CE Marking a single machine.

CE marking of a single machine is a relatively simple process. The limits of the machine should be determined, maximum speed, pressures, etc. and a description documented. At this point a basic risk assessment should be carried out to determine what hazards are likely to occur, and at this point, it is possible to design out the hazards and design in safeguards.

Maintenance should be considered, to enable components to be changed safely, but also efficiently. CE marking doesn’t require things to be efficient, but good design does. At this point, review what Directives may apply. If electrically powered, then the EMC Directive will probably apply, if pressure systems are involved then the Pressure Equipment Directive, and if an explosive atmosphere is likely, then ATEX Directive may need to be considered.

Note: New EMC, PED, and ATEX Directives came into force in 2016.

When a design is in place, a prototype can be built. Calculations for cables, components, stress etc. should be carried out at this point. They may need updating at a later point as things change, but should be done in the early stages.
At this point EN Standards come into place. If there is a ‘C’ type standard for the type of equipment, then it should be followed as much as possible. EN 619 is for conveyors, EN 201 for injection moulding machines for example.

For the latest EN standards that apply to the Machinery Directive

Electrical systems should be designed using EN 60204-1; Safety related control systems designed using EN 13849 or EN 62061, either way, the design needs to be validated before the machine goes into service. It is never good practice for the designer to carry out the validation. The Essential Health and Safety Requirements (EHSR’s) of the Machinery Directive should be followed at this point, to ensure compliance can be achieved.

Once a machine is built, the EHSR’s should be gone through individually, against the machine, explaining how the machine complies, or if it doesn’t, carrying out risk assessments to determine how to make it comply. These should all be documented as evidence that the CE process has been gone through, and stored in a Technical File. The File does not have to exist, however does need to be able to be assembled in a timely manner, if required by the Health and Safety Authorities. To this end, it is worth either saving everything in a Directory, or printing it out in a Technical File. Declarations provided by component or sub suppliers need to be either scanned and saved or stored in the Technical File.

All machinery must meet section 1 of the EHSR’s in Annex I of the Directive, however if the machine is for contact with food or pharmaceuticals, Section 2 should also be addressed, if mobile equipment then Section 3, if lifting equipment Section 4, if for underground work then Section 5 and for lifting of people, Section 6.

If any tests are required, lifting tests, noise tests, vibration, EMC etc., these should be done at this point (or earlier), and the results documented. If the machine fails, then further work may need to be done.

An Instruction manual needs to be written detailing not only how to operate the machine, but how to handle and transport it, install it, commission it, program or clean it, operate it, maintain it and finally dismantle and dispose of it. As good practice, the software file used to validate the safety related control system should be designed to the end user, so that modifications can be made later.

Once any rework is carried out, the machine tested and working correctly, then a Declaration of Conformity can be produced and the CE marking applied to the machine.

A copy of the Declaration must be in the Instructions, the original should be held by the manufacturer. The manufacturers name and address and details of the machine must be affixed to the machine, so that the Declaration can be cross referenced to it, this is a good place to mount the CE marking. The CE marking must be in the same format as the plate.

Partly completed machinery

If building a machine that is designed to be incorporated into another machine or a system, a conveyor without any controls for example, that is to be incorporated into a system that another manufacturer is designing the controls for, then the same basic process is followed as above, but only the EHSR’s that apply are considered. So guarding would be considered to ensure that nip points are protected, but the control EHSR’s would all be Not Applicable. A Technical File would be compiled, listing the EHSR’s and how the equipment complies, and identifying which are Not Applicable.

A plate would be attached to the machine, but no CE marking should be applied. A Declaration of Incorporation should be drawn up, listing the EHSR’s that have been addressed. An Instruction Manual explaining how to incorporate the machine should be provided. If there are safety related components provided, an assessment should be provided demonstrating what Performance Level or Safety integrity Level has been reached under EN 13849 or EN 62061 respectively. Ideally a copy of the software file used to demonstrate the calculations should be supplied.

Complex Assemblies

If building a complex assembly of machines, such as a robot cell, where a robot takes a component and transfers it between different machines or jigs, and different processes are carried out, then it is still a very similar process. In this instance, many of the machines supplied will either be CE marked in their own right, or come with Declarations of Incorporation.

The integrator has to design a safe system, so must start with the basics and define the limits of the machinery, weights, speeds etc. to determine an efficient way of working. Hazards need to be considered and designed out where possible. Safeguards need to be designed in, and the same process followed as for the CE marking of a single machine.

This can be complicated, depending upon the complexity of the system. A Distribution depot with miles of conveyor has to follow the same process, as does a production line in a factory. Either way, the limits need to be determined, EHSR’s addressed and risk assessments carried out, to be held in a Technical File. Maintenance becomes extremely important in larger systems, as it needs to be determined how to achieve safe access to all areas for maintenance and adjustment, considering access for people, but also heavy components.

Ultimately a plate with a CE mark and a Declaration of Conformity will need to be issued. Contracts should specify who is responsible for the CE marking of a complex assembly at the start of the project, to ensure there is no confusion. Safe Machine Ltd. can work with integrators to ensure this is done correctly.

Interchangeable Equipment

Where a machine is designed for use with another, such as an excavator bucket, demountable gritter body or something driven by a tractor, the CE process should be followed as if for a single machine. The key issue is if this is done by the operator, it can be considered interchangeable equipment. If a team of engineers is required, then it is not.

The relative sections in the EHSR’s must be addressed. Instructions form an important part, as they have to explain how to handle the equipment safely. The CE marking will be applied to the equipment on a plate, which may also include things like mass or power.

Fundamental Changes

If an existing machine is modified to change its function or performance, then the Machinery Directive applies where the modified machinery is considered “new” to the EEA market. For example, the fitting of CNC  (computer) control to a previously manually operated machine substantially alters the way the original machine is operated and controlled. Consequently such a modification introduces significant new hazards (e.g. automatic programmed operation). This will require full assessment before modifications to the design and construction of the machine are made to ensure they are safe and prior to it being placed on the market or put into service. In this case, where very substantial modifications / additions have been made full compliance with the Machinery Directive is required for the resultant product (conformity assessment, drawing up of a technical file, issuing a Declaration of Conformity and CE marking).

This is because a new machine has been created even though the original manually operated machine may have previously been in use in an EEA country. Where the machine is large and complex the part modified may not affect other parts of the machine. In this case, only the parts and systems modified, or which could have been affected, need to be reassessed. The other parts not affected do not need a new conformity assessment, but the assessment of what is not affected should be included in the technical file.

For further details see the HSE website


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