CE marking & your legal obligations

Transcription

1 CE marking & your legal obligations This presentation is intended to provide a practical approach guide to what you need to know about the CE marking requirements for electrical and electronic equipment placed on the European Market CE marking - A practical approach guide to what you need to know about CE marking Presented by Richard Poate Senior Manager, TÜV SÜD Product Service 1

2 Who am I? Name Title: Employer: Experience: Richard Poate Senior Manager TÜV SÜD Product Service 19 Years experience in Product Testing and Approval History: Worked for MoD, NHS, Industry, TÜV SÜD Product Service Telephone: Slide 2

3 Contents CE marking and your legal obligations What is CE marking? What are EU Directives? What is Due Diligence? How is CE marking enforced? Declaration of Conformity What is a Technical File? Overview of the Low Voltage and EMC Directives How to identify which Directives apply Harmonised Standards Presumption of Conformity Placing products on the market Technical documentation required to demonstrate compliance Technical File contents and format Slide 3

4 What is CE marking? Confusion Everywhere??? Chinese Export??? Initials CE come from the French term Conformité Européenne, it is a declaration that products meet the requirements of all applicable European Directives. Slide 4

5 CE marking = Safety and Quality?? Consumers, Importers, Distributors and Retailers may perceive and quality.. as a mark of safety But it isn t.! Extract from the European Commission website: there is never a 100% guarantee that a product bearing the CE marking is safe Slide 5

6 What is CE marking? Enables free movement of goods in the EU (some countries outside of the EU have adopted CE marking procedures) Responsibility with manufacturer or importer of goods, whoever places the equipment on the market Relates to EU Directives (European Law) Primarily self certification but not always (some higher risk devices and equipment require the mandatory intervention of a Notified Body) Not evidence of compliance in itself Slide 6

7 CE marking CE marking consists of the initials CE taking the following form: If reduced or enlarged proportions given above must be respected. Must have substantially the same vertical dimension and not be less than 5mm. Slide 7

8 What are EU Directives?

9 What are EU Directives? - Directives set out Essential Requirements - Written in general terms - Must be met before products placed on the market - Standards provide detailed technical requirements - Enable Essential Requirements to be met - Explain how conformity with Essential Requirements met Products meeting Essential Requirements to display CE marking before they are placed on the market Slide 9

10 24 CE marking Directives and 1 Regulation Directive 90/385/EEC 2009/142/EC 2000/9/EC 2009/125/EC 2004/108/EC 94/9/EC 93/15/EEC 92/42/EEC 98/79/EC 95/16/EC 2006/95/EC 2006/42/EC 2004/22/EC 93/42/EEC 2000/14/EC 2009/23/EC 89/686/EEC 97/23/EC 2007/23/EC 1999/5/EC 94/25/EC 2009/48/EC 2009/105/EC Title Active implantable medical devices Appliances burning gaseous fuels Cableway installations designed to carry persons Eco-design of energy related products Electromagnetic compatibility Equipment & protective systems for use in explosive atmospheres Explosives for civil uses Hot water boilers In vitro diagnostic medical devices Lifts Low Voltage Machinery Measuring instruments Medical devices Noise emission in the environment Non-automatic weighing instruments Personal protective equipment Pressure equipment Pyrotechnics Radio Equipment and Telecommunications Terminal Equipment Recreational craft Safety of toys Simple Pressure Vessels Notes: Construction Products do not feature on this list even though CE marking applies. This is because it s status has changed from a Directive to a Regulation. RoHS 2 came into force in January 2013 Slide 10

11 Three commonly used CE marking Directives for electrical equipment: Directive Title 2006/95/EC Low Voltage Directive (LVD) 2004/108/EC Electromagnetic compatibility (EMC) 2011/65/EU Restriction of Hazardous Substances (RoHS 2) Beware other applicable non CE marking Directives: Directive Title 2001/95/EC General Product Safety (GPSD) 2002/96/EC Waste from Electrical and Electronic Equipment (WEEE) 1907/2006/EC REACh (Registration Evaluation and Authorisation of Chemicals Slide 11

12 What is Due Diligence?

13 What is Due Diligence? Knowing what is required! Declaring you have met relevant requirements Demonstrating compliance with applicable Directives Being properly prepared Ready to defend yourself in court Able to produce a technical file Confidence in your compliance case Slide 13

14 How is CE marking enforced?

15 Legal status of Directives Agreed, adopted & accepted by governments of member states into their national law Transposed into UK Law as Statutory Instruments Have the same status as other laws in this country Directive 2006/95/EC Low Voltage Directive 2004/108/EC EMC Directive UK Law The Electrical Equipment (Safety) Regulations 1994 (SI 1994/3260) EMC Regulations 2006 (SI 2006/3418) Slide 15

16 Who enforces the Law? Trading Standards District Councils (Northern Ireland) Ofcom (in relation to protection & management of the radio spectrum) Slide 16

17 Enforcement authorities can: Challenge products on the market Pull samples from the market for examination Request Technical Files Enlist laboratories to test or check products Respond to public complaint Notify member states (e.g. RAPEX) Instigate criminal proceedings: banning products from sale ordering product recalls fines imprisonment Slide 17

