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 Compliance Services Manager, 1

2 Who am I? Name Title: Employer: Experience: Richard Poate Compliance Services Manager Ltd 18 Years experience in Product Testing and Approval History: Telephone: Worked for MoD, NHS, Industry, 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 LV 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 Technical file format

4 What is CE marking? CE marking = Confusion Everywhere??? Chinese Export??? The initials "CE come from the French term Conformité Européenne The marking is a declaration by the manufacturer that their product(s) meet the requirements of all applicable European Directive(s).

5 CE marking = Quality?? Although many consumers, importers and retailers may perceive CE marking as a quality mark, it is not! 5

6 What is CE marking? Designed to enable free trade around European Union (EU) member States (some non EU countries have adopted CE marking procedures) Places responsibility with the manufacturer or importer of goods, whoever places the equipment on the market Relates to EU Directives (European Law) Primarily self certification Not evidence of compliance in itself 6

7 CE Conformity marking The CE conformity marking shall consist of the initials CE taking the following form: If the CE marking is reduced or enlarged the proportions given in the above drawing must be respected. The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5mm. 7

8 What are EU Directives?

9 What are EU Directives? "New Approach" Directives (Community Law) set out essential requirements (e.g. electrical safety), written in general terms, must be met before products may be sold in the UK or anywhere in the European Community European harmonised standards provide detailed technical information enabling manufacturers to meet essential requirements Directives explain how manufacturers can demonstrate conformity with the essential requirements Products meeting essential requirements are to display CE marking, as described in the particular directive, which means they can be sold anywhere in the Community / European Economic Area (EEA)

10 CE marking Directives 21 CE marking Directives: Directive 2006/95/EC Amended by Title of directive Low Voltage 87/404/EEC 90/488/EEC 93/68/EEC Simple Pressure Vessels 88/378/EE 93/68/EEC Safety of toys 89/106/EEC 93/68/EEC Construction products 2004/108/EC 2006/42/EC Electromagnetic compatibility (EMC) Machinery 89/686/EEC 93/68/EEC 93/95/EEC 96/58/EC Personal protective equipment (PPE) 90/384/EEC 93/68/EEC Non-automatic weighing instruments 90/385/EEC 93/42/EEC 93/68/EEC 2007/47/EC Active implantable medical devices 90/396/EEC 93/68/EEC Appliances burning gaseous fuels

11 CE marking Directives Directive Amended by Title of directive 92/42/EEC 93/15/EEC 93/42/EEC 94/9/EC 93/68/EEC 2004/8/EC 2005/32/EC 98/79/EC 2000/70/EC 2001/104/EC 2007/47/EC Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels Explosives for civil uses Medical devices 94/25/EC 2003/44/EC Recreational craft 95/16/EC 97/23/EC 98/79/EC 1999/5/EC 2000/9/EC 2004/22/EC Equipment explosive atmospheres (ATEX) Lifts Pressure equipment In vitro diagnostic medical devices Radio Equipment and Telecommunications Terminal Equipment Cableway installations designed to carry persons Measuring instruments 11

12 Summary of applicable directives The CE marking Directives below are the ones that would most typically be applicable to common electrical products: Directive 2006/95/EC Title of Directive Low Voltage Directive (LVD) 2004/108/EC Electromagnetic compatibility (EMC)

13 Other Applicable Directives Just because a Directive does not call for CE marking does not mean the Directive is not applicable. E.g. Directive 2001/95/EC 2002/96/EC 2002/95/EC Title of Directive General Product Safety (GPSD) Waste from Electrical and Electronic Equipment (WEEE) Restriction of Hazardous Substances (RoHS) 1907/2006/EC REACh (Registration Evaluation and Authorisation of Chemicals 13

14 What is Due Diligence?

15 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 Being able to produce a technical file Being confident in your compliance case

16 How is CE marking enforced?

17 Legal status of Directives Directives agreed, adopted & accepted by governments of member states into their national law Directives transposed into UK Law as Statutory Instruments This gives Directives 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) 17

18 Who enforces the Law? In Great Britain: Local trading standards The Office of Communications (Ofcom) where enforcement relates to protection & management of the radio spectrum In Northern Ireland: District Councils Ofcom where enforcement relates to protection & management of the radio spectrum 18

19 Market surveillance Enforcement authorities can: Challenge any product on the market Pull samples from the market for examination Request a manufacturer, importer or retailer to provide their technical file Enlist the assistance of 3 rd party test laboratories to test or check products Respond to public complaint Notify other member states (RAPEX) Instigate criminal proceedings resulting in potential: banning of product from sale ordering a product recall payment of fines imprisonment of responsible persons 19

