CE Marking of Machinery

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1 CE Marking of Machinery Presented by Paul Laidler Business Director, The Machinery Division Machinery Division Machinery Directive. Low Voltage Directive. EMC Directive Evaluation and on site Field Testing. Pressure Equipment Directive. ATEX Directive. PUWER Inspections. Country Wide Seminars. In house tailor made Seminars. are the PPMA preferred supplier for technical consultancy related to regulatory matters in the UK & European Union TÜV Machinery SÜD Product Service Safety 1

2 Responsibilities The Manufacturer The User Machinery Safety in respect of European Directives. HowDoWeComply? 2

3 Significance of CE. BENEFITS. IMPLICATIONS. REQUIREMENTS. 3

4 Directives that could apply The Machinery Directive 2006/42/EC. The Low Voltage Directive 2006/95/EC. The EMC Directive 2004/108/EC. The Pressure Equipment Directive 97/23/EC. Why do we have to comply? Because all of the European directives are brought into UK law by the issue of Regulations that make it a criminal offence punishable by fines and imprisonment not to comply. What are the Regulations? The Supply of Machinery ( Safety ) Regulations 2008 as amended. SI The Electrical Equipment ( Safety ) Regulations 1994 as amended. SI The Electromagnetic Compatibility Regulations 1992 as amended. SI The Pressure Equipment Regulations 1999 as amended. SI

5 Machinery Directive 2006/42/EC This Directive applies to the following products: (a) machinery; (b) interchangeable equipment; (c) safety components; (d) lifting accessories; (e) chains, ropes and webbing; (f) removable mechanical transmission devices; (g) partly completed machinery; Machinery Directive 2006/42/EC Firstly what is a machine? An assembly fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application. Machinery Directive 2006/42/EC 5

6 What is a machine? Definitions of Machinery that has to comply. An assembly of machines and / or partly completed machinery which, in order to achieve the same end are arranged and controlled to function as an integral whole. What is a machine? 6

7 Definitions of Machinery that has to comply. Interchangeable equipment means a device which, after placing into service with machinery or tractor is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool. Definitions of Machinery that has to comply. Lifting apparatus whose only power source is directly applied Human effort. 7

8 Definitions Lifting. An assembly of linked parts or components at least one of which moves and which are joined together, intended for lifting loads and whose only power source is direct applied human effort are included in the directive. lifting accessory means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself. Lifting Lifting Or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories; 8

9 Definition of a Safety Components. which serves to fulfil a safety function, which is independently placed on the market, the failure and/or malfunction of which endangers the safety of persons. Safety Devices Annex V Indicative list: Extraction systems. Guards and protection devices. Control devices for calling lifting appliances and anti fall devices for hoists. Protective devices designed to detect the presence of a person. Safety belts and seat harnesses. Hydraulic non return valves where they are used to prevent falls. Safety Devices 9

10 Other Scenarios If you are creating a complex assembly by interlinking a series of existing machines you are in Effect creating something new. Therefore who ever is carrying out the work must ensure that the whole assembly complies with the Directive. Regardless of the age of the machines. Other scenarios If you are altering the function or performance of a machine or complex assembly you are again creating something new and must ensure that the Directive is complied with. Changing Function or performance Changing a machine in a complex assembly or component in a single machine. If the function or performance are not altered this is classed as a repair and no action other than a risk assessment and compliance with PUWER 98 is required. 10

11 Exemptions Extended to include Means of transport now includes trailers Household appliances Audio and video equipment IT equipment Office machinery and equipment Circuit breakers and switches High voltage switch gear & transformers Motors of all types In-House machinery These regulations also applies to in-house machinery. a) where the manufacturer of relevant machinery himself puts that machinery into service. b) having imported machinery from a country or territory outside the EEA, puts that machinery into service. 11

12 Responsible Person The manufacturer or his Authorised Representative must carry out a Risk Assessment on the machinery in order to determine the health and Safety Requirements which apply to the machinery have been met. The manufacturer or his Authorised Representative must determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof. If you don t comply... Non compliance Could result in prosecution and penalties. a) On summary conviction a fine not to exceed the statutory maximum ( 20,000) and or 12 Months in prison. b) On conviction on indictment an unlimited fine and or 2 years in prison. 12

13 Penalties Failure to provide a Technical File. Failure to provide operating instructions. Failure to provide a Declaration of Conformity. Incorrect application of the CE mark. None application of the CE Mark. A fine not exceeding level 5. ( 20, at this time). How to comply Step 1 The Essential Health and Safety Requirements. 1. The EHSR s laid down in the Directives are mandatory. 2. They are split into six sections: 1. General. 2. Foodstuffs, Medical. 3. Mobile Machinery. 4. Lifting Equipment. 5. Underground Machinery. 6. Lifting or Moving of Persons. EHSRs The first EHSR asks us to carry out a risk assessment. First we must identify all the hazards, that is any thing that has the potential to cause harm. Then we must access the risk, that is the likelihood of a person or persons coming into contact with the hazard and how much damage it would cause. 13

