ce machinery directive

8/13/2019 CE Machinery Directive

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S. Haugen &M. Rausand

EU Directives

MachineryDirective

Machinery

Annexes

EHSR

CE-mark

Dangerousmachines

Declaration of conformity

Standards

Risk reduction

Riskassessment

Risk AssessmentSection 17.10

The EU Machinery Directive

Stein Haugen Marvin [email protected] [email protected]

RAMS GroupDepartment of Production and Quality Engineering

NTNU

(Version 0.1)

S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 1 / 41
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European legislation

The legislation in the European Union (EU) builds on:

RegulationsDirectives

European (EN) Standards



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The EU open market requires

Free movement of:GoodsPersonsServicesCapital

To obtain free movement of goods, we have to removebusiness barriers like:

Physical barriers (controls at national borders) Technical barriers (national safety requirements)Fiscal (nancial) barriers (taxes)



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The new method

Directives give basic requirements to safety, health,and the environment (SHE) ( - and do not containtechnical specications)

Technical specications are given in harmonizedstandards

It is up to the user whether or not she wants to complywith the standards

Products that are made according to harmonizedstandards are assumed to comply with the directives

Essential health and safety requirements (EHSR)

The new approach was created to overcome thedifculties of the old approach, which lead to highlytechnical and complex directives.



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New method directives

EU C ommission

EU P arliament

EU Directive

EN Standards

National laws

EU New method (1985 -)Essential health and safetyrequirements (EHSR)

Harmonized standards

t

CEN, CENEL EC, ETSI

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Two main types of directives

Business barrier directives (100A)(e.g., the Machinery Directive). These directives arealso called maximum directives

Minimum directives (118A)(e.g., the Environmental Impact Assessment (EIA)Directive, and the Seveso II Directive)



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Benets of product directives

Before, manufacturers had to comply with multipleconicting national compliance systems

A product that complies with the requirements can besold in all member countries in EU/EEA

The required activities may result in safer productsand/or enhanced manufacturing processes



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Standards organizations

The EU standards are developed by:

CEN (Comit Europen de Normalisation)

CENELEC (Comit Europen de NormalisationElectrotechnique)ETSI (European Telecommunication StandardsInstitute)

A total of approximately 750 standards support the

Machinery Directive.



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The Machinery Directive

The rst Machinery Directive, 89/392/EEC, wasapproved in 1989

The current version is 98/37/EEC - approved in 1998

A new version, 2006/42/EC was approved in 2006 -and will enter into force in 2008

The revised directive 2006/42/EC does not introduce anyradical changes compared with 98/37/EC but aims toconsolidate the achievements of the Machinery Directivein terms of free circulation and safety of machinery whileimproving its application.



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Objectives of the Directive

The objectives of the Machinery Directive are:

To ensure free circulation of machinery on the internal

market To ensure a high level of protection of users and otherexposed persons against risk

To ensure safety by design



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Stakeholders

The main parties that should be interested in the EUMachinery Directive are:

Manufacturers of machinery

Their representatives in the European UnionImporters

Trade companies

The responsible for placing the product on the EUmarket



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Placing on the market

A product is placed on the EU market when it is madeavailable for the rst time. This is considered to take placewhen a product is transferred from the stage of manufacture with the intention of distribution or use onthe EU market.

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What is machinery?

Machinery : An assembly, tted with or intended to betted with a drive system other than directly appliedhuman or animal effort, consisting of linked parts orcomponents, at least one of which moves, and which are joined together for a specic application

An assembly referred to in the rst indent, missing onlythe components to connect it on site or to sources of energy and motion.

For more details, see the Machinery Directive Article 2.



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Interchangeable equipment

Interchangeable equipment : A device which, after the

putting into service of machinery or of a tractor, isassembled with that machinery or tractor by the operatorhimself in order to change its function or attribute a newfunction, in so far as this equipment is not a tool;


Ri k


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Safety components

Safety component : A component, provided that it is notinterchangeable equipment, which the manufacturer or hisauthorized representative established in EU places on themarket to fulll a safety function when in use and thefailure or malfunction of which endangers the safety orhealth of exposed persons.

Safety components are listed in Annex V of the directive.An example of a safety component is an emergency stopdevice.



