Expertise
 

CE marking knowledge base

CE marking knowledge base
1. Is my product covered by the Machinery Directive?

The definition of machinery used by the Machinery Directive is complicated. It says,
Machinery means:

  • 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,
  • an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,
  • an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,
  • assemblies of machinery referred to in the first, second and third indents or partly completed machinery which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
  • 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 directly applied human effort.
The directive also includes equipment such as safety components and lifting accessories and excludes equipment such as fairground and amusement park rides, weapons and certain means of transport.
Not sure whether your product is in or out of the Machinery Directive? Contact us and we’ll talk you through the definitions.

2. Is my product in Annex IV?

The Machinery Directive includes an Annex IV that lists machinery for which special procedures are to be followed for assessing conformity (including, for example, EC type-examination by a Notified Body and Full quality assurance). If your product is machinery that is in one of the categories described in Annex IV then you must use the correct procedure for assessing compliance with the Machinery Directive. amtri veritas is a Notified Body for many of these types of machinery and can carry out an EC-type examination for you. Contact us to find out whether your machinery is in Annex IV of the Machinery Directive and how we can help.

3. What Standards do I need to meet?

The short answer is that there is no legal requirement for your product to meet any standards at all.
The long answer is that many standards give a presumption of compliance with safety legislation such as the Machinery Directive (implemented as the Supply of Machinery (Safety) Regulations) that you are legally required to meet and so are very useful to you.Harmonised standards (those that have been published in the Official Journal of the European Union) are therefore a very effective way of demonstrating that you have met your obligations of ensuring that your machine is safe and complies with the relevant product safety legislation.Some examples of different types of harmonised standards are

  • EN 12100 Safety of machinery – General principles for design – risk assessment and risk reduction.
  • EN 349 Safety of machinery – Minimum gaps to avoid crushing of parts of the human body.
  • EN 13850 Safety of machinery – Emergency stop function – Principles for design.
  • EN 692 Machine tools – Mechanical presses – Safety.
Perhaps the most useful harmonised standards are the C-type standards that apply to a particular machine or group of machines (e.g. EN 692 above).
If you are able to comply with such a standard, then you are well on the way to meeting the Essential Health and Safety Requirements (EHSRs) of the Machinery Directive.
Of course, standards call up other standards and require you to comply with them too …Standards are not mandatory – contact us if you need help on what the relevant standards are and how to apply them to meet your obligations under the Machinery Directive.

4. Does my product need CE Marking?

The CE Mark is the symbol that tells a user that a product complies with all the European product legislation that is required for it to be placed on the market within Europe. Some examples of European Directives that enact product legislation and that may require you to fix a CE Mark to your product are:

Machinery Directive

Machinery (equipment with at least one moving part powered by energy other than directly applied manual effort), machinery without its power source, assemblies of machinery, manually-powered lifting equipment, interchangeable equipment, safety components, lifting accessories, chains ropes and webbing for lifting, etc.

Electromagnetic Compatibility Directive

Electrical and electronic apparatus, components, mobile installations and fixed installations.

Low Voltage Directive

Electrical equipment where the hazards are mostly electrical and voltages are less than 1000 VAC and 1500 VDC.

Outdoor Noise Directive

Certain types of equipment for outdoor use.

Pressure Equipment Directive

Vessels, piping and accessories subject to gauge pressure exceeding 0.5 bar.

Not sure which directive applies to your product? Contact us to find out.

5. Has EN 13849 replaced EN 954?

EN 13849 Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design replaced EN 954-1 on 29 December 2009 when it was published as a Harmonised Standard in the Official Journal of the European Union.

This means that you should expect to make the Safety-Related Parts of Control Systems (SRP/CS) on machinery comply with EN 13849 and use the newer probabilistic analysis based on Performance Levels rather than the plain circuit categories of the older standard. EN 13849 now covers SRP/CS with hydraulic and pneumatic components as well as electrical components.

Some C-type standards for particular machines or groups of machines still call up EN 954-1 - until these standards are revised you may continue to comply with EN 954-1 but you will have to change over as soon as a revised version calls up EN 13849 - and this could happen sooner than you think. Once a harmonised standard has been superseded you lose the presumption of conformity it gives with European directives.

