basics of safety standards & legislation

06/06/2013

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Step 2 – Intermediate Level – Technical Machine Safety

2 Day Training

LEGO Basic Safety Training, June 11,12 2013

Certified Machinery Safety Expert (TÜV Nord/Pilz),Machinery Safety Consultant Pilz de México, Convento de Actopan 36 Col. Jardines de Santa Monica, 54050Tlalnepantla, Edo de Mex

� Topics

Risk Assessment

Safety Components & Safeguarding Techniques

Electrical Safety

Safety Control

Lock Out Tag Out – Control of Hazardous Energy

Basics of Safety Standards & Legislation

CE Marking

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� Topics


Motivation for SafetyKey Safety QuestionsHealth & Safety ManagementIntroduction to Safety LegislationStandardsApplications to Machinery and PlantAdvantages of Compliance

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� Motivation for Safety

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What are some of the effects of not considering health and safety issues?

� The incalculable cost of human suffering, much of which is easily preventable

� The threat and consequence of prosecution or other enforcement action

� The potential loss of future business

Why Safety?

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� Motivation for Safety

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Economic: The total cost of accidents is like a floating iceberg

10% is visible and above sea level– Cost of recovering from injury– Employers liability– Third party / public liability– Product liability

90% is not visible and below sea level

Accident Costs

– Cost of recovering from injury– Product and material damage– Plant and building damage– Tool and equipment damage– Supervisors’ time diverted– Emergency supplies– Clearing the site

– Production delays– Fines & Legal costs– Overtime work– Substitute labour– Investigation time– Clerical effort– Loss of expertise

� Topics



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� Key Safety Questions

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Questions to Address

1. Why should machinery/ plant be safe?

2. What is (machinery/ plant) safety?

3. What is the workers perspective?

4. What is an accident?

5. What is a hazard? What is a risk?

6. What are safety components?

7. Who should be carrying out safety functions?

8. When can a system / machine / plant be considered to have an acceptable level

of safety?

9. How much should be invested in safety?


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Question 1 Why should machinery/ plant be safe?

� It is the moral obligation of employers to provide safe work equipment, according to article 23.1 from the:

� UNIVERSAL DECLARATION OF HUMAN RIGHTS*Everyone has the right to work, to free choice of employment, to just and favourable conditions of work and to protection against unemployment

*Adopted by UN General Assembly Resolution 217A (III) of 10 December 1948

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Question 2 What is (machinery / plant) safety?

� Safety is the freedom of unacceptable risk


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As a:� Machine manufacturer, Safety

manager, Maintenance manager, Production manager, Engineering manager or Plant engineeryou should be aware that the worker at the machine assumes that the machine is safe

However employee safety responsibilities include:� Recognizing safety hazards� Maintaining good housekeeping� Reporting safety hazards� Working safely� Using personal protective equipment

(PPE)� Making the most of safety training

Question 3 What is the workers perspective?

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Workers Perspective??

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An accident is any unforeseen or unexpected event that may or may notresult in injury or damage to property or equipment

FACT: In the time it took you to read this slide, about 10 Europeans suffered disabling injuries in accidents in industry

Question 4 What is an accident?

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Question 4 Accidents Primary Causes

Primary Causes = Unsafe Acts and Unsafe Conditions

� Management need to concentrate on the nature of the accident rather than the outcome

� It must be clearly understood that the primary cause of the accident is not always necessarily the most important feature; secondary causes, usually in the form of system failures can continue unless action is taken


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Unsafe Acts

� Working without authority� Failure to warn others of danger� Using unsafe equipment� Using wrong equipment� Failure to issue control measures� Horseplay � Etc…

Unsafe Conditions

� Inadequate or missing machine guards

� Defective tools or equipment� Fire Hazards� Ineffective housekeeping� Excessive noise� Poor ventilation and lighting� Etc…

Question 4 Accidents Primary Causes

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Management System Pressures

� Financial restrictions� Lack of commitment� Lack of policy� Lack of standards� Lack of training

Social Pressures

� Group attitude� Tradition� Society attitudes to risk taking� ‘Acceptable’ behaviour in the

workplace

Question 4 Accidents Secondary Causes


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Question 5 What is a hazard? What is a risk?

Hazard:� ‘hazard’ means a potential source of injury or damage to health

Risk:� ‘risk’ means a combination of the probability and the degree of an injury or damage

to health that can arise in a hazardous situation

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Question 6 What are Safety Components?

