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Machinery Safety Machinery Safety Directive Directive 98/37/EC 98/37/EC

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Page 1: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Machinery Safety DirectiveMachinery Safety Directive98/37/EC98/37/EC

Page 2: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Free movement of goodsFree movement of goods

Free movement of goods is one of the 4 basic principles in Free movement of goods is one of the 4 basic principles in European Community (EC). Beside the free movement of European Community (EC). Beside the free movement of goods the EC established also:goods the EC established also:

– free movement of free movement of servicesservices,,– free movement of free movement of capitalcapital and, and,– free movement of free movement of workersworkers (people). (people).

To establish free movement of goods EU introduced the To establish free movement of goods EU introduced the following principles: following principles: harmonization of essential harmonization of essential requirements, mutual recognition of conformity requirements, mutual recognition of conformity assessment procedures , and prevention of new assessment procedures , and prevention of new barriers for trade.barriers for trade.

Page 3: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Single MarketSingle Market

Free movement of goods is a cornerstone of the single Free movement of goods is a cornerstone of the single market. The mechanisms in place to achive this aim are market. The mechanisms in place to achive this aim are based on prevention of new barriers to trade mutual based on prevention of new barriers to trade mutual recognition and technical harmonisation.recognition and technical harmonisation.

Member states of ECMember states of EC: : Austria, Austria, Belgium, Belgium, Czech Republic, Cyprus,Czech Republic, Cyprus, Denmark, Denmark, Estonia,Estonia, Finland, France, Finland, France, Germany, Greece, Germany, Greece, Hungary,Hungary, Italy, Italy, Ireland, Ireland, Latvia, Lithuania,Latvia, Lithuania, Luxemburg, Luxemburg, Malta,Malta, Netherlands, Netherlands, Poland,Poland, Portugal, Portugal, Slovakia, Slovenia,Slovakia, Slovenia, Spain, Sweden, United KingdomSpain, Sweden, United Kingdom; ; And member states of EFTA: And member states of EFTA: Norway, Iceland, LichtensteinNorway, Iceland, Lichtenstein..

Page 4: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Harmonisation of requirements Harmonisation of requirements for productsfor products

Harmonisation of:Harmonisation of:• Technical legislation (essential requirements);Technical legislation (essential requirements);• Standards;Standards;• Conformity assessment procedures;Conformity assessment procedures;• Market surveillance activities.Market surveillance activities.

Page 5: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Harmonisation of technical Harmonisation of technical legislation 1(2)legislation 1(2)

Product Liability DirectiveProduct Liability Directive

General Product Safety DirectiveGeneral Product Safety Directive

Council Resolutions on New Approach &Council Resolutions on New Approach &Global ApproachGlobal Approach

Council Decision on ModulesCouncil Decision on Modules

New Approach Directives - New Approach Directives - NADNAD

Page 6: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

• Product Liability Directive – PLD, OJ 85/374/EEC;Product Liability Directive – PLD, OJ 85/374/EEC;• General Product Safety Directive – GPS, OJ 92/59/EEC General Product Safety Directive – GPS, OJ 92/59/EEC

(new 2001/95/EC);(new 2001/95/EC);• Council Resolution on New Approach (7 May 1985);Council Resolution on New Approach (7 May 1985);• Council Resolution on Global Approach (21 December Council Resolution on Global Approach (21 December

1989);1989);• Modular Approach Decision – MAD, OJ 90/683/EEC;Modular Approach Decision – MAD, OJ 90/683/EEC;• Directive 98/34/EC - procedure for the provision of Directive 98/34/EC - procedure for the provision of

information in the field of technical standards and information in the field of technical standards and regulations;regulations;

• New Approach Directives (2New Approach Directives (244 directives). directives).

Harmonisation of technical Harmonisation of technical legislation 2(2)legislation 2(2)

Page 7: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

New Approach Directives 1(4)New Approach Directives 1(4)

• 73/23/EEC 73/23/EEC Low voltage equipment Low voltage equipment • 87/404/EEC 87/404/EEC Simple pressure vessels Simple pressure vessels • 88/378/EEC 88/378/EEC Toys safety Toys safety • 89/106/EEC 89/106/EEC Construction products Construction products • 89/336/EEC 89/336/EEC Electromagnetic compatibility Electromagnetic compatibility

(new directive 2004/108/EC)(new directive 2004/108/EC)• 89/686/EEC 89/686/EEC Personal protectivePersonal protective equipment equipment • 90/384/EEC 90/384/EEC Non-automatic weighing Non-automatic weighing

instruments instruments • 90/385/EEC 90/385/EEC Medical devices: ActiveMedical devices: Active

implantable implantable • 90/396/EEC 90/396/EEC Appliances burning gaseous fuels Appliances burning gaseous fuels

Page 8: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

New Approach Directives 2(4)New Approach Directives 2(4)