20 RAPEX examples (wk ) These examples were notified to ALL Member States Voltage tester set, mm. The package includes 2 voltage testers. Inscriptions: longer voltage tester: Black Bull; shorter one. Made in China V AC. Product poses a risk of electric shock as the un-insulated metal tips of both testers are too long and users could touch the live metal ends by accident. The protecting rims on the handles, intended to stop the users' fingers slipping off the handle, are not large enough. The product does not comply with the Low Voltage Directive (LVD) and the relevant European standard EN Withdrawal from the market and recall from consumers ordered by the authorities. Lighting chain 100 Icicle Curtain lights. Country of origin: Unknown. Electric shock / Fire The product poses a risk of fire and electric shock because: - the wires are not properly fixed in the bulb sockets; - the cross-sectional area of the wires is not sufficient; - the bulb sockets are not sufficiently resistant to heat and fire. The product does not comply with the Low Voltage Directive (LVD) and the relevant European standard EN

21 Declaration of Conformity (DoC)

22 What is a DoC? 1. A formal statement that the product complies with: applicable Directives applicable Standards 2. Signed by responsible person within the organisation (e.g. company director) 3. It is not evidence of compliance in itself 4. Minimum legal requirement

23 What is the relevance of a DoC Legal claim that product(s) comply with all applicable Directives Manufacturer attests conformity with all relevant Directives and takes sole legal responsibility Signatory accepts liability for compliance with the Directives Signatory may be subject to prosecution or imprisonment In some instances Directives may require a Notified Body to issue a Certificate of Conformity in order to verify compliance of the product or consistency of production. 23

24 The DoC must include Name & address of the manufacturer (or their authorised representative) Description of the electrical equipment including type, model and any other information that relates the equipment to the Declaration Reference to harmonised standards applied and 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 empowered to enter into commitments on behalf of the manufacturer (or their authorised representative) The last two digits of the year in which CE marking was affixed

25 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:

26 What are Technical Files? Your documented evidence to show that the product(s) properly complies with the requirements of the Directives which apply to it.

27 Technical Files Technical documentation must be such as to enable enforcement authorities to assess the conformity of the electrical equipment to the requirements of the Regulations It must cover design, manufacture and operation of electrical equipment It can be the same document as your design file for the equipment Most importantly, it forms the basis of your compliance (safety) case!

28 Identification of applicable Directives Review the scope of the Directives Seek assistance of a Notified Body Refer to official guidance on-line EU UK Europa (offical website of the European Union) Official source of information relating to all European Directives BERR (Formerly DTI) irect/index.html Provides on-line and downloadable guidance to Directives 28

29 Scope of Low Voltage Directive (LVD) Applies to: All electrical equipment designed for use with a voltage rating of between Vac and Vdc Voltage ratings refer to the voltage of the electrical input or output, not to voltages which may appear inside the equipment. Broadly Speaking the Directive covers: Consumer goods Capital goods Electrical appliances Lighting equipment including ballasts Switch gear and control gear Electric motors and alternators Electrical wiring Appliance couplers and cord sets Electrical installation equipment Cable management systems 29

30 Components Are components included in the scope? Basic electrical components are not covered Cannot comply as a stand alone item Their compliance depends on:- how they are installed the application is characteristics of the final product CE marking should not be applied! Components which have a function in their own right are covered Compliance with essential requirements can be demonstrated component power supply 30

31 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 31

32 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

33 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. 33

34 Fixed Installations a 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 May be 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 Certain Apparatus Equipment exclusively for a fixed installation need not be subject to CE marking 34

35 Essential Requirements Equipment shall be designed and 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 35

36 Essential Requirements Fixed Installations: Follow good engineering practice, respecting the information on the intended use of its components These good engineering practices are required to be documented The responsible person in relation to a fixed installation is required to hold this documentation for as long as the fixed installation is in operation There are no conformity assessment or CE marking requirements for fixed installations 36

37 What are Harmonised Standards? A "Harmonised Standard" is a standard that: Supports one or more Directives Has been produced by CEN or CENELEC Has been published in the Official Journal of the EC (OJ) Has been published by at least one national standards body Provides a presumption of conformity with the Essential Requirements These standards, produced under a mandate from Member States through the Commission, provide the technical measures to meet the EHSRs

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

39 Placing Product on the market Before a product is placed on the market the: Manufacturer must compile technical documentation Manufacturer (or authorised representative) must draw up the DoC Manufacturer (or authorised representative) must affix CE marking If one of the CE marking Directives applies then you must apply CE marking

40 Technical File Contents

41 Technical File Contents General description of the electrical equipment. This requirement can normally be met by the description (including model number etc.) found in the equipment manual. Conceptual design This can be met by a general assembly drawing and / or photographs plus a block diagram. The drawings should relate to a particular model number and year of manufacture. Circuit diagrams are 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 operation description. List of standards applied (in full or part) and descriptions of solutions adopted to satisfy requirements of the Directive (where standards have not been applied)

42 Technical File Contents List of Components - complete list of all components, materials & parts used - safety 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 the manufacturer considers to be 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.

43 Technical File format Must contain all the 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 Be easy to produce all documentation on short notice Be easy to maintain and keep up to date You can t just do it then forget about it! 43

44 Thanks for Listening Any Questions? Richard Poate Compliance Services Manager, Tel: +44(0)