ce marking of machinery

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TÜV SÜD Product Service

CE Marking of Machinery

Presented by Paul LaidlerBusiness Director, The Machinery Division TÜV SÜD Product Service

• Machinery Directive.• Low Voltage Directive.• EMC Directive Evaluation and on site Field Testing.• Pressure Equipment Directive.• ATEX Directive.• PUWER Inspections.

Machinery Division


PUWER Inspections.• Country Wide Seminars.• In house tailor made Seminars.

TÜV SÜD Product Service are the PPMA preferred supplier for technical consultancy

related to regulatory matters in the UK & European Union

TÜV SÜD Product ServiceMachinery Safety

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The Manufacturer

The User

Responsibilities


Machinery Safety in respect of European Directives.

How Do We Comply ?


How Do We Comply ?


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Significance of CE.

• BENEFITS.

• IMPLICATIONS.


• REQUIREMENTS.

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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


• 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 1597.

• The Electrical Equipment ( Safety ) Regulations 1994 as amended. SI 3260.

• The Electromagnetic Compatibility Regulations


g p y g1992 as amended. SI 2372.

• The Pressure Equipment Regulations 1999 as amended. SI 2001.

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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;


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.



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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


whole.

What is a machine?


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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


operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool.



Lifting apparatus whose only power source is directly applied Human effort.


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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


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;


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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


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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


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.


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


classed as a repair and no action other than a risk assessment and compliance with PUWER 98 is required.

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Exemptions Extended to include

• Means of transport now includes trailers

• Household appliances

• Audio and video equipment

• IT equipment

Offi hi d i t


• 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 thatmachinery into service.

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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


• 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


Months in prison.

b) On conviction on indictment an unlimited fine and or 2 years in prison.

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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.

(£20,000.00 at this time).

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

How to comply


1. General. 2. Foodstuffs, Medical.

3. Mobile Machinery. 4. Lifting Equipment.

5. Underground Machinery. 6. Lifting or Moving of Persons.

EHSRs

• The first EHSR 1.1.2 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.

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EHSRs

1.3.1 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.


unexpected movement.

This requirement also applies during transportation, assembly, dismantling, scrapping and any other action involving machinery.

EHSRs

• 1.4.1 Guards and protection devices;

Must be securely held in place.


Guards must protect against the ejection or falling of materials and objects.

EHSRs

• 1.4.2.1 Fixed guards;

• Must be fixed with systems that can be opened only with tools.

Their fixing systems must remain attached to the


• Their fixing systems must remain attached to the guards when removed.

• Where possible guards must be incapable of remaining in position without their fixings.

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EHSRs

• 1.7.4 Instructions;

All machinery must be accompanied with instructions in an Official Community language or languages of the member state it is being placed


languages of the member state it is being placed on the market.

The word “original” must appear on the language version.

EHSRs

• 1.7.4 Instructions;

A translation must be provide by the manufacturer or his Authorised representative or by the person bringing the machinery into that language area


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


• To do this we can use EuroNorm ( EN Standards).

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EN Standards

The EHSR’s are mandatory the EN Standards are not however:

“Machinery manufactured in conformity with specified published European Harmonised


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.

TYPE C

STANDARDS

BS EN ISO 12100

Safety of machinery Basic concepts, general

principles for design Risk Assessment BS EN ISO 13849 - 1

Safety Related ControlSystems

BS EN 60204 - 1

ElectricalEquipment

EN Standards


for Machines

PR EN 418

Emergency Stop

SPECIFIC PROTECTIVEDEVICE STANDARDS

2 Hand ControlsLight Curtains

Safety Switches etc

BS EN 414

Safety of machineryRules for drafting andPresentation of safety

standards

BS EN ISO 13850

Emergency Stop

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EN Standards

Examples of “B” type standards.

• BS EN 953 Relates to the selection and manufacturing of Guards.


• BS EN ISO 13857 Relates to the positioning of guards to protect the upper limbs and the lower limbs.

EN Standards

BS EN ISO 13857

SCOPE.

• This standard establishes values for safety


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 13857


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BS EN ISO 13857


Examples of C type standards.

BS EN 415 “Safety of Packaging Machines” in 9 parts: part 4 applies to Palletisers and

EN Standards


De-Palletisers.

BS EN 10218 “Industrial Robots Recommendations for Safety”.

BS EN 12417 “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


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.

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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

How to comply


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


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Functional Safety

• ISO 13849

• IEC 62061


• Both these standards look at the Architecture of the safety system.

Functional Safety

• ISO 13849-1

• Is a replacement for EN 954-1 can be used for any energy source.

• But if a specifically designed PLC is controlling the safety system please refer to


controlling the safety system please refer to IEC 62061.

Functional Safety


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Functional Safety


Functional Safety

• ISO 13849-1

• 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))

D i t hit t th t i it bl f th


• Devise a system architecture that is suitable for the Performance Level

• Validate the design to check that it meets the requirements of the initial risk assessment

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Risk Graph


Further training

1 day machinery safety seminars:

• Bolton – March 6th

• York – March 14th

• Fareham – May 1st


• Peterborough – May 29th

• Scotland – June 7th

Bookings can be made at www.tuvps.co.uk/training

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 www.laidler.eu

Later this year

• Electrical Machinery Safety

• Functional Machinery Safety

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END


Tel. +44 (0) 1642 345637Fax +44 (0) 1642 345643

E-Mail: [email protected]

www.tuvps.co.uk

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