Safety Control System

E-Stop

Light Curtain

Safety Sensors

Safety Mat and Bumper

Two Hand Control


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Question 6 What are Safety Components?

Fixed and Mobile Guard Systems

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Question 7 Who should be carrying out safety functi ons?

Competence means having the necessary qualifications, experience and training to be able to: � Identify all hazards, � To assess the risk related to them and � To know what control measures will reduce risk to an acceptable level

According to European Legislation personnel responsible for safety “should be able to demonstrate competence”. � Qualifications, Example: Occupational Safety and Health (MIOSH)� Training: Demonstrates knowledge specific to particular machinery, products or

processes � Experience: Demonstrates knowledge gained through experience


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Question 8 When is there an acceptable level of saf ety?

When can a system / machine / plant be considered to have an acceptable level of safety?� The machine/ system/ plant has been assessed� All hazards have been identified� Appropriate safety meassures have been designed to reduce the risk to an

acceptable level� A theoretical test and analysis of the performance of the new safety system has

been calculated� Safety system has been implemented� Practical tests of the safety system and fault simulation on original components,

especially in areas where doubt exists, have been performed� Validated components and principles have been used� All safety system, test, components etc... are properly documented� All of above has been done by competent people strictly following current

standards and directives

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Question 9 How much should be invested in safety?

This model links the cost of accidents and the cost of risk reduction.At point A the total costs are the lowest.

Safety resources

Cost

Total Cost

Total Accident Cost

Total Safety Cost

A

SAFETY IS AN OBLIGATION.

NOT AN OPTION!!!!!!!


Safety First

You should quantify

the safety first !

There is always a safer way !!!!There is always a safer way !!!!

Or more ………

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� True or False…

Inadequate or missing machine guards is a secondary cause of accidents.

Management need to concentrate on the nature of the accident rather than the outcome.

Emergency Stops, Light Curtains and Safety Signs are not forms of Safety Components.

Primary Causes of accidents are Unsafe Acts and Social Pressures.

A machine has an acceptable level of safety when all hazards have been identified and adequately controlled.

�

�

�

�

�

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� Topics



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� Health and Safety Management

The systematic use of techniques to identify and remove hazards, the control of risks which remain, and the use of methods to influence the behaviour and encourage safe practices. This is the primary responsibility of management.

Responsibilities

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� Health and Safety Management

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1. How Health and Safety will be managed in detail

2. Securing of effective Communication Channels

3. Identify relevant and attainable objectives and targets

4. Gather information from active and re-active monitoring systems

5. Periodic reviews and audits of the system

6. Continuous improvement to foster a proactive rather than reactive environment

Safety Management System Overview

6. Continuous

Improvement

1. Health & Safety

Policy Statement

2. Planning &

Organisation

4. Measuring

Performance

3. Implementation

& Operation

5. Management

Review

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� Topics



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� Introduction to Safety Legislation

European Union Safety Law

� The EU Commission issues Directives� Approved Authorised Bodies (e.g. CEN, CENLEC) issue EU Normatives� A State sponsored body exists in each member state to secure Safety, Health and

Welfare at work� The Government transpose these Directives into Laws, while the local enforcement

agency enforce the Laws and issue Guidance Documentation

RECOMMENDATIONS

LAWS

EU NORMATIVES

AUTHORISED BODIES

EU DIRECTIVES

EU CommissionLocal Enforcement

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Machinery Directive must be implemented in law by all states in the European Economic Area. The directive deals with the requirements to achieve CE Marking

European Directives Geographical Scope

Austria

Belgium

Bulgaria

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Iceland

Ireland

Italy

Latvia

Liechtenstein

Lithuania

Luxembourg

Malta

Netherlands

Norway

Poland

Portugal

Romania

Slovakia

Slovenia

Spain

Sweden

United Kingdom

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CE Marking Principles

� CE marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer

� The CE marking affixed to products is a declaration by the person responsible that:– The product conforms to all applicable Community provisions– The appropriate conformity assessment procedures have been completed

� Specific directives had been put in place providing the legal regulation for the affixing of the CE marking

� The CE marking is not a mark of origin, as it does not indicate that the product was manufactured in the European Community

� CE is only a claim by the manufacturer that the machinery is safe and that they have met relevant supply law. The user, also has to check that it is, in fact, safe before the machinery is used.