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What is a machine? The following machines are exempted from the scope of the Machinery Directive:

Manually powered machinery (except for lifting)Machinery for medical use, used in direct contact withpatientsSpecial equipment for use in fairgrounds and/or

amusement parksSteam boilers, tanks and pressure vesselsMachinery used for nuclear purposesFirearms

Seagoing vesselsAgricultural and forestry tractorsand so on

A complete list of excluded machinery is found in Article 1,

para. 3 of the Directive.S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 17 / 41

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Requirements

The manufacturer or his representative, resident in the EUis responsible for the following:

To carry out a hazard assessment to analyze all of therisks related to the machinery and if required apply

measures to reduce these To ensure that the machinery conforms to the relevantessential health and safety requirements

To draw up an EU declaration of

conformity/incorporation and afx a CE mark To draw up a technical le


Risk


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Machines for own use

The Machinery Directive also applies for companiesproducing machines for own use.

Para: 8.7: . . . The same obligations shall apply to anyperson assembling machinery or parts thereof or safetycomponents of various origins or constructing machineryor safety components for his own use.


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Annexes to the MachineryDirective

1 Essential health and safety requirements (EHSR)relating to the design and construction of machineryand safety components

2 Contents of the declaration of conformity

3 CE-marking4 Dangerous machines and safety components that

need a special procedure and involvement of anotied body

5 List of safety components6 Assembly instructions7 Technical le

(The above titles are abbreviated)S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 20 / 41

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Contents of Annex I

Annex I denes the essential health and safetyrequirements (EHSR) the machines must fulll. Annex Ihas the following chapters:

EHSR (general)

EHSR for certain categories of machinery

EHSR to offset the particular hazards due to themobility of machines

EHSR to offset the particular hazards due to liftingoperations

EHSR for machinery intended for underground work

EHSR to offset the particular hazards due to lifting ormoving of persons


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Example of EHSR in Annex I1.2.1 Safety and reliability of control systems

Control systems must be designed and constructed in sucha way as to prevent hazardous situations from arising.Above all, they must be designed and constructed in sucha way that:

They can withstand the intended operating stressesand external inuencesA fault in the hardware or the software of the controlsystem does not lead to hazardous situationsErrors in the control system logic do not lead tohazardous situationsReasonably foreseeable human error during operationdoes not lead to hazardous situations

Comment: This is an example of an EHSR that needs to be

elaborated and specied in a standard.S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 22 / 41

Risk
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Example of EHSR in Annex I

1.7.3 Marking of machinery

All machinery must be marked visibly, legibly, andindelibly with the following minimum particulars:

The business name and full address of themanufacturer and, where applicable, his authorizedrepresentative,

The CE marking (as specied in Annex III)

Designation of series or type

Serial number (if any)

The year of construction


Risk
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CE-mark

CE is an abbreviation for Communaut Europenne beingthe French way of saying European Community.


Risk


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Foreseeable misuse

Annex I, para. 1.1.2 c): When designing and constructingmachinery and when drafting the instructions, themanufacturer or his authorized representative mustenvisage not only the intended use of the machinery butalso any reason- ably foreseeable misuse thereof.

The machinery must be designed and constructed in sucha way as to prevent abnormal use if such use wouldengender a risk. Where appropriate, the instructions mustdraw the users attention to wayswhich experience hasshown might occurin which the machinery should not beused


RiskA


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Examples of dangerousmachines in Annex IV

Circular saws

Band saws

Portable chain-saws

PressesPlaning machines for woodworking

Machines for manufacture of pyrotechnics

and so on

The above list is abbreviated - see Annex IV for a completelist.


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Instructions handbook The required contents of the instructions handbook is

listed in Annex I, para. 1.7.4Foreseen use of the machinery

Workstations likely to be occupied by operatorsInstructions for safe:

putting into serviceusehandlingassembly, dismantlingadjustment

maintenance (service and repair) Training instructions (if necessary)

and so on

See Annex I for details


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Technical le

An overall drawing of the machinery together with

drawings of the control circuitsFull detailed drawings, accompanied by anycalculation notes, test results, etc. required to checkthe conformity of the machinery with the essential

safety requirementsA list of: The EHSRsApplicable harmonized standardsOther standards used

Other technical specicationsthat were used when the machinery was designed

A description of methods adopted to eliminatehazards presented by the machinery

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After performing a critical design review, making changesto the product design that will minimize risks of harm, andcompiling the Technical le, the manufacturer may afxthe CE-mark and prepare a Declaration of conformity. The Declaration must identify:

