CE Compliance. Silva Management. September 18th, 2014 David Norris. C Eng. FI Mech E.

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3 David Norris C Eng. FI Mech E. Recent employment positions. Consultant to Machine Tool companies. Technical Director, Bridgeport Machines Ltd. Engineering V.P., Bridgeport Machines Inc.

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5 We will consider why we have a CE mark. We will look at some history. Have a brief look at legislation. Overview of what procedures Manufacturers and Importers of machinery need to consider. Look at documentation that should be prepared. We will look at an example. We will end with questions, and any discussion that arises.

6 So, why a CE Mark? It enables free movement throughout the EU and EFTA. The UK legislation to enable CE use was in 1992 BUT, It is not a mark to signify quality However, quality is implicit within the marked product. It is mandatory on most electro-mechanical goods, but not everything. AND It is a mark recognised throughout the world, not just in Europe.

7 What goods are required to be CE marked. Machinery Electrical equipment Electronic equipment Personal protective equipment Pressure equipment Medical devices Radio and telecommunication equipment Gas appliances Lifts Recreational equipment Construction products Hot water boilers Measuring equipment Not required for; Chemicals Pharmaceuticals Cosmetics Foodstuffs

8 So, what is the history? Robert Schuman, French politician Jean Monnet, French diplomat The Schuman plan was published in 1950.

9 The Schuman plan. The plan argued a case for the control of production of materiel that would be essential for preparation of war. They proposed a Higher Authority to pool the production of Coal and Steel. Six mainland European countries saw the political and economic benefits, and the European Coal and Steel Community was established in 1951.

10 Further European integration The Coal and Steel Community led to greater European conversations and to the Treaty of Rome in So, now we have the Common Market

11 Political integration continues apace, viz; 1973 UK join the Common Market 1986 The Single European Act is signed, that is, greater political integration is agreed The Polish shipyard strikes begin the start of the eastern Europe break-up 1989 Berlin wall falls, and Germany is unified Maastricht and the formation of the EU.

12 In terms of free movement of goods, the key signing was the Single European Act of The Act established the principles of free movement of goods and people, and set the objective of achieving a single market by the end of So, standards had to set and agreed. A good historic example of trade conflict is the German Beer purity law of 1516

13 Europe, in the late 1980s was well-placed to set the required standards needed. Each country had it s own well-established National Standards organisation.

14 BSi, established in 1901 AFNOR, created in 1926 DIN, formed in 1917 IEC, formed in 1906 ISO, formed in 1947 CEN, Formed in (Issues EN standards)

15 So, back to the question of free movement. Political integration continues apace, and in respect of the safety of goods, Directive 89/392/EEC was issued. Transposed into UK law by the Supply of Machinery (Safety) Regulations There have been amendments to the requirements.

16 The UK, and all other countries (but of course following our lead), have had safety legislation within the workplace for many years. We have also had product standardisation for many years, but little in the way of product safety legislation.

17 The Supply of Machinery Act specifies that duties relating to Machinery Safety are laid on designers and suppliers of machinery for use at work. This is a so-called Product-Directive, and the relevant products have to meet certain Essential health and safety requirements ( EH&SR s ) The affixing of the CE mark claims compliance with all relevant EU Directives.

18 EH & SR s Principles of safety integration Materials and products health and safety Lighting Lifting Reliability of the control system Control devices Starting and stopping devices Emergency stops Mode selection Power supply failure Stability. Risk of break-up during operation Risk of ejected objects Hazards associated with moving parts Characteristics of the guarding Fire, explosion, noise, vibration, radiation etc.

19 Conformity Assessment procedures Most machinery is assessed through the production of a Technical file. The technical file is the record of actions and decisions taken throughout the product development, as; initial specification design development and testing production and market introduction.

20 The importance of good documentation. Every company producing machinery should consider formal registration to ISO Ideally accreditation to ISO should also be sought.

21 Technical file content. A general description of the machinery. Overall drawing of the machinery. Circuit diagrams and control flowcharts. Design notes and calculations. Any test results. Design reviews. Minutes of Risk Assessments made against the relevant EH & SR. Description of protective measures taken to eliminate identified hazards and indications of residual risks. A copy of the instructions for the machinery. Any Declaration of Incorporation of assemblies used. A copy of the Declaration of Conformity.

22 Reference to the European Standards. For machinery (in general) the following standards will apply; EN : 2007 Safety of Machinery, Risk Assessment together with, EN 60204:2006 EN 12100: 2010 Safety of Machinery, Electrical Safety of Machinery, General principles

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26 CE Compliance Technical file content. A general description of the machinery. Overall drawing of the machinery. Circuit diagrams and control flowcharts. Design notes and calculations. Any test results. Design reviews. Minutes of Risk Assessments made against the relevant EH & SR. Description of protective measures taken to eliminate identified hazards and indications of residual risks. A copy of the instructions for the machinery. Any Declaration of Incorporation of assemblies used. A copy of the Declaration of Conformity.