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Products to be CE Marked

� The CE marking is mandatory and must be affixed before any product subject to it is placed on the market and put into service, except where specific directives require otherwise. In concrete they apply to:– All new products, whether manufactured in the Member States or in third party

countries– Used and second-hand products imported from third party countries– Substantially modified products that are subject to directives as new products

� Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives

� The CE marking must be affixed by the manufacturer, or by the authorisedrepresentative established within the Community

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Principle Directives Machinery Directive - 2006/42/EC

� Instrument that all EU Member States have adopted to establish the safety requisites machinery must possess in order to be introduced to the Community Market

� The Directive aims to ensure identical Safety requirements for machinery in every state

� Originally came into force on 14th June 1989� Directive 2006/42/EC came into force on 29th December 2009 � The Machinery Directive has the power of law in the European Union� To ensure the free movement of goods in all the member states� To ensure identical Safety requirements for machinery in every country� To ensure a high level of safety

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Machinery DirectiveBasic Principles and Objectives

� Products legally manufactured or marketed in one country should move freely throughout the Community

� The mechanisms in place to achieve this aim are based on prevention of new barriers to trade, mutual recognition and technical harmonisation

� The technical specifications of products meeting the essential requirements set out in the directives are laid down in harmonised standards

� Application of harmonised or other standards remains voluntary� Harmonisation is limited to essential requirements� Only products fulfilling the essential requirements may be placed on the market

and put into service

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Machinery DirectiveBasic Principles and Objectives

� European Directives must be implemented in law by all Member States

� All member states shall ensure the free movement and putting into service of machinery bearing a CE marking and having an EC conformity

� The placing on the market and putting into service can only take place when � The product complies with the provisions of all applicable directives � When the conformity assessment has been carried out in accordance with all

applicable directives

� In cases where machinery which does not comply with European directives, the Member State shall take appropriate action against whom so ever has affixed the marking and shall so inform the Commission and other Member States

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Machinery DirectiveMain Players

Who does the legal framework affect?

� O.E.M.’s

� Machines Imported into the European Union

� Machines Built For Own Use

� Machines Built For Sale into the European Union

� Machines altered beyond Their original Limits

� New machines (currently being place in the market or put into service)

� Old machines (if being place into the market or substantially modified)

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Machinery Directive ResponsibilitiesManufacturer

� A manufacturer is the person who is responsible for designing and manufacturing a product with a view to placing it on the Community market on his own behalf

� The manufacturer has an obligation to ensure that a product intended to be placed on the Community market is – Designed – Manufactured– Conformity assessedto the essential requirements in accordance with the provisions of the applicable Directives

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Principle Directives Low Voltage Directive - 2006/95/EC

� This regulation applies to all electrical equipment that are designed or adapted for use between 50V – 1000VAC and 75V – 1500VDC used in the workplace or domestic environment

� The goal of this directive is to ensure that electrical equipment placed in service within the EC is safe

� Originally adopted 1973 under EEC directive 73/23/EEC� Harmonized EN standards can be used to determine compliance, some key

standards to aid compliance are:– EN 60204 Safety of Machines - Electrical Equipment of Machines– EN 60335 Safety of household appliances– EN 60947 LV Switchgear and control gear– EN 60598 Luminaries

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Principle Directives Electromagnetic Directive - 2004/108/EC

� To ensure electromagnetic interference from electrical/ electronic devices does not disrupt other devices

� To ensure electrical/ electronic devices are not disrupted by electromagnetic interference from other devices

� Entered into European Law on 28th October 1992� Came fully into force on 1st January 1996� Key factors to consider in order to comply are:

– Use proprietary control equipment– Follow correct procedures and standards– Use braided earth cables for all flexible out of panel wiring – Follow suppliers instructions for variable speed drives, etc– Fit all necessary filtering

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Principle DirectivesMin. Safety & Health Reqs Directive - 89/655/EEC

� Superseded by Directive 2009/104/EC with no significant changes� To ensure compliance with minimum requirements regarding safety and health at

work in order to ensure the safety of workers� The employer shall take the necessary measures to ensure that work equipment

made available to workers is suitable for the work with impairment to their safety or health

� Entry into force on 31st December 1992 � All the machines should comply with the requirements no later than four years after

that date 31st December 1996 � Key factors to comply are:

– Requirements on control and electrical systems– Conditions of work equipment– Training of workers– Written safety instructions

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� Topics



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� Standards

Definitions

� Standards ensure minimum desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability - and at an economical cost

� Standards are formal documents containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose

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� Standards

The main reasons are: � Worldwide progress in trade

liberalisation� Interpenetration of sectors� Worldwide communications systems� Global standards for emerging

technologies� Developing countries worldwide.