There are free software tools available to assist with the analysis needed to comply with EN 13849 but these depend on a good understanding of the concepts and methods in the standard.

amtri veritas offers a range of training courses in the use of EN 13849 as well as help and advice. Please Contact us if you are interested.

6. What is the difference between SIL and PL?

Both SIL (Safety Integrity Level) and PL (Performance Level) are measures of the reduction in risk provided by a safety function of a control system. For systems that are operating continuously, SIL and PL are both defined as ranges of the probability of dangerous failure per hour and they overlap. PL a has no eqivalent SIL, and SIL 4 has no equivalent PL, but between these extremes there is the following correspondence:

  • PL b: SIL 1
  • PL c: SIL 1
  • PL d: SIL 2
  • PL e: SIL 3
The main difference between them is that SILs are used when working with EN 62061 and PLs are used when working with EN 13849. EN 13849 is more suitable for simpler safety-related control systems made up mostly of off-the-shelf safety components or pneumatic or hydraulic components. EN 62061 is for electrical and electronic control systems only and is more suitable for more complex systems. Two other standards that use SILs for safety in the process sector are EN 61508 and EN 61511. Not sure which standard to use for ensuring the safety of a control system? Contact us for more help or advice.

7. How do I CE mark my product.doc

The CE Mark is the symbol that tells a user that a product complies with all the European product legislation that is required for it to be placed on the market within Europe.
So there are six steps to CE Marking:

  • Identify which directives apply to your product.
  • Establish what you need to do to comply with each directive – meet Essential Health and Safety Requirements (EHSRs), carry out tests, draw up documentation, prepare certificates, etc.
  • Identify whether examination or testing by a Notified Body is necessary.
  • Carry out the necessary testing.
  • Draw up the necessary documentation
  • Fix the CE Mark to your product and draw up the Declaration of Conformity.

The CE Mark must have the form:

ce

If it is reduced or enlarged the proportions must be respected. The various components of the CE Mark must have substantially the same vertical dimension, which may not be less than 5mm. The minimum dimension may be waived for small-scale equipment.
The CE Mark must be fixed to the product near the name of the manufacturer (or his authorised representative) using the same technique.
Contact us if you need help with CE marking.

8. When do I need to involve a notified body.doc

Notified bodies are impartial organisations that have a statutory role in a conformity assessment process for one or more European Product Directives.

For example, Notified Bodies for the Machinery Directive make EC-type examinations of machinery listed in Annex IV of the directive.

If your machinery is listed in Annex IV of the Machinery Directive and an applicable C-type harmonised standard covers all the relevant Essential Health and Safety Requirements (EHSRs) then you may ask a Notified Body to make an EC-type examination; if there is no applicable C-type standard or your machinery is not fully covered by the standard or the standard does not fully cover the relevant EHSRs then you must ask a Notified Body either to make an EC-type examination or to assess your Quality System to ensure that is capable of producing compliant machinery.

amtri veritas is a Notified Body under the Machinery Directive for most of the types of machinery listed in Annex IV. Contact us for information on EC-type examinations or Quality System assessments.

9. Machinery Directive and Puwer.doc

The Machinery Directive (as the Supply of Machinery (Safety) Regulations) applies to manufacturers and others placing machinery on the market; PUWER (The Provision and Use of Work Equipment Regulations) applies to employers and others who provide machinery to people for use in the course of their work.

puwer

The overlap is not complete because the Machinery Directive also applies to equipment that is not supplied as work equipment (safety components, for example) and PUWER also applies to work equipment that is not machinery (step ladders, for example).
An example of how this works in practice is:

  • A manufacturer has to make sure that his machinery is safe for the purpose for which it is intended and safe for use by the people who are intended to use it – Machinery Directive.
  • An employer has to make sure that work equipment is fit for the environment in which it is used, is suitable for the purpose for which it has been supplied and that the people who use it are equipped to use it safely – PUWER.

Risk Assessment is an important part of the responsibility of both parties in ensuring safe machinery and work equipment.
amtri veritas offers training in Risk Assessment for both the Machinery Directive and PUWER. Why not contact us for more help or advice?

