Download
1 / 79
E N D
4. Machinery Directive.
Low Voltage Directive.
EMC Directive Evaluation and on site Field Testing.
Pressure Equipment Directive.
ATEX Directive.
PUWER Inspections.
Country Wide Seminars.
In house tailor made Seminars.
5. The Manufacturer
The User
10.
27 different countries
27 different legal systems
All countries introduce the same laws into their own legal systems
The Directives are adopted as Laws and must be complied with before supplying equipment into the European Economic Area (EEA).
11. The Machinery Directive 2006/42/EC.
The Low Voltage Directive 2006/95/EC.
The EMC Directive 2004/108/EC.
The Pressure Equipment Directive 97/23/EC.
Why comply?
Because all of the European directives are brought into UK law by the issue of Regulations that make it a criminal offence punishable by fines and imprisonment not to comply.
12. New Approach
Demonstrate compliance with the Essential Health and Safety Requirements.
Carry out the appropriate conformity assessment procedure (Tech File ).
Draw up and issue the Declaration of Conformity or Incorporation.
Apply the CE Mark.
Make sure that it is safe.
13. This Directive applies to the following products:
(a) machinery;
(b) interchangeable equipment;
(c) safety components;
(d) lifting accessories;
(e) chains, ropes and webbing;
(f) removable mechanical transmission devices;
(g) partly completed machinery;
14.
An assembly fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components , at least one of which moves, and which are joined together for a specific application.
Article 2 Definitions 1(1)a to (f).
15.
Machinery referred to in 1 missing only the components to connect it on site or to sources of energy and motion.
Lifting apparatus whose only power source is directly applied Human effort.
16.
19. Lifting.
An assembly of linked parts or components at least one of which moves and which are joined together, intended for lifting loads and whose only power source is direct applied human effort are included in the directive.
lifting accessory means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself.
20. Or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;
21. which serves to fulfil a safety function,
which is independently placed on the market,
the failure and/or malfunction of which endangers
the safety of persons.
22. Extraction systems.
Guards and protection devices.
Control devices for calling lifting appliances and anti fall devices for hoists.
Protective devices designed to detect the presence of a person.
Safety belts and seat harnesses.
Hydraulic non return valves where they are used to prevent falls.
23.
Electro sensitive devices.
Monitoring devices for loading and movement control in lifting machinery.
Safety logic units for E stops or interlocks.
Solenoid valves controlling dangerous movements of machinery.
25. Other Scenarios where the Machinery Directive could apply?
If you are creating a complex assembly by interlinking a series of existing machines you are creating something new. Therefore who ever is carrying out the work must ensure that the whole assembly complies with the Directive, regardless of the age of the machines.
26. Other Scenarios where the Machinery Directive could apply?
If you are altering the function or performance of a machine or complex assembly you are again creating something new and must ensure that the Directive is complied with.
27. Changing a machine in a complex assembly or component in a single machine.
If the function or performance are not altered this is classed as a repair and no action other than a risk assessment and compliance with PUWER 98 is required.
28. The manufacturer or the importer will generally have to be able to assemble a file containing technical information relating to the machine.
The machine will have to carry the CE mark and other information.
Normally this is a self declaration process, however if the machine is listed in annex 4 of the directive, (schedule 4 of the UK regulations) then it may have to
be examined by an approved notified
body.
29. These regulations also applies to in-house machinery.
where the manufacturer of relevant machinery himself puts that machinery into service.
having imported machinery from a country or territory outside the EEA, puts that
machinery into service.
30. Non compliance could result in prosecution and penalties.
On summary conviction a fine not to exceed the statutory maximum and or 3 Months in prison.
b) On conviction on indictment an unlimited fine and or 2 years in prison.
31. Authorised Representative
The authorised representative is the person who is established in the EU who has received a written mandate from the manufacturer to perform, on their behalf, all or part of the obligations and formalities imposed on manufacturers.
33.
Failure to provide a Technical File.
Failure to provide operating instructions.