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28 Technical file content. A general description of the machinery. Overall drawing of the machinery. Circuit diagrams and control flowcharts. Design notes and calculations. Any test results. Design reviews. Minutes of Risk Assessments made against the relevant EH & SR. Description of protective measures taken to eliminate identified hazards and indications of residual risks. A copy of the instructions for the machinery. Any Declaration of Incorporation of assemblies used. A copy of the Declaration of Conformity.

29 An example of a machinery product.

30 What did the designers have to think about to achieve CE compliance? Start first with the relevant EU standards. 2006/95/EC Low Voltage Directive. 2004/108/EC Electromagnetic Compatibility Also think about Instructions to be supplied with the product.

31 2006/95/EC Low Voltage Directive.

32 2006/95/EC Low Voltage Directive.

33 2006/95/EC Low Voltage Directive.

34 CAUTION CAUTION SIGNS FOR INSTALLATION Keep ventilation opening in the appliance enclosure or mounting structure clear of obstruction. Allow the appliance to stand for 2 hours after installation. The installation or any service of this appliance is recommended by a qualified technician or service company. - Failing to do so may result in an electric shock, fire, explosion, problems with the product, or injury. WARNING SEVERE WARNING SIGNS FOR USING Do not touch the power plug with wet hands. - This may result in an electric shock. Do not store articles on the top of the appliance. - When you open or close the door, the articles may fall and cause a personal injury and/ or material damage. Do not put items filled with water on the refrigerator. - If spilled, there is a risk of fire or electric shock. Do not touch the inside walls of the freezer or products stored in the freezer with wet hands. - This may cause frostbite. Do not use or place any substances sensitive to temperature such as inflammable sprays, inflammable objects, dry ice, medicine, or chemicals near the refrigerator. Do not keep volatile or inflammable objects or substances (benzene, thinner, propane gas, alcohol, ether, LP gas and other such products etc.) in the refrigerator. - This refrigerator is for storing food only. - This may result in a fire or an explosion. Do not store pharmaceuticals products, scientific materials or temperature-sensitive products in the refrigerator. - Products that require strict temperature controls safety information _07 must not be stored in the refrigerator. Do not place or use electrical appliance inside the refrigerator/freezer, unless they are of a type recommended by the manufacturer. If you smell pharmaceutical or smoke, pull out power plug immediately and contact your Samsung Electronics service center. If any dust or water is in Refrigerator, pull out power plug and contact your Samsung Electronics service center. - Otherwise there is a risk of fire. If gas leak is detected, avoid any naked flames or potential sources of ignition and air the room in which the appliance is standing for several minutes. Do not use mechanical devices or any other means to accelerate the defrosting process, other than those recommended by the manufacturer. Do not damage the refrigerant circuit. 08_ safety information Do not spray volatile material such as insecticide onto the surface of the appliance. - As well as being harmful to humans, it may also result in an electric shock, fire or problems with the product. Do not use a hair dryer to dry the inside of the refrigerator. Do not place a lighted candle in the refrigerator for removing bad odours. - This may result in an electric shock or fire. Fill the water tank, ice tray and water cubes only with potable water (mineral water or purified water). - Do not fill the tank with tea, juice or sports drink, this may damage the refrigerator. Do not let children hang on the door. If not, a serious injury may occur. - Risk of children entrapment. Do not let children enter inside the refrigerator. Do not leave the doors of the refrigerator open while the refrigerator is unattended and do not let children enter inside the refrigerator. Do not allow babies or children go inside the drawer. - It can cause death from suffocation by entrapment or personal injury. Do not sit on the Freezer door. - The door may be broken and cause a personal injury. To prevent children entrapment, you must reinstall the divider using provided screws after cleaning or other actions if you removed the divider from the drawer. Do not use mechanical devices or any other means to accelerate the defrosting process, other than those recommended by the manufacturer. Do not damage the refrigerant circuit. Do not put fridge shelf in upside down. Shelf stopper could not work. - It may cause a personal injury because of glass shelf drop. In the event of a gas leak (such as propane gas, LP gas, etc.), ventilate immediately without touching the power plug. Do not touch the appliance or power cord. Do not use a ventilating fan. - - A spark may result in an explosion or fire. Use only the LED Lamps provided by manufacturer or service agent. Children should be supervised to ensure that they do not play with the appliance. Keep fingers out of pinch point areas; clearances between the doors and cabinet are necessarily small. Do not let children hang on the door. If not, a serious injury may occur. There is a Risk of children entrapment. Do not let children enter inside the refrigerator. Bottles should be stored tightly together so that they do not fall out. This product is intended only for the storage of food in a domestic environment. safety information _09

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36 Summary. I am confident that major on-shore manufacturers do take the affixing of a CE seriously. I am equally confident that major companies importing goods from outside the EU also take the regulations seriously. But, not so sure about some imports, especially from South-East Asia.

37 Summary. CE Compliance To be sure that the goods are compliant, check the Certificate of Conformance, and look at the signature, the name of the person and the address validating the declaration. It has been my experience that major manufacturers in Japan, Korea, Taiwan and China are the most competent and thorough in the assessment against the Regulations.

38 Summary. Questions and discussion.