10. Use of pesticides and the Machinery Directive

On 15 December 2011 the Machinery Directive 2006/42/EC incorporated the amending directive 2009/127/EC which added some supplementary Essential Health and Safety Requirements (EHSRs) for machinery for pesticide application. The Machinery Directive has always applied to machines for pesticide application – this amendment requires them to meet some extra requirements. There has been some confusion about which pesticide application devices are covered by the directive – it comes down to whether the devices are machinery within the scope or outside it. The directive defines a machine as, amongst other things, an assembly of parts at least one of which moves assembled for a specific purpose driven by something other than directly applied manual effort. Consider some devices that might be used for spraying pesticides:

Agricultural Sprayer towed by tractor

Moving parts: plenty; drive: PTO from tractor; machinery: yes.

Knapsack Sprayer

Moving parts: pump handle; drive: pressurised air; machinery: yes.

Syringe Sprayer

Moving parts: syringe handle; drive: directly applied manual effort: machinery: no.

The Agricultural Sprayer and the Knapsack Sprayer are machinery and must meet the general and supplementary EHSRs of the Machinery Directive. The Syringe Sprayer is not machinery and is outside the scope of the Machinery Directive, even when used to apply pesticides. amtri veritas has worked with machinery for pesticide application – contact us to see if we can help you.

11. What is a harmonised standard.doc

The Machinery Directive allows you to presume compliance with if you comply with certain standards – the harmonised standards.
There are three types of harmonised standards:

  • type-A standards: (basic safety standards) giving basic concepts, principles for design and general aspects that can be applied to machinery
  • type-B standards: (generic safety standards) dealing with one safety aspect or one type of safeguard that can be used across a wide range of machinery
    • type-B1 standards on particular safety aspects (e.g. safety distances, surface temperature and noise)
    • type-B2 standards on safeguards (e.g. two-hand controls, interlocking devices, pressure sensitive devices and guards)
  • type-C standards: (machine safety standards) dealing with detailed safety requirements for a particular machine or group of machines.
When a type-C standard deviates from one or more technical provisions dealt with by a type-A or a type-B standard, the type-C standard takes precedence.
Some examples of different types of harmonised standards are
  • EN 12100 Safety of machinery – General principles for design – risk assessment and risk reduction (type-A).
  • EN 349 Safety of machinery – Minimum gaps to avoid crushing of parts of the human body (type-B1).
  • EN 13850 Safety of machinery – Emergency stop function – Principles for design (type-B2).
  • EN 692 Machine tools – Mechanical presses – Safety (type-C).
All harmonised standards have been published in the Official Journal of the European Union. To identify them, search the Internet for ‘machinery directive list of harmonised standards’. They can be purchased on-line from national standards organisations (e.g. BSI).
There are many harmonised standards and they cross-reference each other so that complying with one may mean complying with others. Navigating this intricate network is difficult - contact us to find out how we can help you.

12. When can I self-certify.doc

The Machinery Directive divides machinery into two categories: machinery listed in Annex IV and everything else (non-Annex IV machinery).
Annex IV machinery
You may only self-certify if

  • either there is a C-type harmonised standard that applies to your machinery and covers all the relevant Essential Health and Safety Requirements (EHSRs)* and you have complied with it fully, and
  • either you follow the procedure for assessment of conformity with internal checks on manufacture in Annex VIII of the directive (drawing up a technical file and then taking all measures necessary to ensure that the machinery is manufactured to the technical file)
  • or you follow the full quality assurance procedure in Annex X of the directive.
  • or there is not a C-type harmonised standard that applies to your machinery and you follow the full quality assurance procedure in Annex X of the directive.

Non-Annex IV machinery
You may self-certify.
If you intend to self-certify, amtri veritas offers a voluntary examination that is made with the same rigour as the EC-type examination needed for Annex IV machinery that you do not self-certify. Voluntary examinations provide a valuable and independent confirmation the your machinery meets the requirements of the directive.
Contact us to find out more.

*For example EN 280:2013+A1:2015 is the C-type harmonised standard for Mobile Elevating Work Platforms (MEWPs). If you manufacturer a MEWP intended for underground use the standard does not cover the EHSRs in Section 5 of Annex I of the directive for machinery intended for underground work.

 
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