Who you are

What product it refers to

What directives are involved

What standards are applicable

Where test results can be found

Who is responsible in your company

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Eight steps

1 Does the Machinery Directive apply?2 Do other legislations apply?3 Who is responsible?

4 Hazard analysis5 Principles of safety requirements6 Use European standards for details7 Documentation8 Declaration of conformity and CE Mark


RiskAssessment
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Standards related to theMachinery Directive

A-StandardsDesign principles and methods for all machinery

B1 -StandardsAspects of safety valid for a wide range of machinery

B2 -StandardsAspects of safety devices valid for a wide range of machinery

C-StandardsSafety of one category of machinery

The use of standards is not mandatory. Conformity withthe EHSRs may also be demonstrated directly.


RiskAssessment
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Examples of standards

A-StandardsEN 292 (Basic machine safety issues)EN 1050 (Risk analysis)

B1 -StandardsEN 294 (Safety distances to avoid that parts of the humanbody are endangered)

B2 -StandardsEN 418 (Emergency stop equipment)

C-StandardsEN 1218 (Safety requirements related to wood treatmentmachinery)


RiskAssessment

l d d d


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EN, national and ISO standards

When EN standards are issued, they are (normally)published as national standards, for example:

EN 292-1 ) NS-EN 292-1 in Norway, and BS-EN 292-1

in Britain.Many EN standards are now transformed into internationalstandards, for example:

EN 292-1 ) ISO 12100-1

EN 1050 ) ISO 14121


RiskAssessment

S f i k d i


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Strategy for risk reduction

The designer shall take the following actions: (ISO12100-1)

Specify the applications and limitations of the machine

Identify the hazards and evaluate the risk

If possible, remove the hazards or reduce the risk asfar as possible

Implement barriers and/or safety functions against theresidual risks

Inform and warn the user against residual risksConsider other required actions


RiskAssessment

S f i k d i


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Strategy for risk reduction

When describing the application(s) of the machine, wehave to consider:

Potential incorrect use resulting from carelessnessand foreseeable misuse (e.g., childrens use of themachine)

Reex actions of operators when failures of themachine occur

Expect that the simplest way to carry out actions isselected by the users of the machine

Consider actions by special users like disabled,children, and so on.


RiskAssessment

Ri k t


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Risk assessment

The manufacturer of the machinery or his authorizedrepresentative must ensure that a risk assessment iscarried out in order to determine the health and safetyrequirements which apply to the machinery. Themachinery must then be designed and constructed takinginto account the results of the risk assessment.

Machinery under the scope of the machinery directive

must comply with the ESRSs of Annex I of the Directiveconcerning design and construction.


RiskAssessment

P d i k t
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Proposed risk assessmentmethods

The following methods are proposed in ISO 12100 (EN1050):

Preliminary hazard analysis (PHA)

What-if analysis

Failure modes and effects analysis (FMEA)

Fault simulation for control systems

MOSAR

Fault tree analysis (FTA)Delphi technique

A detailed list of relevant hazards is provided in ISO 12100

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S H & PHA worksheet
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Risk reduction

Riskassessment

PHA worksheetFor machinery risk analysis

For simple machinery systems it is often sufcient to use a

version of preliminary hazard analysis (PHA) for the riskanalysis. The last three columns are used to document riskreduction in (i) design, (ii) guards and protectivemeasures, and (iii) information about risk and special

requirements like certicates.

Ref Hazard Event/where Cause Consequence P C Design/constr. Protection Inform.

System/eq uipment:

Phase:

Performed by:

Date:

For further information about PHA, see the PHA presentation.

http://www.ntnu.edu/employees/stein.haugenhttp://www.ntnu.edu/employees/marvin.rausandhttp://www.ntnu.edu/employees/stein.haugenhttp://www.ntnu.edu/employees/marvin.rausandhttp://www.ntnu.edu/ross/books/riskhttp://www.ntnu.edu/ross/books/riskhttp://www.ntnu.edu/employees/marvin.rausandhttp://www.ntnu.edu/employees/stein.haugenhttp://www.ntnu.edu/employees/marvin.rausandhttp://www.ntnu.edu/employees/stein.haugen

ce machinery directive

Documents