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Implementation of Technical Regulations on Company Level

Breakout session

Safety of Machinery Directive

Expert: Robert Huigen

Chamber of Commerce and Industry, Ljubljana

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Community Policy (I)

Main goals:

• safety of equipment

• environmental acceptability

• economic efficiency

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Community policy (II)

Tools:

• European regulations– Machinery directive (98/37/EC)– Workers’ safety directive (89/655/EEC)– supplementary: European standards (CEN &

CENELEC)

• national regulations

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New Approach European Directives

• mandatory through national legislation

• give essential safety- and health requirements

• provide certification procedures

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Compliance of products with applicable European Directives

by :

• common Essential requirements

• common certification procedures

• using European standards

• verification tests by (no)tified (bo)dies

• appropriate measures by member states

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European standards

• implemented nationally as:

BS EN, DIN EN, NF EN, SIST EN, etc.same content, different language

• technical implementation (requirements & test methods) of essential requirements of the relevant New Approach directive

• Compliance with standards is voluntary

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Types of machinery standards

• type A: deals with basic safety concepts applicable to all types of machinery

• type B: deals with one safety aspect that can be applied to wide range of machinery

• type C: deals with detailed safety requirements for specific (or group of) machines or safety components

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New Approach Directives and European standards

The use of European standards gives the presumption of conformity with the essential requirements of the relevant

directive

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Useful definitionsfrom the view of the Machinery directive• Machine: ready to use

e.g. turning machine, hydraulic excavator, compressor, hydraulic jack, wood working machine

• Safety component: primary function contributes to safety machine and placed on the market separately e.g. lightscreens, emergency stop devices, roll bars

• Component: all other machinery partse.g. frames, vessels & piping, bolts & nuts, driving components & gearboxes, wheels & borders

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Machinery: definition (I)Three cumulative requirements :1) an assembly of linked parts or

components, at least one of which moves,

2) with the appropriate actuators, control and power circuits etc.,

3) joined together for a specific application,in particular for the processing, treatment, moving or packaging of a material

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Machinery: definition (II)

Definition put in a different way :

“Machinery can only be marked with CE if :

• the product is ready for use by the end user

• the final product can function independently without the help of any other machinery or component in order to fulfil its function, apart from the supply of energy”

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Machinery: definition (III)

Also considered as machinery are :• an assembly of machines or complex

installation (e.g. production line)

• interchangeable equipment (e.g. all machinery towed by a tractor)

• safety components (e.g. emergency stop device)

• all lifting accessories (specific form of interchangeable equipment)

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Declarations of conformity (I)

Three types of declarations :

• II A : declaration of conformity for machinery within the scope of the Machinery directive (mandatory)

• II C : declaration of conformity for safety components within the scope of the Machinery directive (mandatory)

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Declarations of conformity (II)

II B : free declaration in which the manufacturer states that the product does NOT comply with the Machinery directive (not mandatory)(meant for business-to-business purposes only,

content of II B declaration often already part of the quotation)

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Declarations of conformity (III)

• business name of the manufacturer or name of the authorized representative established in the EEA

• full address, place and country• description of the machinery (make, type, serial

number etc.)• applicable directive(s)• applicable standard(s) or other such specifications• name and address of the notified body involved• Identification of the person signing

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MANUFACTURERType of

machine and safety components

Manufacturer choice

Technical Construction file

(Annex V)

EC type examination (Annex VI) MODULE

B (*)

Technical file (Annex VI) sent to nofied Body

Technical file (Annex VI) submitted to N.B.

for certification of adequacy for the file

EC type examination (Annex VI) MODULE

B (*)

EC Conformity declararation with

essential requirements MODULE A

Conformity declaration to type covered by the EC type examanation

MODULE C (*)

Not referred to in Annex IV

Referred to in Annex IV and complying with

standards

Rerred to in Annex IV,

without meeting or only partly meeting the

standards, or if no such

standards exist

Certification procedure (I)

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A Notified body is : Designated by a member state and notified to the

Commission A third party with the competence to evaluate the

conformity of the products referred to the directive concerned

Only notified for machinery and safety components listed in Annex IV (one or more of the items listed)

Meets the requirements laid down in annex VII

Notified bodies (I)

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A Notified body :

Carries out EC-type examinations as described in annex VI

Draws up EC-type examination certificatesKeeps a copy of the technical file

Notified bodies (II)

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Meets the criteria in a harmonized standard, e.g. en 45001Shall have a quality systemDo not have to be approved by member statescan be used when a manufacturer doesn’t have the skills or resources to verify the requirements of a standardprovides testing and/or measurements

Competent bodies

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CE marking (I)

• Always CE: on machines

• Never CE: on safety components falling within the scope of the Machinery directive

• Choice of CE: equipment showed at trade fairs

• CE marking always possible on the basis of other directives

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CE marking (II)

Excluded from the obligation of CE markingmachinery on trade fairs, exhibitions, etc. but :• keep visitors at a safe distance• take care of adequate safety measures during

demonstrations (e.g. authorized operators)• provide in a visible sign that clearly indicates that

such machinery or safety components do not conform and that they are not for sale in the showed form

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CE marking (III)

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How to prove conformity?

By

1 inventory of all hazards emanating from the machine

2 risk-analysis (which hazards can turn into risks?)