• 92/42/EEC92/42/EEC Hot water boilersHot water boilers• 93/15/EEC 93/15/EEC Explosives for civil uses Explosives for civil uses • 93/42/EEC 93/42/EEC Medical devices: General Medical devices: General • 94/9/EC 94/9/EC Equipment and protective Equipment and protective

systems in potentially explosive systems in potentially explosive atmospheres atmospheres

• 94/25/EC 94/25/EC Recreational craft Recreational craft • 9944//6262/EC /EC Packaging and packaging wastePackaging and packaging waste • 96/57/EC96/57/EC Refrigeration appliancesRefrigeration appliances• 95/16/EC 95/16/EC Lifts Lifts • 97/23/EC 97/23/EC Pressure equipment Pressure equipment

Page 9: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

New Approach Directives 3(4)New Approach Directives 3(4)

• 98/37/EC 98/37/EC Machinery safety Machinery safety • 98/79/EC 98/79/EC Medical devices: In vitro Medical devices: In vitro

diagnostic diagnostic • 99/5/EC 99/5/EC Radio and telecommunications Radio and telecommunications

terminal equipment terminal equipment • 00/9/EC 00/9/EC Cableway installations designed to Cableway installations designed to

carry personscarry persons• 00/14/EC00/14/EC NoiseNoise• 04/22/EEC04/22/EEC Measuring instrumentsMeasuring instruments

Useful information about New Approach Directives:Useful information about New Approach Directives:http://www.newapproach.orghttp://www.newapproach.org

Page 10: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

New Approach Directives 4(4)New Approach Directives 4(4)

Member states of EC have to implement the New Approach Member states of EC have to implement the New Approach Directives in national technical legislation without any Directives in national technical legislation without any modifications.modifications.

It is a duty of Member states to cancel all national technical It is a duty of Member states to cancel all national technical legislation which is in contrary with New Approach legislation which is in contrary with New Approach Directives.Directives.

Page 11: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

New Approach DirectiveNew Approach Directive

Product complies with all applicable NADProduct complies with all applicable NAD (and EN (and EN standards), there are no additional requirements in any standards), there are no additional requirements in any

member state. The product has free access to the internal member state. The product has free access to the internal market of EC.market of EC.

Conformity assessment proceduresConformity assessment procedures

Page 12: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

StandardisationStandardisation

Harmonised EN standards (the reference numbers are Harmonised EN standards (the reference numbers are published in Official Journal) are essential tool to implement published in Official Journal) are essential tool to implement requirements of NAD. Application of harmonised standards requirements of NAD. Application of harmonised standards is voluntary.is voluntary.

The European Commission gave the mandate for The European Commission gave the mandate for preparation of harmonised EN standards to following preparation of harmonised EN standards to following institutions: institutions: CENCEN (common standards and standards not (common standards and standards not in in the scope of CENELEC and ETSI), the scope of CENELEC and ETSI), CENELECCENELEC (electrotehnical standards), and (electrotehnical standards), and ETSIETSI (telecommunication (telecommunication standards).standards).

Page 13: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Basic structure of New Approach Basic structure of New Approach DirectivesDirectivesStandard elements of the New Approach Directives:Standard elements of the New Approach Directives:• Scope (defines the range of products or phenomena Scope (defines the range of products or phenomena

covered);covered);• Placing on the market and putting into service;Placing on the market and putting into service;• Essential requirements;Essential requirements;• Free movement;Free movement;• Presumption of conformity;Presumption of conformity;• Safeguard clause;Safeguard clause;• Conformity assessment procedures;Conformity assessment procedures;• Notified Bodies (requirements);Notified Bodies (requirements);• CE marking;CE marking;• Coordination of implementation;Coordination of implementation;• Transposition and transitional provisions.Transposition and transitional provisions.

Page 14: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Purpose of Machinery directivePurpose of Machinery directive

The Directive lays down essential requirements for human health The Directive lays down essential requirements for human health and safety mostly concerning operators and persons near to and safety mostly concerning operators and persons near to machinery. machinery. The essential safety requirements do not directly concern The essential safety requirements do not directly concern environmental protection or the technological performance of environmental protection or the technological performance of machinery. Some of them can obviously help to ensure these. By machinery. Some of them can obviously help to ensure these. By way of an example, intrinsic reduction of machinery noise for the way of an example, intrinsic reduction of machinery noise for the operator helps to reduce environmental noise. operator helps to reduce environmental noise. It is nevertheless possible that the essential safety requirements It is nevertheless possible that the essential safety requirements are difficult to reconcile with other requirements; the collection of are difficult to reconcile with other requirements; the collection of gases from machinery and their discharge outside can be an gases from machinery and their discharge outside can be an environmental hazard; compliance with safety clearances can environmental hazard; compliance with safety clearances can give rise to food hygiene problems. give rise to food hygiene problems. Standardization will endeavour to reconcile these various safety Standardization will endeavour to reconcile these various safety requirements. requirements. In the technical fields not covered by a European Directive, the In the technical fields not covered by a European Directive, the Member States remain free to adopt regulations that are in line Member States remain free to adopt regulations that are in line with the Treaty.with the Treaty.

