CE-märkning. CE-märkning

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Adele Wilkins
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1 CE-märkning Johan Nilsson Biomedicinsk teknik, LTH CE-märkning Varför? Säkerhets och hälsoskäl - etablera en rimlig nivå för produktsäkerhet. Kraven ska tolkas som minimi-nivå. Kvalité - Tillverkaren kan (med hänsyn till kunden) lägga sig på en högre produktsäkerhetsnivå.

tillämpliga (lag)krav på produkt- och hälso-säkerhet.

2 CE-märkning CE-märket (Conformité Européenne, eg. Communauté Européenne): Visar att produkten uppfyller alla tillämpliga (lag)krav på produkt- och hälso-säkerhet. CE-mäkta produkter kan fritt marknadsföras inom EU/EESområdet. Inte China Export..

3 CE-märkning Vem är ansvarig? Tillverkaren eller tillverkarens representant inom EU/EES, eller det företag som marknadsför produkten inom EU/EES. eller det företag som sätter samman en produkt för intern användning. Tänk på: S-märkningen är inte längre obligatorisk. S- märkningen godkändes av en oberoende tredje part - SEMKO. The New Approach Directives Innehåller fundamentala krav Low voltage (73/23/EEC) Industrial Trucks (74/150/EEC) Motor Vehicles trailers (70/50/56 EEC) Products labeling directive (83/374 EEC) Simple Pressure Vessels (87/404/EEC) Safety of Toys (87/378/EEC) Construction Products (89/106/EEC) Electromagnetic Compatibility (2004/108/EEC) Machinery Safety (98/37/EC) Personal Protective Equipment (89/686/EEC) Non-automatic Weighing Instruments (90/384/EEC) Active Implantable Medical Devices (90/385/EEC) Gas Appliances (90/396/EEC) Telecommunications Terminal Equipment (91/263/EEC) Mobile Machinery (91/368 EEC Hot Water Boilers (92/42/EEC) Medical Devices (93/42/EEC) Lift Machinery (93/44 EEC) Explosive for Civil Uses Directive (93/5/EEC) Satellite Earth Station Equipment (94/9/EEC) Recreational Craft (94/25/EEC) Packaging & packaging waste (94/62EEC) Lift Safety (95/16 EEC) Energy Labeling (97/75 EEC) Pressure Equipment (97/23/EEC)

4 Harmoniserade Standarder Direktiven innehåller fundamentala krav på hälso- och produktsäkerhet. Detaljerade krav och tekniska lösningar finns i Standarder (Produktfamiljstandarder eller Generiska standarder). T ex EN 292 Maskinsäkerhet. EU-standarder överförs till nationella standarder i varje land. T ex SS-EN 292. De standarder som anses uppfylla kraven i direktiven kallas för Harmoniserade Standarder. Dessa standader publiceras i the EU Official Journal. Dvs, en produkt som designats enligt en Harmoniserad standard kommer att därför att uppfylla kraven i dirketiven. Standards Organisations Ref: World standards IEC - International Electrotechnical Commission ISO - International organization for Standardization European standards CEN - European Committee for Standardization CENELEC - European Committe for Electrotechnical Standardization ETSI - European Telecommunications Standards Institute Swedish standards BST - Byggstandardiseringen HSS - Hälso- och sjukvårdsstandardiseringen IKH - Kran- och Hisstandardiseringen ITS - Informationstekniska standardiseringen SEK - Svenska Elektriska Kommissionen SIS - Standardisering I Sverige SMS - Svensk Material- & Mekanstandard STG - Allmänna Standardiseringsgruppen TKS - Tryckkärlsstandardiseringen

5 Harmoniserade Standarder En produkts overenstämmelse med Harmoniserade standarder visas genom självcertifiering - tillverkaren garanterar att produkten uppfyller kraven. I en del fall, t ex medicinteknisk utrustning, krävs kontroll av oberoende organ. Technical Construction File TCF Must be compiled before the CE mark can be affixed, and the product is sold in the EU. The TCF must be produced in one of the official languages of the European Union and be made available to the responsible authorities in any EU country. The main parts are: Declaration of Conformity A general description of the product Design and production drawing and diagrams Detailed technical data for essential aspects of the product List of standards and/or solutions applied Report of calculations and tests that have been carried out Certificate and inspection reports In the case of series production, the internal conditions that have been observed to safeguard compliance with the directive CE user manual

6 Declaration of Conformity It should contain the following: Name and address of the manufacturer or his authorized representative established within the Community A description of the product Reference to the harmonized standards Where appropriate, reference to the specifications on which conformity is declared Identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer or his authorized representative established within the community The last two digits of the year in which the CE marking was affixed (for the first time) The declaration of Conformity must be drawn up at least in one of the official languages of the community. Declaration of Conformity Example