3 risk-evaluation (comparising of risks)

4 risk-reduction (in this given order : by redesign, protection measures, information to user)

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Dealing with safety

in this imperative order:

• integrate safety (built-in safety by design)

• reduce residual risks by shielding and/or guarding

• warn and inform in case of inevitable risks (indicate whether specific training and/or personal protective equipment are required)

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Nature of possible hazards

• mechanical (moving parts)

• energy source (electrical, hydraulical, thermical etc.)

• ergonomical (physical stress, work position, man-machine-interface, noise etc.)

• other (general work place safety)

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Technical file

• the manufacturer must be able to produce a technical file comprising all safety related information on request of the competent national authorities

• it must be kept available for the authorities for at least 10 years following the date of manufacture of the machinery or of the last unit produced, in the case of a series manufacture

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Contents of the technical file (I)

The technical file contains at least :• an overall drawing of the machinery together

with drawings of the control circuits,• full detailed drawings, accompanied by any

calculation notes, test results etc. required to check the conformity of the machinery with the essential health and safety requirements,

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Contents of the technical file (II)• a list of :

– the essential health and safety requirements,– standards,– other technical specifications, which were used

when the machinery was designed ;• a description of methods adopted to eliminate

hazards presented by the machinery,• if he so desires, any technical report or certificate

obtained from a competent body or laboratory,

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Contents of the technical file (III)• if he declares conformity with a specified

European standard which provides therefore, any technical report giving the results of tests carried out at his choice either by himself or by a competent body or laboratory,

• a copy of the instructions for the machinery,• for series manufacture, the internal measures that

will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

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Safety related changes to machinery

• changing performance (e.g. velocity, capacity, power)

• other destination (e.g. excavator becomes lifting equipment)

• new application (e.g. sawing of different product, aluminium on woodworking machine)

• new combination (of production line)

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Changing of machinery already put into service (I)

Machinery with CE :

• Any safety related change includes a new risk assessment of the whole machinery

• performer of the change :– becomes manufacturer of a changed product:

placing on the market starts again!– must draw up a new declaration of conformity,

an additional technical file and manual

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Changing of machinery already put into service (II)

Machinery without CE :• Any safety related change includes a risk

assessment of the whole machinery• performer of the change:

– becomes manufacturer of a new product– must draw up a declaration of conformity, a

technical file and a manual– must affix the CE marking

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Production lines (I)

Production line without the CE marking:• It is allowed to consider the replacing of separate

modules (machines) as replacing of parts of the production line (spare parts must be comparible in design, performance, etc.)

• spare parts must not (but advisable) bear the CE marking if applicable

• safety related changes to one module do not lead to the CE marking of the whole production line

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Production lines (II)

Production line without the CE marking :• Notice ! Any other changes than replacing worn-

out parts/machines can lead to the CE marking of the relevant module or even the complete line!– e.g. replacing the complete control system by a

different type and/or lay-out leads to the CE marking of the whole line!

– e.g. replacing one module by a CE marked module does not lead to the CE marking of the whole line!

– always look at interacting risks!

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Production lines (III)

The production line as a whole is CE marked :

• Any safety related change includes a new risk assessment of the whole line

• performer of the change :– becomes manufacturer of a changed line:

placing on the market starts again!– must draw up a new declaration of conformity,

an additional technical file and manual

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Production lines (IV)

Changing activities by the user and possible loss of product liability :

• the performer - as the new manufacturer - becomes first in liability

• the original manufacturer of the complete line or separate module remains liable for those parts of his product not being influenced by any changes (now becomes second in liability)

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Machinery directive and Workers’ safety directive

• employer always responsible for the health and safety of the worker

• employer responsible for the suitability of the work equipment put at the workers’ disposal

• manufacturer responsible for the intrinsic safety of his products

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Product liability (I)(85/374/EEC)

• Definition of product liability

• Addressees of product liability

• Calling in of product liability

• Expiration of product liability

• CE and product liability

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Product liability (II) (85/374/EEC)

• Manufacturers/producers/importers/brand name owners:– Risk-based liability for safety of product– Reversal of the burden of proof

• Trade:– Liable for product quality– burden of proof with purchaser

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The basic manual structure (I)

Title page

Preface/foreword1. Introduction2. Description and process information3. Safety4. Transport and storage5. Mounting/assembling and installation

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The basic manual structure (II)

6. Commissioning7. Operation8. Troubleshooting9. Cleaning and maintenance10. Overhaul11. Dismantling and disposal

Index

Appendices

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How does a technical writer work Additional information (not in the Machinery Directive)

• Find the essential source information

• Design the text structure

• Write the draft text

• Prepare the final text

• Validate

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Different kinds of texts in manuals Additional information (not in the Machinery Directive)

• General introductory texts

• Texts that describe machinery parts

• Texts that describe process information

• Texts that describe working instructions- descriptive- imperative

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Formulating technical instructions (I) Additional information (not in the Machinery Directive)

A complete set of instructions consists of four parts :

1) number the action or use typographical symbols

2) use the imperative mood to formulate the action (e.g. ‘push button A’)

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3) give the why, the meaning of the action, the process that starts

4) indicate the possible check oncorrectness of the action or the cause of

the action

Formulating technical instructions (II) Additional information (not in the Machinery Directive)

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Different ways to present instructions Additional information (not in the Machinery Directive) • structured texts

• visual algorithms

• flow charts

• questionnaires

• illustrations and (line) drawings

• photographs

• quick reference guide