Page 15: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Scope 1(Scope 1(44))Directive addresses machinery and safety components. The Directive addresses machinery and safety components. The guiding principle is that machinery is fundamentally guiding principle is that machinery is fundamentally “mechanical”. However, there are some basic definitions “mechanical”. However, there are some basic definitions which help to determine what is “machinery”:which help to determine what is “machinery”: an assembly of partsan assembly of parts;; the parts must be linkedthe parts must be linked. This does not exclude machinery . This does not exclude machinery which is sold dismantledwhich is sold dismantled for ease of transport or in kit form, as for ease of transport or in kit form, as the manufacturer is obliged to design histhe manufacturer is obliged to design his machinery in machinery in accordance with the Directive.accordance with the Directive. one of the parts must moveone of the parts must move. This movement must result . This movement must result from external energyfrom external energy (electricity, battery, fuel, etc.) or stored (electricity, battery, fuel, etc.) or stored energy (spring, weight).energy (spring, weight). for a specific applicationfor a specific application. This implies that machinery which . This implies that machinery which is unfinished, to theis unfinished, to the extent that it cannot function, is not extent that it cannot function, is not covered by the Directive.covered by the Directive.

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Scope Scope 22((44)) the term “machinery” also covers an assembly of machines the term “machinery” also covers an assembly of machines

or complex installationor complex installation. A “complex installation” means an . A “complex installation” means an assembly of machinery, appliances and mechanisms which, in assembly of machinery, appliances and mechanisms which, in order to contribute to the same result, generally the same order to contribute to the same result, generally the same production, are arranged and installed so as to be interdependent production, are arranged and installed so as to be interdependent in operation.in operation.

Safety components:Safety components:– electro-sensitive devices to detect persons (non-material electro-sensitive devices to detect persons (non-material

barriers, sensor mats, electromagnetic detectors, etc.);barriers, sensor mats, electromagnetic detectors, etc.);– logic units which ensure the safety functions of bi-manual logic units which ensure the safety functions of bi-manual

controls;controls;– automatic movable screens (power-operated guards) to protect automatic movable screens (power-operated guards) to protect

metalworking presses, injection or compression plastics- or metalworking presses, injection or compression plastics- or rubber-moulding machines with manual loading or unloading;rubber-moulding machines with manual loading or unloading;

– roll-over protective structures (ROPS);roll-over protective structures (ROPS);– falling-object protective structures (FOPS).falling-object protective structures (FOPS).

Page 17: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Scope Scope 33((44))The examples below illustrate definition of a “safety component”.The examples below illustrate definition of a “safety component”.• emergency stopping devices;emergency stopping devices;• non-return valves designed as safety devices for equipment’s non-return valves designed as safety devices for equipment’s

hydraulic systems;hydraulic systems;• safety belts and restraining devices in the event of overturning;safety belts and restraining devices in the event of overturning;• control or monitoring modules of safety-related parts of control control or monitoring modules of safety-related parts of control

systems, such as the position detectors in a locking mechanism;systems, such as the position detectors in a locking mechanism;• products preventing undesired operation of machinery;products preventing undesired operation of machinery;• products preventing repetition of a machine cycle;products preventing repetition of a machine cycle;• temperature-control products or systems to keep machinery within temperature-control products or systems to keep machinery within

safe operating limits;safe operating limits;• smoke or dust extraction systems for machinery;smoke or dust extraction systems for machinery;• guards and their locking mechanisms;guards and their locking mechanisms;• noise reduction enclosures;noise reduction enclosures;• anti-derailment mechanisms for suspended lifting machinery;anti-derailment mechanisms for suspended lifting machinery;• load control devices for lifting equipment;load control devices for lifting equipment;• hold-to-run controls.hold-to-run controls.

Page 18: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Scope Scope 44((44))

Page 19: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Products excluded from Machinery Products excluded from Machinery directive 1(directive 1(33))

The products excluded from the scope of this Directive:The products excluded from the scope of this Directive:• machinery whose only power source is directly applied machinery whose only power source is directly applied

manual effort, unless it is a machine used for lifting or manual effort, unless it is a machine used for lifting or lowering loads,lowering loads,

• machinery for medical use used in direct contact with machinery for medical use used in direct contact with patients,patients,

• special equipment for use in fairgrounds and/or special equipment for use in fairgrounds and/or amusement parks,amusement parks,

• steam boilers, tanks and pressure vessels,steam boilers, tanks and pressure vessels,• machinery specially designed or put into service for machinery specially designed or put into service for

nuclear purposes which, in the event of failure, may result nuclear purposes which, in the event of failure, may result in an emission of radioactivity,in an emission of radioactivity,