Why Standards?

For example, the format of the credit cards, phone cards, and "smart" cards that have become commonplace is derived from an ISO International Standard. Adhering to the standard, which defines such features as an optimal thickness (0,76 mm), means that the cards can be used worldwide

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� Standards

Standards for Safe Construction of Machines & Plant s

� INTERNATIONAL � EUROPE � NATIONAL

� IEC / ISO Standards � EN / ISO / IEC Standards

� DIN / EN / ISO IEC Standards

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� Standards

Standards Relationship

Etc…

ANSI/RIA/ISO

10218-1

(ANSI/ISO 12100-1)

EN ISO 10218-1

ISO 10218-1

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� Standards

Electrical Standards Relationship

Etc…

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Etc…

� Standards

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Structure of Standards

The structure of the European harmonised standards contains many interlinking standards, which allow the build of a machine without special designed machine safety standards.

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� Standards

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� Type-A standards (basic safety standards) giving basic concepts, principles for design, and general aspects that can be applied to all machinery

� Examples: – EN ISO 12100 - Safety of

Machinery - General Principles of Design – Risk assessment and risk reduction

Standard Types “A” Standards

� Standards

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� Type-B standards (generic safety standards) dealing with:

– one safety aspect (Type B-1) or

– one type of safeguard that can be used across a wide range of machinery (Type B-2)

Standard Types “B” Standards

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� Standards

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Standard Types “B” Standards - Examples

B1 Examples:

� EN 60204-1 Safety of Machinery - Electrical equipment of industrial controls

� EN 954-1/EN13849-1 Safety of Machinery - Design of safety related control systems

� EN 13857 Safety of Machinery - Safety distances to prevent danger zones being reached by upper and Lower limbs

B2 Examples:

� EN 953 Safety of Machinery - General requirements for the design and construction of guards.

� EN 574 Safety of Machinery - Two hand controls� EN 1760-1 Safety of Machinery - General principles for the design and testing of

pressure sensitive mats and pressure sensitive floors.

� Standards

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� Type-C standards (machine safety standards) dealing with detailed safety requirements for a particular machine or group of machines

� Examples:– EN 692 – Machine Tools-

Mechanical Presses - Safety– EN 693 – Machine Tools - Safety -

Hydraulic Presses – EN 422 – Rubber and Plastics

Machines - Safety– EN 201 - Plastics and rubber

machines. Injection mouldingmachines. Safety requirements

Standard Types “C” Standards

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� Standards

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� EN 349 - Minimum gaps to avoid crushing parts of the human body.

� EN 1088 - Interlock devices associated with Guards.� EN 1037 - Prevention of unexpected start up.� EN ISO 13855 - Positioning of safeguards with respect to the approach speeds of

parts of the human body � EN ISO 13850 - Emergency stop - Principles for design � EN ISO 4413 - Hydraulic fluid power - General rules and safety requirements for

systems and their components � EN ISO 4414 - Pneumatic fluid power - General rules and safety requirements for

systems and their components

� EN ISO 14122 series - Permanent means of access to machinery� EN 62061 - Functional safety of safety-related electrical, electronic and

programmable electronic control systems

Other Relevant Standards to Consider with Machinery

� Standards

A Type standard exampleISO 12100 General principles for design, Risk asses sment

� The standard establishes general principles intended to be used to meet the risk reduction objectives established in ISO 12100:2010

� Its primary purpose is to provide designers with an overall framework and guidance to enable them to produce machines that are safe for their intended use

� These principles bring together knowledge and experience of the design, use, incidents, accidents and harm related to machinery in order to assess the risks posed during the relevant phases of the life cycle of a machine

� The new ISO 12100:2010 supersedes ISO 12100 Parts 1 and 2, and also ISO 14121-1 and its content is identical to those contained in the superseded

� It is an editorial integration of these 3 standards � There are minor changes to the wording� ISO 12100:2010 is harmonized to the Machinery Directive

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� Standards

A Type standard exampleISO 12100 General principles for design, Risk asses sment

Risk Estimation Aspects to consider when establishing elements of risk:� Persons exposed� Type, frequency and duration of exposure� Relationship between exposure and effects� Human factors� Suitability of protective measures� Possibility of defeating or circumventing protective measures� Ability to maintain protective measures� Information for use

Risk Evaluation:� Completed after risk estimation to establish if risk reduction is required or if safety

has been achieved. If risk reduction is required the 3 step method outlined in EN ISO 12100 is recommended to be applied.