14 EHSRs Stability; Machinery and its components must be designed and constructed that they are stable enough for use without risk of overturning, falling or unexpected movement. This requirement also applies during transportation, assembly, dismantling, scrapping and any other action involving machinery. EHSRs Guards and protection devices; Must be securely held in place. Guards must protect against the ejection or falling of materials and objects. EHSRs Fixed guards; Must be fixed with systems that can be opened only with tools. Their fixing systems must remain attached to the guards when removed. Where possible guards must be incapable of remaining in position without their fixings. 14

15 EHSRs Instructions; All machinery must be accompanied with instructions in an Official Community language or languages of the member state it is being placed on the market. The word original must appear on the language version. EHSRs Instructions; A translation must be provide by the manufacturer or his Authorised representative or by the person bringing the machinery into that language area. These instructions must be marked with the word Translation. EN Standards Now we have decided on the control measures we must ensure that they will comply with the EHSR s. To do this we can use EuroNorm (EN Standards). 15

16 EN Standards The EHSR s are mandatory the EN Standards are not however: Machinery manufactured in conformity with specified published European Harmonised standards will be presumed to comply with Essential Health and Safety Requirements covered by those standards EN Standards There are three types of standard. A type apply to all machines. B type are designed to promote safety and split in to B1 and B2. C type apply to a specific type of machine. EN Standards BS EN Electrical BS EN ISO Equipment Safety of machinery Basic concepts, general principles for design Risk Assessment BS EN ISO Safety Related Control Systems TYPE C STANDARDS for Machines BS EN 414 Safety of machinery Rules for drafting and Presentation of safety standards BS EN PR ISO EN Emergency Stop SPECIFIC PROTECTIVE DEVICE STANDARDS 2 Hand Controls Light Curtains Safety Switches etc 16

17 EN Standards Examples of B type standards. BS EN 953 Relates to the selection and manufacturing of Guards. BS EN ISO Relates to the positioning of guards to protect the upper limbs and the lower limbs. EN Standards BS EN ISO SCOPE. This standard establishes values for safety distances to prevent danger zones being reached by the upper limbs of persons of 3 years of age and above. Values for safety distances to prevent danger zones being reached by the lower limbs of persons of 14 years of age and above. BS EN ISO

18 BS EN ISO EN Standards Examples of C type standards. BS EN 415 Safety of Packaging Machines in 9 parts: part 4 applies to Palletisers and De-Palletisers. BS EN Industrial Robots Recommendations for Safety. BS EN Safety of Machine tools Machining Centres. How to comply Step 2 the Technical Construction File (TCF). The TCF will be required to be produced by the responsible person if there is a reason to doubt that the machine conforms with the Directive. It can be kept electronically however you must be able to assemble it in a time given by the enforcement authorities. The figure being banded around is 48 hours. 18

19 How to comply Step 2 the Technical Construction File (TCF). The file must be kept for a period of ten years after production of the last machine of the type that the TCF refers too. The TCF is the only way to demonstrate that you have complied with the EHSR s and other provisions of the Directive. How to comply Step 3 How to comply Step 4: Affix the CE Marking 19

20 Functional Safety ISO IEC Both these standards look at the Architecture of the safety system. Functional Safety ISO Is a replacement for EN can be used for any energy source. But if a specifically designed PLC is controlling the safety system please refer to IEC Functional Safety 20

21 Functional Safety Functional Safety ISO Introduces Performance levels (probability of a dangerous failure per hour) a,b,c,d,e. Based on the Safety Related Parts of the control system (SRP/CS). Data to be obtained from manufacturer Mean Time To (dangerous) Failure MTTD. Four stage approach Perform a risk assessment For the identified risks, allocate the safety measure (Performance Level (PL)) Devise a system architecture t that t is suitable for the Performance Level Validate the design to check that it meets the requirements of the initial risk assessment 21

22 Risk Graph Further training 1 day machinery safety seminars: Bolton March 6 th York March 14 th Fareham May 1 st Peterborough May 29 th Scotland June 7th Bookings can be made at Further training University Certificate in Professional Development European Machine Safety Requirements Unique, university accredited course for machinery safety CE, PUWER, Risk Assessment, EN Standards Dates and online booking currently available at Later this year Electrical Machinery Safety Functional Machinery Safety 22

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