• radioactive sources forming part of a machine,radioactive sources forming part of a machine,• firearms,firearms,

Page 20: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Products excluded from Machinery Products excluded from Machinery directive directive 22((33))• storage tanks and pipelines for petrol, diesel fuel, storage tanks and pipelines for petrol, diesel fuel,

inflammable liquids andinflammable liquids and dangerous substances.dangerous substances.• means of transport, i.e. vehicles and their trailers intended means of transport, i.e. vehicles and their trailers intended

solely for transportingsolely for transporting• passengers by air or on road, rail or water networks, as passengers by air or on road, rail or water networks, as

well as means of transport inwell as means of transport in so far as such means are so far as such means are designed for transporting goods by air, on public road ordesigned for transporting goods by air, on public road or rail networks or on water. Vehicles used in the mineral rail networks or on water. Vehicles used in the mineral extraction industry shall notextraction industry shall not be excluded,be excluded,

• seagoing vessels and mobile offshore units together with seagoing vessels and mobile offshore units together with equipment on board suchequipment on board such vessels or units,vessels or units,

• cableways, including funicular railways, for the public or cableways, including funicular railways, for the public or private transportation ofprivate transportation of persons,persons,

• agricultural and forestry tractors, as defined in Article 1(1) agricultural and forestry tractors, as defined in Article 1(1) of Council Directiveof Council Directive 74/150/EEC,74/150/EEC,

Page 21: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Products excluded from Machinery Products excluded from Machinery directive directive 33((33))• machines specially designed and constructed for military or machines specially designed and constructed for military or

police purposespolice purposes,,• lifts which permanently serve specific levels of buildings lifts which permanently serve specific levels of buildings

and constructions, having aand constructions, having a car moving between guides car moving between guides which are rigid and inclined at an angle of more than 15which are rigid and inclined at an angle of more than 15 degrees to the horizontal and designed for the transport of:degrees to the horizontal and designed for the transport of: persons,persons, persons and goods, persons and goods, goods alone if the car is goods alone if the car is accessible,accessible,

• means of transport of persons using rack and pinion rail means of transport of persons using rack and pinion rail mounted vehicles,mounted vehicles,

• mine winding gear,mine winding gear,• theatre elevators,theatre elevators,• construction site hoists.construction site hoists.

Page 22: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Essential health and safety requirements Essential health and safety requirements – Annex 1 1(– Annex 1 1(99))

1.1. The obligations laid down by the essential health and safety The obligations laid down by the essential health and safety requirementsrequirements apply only when the corresponding hazard exists for apply only when the corresponding hazard exists for the machinery the machinery or safety component or safety component inin question when it is used under question when it is used under the conditions foreseen by the manufacturer. the conditions foreseen by the manufacturer.

2.2. The essential health and safety requirements laid down in this The essential health and safety requirements laid down in this Directive areDirective are mandatory. However, taking into account the state of mandatory. However, taking into account the state of the art, it may not bethe art, it may not be possible to meet the objectives set by them. In possible to meet the objectives set by them. In this case, the machinery mustthis case, the machinery must as far as possible be designed and as far as possible be designed and constructed with the purpose ofconstructed with the purpose of approaching those objectives.approaching those objectives.

3.3. The essential health and safety requirements have been grouped The essential health and safety requirements have been grouped according toaccording to the hazards which they cover.the hazards which they cover.

4.4. Machinery presents a series of hazards which may be indicated Machinery presents a series of hazards which may be indicated under moreunder more than one heading in this Annex.than one heading in this Annex.

5.5. The manufacturer is under an obligation to assess the hazards in The manufacturer is under an obligation to assess the hazards in order toorder to identify all of those which apply to his machine; he must then identify all of those which apply to his machine; he must then design anddesign and construct it taking account of his assessment.construct it taking account of his assessment.

Page 23: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Essential health and safety requirements Essential health and safety requirements – Annex 1 – Annex 1 22((99))

DefinitionsDefinitionsFor the purpose of this Directive:For the purpose of this Directive:a)a) ‘‘danger zone’ means any zone within danger zone’ means any zone within

and/or around and/or around mmachinery in whichachinery in which an an exposed person is subject to a risk to exposed person is subject to a risk to his health or safety;his health or safety;

b)b) ‘‘exposed person’ means any person exposed person’ means any person wholly or partially in a danger zone;wholly or partially in a danger zone;

c)c) ‘‘operator’ means the person or operator’ means the person or persons given the task of installing,persons given the task of installing, operating, adjusting, maintaining, operating, adjusting, maintaining, cleaning, repairing or transportingcleaning, repairing or transporting machinery.machinery.

