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8/13/2019 CE Machinery Directive
1/41
RiskAssessment
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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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
European legislation
The legislation in the European Union (EU) builds on:
RegulationsDirectives
European (EN) Standards
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 2 / 41
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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)
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 3 / 41
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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.
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 4 / 41
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-markDangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 5 / 41
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-markDangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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)
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 6 / 41
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7/41
RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-markDangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 7 / 41
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8/41
RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-markDangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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.
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 8 / 41
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-markDangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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.
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 9 / 41
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-markDangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 11 / 41
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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.
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 12 / 41
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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.
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 13 / 41
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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;
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 14 / 41
Ri k
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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.
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 15 / 41
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Risk
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RiskAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
Risk
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EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 18 / 41
Risk
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S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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.
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 19 / 41
Risk
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sAssessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
Risk
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Assessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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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Risk
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Assessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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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Assessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
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Risk
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Assessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
CE-mark
CE is an abbreviation for Communaut Europenne beingthe French way of saying European Community.
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Risk
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Assessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
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RiskA
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Assessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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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RiskAssessment
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Assessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reductionRiskassessment
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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RiskAssessment
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Assessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reductionRiskassessment
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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RiskAssessment
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Assessment
S. Haugen &M. Rausand
EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reductionRiskassessment
Declaration of conformity
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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RiskAssessment
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EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reductionRiskassessment
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
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RiskAssessment
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EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reductionRiskassessment
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.
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RiskAssessment
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EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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)
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RiskAssessment
l d d d
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EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
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RiskAssessment
S f i k d i
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Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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
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RiskAssessment
S f i k d i
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EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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.
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RiskAssessment
Ri k t
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EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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.
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RiskAssessment
P d i k t
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EU Directives
MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
Risk reduction
Riskassessment
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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MachineryDirective
Machinery
Annexes
EHSR
CE-mark
Dangerousmachines
Declaration of conformity
Standards
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.
S. Haugen & M. Rausand (RAMS Group) Risk Assessment (Version 0.1) 41 / 41
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