18 RAPEX examples (published ) Hair straightener Brand: Urban Living Name: Unknown Type/number of model: HG8058 Batch number/barcode: Description: Yellow and white electric hair straightener in a yellow cardboard box. Country of origin: Unknown (China?) Electric Shock The outer casing of the product can come apart allowing access to live parts. The product does not comply with the Low Voltage Directive and the relevant European standard EN Slide 18

19 RAPEX examples (published ) Coffee maker Brand: K.T.S. Name: Electrical Brewing Pot Type/number of model: NE-201 Batch number/barcode: Description: Coffee maker consisting of two parts. The first part is a white plastic, coverless coffee pot with a handle on the side. The second part is a white, plastic base with a mains lead. The product comes in coloured cardboard packaging. Country of origin: China Burns, Electric Shock, Fire During abnormal operation, thermal fuse fails to operate in time, allowing generation of excessive heat. This can lead to a fire and can leave live wires exposed. There is no water level marking which could lead to the pot being overfilled. In the event that the product is operated beyond a certain time, the pot could overflow when it is lifted from the base. Risk that the user may be scalded. Product does not comply with the Low Voltage Directive and the relevant European standard EN Slide 19

20 RAPEX examples (published ) Socket adaptor Brand: ODDO Electric Name: Unknown Type/number of model: Model D V 16A Batch number/barcode: Description: Socket adaptor with three socket outlets. Plastic packaging with a label. Country of origin: China Electric Shock, Burns The pins may be easily loosened and could come off. A live pin could consequently remain in the socket when the adaptor is removed from the socket. The loosening of the pins may also cause the adaptor to overheat. The product does not comply with the relevant standard IEC Slide 20

21 RAPEX examples (published ) Plastic toy Brand: Unknown Name: Singing Justin Bieber Type/number of model: Model No: 520, Item No: Batch number/barcode: Description: Plastic doll in a cardboard box. Country of origin: China PRODUCT MAY BE COUNTERFEIT Chemical Head contains 30.23% by weight bis (2-ethylhexyl) phthalate (DEHP) and 0.1 % by weight di-butyl phthalate (DBP). Body contains 0.48% by weight bis (2-ethylhexyl) phthalate (DEHP). In addition product contains 0.91% by weight di- isononyl phthalate (DINP). DEHP, DBP and BBP prohibited in all toys and childcare articles, DINP, DIDP and DNOP prohibited in toys or childcare articles that can be placed in the mouth by children. Slide 21

22 RAPEX examples (published ) Mains extension lead Brand: PMS Name: Extension Lead Type/number of model: 2814 Batch number/barcode: Description: Mains extension lead, 2m long with 4 socket outlets. The packaging is made of transparent plastic and coloured cardboard. Country of origin: China Burns, Fire The product can catch fire if exposed to an ignition source. The product does not comply with the Low Voltage Directive and the relevant national standard. Slide 22

23 Declaration of Conformity (DoC)

24 What is a DoC? 1. Formal statement that products comply with: Applicable Directives Applicable Standards 2. Signed by responsible person (e.g. Technical Director) 3. Not evidence of compliance in itself 4. Minimum legal requirement Slide 24

25 What is the relevance of a DoC Legal claim that product(s) comply with applicable Directives Attests conformity with relevant Directives and takes sole legal responsibility Signatory accepts liability for compliance Signatory may be subject to prosecution or imprisonment Some Directives require Notified Body involvement to verify compliance or consistency of production Slide 25

26 DoC must include Name & address of manufacturer (or authorised representative) Description of equipment including type, model and any other information relating the equipment to the Declaration Reference to harmonised standards applied. When harmonised standards have not been applied, references to International or National standard(s) with which conformity is declared. If standards have not been applied, reference should be made to other specifications adopted or to safety objectives applied and satisfied Identification of the signatory The last two digits of the year in which CE marking was affixed Slide 26

27 Example Declaration of Conformity (DoC) EU DECLARATION OF CONFORMITY Date of Issue: Reference Number: Directive: Conforming Apparatus: Date of DoC Serial Number for this DoC Relevant Directive's Equipment Title, Part Number (and Serial Numbers as applicable) Manufacturer: Authorised Representative: Harmonised Standards Referenced or Applied: Specifications with which Conformity is Declared: Relevant standards, amendments and dates of issues If Harmonised Standards are not used then insert standards used and reference number of Notified Body Certificate. xxxxltd hereby declare that the equipment named has been designed (alternative:) tested and found to comply with the relevant sections of the above referenced specifications. The unit complies with all essential requirements of the Directives. Date of placement onto Market: Year Product placed on the European market: Signed: Name: Position: Slide 27

28 What are Technical Files? documented evidence showing product(s) properly comply with the requirements of Directives which apply to it

29 Technical Files Must be such as to enable enforcement authorities to assess conformity to the requirements of the Regulations Must cover design, manufacture and operation Can be the same document as your design file Forms the basis of your compliance (safety) case! Slide 29

30 Identification of applicable Directives Review scope of the Directives Seek assistance of a Notified Body Refer to official guidance on-line Provides on-line and downloadable guidance to Directives Slide 30