Failure to provide a Declaration of Conformity.
Incorrect application of the CE mark.
None application of the CE Mark.
A fine not exceeding level 5.
(5,000.00 at this time).
34. The Four Steps to Compliance.
Complying with the EHSRs
Compiling the Technical Construction File (TCF)
Raising the Declaration of Conformity
Affixing the CE Mark
36. 1.1.1 Definitions
1.1.2 Principles of safety integration
1.1.3 Materials and products used
1.1.4 Integral lighting
1.1.5 Handling of machinery and parts of machinery
1.1.6 Ergonomic principles
1.1.7 Operating positions in hazardous environments
1.1.8 Seating and the provision of seats
37. 1.2 Control systems
1.2.1 Safety and reliability of control systems
1.2.2 Control devices
1.2.3 Control of starting
1.2.4.1 Normal stop control devices
1.2.4.2 Operational stop
1.2.4.3 Emergency stop devices
1.2.4.4 Stop controls for assemblies of machinery
1.2.5 Mode selection
1.2.6 Failure of the power supply
38. 1.3 Protection against mechanical hazards
1.3.1 Stability
1.3.2 Break-up during operation
1.3.3 Falling or ejected objects
1.3.4 Sharp edges and angles and rough surfaces
1.3.5 Combined machinery
1.3.6 Variations in operating conditions
1.3.7 Moving parts
1.3.8.1 Moving transmission parts
1.3.8.2 Moving parts involved in the process
39. 1.3.9 Uncontrolled movements
1.4 Required characteristics of guards and protective devices
1.4.1 General requirements for guards and protective devices
1.4.2 Special requirements for guards
1.4.2.1 Fixed guards
1.4.2.2 Interlocking movable guards
1.4.2.3 Adjustable guards restricting access
1.4.3 Protective devices
40. 1.5 Risks due to other hazards
1.5.1 Electricity
1.5.2 Unwanted static electricity
1.5.3 Energy supply other than electricity
1.5.4 Errors of fitting
1.5 Risks due to other hazards
1.5.1 Electricity
1.5.2 Unwanted static electricity
1.5.3 Energy supply other than electricity
1.5.4 Errors of fitting
41. 1.5.5 Extreme temperatures
1.5.6 Fire
1.5.7 Explosion
1.5.8 Reduction of noise emission
1.5.9 Vibrations
1.5.10 Ionising and non-ionising radiation
1.5.11 External radiation
1.5.12 Laser radiation
1.5.13 Emissions of hazardous materials and substances
42. 1.5.14 Risk of being trapped
1.5.15 Slips, trips and falls
1.5.16 Lightning
1.6 Maintenance
1.6.1 Maintenance
1.6.2 Access to operating positions and servicing points
1.6.3 Isolation of energy sources
1.6.4 Operator intervention
1.6.5 Cleaning of internal parts
43. 1.7 Information for users
1.7.1 Information and warnings on the machinery
1.7.1.1 Information and information devices
1.7.1.2 Warning devices
1.7.2 Warning of residual risks
1.7.3 Marking of machinery
1.7.4 Instructions
1.7.4.1 The drafting and translation of instructions
44. 1.7.4.2 Contents of the instructions particulars of the machinery and the manufacturer
1.7.4.3 Sales literature
For each of the EHSRs, the supplier should be able to demonstrate either compliance, or non applicability.
45. 2.1.1 Hygiene requirements for machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products
2.2.1 Supplementary requirements for portable hand-held and hand guided machinery
2.2.1.1 Declaration of vibrations transmitted by portable hand-held/hand-guided machinery
2.2.2 Portable fixing and other impact machinery
2.3 Machinery for working wood and material with similar characteristics
47.
1.1.2 asks us to carry out a risk assessment.
48. Identify the Hazard.
Example;
A manipulating robot is a hazard.
A moving conveyor is a hazard.
A pallet wrapper is a hazard.
Because they have the potential to do harm!