Page 24: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Essential health and safety requirements Essential health and safety requirements – Annex 1 – Annex 1 33((99))

1.1. General requirements:General requirements: Machinery must be so constructed that it is fitted for its Machinery must be so constructed that it is fitted for its

function, and can be adjusted and maintained without putting function, and can be adjusted and maintained without putting persons at risk when these operations are carried out under persons at risk when these operations are carried out under the conditions foreseen by the manufacturer. The aim of the conditions foreseen by the manufacturer. The aim of measures taken must be to eliminate any risk of accident measures taken must be to eliminate any risk of accident throughout the foreseeable lifetime of the machinery, including throughout the foreseeable lifetime of the machinery, including the phases of assembly and dismantling, even where risks of the phases of assembly and dismantling, even where risks of accident arise from foreseeable abnormal situations. Basic accident arise from foreseeable abnormal situations. Basic elements:elements:– safety integration (machinery design),safety integration (machinery design),– materials & products,materials & products,– lighting,lighting,– handling.handling.

Page 25: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Essential health and safety requirements Essential health and safety requirements – Annex 1 – Annex 1 44((99))

2.2. Controls:Controls: Control systems must be designed and Control systems must be designed and constructed so that they are safe and reliable, in a way constructed so that they are safe and reliable, in a way that will prevent a dangerous situation arising. Above all that will prevent a dangerous situation arising. Above all they must be designed and constructed in such a way that: they must be designed and constructed in such a way that: they can withstand the rigours of normal use and external they can withstand the rigours of normal use and external factors, and errors in logic do not lead to dangerous factors, and errors in logic do not lead to dangerous situations. Basic elements of controls:situations. Basic elements of controls:– Starting devices,Starting devices,– Stopping devices (normal, emergency, complex – Stopping devices (normal, emergency, complex –

diffrenet parts of machinery),diffrenet parts of machinery),– Mode selection,Mode selection,– Failure of power supply,Failure of power supply,– Failure of control systems – circuits,Failure of control systems – circuits,– Software.Software.

Page 26: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Essential health and safety requirements Essential health and safety requirements – Annex 1 – Annex 1 55((99))

3.3. Protection against mechanical hazardsProtection against mechanical hazardsBasic elements:Basic elements:– Stability,Stability,– Break-up during operation,Break-up during operation,– Falling or ejected objects,Falling or ejected objects,– Surfaces, edges, angles,Surfaces, edges, angles,– Combined machinery,Combined machinery,– Variations in the rotational speed of tools,Variations in the rotational speed of tools,– Moving parts: moving transmission parts, moving Moving parts: moving transmission parts, moving

parts directly involved in the process.parts directly involved in the process.

Page 27: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Essential health and safety requirements Essential health and safety requirements – Annex 1 – Annex 1 66((99))4.4. Guards and protection devicesGuards and protection devices (fixed guards, movable (fixed guards, movable

guards, adjustable guards restricting access) must be: guards, adjustable guards restricting access) must be: • be of robust construction, be of robust construction, • not give rise to any additional risk, not give rise to any additional risk, • not be easy to by-pass or render non-operational, not be easy to by-pass or render non-operational, • be located at an adequate distance from the danger be located at an adequate distance from the danger

zone, zone, • cause minimum obstruction to the view of the cause minimum obstruction to the view of the

production process, production process, • enable essential work to be carried out on installation enable essential work to be carried out on installation

and/or replacement of tools and also for maintenance and/or replacement of tools and also for maintenance by restricting access only to the area where the work by restricting access only to the area where the work has to be done, if possible without the guard or has to be done, if possible without the guard or protection device having to be dismantled.protection device having to be dismantled.

Page 28: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Essential health and safety requirements Essential health and safety requirements – Annex 1 – Annex 1 77((99))

5.5. Protection against other hazards:Protection against other hazards:– Electricity supply,Electricity supply,– Static electricity,Static electricity,– Other energy supply,Other energy supply,– Errors of fitting,Errors of fitting,– Extreme temperatures,Extreme temperatures,– Fire,Fire,– Explosion,Explosion,– Noise,Noise,– Vibrations,Vibrations,– Internal and external radiationInternal and external radiation– Laser equipment,Laser equipment,– Emissions of dust, gases, etc.,Emissions of dust, gases, etc.,– Trapping in a machine,Trapping in a machine,– Slipping, tripping, and falling.Slipping, tripping, and falling.

Page 29: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Essential health and safety requirements Essential health and safety requirements – Annex 1 – Annex 1 88((99))

6.6. Maintenance: Maintenance: – Machinery maintenance;Machinery maintenance;– Access to operating positions and servicing points,Access to operating positions and servicing points,– Isolation of energy sources,Isolation of energy sources,– Operator intervention,Operator intervention,– Cleaning of internal parts.Cleaning of internal parts.

Page 30: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Essential health and safety requirements Essential health and safety requirements – Annex 1 – Annex 1 99((99))

7.7. Indicators: Indicators: – Information devices;Information devices;– Warning devices;Warning devices;– Warning of residual risks;Warning of residual risks;– Marking;Marking;– Instructions.Instructions.

