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A division of TÜV SÜD Product Service 1

Working safely with machines

Presented by Derek Coulson


Laidler Associates

Laidler Certification/BABT

Notified Body on the

Machinery Directive

and the EMC Directive

NB No: 0870.

Safety Systems

Technology

Providers, Designers and Installers of

Safety Related Control Systems and

Guarding to EN Standards.

Laidler Associates are the PPMA preferred supplier for technical consultancy related to regulatory matters in the UK & European Union


Laidler Associates

• 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.

• Validation of Safety Related Control Systems


ResponsibilitiesThe Manufacturer

The User


Machinery Safety in respect of European Directives.

How Do We Comply ?


Directives that could apply to machinery.

• 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.

• Amending Directive to the Use of Work Equipment Directive (PUWER 98)


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.

Regulations are based on ‘New Approach’ Directives.

CE Marking to the Machinery Directive came into force in 1995 – there is NO excuse for manufacturers not to comply.


The Machinery Directive how to comply• Demonstrate compliance with the Essential Health and

Safety Requirements.

• Carry out the appropriate conformity assessment procedure (Tech File ).

• Draw up and issue the Declaration of Conformity or Incorporation.

• Apply the CE Mark.

• Make sure that it is safe.


The Low Voltage Directive how to comply• Demonstrate compliance with the Safety Requirements.

• Carry out the appropriate CE marking requirements

( Tech File ).

• Draw up and issue the Declaration of Conformity.




The EMC Directive how to comply• Demonstrate compliance with the Essential Protection

Requirements.

• Generally need to carry out EMC Testing.

• Carry out the appropriate conformity assessment procedure ( Tech File ).

• Draw up and issue the Declaration of Conformity.



Pressure Equipment Directive how to comply

• Demonstrate compliance with the Essential Safety Requirements.

• Carry out the appropriate conformity assessment procedure ( Tech File ).

• If not Sound Engineering Practice, Notified Body required.• Draw up and issue the Declaration of Conformity • Apply the CE Mark.



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;


Definitions of Machinery that must 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.


Definitions of Machinery that must 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.


• 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.

• 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;


Safety devices that fall under the scope of the Directive 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 that fall under the scope of the Directive Annex V Indicative list continued

• Electro sensitive devices.

• Monitoring devices for loading and movement control in lifting machinery.

• Safety logic units for E stops or interlocks.

• Solenoid valves controlling dangerous movements of machinery.


Other Scenarios where the Machinery Directive could apply

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.


• The manufacturer or the importer will generally have to be able to assemble a file containing technical information relating to the machine.

• The machine will have to carry the CE mark and other information.

• Normally this is a self certification process, however if the machine is listed in annex 4 of the directive, then it will probably have to be examined by a notified body.


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.


• Manufacturer

• means any natural or legal* person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;

• Legal personality refers to the ability of an organisation to enter into legal transactions such as holding property or entering into debt. Such as a company.

Article 2 Definitions


• Name and address of the person authorised to compile the technical file, who must be established in the Community;

• The person authorised to compile the technical file is a natural or legal person established in the Community who has been entrusted by the manufacturer with the task of assembling and making available the relevant elements of the technical file in response to a duly reasoned request from the market surveillance authorities of one of the Member States.

• The person authorised to compile the technical file is not, as such, responsible for the design, construction or conformity assessment of the machinery, for drawing up the documents included in the technical file, for affixing the CE marking or for drawing up and signing the EC Declaration of Conformity.

Article 2 Definitions


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 and or 3 Months in prison.

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


How to comply - The Essential Health and Safety Requirements.

The EHSR’s laid down in the Directives are mandatory.

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.


How to comply step 1 the EHSR’s.

• The first EHSR 1.1.2 requires 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.


Control Measures Hierarchy.

• Design the hazard out.

• Remove the need for man machine interface.

• Design in safeguards.

• Reduce the possibility of occurrence.

• Reduce the degree of harm.

• Warn and inform (but only if you can achieve adequate safety).


EuroNorm ( EN Standards ).• Once 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 ).

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”


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

for Machines

BS EN ISO 12100-1 & 2

Safety of machinery Basic concepts, general

principles for designBS EN 954 /EN 13849

Safety Related Control

Systems

PR EN 418

Emergency Stop

SPECIFIC PROTECTIVE

DEVICE STANDARDS

2 Hand Controls

Light Curtains

Safety Switches etc

BS EN 60204 - 1

Electrical

Equipment

BS EN 414

Safety of machinery

Rules for drafting and

Presentation of safety

standards

BS EN 14121-1

Safety of machinery

Risk Assessment

BS EN ISO 13850

Emergency Stop


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.


Examples of C type standards.

BS EN 1853 Agricultural machinery. Trailers with tipping body. Safety.

BS EN ISO 4254-1 Agricultural machinery. Safety. General requirements.

BS EN 474 Series Earth Moving Equipment.