7 New Approach Directives Addressed here: Low voltage (2006/95/EC) Industrial Trucks (74/150/EEC) Motor Vehicles trailers (70/50/56 EEC) Products labeling directive (83/374 EEC) Simple Pressure Vessels (87/404/EEC) Safety of Toys (87/378/EEC) Construction Products (89/106/EEC) Electromagnetic Compatibility (2004/108/EC) Machinery Safety (2006/42/EC) Personal Protective Equipment (89/686/EEC) Non-automatic Weighing Instruments (90/384/EEC) Active Implantable Medical Devices (90/385/EEC) Gas Appliances (90/396/EEC) Telecommunications Terminal Equipment (91/263/EEC) Mobile Machinery (91/368 EEC Hot Water Boilers (92/42/EEC) Medical Devices (93/42/EEC) Lift Machinery (93/44 EEC) Explosive for Civil Uses Directive (93/5/EEC) Satellite Earth Station Equipment (94/9/EEC) Recreational Craft (94/25/EEC) Packaging & packaging waste (94/62EEC) Lift Safety (95/16 EEC) Energy Labeling (97/75 EEC) Pressure Equipment (97/23/EEC) Maskindirektivet Machinery Safety Directive 2006/42/EG Contains Fundamental Safety and Health Requirements for design and construction of machines Implemented in Swedish legislation through AFS 2008:3 och 2009:5 (Maskindirektivet)

8 Machinery Safety Directive What is machinery? (a) an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material, an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole, interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool; (b) 'safety components` means a component, provided that it is not interchangeable equipment, which the manufacturer or his authorised representative established in the Community places on the market to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons. Example of topics covered by the Machinery Safety Directive Risk assessment Emergency stops Machine control units - single fault tolerant Safety components - Ex: Logic for Emergency stop Protective devices Safety distances and minimum distances Hydraulics and pneumatics Ergonomics Noise Vibrations Hot and cold parts Electrical risks

Warn for the remaining hazards The producer must consider both normal use and expected abnormal use of the products Machinery

9 Machinery Safety Directive How to reach safe machinery? 1.Remove hazards in the machine design step 2.Protect hazardous parts from contact 3.Warn for the remaining hazards The producer must consider both normal use and expected abnormal use of the products Machinery Safety Directive Examples Teknisk tidsskrift, 1938 Transmission parts like axes or gear-wheels may cause jamming or crushing - protection by cover If the consequence of a yet very unlikely accident is serious, it is not enough to warn!

10 Machine control unit Standard SS-ISO :1994 Fault tolerance can be achieved by: Partly or full redundance Use of diversity Reduced speed or force for risky movements Supervision of control functions used for safety purposes Acceptance systems Machine control unit Standard SS-ISO :1994 The construction of the system must be fault tolerant: A single fault must not lead to increased risk A single fault that is not discovered must not lead to increased risk if a second fault occures.

11 Risk assessment Standard SS-EN 1050:1996 Risk Seriousness of the injury Probability for the injury to occur Frequency and durability of exposure Probability that a risky event will occur Technical and human possibilities to avoid or limit injury Risk assessment process Start Determining the boundaries of the machine Identifying the sources of risk Estimation of risk Evaluation of risk Is the machine safe? END Yes No Reduction of risk

12 Risk assessment Safety strategy I. Reduce risks through construction II. Remove working tasks from risk area III. Design protective covers for remaining work tasks IV. Inform about remaining risks, surveillance, personal protection equipment V. Warn for still remaining risks Lågspänningsdirektivet Low Voltage Directive 73/23/EEC with amendment 93/68/EEC Applicable for electrical equipment with voltage ratings between 50 and 1000 VAC or VDC.

13 Low Voltage Directive What is electrical equipment? Every product that is used for purposes like generation, transformation, transmission, distribution or use of electric energy, e.g. motors, transformers, apparatus, instruments, protective equipment, cables and house-hold equipment. (IEC) Low Voltage Directive Why safety requirements? Accidents involving electricity - Electric shock Fire caused by electricity

14 Low Voltage Directive Impedance hand - foot or hand - hand Typically in the range of 1kohm - 5 kohm Effect on skin from electric current: < 10 ma/mm 2 No harm ma/mm 2 Redness ma/mm 2 Blisters > 50 ma/mm 2 Gets charred (förkolnas) Low Voltage Directive Effect on human body from electric current: No reaction 0.5 ma unlimited time Notable, no injury 10 ma, 2s / 200 ma, 10 ms Muscles out of control, cramp 40 ma, 3s / 500 ma, 10 ms Risk for auricular fibrillation 80 ma, 3s / 1.5 A, 10 ms (flimmer) 50% auricular fibrillation