Page 31: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Flow chart of conformity assessment Flow chart of conformity assessment proceduresprocedures in in Machinery directiveMachinery directive

MANUFACTURER

Type of machines and

safety components(Annex IV)

Not reffered to in Annex IV

Technical construction file (Annex V)

EC declaration of conformity with essential requirements

MODULE A

Reffered to in Annex IV,without meeting or only

partly meeting the standards, or if such

standards does not exist

EC type examination(Annex VI)MODULE B

Reffered to in Annex IV,

and complying with standards

Typeof machines and

safety components(Annex IV)

Technical file (Annex VI)sent to Notified Body

Technical file (Annex VI)submitted to NB for

certification of adequacyfor the file

EC type examination(Annex VI)MODULE B

EC declaration of conformity covered by the EC type

examinationMODULE A

Safety componentdo not bear CE

marking

Page 32: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Types of machinery and safety Types of machinery and safety components for which intervention of components for which intervention of Notified Body is required 1(Notified Body is required 1(55))1.1. Machinery:Machinery:• Circular saws (single or multi-blade) for working with Circular saws (single or multi-blade) for working with

wood and analogous materials or for working with meat wood and analogous materials or for working with meat and analogous materials.and analogous materials.

• Sawing machines with fixed tool during operation, having Sawing machines with fixed tool during operation, having a fixed bed with manual feed of the a fixed bed with manual feed of the workpiece orworkpiece or with a with a demountable power feed.demountable power feed.

• Sawing machines with fixed tool during operation, having Sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or a manually operated reciprocating saw-bench or carriage.carriage.

• Sawing machines with fixed tool during operation, having Sawing machines with fixed tool during operation, having a built-in mechanical feed device for the work-pieces, a built-in mechanical feed device for the work-pieces, with manual loading and/or unloading.with manual loading and/or unloading.

• Sawing machines with movable tool during operation, Sawing machines with movable tool during operation, with a mechanical feed device and manual loading with a mechanical feed device and manual loading and/or unloading.and/or unloading.

• Hand-fed surface planning machines for woodworking.Hand-fed surface planning machines for woodworking.

Page 33: Machinery Safety Directive 98/37/EC. Free movement of goods Free movement of goods is one of the 4 basic principles in European Community (EC). Beside

Types of machinery and safety Types of machinery and safety components for which intervention of components for which intervention of Notified Body is required Notified Body is required 22((55))• Thicknessers for one-side dressing with manual loading Thicknessers for one-side dressing with manual loading

and/or unloading for woodworking.and/or unloading for woodworking.• Band-saws with a fixed or mobile bed and band-saws with Band-saws with a fixed or mobile bed and band-saws with

a mobilea mobile carriage, with manual loading and/or unloading, carriage, with manual loading and/or unloading, for working withfor working with wood and analogous materials or for wood and analogous materials or for working with meat andworking with meat and analogous materials.analogous materials.

• Combined machines forCombined machines for working with wood and working with wood and analogous materials.analogous materials.

• Hand-fed Hand-fed tenoning machinestenoning machines with several tool holders for with several tool holders for woodworking.woodworking.

• Hand-fed vertical spindle moulding machines for working Hand-fed vertical spindle moulding machines for working withwith wood and analogous materials.wood and analogous materials.

• Portable chainsaws for woodworking.Portable chainsaws for woodworking.

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Types of machinery and safety Types of machinery and safety components for which intervention of components for which intervention of Notified Body is required Notified Body is required 33((55))• Presses, including press-brakes, for the cold working of Presses, including press-brakes, for the cold working of

metals, with manual loading and/or unloading, whose metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.mm and a speed exceeding 30 mm/s.

• Injection or compression plastics-moulding machines with Injection or compression plastics-moulding machines with manual loading or unloading.manual loading or unloading.

• Injection or compression rubber-moulding machines with Injection or compression rubber-moulding machines with manual loading or unloading.manual loading or unloading.

• Machinery for underground working of the following types: Machinery for underground working of the following types: machinery on rails: machinery on rails: locomotives andlocomotives and brake-vans, brake-vans, hydraulic-powered roof supports, internal combustion hydraulic-powered roof supports, internal combustion engines to be fitted to machinery for underground engines to be fitted to machinery for underground working.working.