49. Assess the risk.
That is the likelihood of a person or persons coming into contact with the hazard and how much damage it would cause.
50. Control Measures.
Design the hazard out.
Remove the need for man machine interface.
Design in safeguards.
Reduce the possibility of occurrence.
Reduce the degree of harm.
Warn and inform (but only if you can achieve adequate safety).
51. RE-Assess
We must now re-assess assuming that our control measures have been implemented to ensure that they provide an adequate level of safety.
52. EuroNorm ( EN Standards ).
Now we have decided on the control measures we must ensure that they will comply with the EHSRs.
To do this we can use EuroNorm ( EN Standards ).
53. EN Standards.
The EHSRs are mandatory the EN Standards are not however:
Machinery manufactured in conformity with specified published European Harmonised standards will be presumed to comply with Essential Health and Safety Requirements covered by those standards
54. There are three types of standard.
A type apply to all machines.
B type are designed to promote safety and split in to B1 and B2.
C type apply to a specific type of machine.
56. Examples of B type standards.
BS EN 953 Relates to the selection and manufacturing of Guards.
BS EN ISO 13857 Relates to the positioning of guards to protect the upper limbs and the lower limbs.
58.
The TCF will be required to be produced by the responsible person if there is a reason to doubt that the machine conforms with the Directive.
It can be kept electronically however you must be able to assemble it in a time given by the enforcement authorities.
59. a) a construction file including:
- a general description of the machinery,
- the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,
- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc, required to check the conformity of the machinery with the essential health and safety requirements,
- the documentation on risk assessment demonstrating the procedure followed, including:
60. (i) a list of the essential health and safety requirements which apply to the machinery, means explaining how the machine complies with the requirement.
(ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery, (Risk Assessment).
- the standards and other technical specifications used, indicating the EHSRs covered by these standards,
61. - technical reports giving the results of the tests carried out either by the manufacturer or by a body chosen by the responsible person,
- a copy of the instructions for the machinery,
- any declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,
- a copy of the EC declaration of conformity;
(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.
62. The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.
2. The technical file must be made available to the enforcement authorities and the competent authorities of any other EEA state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.
64. Changes to the Declaration of Conformity.
Name and address of the person who is authorised to compile the Technical File, who must be established in the European Community.
Where appropriate a statement confirming declaration of conformity with other applicable directives.
Must be typewritten or handwritten in capital letters.
67. It is the responsibility of the integrator to ensure that the CE marking is correct.
This should be agreed in contracts or specifications at the start to determine WHO is going to take responsibility.
Determine the Limits of the system;
Go through EN 10218-2 and ensure that all areas have been addressed;
Above all, consider foreseeable misuse!
68. Control Integrity.
Which Standard to use?
EN13849/EN 62061
69.
ISO 13849
IEC 62061
Both these standards look at the Architecture of the safety system.
70.
IEC 62061
An electrical standard to be used when the safety of the machinery is being controlled by a specifically designed safety PLC.
Can only be used on electrical installations.
71.
ISO 13849-1
Is a replacement for EN 954-1 can be used for any energy source.
But if a specifically designed PLC is controlling the safety system please refer to IEC 62061.
73.
ISO 13849-1
Introduces Performance levels (probability of a dangerous failure per hour) a,b,c,d,e.
Based on the Safety Related Parts of the control system (SRP/CS).
Data to be obtained from manufacturer Mean Time To (dangerous) Failure MTTD.
74. Four stage approach for both standards
Perform a risk assessment
For the identified risks, allocate the safety measure (Performance Level (PL)) or Safety Integrity Level (SIL)
Devise a system architecture that is suitable for the Performance Level or SIL
Validate the design to check that it meets the requirements of the initial risk assessment
78. Useful websites
www.europa.eu.int www.ppma.co.uk
www.hse.gov.uk www.bara.co.uk
www.laidler.eu
www.safetysys.co.uk
www.tuvps.co.uk
www.bgia.de (SISTEMA EN13849 software)