Technical Construction File (TCF).• The TCF must be produced by the responsible person if

there is 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 authorities.

• The file must be kept for ten years after production of the last machine of the type that the TCF refers to.

• The TCF is the only way to demonstrate that the EHSR’s and other provisions of the Directive have been complied with.


The operation and instruction manual should contain:

1. A repeat of the information with which the machine is marked.

2. A spare parts list and drawings.

3. Instructions for safe use, putting into service, maintenance, cleaning, adjustment, handling, assembly, dismantling, training, special tools, and noise levels.

4. In the language of the country of intended use.


• It is up to the manufacturer to ensure that the machine can be transported, unloaded, installed, commissioned, scrapped and put into use safely.


Step 3

Declaration of Conformity or Incorporation.

This has to accompany the machine.


Changes to the Declaration of Conformity.

• Name and address of the person who is authorised to compile the Technical File, who must be established in the European Community.

• Where appropriate a statement confirming declaration of conformity with other applicable directives.

• The place and date of the declaration.


The Declaration of Incorporation is used with a machine which is specifically designed to be incorporated into a complex assembly and not capable of independent work.


The CE Mark denotes that the manufacturer has declared his product in compliance with all applicable Directives.

It is illegal to affix the CE mark to a machine unless it complies with all applicable Directives.


PUWER 98.

Implementing the Work Equipment Directive 89/655/EEC.

APPLIES TO ALL WORK EQUIPMENT REGARDLESS OF AGE, INCLUDING CE MARKED EQUIPMENT.


PUWER 98.

Made under the Health & Safety at Work Act 1974.

Only applies where the HSWA applies.

Does not require a CE mark, Technical File or Declaration of Conformity.


LAY OUT OF PUWER 98.

•Part I Introduction.

•Part II General. Regs 1 to 24.

•Part III Mobile Work Equipment. Regs 25 to 30.

•Part IV Power Presses. Regs 31 to 35.

•Part V Miscellaneous. Regs 36 to 39.


PUWER 98.

Regulations 1 to 9 with the exception of regulation 6 are to do with Policies and Procedures and cover 3 main sections.

•Maintenance.

•Operators.

•General.


Regulation 6 Inspection.

Where the safety of work equipment depends on installation it must be inspected:

a) After installation and before being put into service for the first time or

b) After assembly at a new site or in a new location.

c) At suitable intervals, and

d) Each time circumstances liable to jeopardise the safety have occurred.


Regulation 10 Conformity with Community Requirements.

Requires that an Employer must ensure that any equipment that is subject to European Directives complies with all applicable Essential Health and Safety Requirements of the Directives that apply to it.

Declaration of conformity / incorporation.

Relevant paperwork, documents, instructions etc.


Regulations 11 to 24 look at the specific safety requirements for machinery.Regulation 11 Dangerous parts of machinery, guards etc

Regulation 12 Protection against specified hazards, fire etc

Regulation 13 High or Very Low Temperatures

Regulation 14 Controls for Starting or Making a Significant Change in Operating Conditions

Regulation 15 Stop Controls

Regulation 16 Emergency Stops

Regulation 17 Controls


Regulations 11 to 24 look at the specific safety requirements for machinery.Regulation 18 Control Systems

Regulation 19 Isolation of Energy Sources

Regulation 20 Stability

Regulation 21 Lighting

Regulation 22 Maintenance

Regulation 23 Markings

Regulation 24 Warnings


Regulations 25 to 29 - Mobile work equipment

No employee is to be carried by mobile work equipment unless- It is suitable for carrying persons.

If there is a risk of crushing by work equipment rolling over it must be fitted with a suitable restraining system.

Stabilising the work equipment. ROPS, FOPS & TOPS.

Roll over protective structure, Fall over protective structure, Tip over protective structure.


Control Integrity.

Which Standard to use?

EN 954-1

EN 13849 – 1

EN 62061


Safety Related Control Systems• The old standard for SRCS was EN 954, based on

redundancy, the more dangerous the machine, the more redundancy was built in.

• This was superseded, although due to problems with the replacement standards, the use has been extended until end of 2011.

• EN 13849 and EN 62061 are both based on architecture of control systems, and work on mean time to failure of components.


Safety Related Control Systems• EN 13849 uses Performance Levels a to e.

• EN 62061 uses Safety Integrity Levels 1 to 3.

• Both standards are good for new systems where data is available for components, and wiring diagrams and parts lists are available for the build of the machine.

• Both require validation, a free software package is available from www.bgia.de, called SISTEMA, this is suitable for EN 13849 only.

• At a recent symposium in Brussels, the conclusion appeared to be that machine builders need help.

http://www.bgia.de/


CONCLUSION

• If buying machinery, ensure it is CE marked correctly, all documentation available.

• If using machinery, ensure PUWER assessments are carried out and up to date.

• Any questions please ask now, or later at

[email protected]

mailto:[email protected]


Thank you for your

attention

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