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Types of machinery and safety Types of machinery and safety components for which intervention of components for which intervention of Notified Body is required Notified Body is required 44((55))• Manually-loaded trucks for the collection of household Manually-loaded trucks for the collection of household

refuserefuse incorporating a compression mechanism.incorporating a compression mechanism.• Guards and detachable transmission shafts with universal Guards and detachable transmission shafts with universal

joints.joints.• Vehicles servicing lifts.Vehicles servicing lifts.• Devices for the lifting of persons involving a risk of falling Devices for the lifting of persons involving a risk of falling

from afrom a vertical height of more than three metres.vertical height of more than three metres.• Machines for the manufacture of pyrotechnicsMachines for the manufacture of pyrotechnics

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Types of machinery and safety Types of machinery and safety components for which intervention of components for which intervention of Notified Body is required Notified Body is required 55((55))2.2. Safety componentsSafety components• Electro-sensitive devices designed specifically to detect Electro-sensitive devices designed specifically to detect

persons inpersons in order to ensure their safety (non-material order to ensure their safety (non-material barriers, sensor mats,barriers, sensor mats, electromagnetic detectors, etc.).electromagnetic detectors, etc.).

• Logic units which ensure the safety functions of bimanual Logic units which ensure the safety functions of bimanual controls.controls.

• Automatic movable screens to protect the presses.Automatic movable screens to protect the presses.• Roll-over protection structures (ROPS).Roll-over protection structures (ROPS).• Falling-object protective structures (FOPS).Falling-object protective structures (FOPS).

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EC Declaration of ConformityEC Declaration of Conformity 1(2) 1(2)

All machines and safety components must be accompanied All machines and safety components must be accompanied by the EC Declaration of Conformity.by the EC Declaration of Conformity.

Content of EC Declaration of Content of EC Declaration of ConformityConformity for machinery: for machinery:• name and address of the manufacturer or his authorised representative established in the name and address of the manufacturer or his authorised representative established in the

Community;Community;• description of the machinery;description of the machinery;• all relevant provisions complied with by the machinery;all relevant provisions complied with by the machinery;• where appropriate, name and address of the notified body and number of the EC type-where appropriate, name and address of the notified body and number of the EC type-

examination certificate;examination certificate;• where appropriate, the name and address of the notified body to which the file has been where appropriate, the name and address of the notified body to which the file has been

forwarded;forwarded;• where appropriate, the name and address of the notified body which has carried out the where appropriate, the name and address of the notified body which has carried out the

verification;verification;• where appropriate, a reference to the harmonised standards;where appropriate, a reference to the harmonised standards;• where appropriate, the national technical standards and specifications used;where appropriate, the national technical standards and specifications used;• where appropriate,where appropriate, a statement that the machinery must not be put into service until the a statement that the machinery must not be put into service until the

machinery into which it is to be incorporated has been declared in conformity with the machinery into which it is to be incorporated has been declared in conformity with the provisions of the Directive;provisions of the Directive;

• identification of the person empowered to sign on behalf of the manufacturer or his identification of the person empowered to sign on behalf of the manufacturer or his authorised representatives.authorised representatives.

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EC Declaration of ConformityEC Declaration of Conformity 2(2) 2(2)

• name and address of the manufacturer or his authorised representativename and address of the manufacturer or his authorised representative established in the Community,established in the Community,

• description of the safety component,description of the safety component,• safety function fulfilled by the safety component, if not obvious from thesafety function fulfilled by the safety component, if not obvious from the

description,description,• where appropriate, the name and address of the notified body and thewhere appropriate, the name and address of the notified body and the

number of the EC type-examination certificate,number of the EC type-examination certificate,• where appropriate, the name and address of the notified body to whichwhere appropriate, the name and address of the notified body to which the the

file was forwardedfile was forwarded• where appropriate, the name and address of the notified body whichwhere appropriate, the name and address of the notified body which carried carried

out the verificationout the verification• where appropriate, a reference to the harmonised standards,where appropriate, a reference to the harmonised standards,• where appropriate, the national technical standards and specificationswhere appropriate, the national technical standards and specifications used,used,• identification of the person empowered to sign on behalf of theidentification of the person empowered to sign on behalf of the manufacturer manufacturer

or his authorised representative established in theor his authorised representative established in the Community.Community.

Content of EC Declaration of Conformity for safety Content of EC Declaration of Conformity for safety component:component:

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Instructions 1(Instructions 1(22)) All machinery must be accompanied by instructions including at All machinery must be accompanied by instructions including at

leastleast the following:the following:• a repeat of the information with which the machinery is marked,a repeat of the information with which the machinery is marked,

except the serial number together with any appropriateexcept the serial number together with any appropriate additional information to facilitate maintenance (e.g. addresses additional information to facilitate maintenance (e.g. addresses ofof the importer, repairers, etc.),the importer, repairers, etc.),

• foreseen use of the machinery,foreseen use of the machinery,• workstation(sworkstation(s) likely to be occupied by operators,) likely to be occupied by operators,• instructions for safe:instructions for safe: putting into service,putting into service, use,use, handling, giving handling, giving

the mass of the machinery and its variousthe mass of the machinery and its various parts where they are parts where they are regularly to be transported separately,regularly to be transported separately, assembly, dismantling,assembly, dismantling, adjustment,adjustment, maintenance (servicing and repair),maintenance (servicing and repair),

• where necessary, training instructions,where necessary, training instructions,• where necessary, the essential characteristics of tools which where necessary, the essential characteristics of tools which

may bemay be fitted to the machinery.fitted to the machinery.