� It is important to check no additional hazards have been created when new safety measures are applied.

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� Standards

B Type standard exampleEN ISO 13849-1 and EN 62061, Safety-Related Control Systems

� Identify the hazards on the respective machine� Assess risk parameters S, F, P in accordance

with Annex A� Determine the required performance level PLr � Confirm the performance level achieved

considering the:– Category– MTTFd – DC– CCF– of the safety-related parts

� Compare the performance level PL with the required performance level PLr

� Validate whether all the requirements have been met?

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� Standards

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Plastics and rubber machines -Injection Moulding Machines -Safety requirements

� Specifies the essential safety requirements for injection mouldingmachines for the processing of plastics and/or rubber.

� The safety requirements for the interaction between injection mouldingmachines and ancillary equipment are specified.

C Type Standard ExampleEN 201

� Standards

Ergonomics

Ergonomics must now be considered according to1.1.6 of the Essential Health and Safety Requirements of the new Machinery Directive 2006/42/EC:

Under the intended conditions of use, the discomfort, fatigue and physical and psychological stress faced by the operator must be reduced to the minimum possible, taking into account ergonomic principles such as:� Allowing for the variability of the operator's physical dimensions strength and

stamina � Providing enough space for movements of the parts of the operator's body� Avoiding a machine-determined work rate� Avoiding monitoring that requires lengthy concentration � Adapting the man/machinery interface to the foreseeable characteristics of the

operators.

Relevant Standards:� EN 614: 2006 - Safety of machinery - Ergonomic design principles

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� Standards

Causes of poor ergonomics :� Repeated use of vibrating equipment or machinery � Poor workstation layout and/or incorrect height of workstations� Improper tools� Application of excessive force� Lifting/ pushing heavy loads� Working with poor posture� Repetitive Work, Pace of Work

Perform Risk Assessment by:� Referring to specific C standard for the machine - if the C standard does

not specify ergonomic requirements, reference general ergonomic standards

� Conferring with the users of the machine and engagement of employees is crucial in the correct identification and resolution of issues.

Ergonomics

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� Topics



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� Application to Machinery and Plant

� European Normatives provide a presumation of conformity to the Machinery Directive

� Application of appropriate Normatives can be used for complaince with specific EHSR‘s

� Type C standards can allow a presumption of conformity for a whole machine

Overview

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Safety ProcessApplication of Legislation and Standards

Training (Additional measures)

Inform and warn (Residual Risk)

Risk Reduction Safeguards

Risk Reduction Design

Limits of Acceptable Risk

Risk Assessment

Machine Limits

e.g. EN 626

e.g. EN 842

e.g. EN 953

e.g. EN ISO 13849-1

e.g. EHSR

e.g. EN ISO 12100

e.g. EN ISO 12100

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Useful Links

European Directives may be found :http://eur-lex.europa.eu/en/index.htm

� Machinery Directivehttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:157:0024:01:EN:HTML

� Use of Work Equipment Directivehttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:260:0005:01:EN:HTML

This site also includes details of local transposition of the directives.

Standards relevant to Machinery:http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/machinery/index_en.htm

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� Topics



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� Advantages of Compliance

� Compliance with legislation. Legal protection

� Safe products make good business sense. Market perception

� Organizational culture

� Natural link between safety and reliability

� Employee well-being

� Points to other management failures

� Diagnosis easily possible

� Direct costs: compensation, insurance costs

� Indirect costs: downtime, investigation, replacement of staff, etc.

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� True or False………

Manufacturer or authorised representative must ensure a Risk Assessment is undertaken to determine the Health and Safety Requirements applicable to a machine. �

�

�

�

�

Ergonomics does not need to be considered for the new Machinery Directive

EN 954-1 may not be used to gain a presumption of conformity with Safety Legislation

The machine user must check that the machine is safe before the machinery is used.

Machinery compliance reduces indirect costs such as downtime, investigation, replacement of staff, etc.

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key safety questions8question

acceptable level of