consumption of electrical and electr. household and office equipment Regulation Scope* Household appliances: Washing machines, Clothes dryers, Dish washing machines, Electric ovens Electric hot plates, Microwave ovens, Toasters, Fryers, Grinders, coffee machines and equipment for opening or sealing containers or packages, Electric knives, Other appliances for cooking and other processing of food, cleaning, and maintenance of clothes, Appliances for hair cutting, hair drying, tooth brushing, shaving, massage and other body care appliances, Scales Information technology equipment intended primarily for use in the domestic environment Consumer equipment: Radio sets, Television sets, Video cameras, Video recorders, Hi-fi recorders, Audio amplifiers, Home theatre systems, Musical instruments, and other equipment for the purpose of recording or reproducing sound or images, including signals or other technologies for the distribution of sound and image other than by telecommunications Toys, leisure and sports equipment: Electric trains or car racing sets, Hand-held video game consoles, Sports equipment with electric or electronic components, other toys, leisure and sport equipment Note: Out of scope is equipment placed on the market with low voltage external power supply 40

41 Ecodesign Directive Regulation No 1275/2008: Standby and off mode electric power Consumption of electrical and electr. household and office equipment 41

42 Ecodesign Directive Regulation No 1275/2008: Standby and off mode electric power Consumption of electrical and electr. household and office equipment For the purposes of conformity assessment, information to be provided by manufacturers in the technical documentation shall contain the following elements: For each standby and/or off mode: the power consumption data in Watts rounded to the second decimal place, the measurement method used, description of how the appliance mode was selected or programmed, sequence of events to reach the mode where the equipment automatically changes modes, any notes regarding the operation of the equipment Test parameters for measurements: ambient temperature, test voltage in V and frequency in Hz, total harmonic distortion of the electricity supply system, information and documentation on the instrumentation, set-up and circuits used for electrical testing; The characteristics of equipment relevant for assessing conformity 42

43 EC No 278/2009 Ecodesign requirements related to electric power consumption in no-load condition and average active efficiency of external power supplies Exception: Below products are not applicable to this regulation Voltage converters; Uninterruptible power supplies; Battery chargers; Halogen lighting converters; External power supplies for medical devices; External power supplies placed on the market no later than 30 June 2015 as a service part or spare part for an identical external power supply which was placed on the market not later than one year after this Regulation has come into force, under the condition that the service part or spare part, or its packaging, clearly indicates the primary load product(s) for which the spare part or service part is intended to be used with. 43

44 Ecodesign Directive Regulation No 278/2009: Ecodesign requirements related to electric power consumption in no-load condition and average active efficiency of external power supplies 44

45 Ecodesign Directive Regulation No 278/2009: Ecodesign requirements related to electric power consumption in no-load condition and average active efficiency of external power supplies Power range Power(W) Efficiency limit (Output power) for Non Low vol. EPS for Low vol. EPS <1 watt watt Po 51 watts > 51 watts

46 CE marking Attention The Compliance to the CE mark is a self declaration by the manufacturer/importer that the product is in compliance with ErP Directive. However, in order to avoid liability issues during a possible law suite, an assessment of the product at a third party laboratory is highly recommended. 46

47 CE marking The EC declaration of conformity must contain the following elements: The name and address of the manufacturer or of its authorized representative A description of the model sufficient for its unambiguous identification; Where appropriate, the references of the harmonized standards applied; Where appropriate, the other technical standards and specifications used; Where appropriate, the reference to other Community legislation providing for the affixing of the CE mark that is applied; and The identification and signature of the person empowered to bind the manufacturer or its authorized representative. The characteristics of equipment relevant for power consumption, as applicable, including the time taken to automatically reach standby, or off mode, or another condition which does not exceed the applicable power consumption requirements for off mode and/or standby mode 47

48 Penalties Overview The Member States shall lay down the rules applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive, taking into account the extent of non-compliance and the number of units of non-complying products placed on the Community market. 48

49 Energy Efficiency Verified Necessary Documents / Items Detailed information To grant the usage of the label with keyword TRG Application form Test Reports for Energy Efficiency standard / Ecodesign Regulation, issued by TUV Rheinland Group. Factory inspection report from TUV Rheinland Group (CIG 23) GS-Mark or Q-Certificate (with safety evidence, example CB!) For TdC website Product Photo Logo from client Product description, for what standards it is compliant Link to manufacturer homepage Language? (German, English, Japanese; other languages will be extra charged) 49

50 Ecodesign verified Ecodesign Directive Standby/off-mode/On-Mode Noise Emissions Life Cycle thinking PPW Directive Product Packaging If one of this items is missing, TRG will offer the service for this item. Chemical Emissions IEC/EN Assessment and Report + Factory Inspection + Safety assessment (GS or Q-Cert.+CB) RoHS Directive Hazardous substances Battery Directive REACH WEEE Directive End of life 50

51 TÜV Rheinland Singapore Pte Ltd 25 International Business Park #03-13/14 German Centre Singapore Tel : Fax : Website : 51