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Instructions Instructions 22((22))• Where necessary, the instructions should draw attention to Where necessary, the instructions should draw attention to

ways in whichways in which the machinery should not be used.the machinery should not be used.

• The instructions must be drawn up in one of the Community The instructions must be drawn up in one of the Community languageslanguages by the manufacturer or his authorised by the manufacturer or his authorised representative established in therepresentative established in the Community. On being put into Community. On being put into service, all machinery must beservice, all machinery must be accompanied by a translation of accompanied by a translation of the instructions in the language orthe instructions in the language or languages of the country in languages of the country in which the machinery is to be usedwhich the machinery is to be used..

• In the case of machinery which may also be intended for use In the case of machinery which may also be intended for use by nonby non--professionalprofessional operators, the wording and layout of the operators, the wording and layout of the instructions for use,instructions for use, whilst respecting the other essential whilst respecting the other essential requirements mentioned above, mustrequirements mentioned above, must take into account the take into account the level of general education and acumen that canlevel of general education and acumen that can reasonably be reasonably be expected from such operators.expected from such operators.

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Technical documentation 1(3)Technical documentation 1(3)• Before drawing up the EC declaration of conformity, the Before drawing up the EC declaration of conformity, the

manufacturer, or hismanufacturer, or his authorised representative in the authorised representative in the Community, shall have ensured and be able toCommunity, shall have ensured and be able to guarantee that guarantee that the documentation listed below is and will remain available onthe documentation listed below is and will remain available on his premises for any inspection purposes:his premises for any inspection purposes:

a)a) a technical construction file comprising:a technical construction file comprising:

– an overall drawing of the machinery together with an overall drawing of the machinery together with drawings of thedrawings of the control circuits,control circuits,

– full detailed drawings, accompanied by any calculation full detailed drawings, accompanied by any calculation notes, testnotes, test results, etc., required to check the conformity of results, etc., required to check the conformity of the machinery withthe machinery with the essential health and safety the essential health and safety requirements,requirements,

– a list of: the essential requirements of this Directive,a list of: the essential requirements of this Directive, standards, andstandards, and other technical specifications, which were other technical specifications, which were used when theused when the machinery was designed,machinery was designed,

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Technical documentation Technical documentation 22(3)(3)

– a description of methods adopted to eliminate a description of methods adopted to eliminate hazards presented byhazards presented by the machinery,the machinery,

– if he so desires, any technical report or certificate if he so desires, any technical report or certificate obtained from aobtained from a competent body or laboratory ,competent body or laboratory ,

– if he declares conformity with a harmonised standard if he declares conformity with a harmonised standard whichwhich provides provides thereforetherefore, any technical report giving , any technical report giving the results of teststhe results of tests carried out at his choice either by carried out at his choice either by himself or by a competent body orhimself or by a competent body or laboratory,laboratory,

– a copy of the instructions for the machinery;a copy of the instructions for the machinery;

b)b) for series manufacture, the internal measures that will be for series manufacture, the internal measures that will be implemented toimplemented to ensure that the machinery remains in ensure that the machinery remains in conformity with the provisions ofconformity with the provisions of the Directive.the Directive.

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Technical documentation Technical documentation 33(3)(3)

• The documentation shall be drawn up in one of theThe documentation shall be drawn up in one of the official official languages of the Communitlanguages of the Communityy, with the exception of the, with the exception of the instructions for the machineryinstructions for the machinery..

• The documentation shall be retained and keptThe documentation shall be retained and kept available available for the competent national authorities for at least 10 yearsfor the competent national authorities for at least 10 years following the date of manufacture of the machinery or of following the date of manufacture of the machinery or of the last unitthe last unit produced, in the case of series manufacture.produced, in the case of series manufacture.

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Useful internet linksUseful internet links

• Basic internet page for Machinery Directive:Basic internet page for Machinery Directive:http://europa.eu.int/comm/enterprise/mechan_equipment/http://europa.eu.int/comm/enterprise/mechan_equipment/machinery/index.htm;machinery/index.htm;

• List of harmonised standards:List of harmonised standards:http://europa.eu.int/comm/enterprise/newapproach/http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/machines.html;standardization/harmstds/reflist/machines.html;

• List of Notified Bodies:List of Notified Bodies:http://europa.eu.int/comm/enterprise/mechan_equipment/http://europa.eu.int/comm/enterprise/mechan_equipment/machinery/nb.htm;machinery/nb.htm;

• Guidelines:Guidelines:http://europa.eu.int/comm/enterprise/http://europa.eu.int/comm/enterprise/mechan_equipment/machinery/index.htmmechan_equipment/machinery/index.htm