15 Low Voltage Directive Safety strategy for faults 0 fault Normal function, no hazard 1 fault? Function, no hazard >1 fault? Function, hazard Low Voltage Directive Examples of solutions Protective earth (Class I equipment) Double isolation V cables, standard equipment with no protective earth (Class II equipment)

16 Low Voltage Directive Examples of solutions against fire Fuses Shielding - Reduce supply of air (oxygen) - Transistor in own metal housing Thin bond wires in components EMC Directive 2004/108/EG Essential requirements The electromagnetic disturbance generated must not exceed a level not allowing radio and telecommunications equipment and other apparatus to operate as intended (emission) The apparatus must have an adequate level of intrinsic immunity to electromagnetic disturbance to enable it to operate as intended (immunity)

17 EMC Standards Emissions test 150 khz - 30 MHz: Conducted 30 MHz - 1 GHz: Radiated EMC Standards Ex of immunity tests Radiated RF field 80 MHz - 1 GHz Electrostatic discharge Electrical fast transients on power and I/O ports Surge AC power voltage dips

18 EMC Standards Ex på emissionskrav EMC Standards Ex på Immunitetskrav - Hem, kontor

EMC Standards Ex på Immunitetskrav - Industri Medical Devices Directive 93/42/EEC Contains all fundamental health and safety requirements relevant for medical devices The

19 EMC Standards Ex på Immunitetskrav - Industri Medical Devices Directive 93/42/EEC Contains all fundamental health and safety requirements relevant for medical devices The different aspects of the Machinery, Low Voltage and EMC directives are included in the medical Devices Directive. Medical Devices do therefore only need to meet the requirements of MDD

20 Software Currently no requirements on development process except for Medical Devices Consequences of software faults must be taken into account Watchdog Unused program memory areas IP-klassning

21 WEEE Waste Electrical and Electronic Equipment Directive 2002/96/EC Manufacturer responsible for disposal of electrical and electronic equipment Users (private household) should be able to return waste free of charge Products must be marked with RoHS Restriction of Hazardous Substances Directive 2002/95/EC Restricts the use of six substances: Lead Mercury Cadmium Hexavalent chromium (Cr 6+ ) Polybrominated biphenyls (PBB) Polybrominated diphenyl ether (PBDE) Batteries not included Covered by Battery Directive (2006/66/EC)

22 Restricts the use of: Lead Mercury Cadmium Recycling Battery Directive 2006/66/EC Anmälningsplikt Elektriska och elektroniska produkter samt batterier Naturvårdsverkets EE och batteriregister Gäller företag som för in eller tillverkar och sätter sådan produkter på den svenska marknaden

23 Quality control of production The manufacturer must assure that each produced piece of equipment fullfils the requirements Responsible for implementation of the directives in Sweden Machinery Safety Directive - Arbetsmiljöverket ( Low Voltage Directive - Elsäkerhetsverket ( EMC Directive - Elsäkerhetsverket Medical Device Directive - Socialstyrelsen

24 Responsible for co-ordination of the market control and certification of third-part test laboratories SWEDAC - Styrelsen för ackreditering och teknisk kontroll Useful links - Sveriges provnings och forskningsinstitut - SWEDAC europa.eu.int/comm/enterprise/newapproach/legislation/ guide/legislation.htm - EU hemsida för the New Approach / - svensk EU-information

25 Risk assessment Standard SS-EN 1050:1996 Risk Seriousness of the injury Probability for the injury to occur Frequency and durability of exposure Probability that a risky event will occur Technical and human possibilities to avoid or limit injury Machine control unit Standard SS-ISO :1994 The construction of the system must be fault tolerant: A single fault must not lead to increased risk A single fault that is not discovered must not lead to increased risk if a second fault occures.

26 Risk assessment process Start Determining the boundaries of the machine Identifying the sources of risk Estimation of risk Evaluation of risk Is the machine safe? END Yes No Reduction of risk Menotreat 52

27 Ex: Risk assessment of a device Menotreat Pressure sensor Tubing Treatment balloon Display Keyboard Control unit Pump Heater Power supply Ex: Risk assessment of a device Menotreat Patient safety! LVD - electrical aspects, shock, leakage currents. MSD - machinery safety aspects, get jammed, (kläm), heat, EMC - immunity, emissions Material, Silicone-other Software-validation, fault tolerant.

28 The end

CE marking & your legal obligations

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