31 Low Voltage Directive (LVD) applies to All electrical equipment designed for use with a voltage rating between Vac and Vdc Note: voltage ratings refer to inputs or outputs not to voltages which may appear inside equipment Broadly it covers: Consumer goods Electrical appliances Electric motors and alternators Electrical wiring Electrical installation equipment Capital goods Switch gear and control gear Lighting equipment including ballasts Appliance couplers and cord sets Cable management systems Slide 31

32 Are components included in the scope? Basic electrical components are not covered Cannot comply as stand alone items Compliance depends on:- use and installation application final product CE marking should not be applied! Components with function in their own right are covered Compliance with essential requirements can be demonstrated, e.g. component power supply Slide 32

33 Essential Health and Safety Requirements Products must: be marked with their rated characteristics be clearly identified with brand or trade mark (or on packaging if not possible) be made so that it can be safely and properly assembled and connected protect against hazards arising from the electrical equipment: persons/domestic animals protected against physical injury or other harm no temperatures, arcs or radiation which would cause a danger insulation must be suitable for foreseeable conditions Protect persons/domestic animals/property against hazards which may be caused by external influences: Equipment meets expected mechanical requirements Equipment shall be resistant to non-mechanical influences in expected environmental conditions; Equipment shall be safe under foreseeable conditions of overload Slide 33

34 Scope of EMC Directive EMC Directive Two product categories APPARATUS FIXED INSTALLATIONS Any finished appliance or combination thereof A particular combination of apparatus used permanently at pre-defined locations

35 Apparatus Apparatus covers a variety of finished appliances e.g. White goods Audio visual equipment Sound recording equipment IT systems Industrial equipment Signalling equipment Mobile installations, defined as a combination of apparatus (and where applicable other devices) intended to be moved and operated in a range of locations, are deemed to be apparatus. Slide 35

36 Fixed Installations particular combination of several types of apparatus assembled, installed and intended for permanent use at a pre-defined location size or extent not defined responsible person must be defined not necessarily an EMC expert maybe owner, installer, maintainer (as appropriate) must be defined before installation is put into service must be a permanent installation in one location (for life) modifications permitted Equipment exclusively for a fixed installation need not be subject to CE marking Slide 36

37 Essential Requirements Equipment designed & manufactured to ensure that: Electromagnetic disturbance generated does not exceed a level above which radio and telecommunications equipment or other equipment cannot operate as intended Has a level of immunity to electromagnetic disturbances expected in its intended use which allows it to operate without unacceptable degradation of its intended use Slide 37

38 Fixed Installations: Follow good engineering practice, respecting the information on intended use of components These good engineering practices to be documented Responsible person required to hold this documentation for as long as the fixed installation is in operation No conformity assessment or CE marking requirements for fixed installations Slide 38

39 What are Harmonised Standards? Harmonised Standard: Support one or more Directives Have been produced by CEN or CENELEC Have been published in the Official Journal of the EC (OJ) Have been published by at least one national standards body Presumption of conformity with Essential Requirements Produced under mandate from Member States, provide technical measures to meet the EHSRs Slide 39

40 In other words Directives state legal objectives (EHSR s) to be met (*1) and Harmonised Standards identify technical means (requirements) to meet these legal objectives Harmonised Standards are one way of meeting EHSRs and are never intended to be mandatory, however compliance with them does give a valuable presumption of conformity. *1 The EHSR s of the Machinery Directive do contain technical requirements. Slide 40

41 Placing Product on the market Before product is placed on the market Technical documentation must be compiled and be available DoC must be drawn up and signed CE marking must be affixed If one or more CE marking Directives apply then you must apply CE marking Slide 41

42 Technical File Contents

43 Technical File Contents General description of the equipment This can normally be met by the description found in the equipment manual Conceptual design This can be met by a general assembly drawing and / or photographs plus block diagram. The drawings should relate to a particular model number and year of manufacture. Circuit diagrams also required. Descriptions / explanations necessary for the understanding of drawings & schemes referred to previously and the operation of the electrical equipment To some extent the equipment manual may meet this requirement but it may be necessary to include a schematic and operation description List of standards applied (in full or part) and descriptions of solutions adopted to satisfy requirements of Directives (when standards have not been applied) Slide 43

44 Technical File Contents List of Components - Complete list of all components, materials & parts used - Approval information on critical components and materials Results of design calculations made, examinations carried out etc. In many cases test reports will meet this requirement if they can demonstrate that the design calculations have been made correctly. Test reports. Could include test reports drawn up by the manufacturer, a Notified Body or any other person considered competent These reports will demonstrate how the product complies with the relevant Directives. Typically this will be by the application of harmonised standards. A copy of the EC Declaration of Conformity Slide 44

45 Technical File format Must contain all required information Can be a traditional paper file Information may be stored electronically hyperlinks can be used to link documents needs to be backed up Must be easy to produce all documentation on request Must be easy to maintain and keep up to date you can t just do it then forget about it! Slide 45

46 Thanks for Listening Any Questions? Richard Poate Senior Manager, TÜV SÜD Product Service Tel: +44(0)