Nick Doe provides an overview on the importance of meeting the Machinery Directive under CE marking
With the latest advancements in machinery and the ever growing complexities, Functional Safety, as part of the Machinery Directive, is now playing a huge role in recognising potential hazards in machine design.
Machines placed on the market in the UK and Europe are required to be CE marked under the Machinery Directive before they are put into service. The Directive applies to machines that are new, and machines that have been built for own use, or where they have been modified or rebranded. It also applies to importers, distributors and suppliers who should ensure that only safe and compliant machinery, ie CE marked and accompanied by a Declaration of Conformity and instructions in the language of the end user, is placed onto the European Economic Area (EEA) market.
With the ever increasing complexities of machine design such as hydraulic, pneumatic, electrical /electronic and more often than not software components, complying to these regulations is key to successful product design and manufacture.
As a systems integrator and machine builder Neilson Hydraulics & Engineering has invested in Functional Safety Fundamentals and Functional Safety Evaluation training to enhance its machine building integration knowledge, so it can carry out competent CE marking of its manufactured equipment, as well as helping new and existing customers meet the ever growing Machine Directive under CE marking.
Most manufacturers sign a Declaration of Conformity and affix the CE mark. This is a visible sign that the manufacturer of the product has fulfilled the requirements of the current Machinery Directive, which includes functional safety risk assessment evaluations and documentation.
The most important requirement of the regulations is that manufacturers or their authorised representatives in the EU must ensure that all new machinery is safe. This includes second hand or refurbished machinery, which is new to the European market and put into service within Europe for the first time.
To enforce the CE marking requirements, the Machinery Directive has now been implemented as national law in all countries within the EEA, which means that the same legal requirements apply to all new machinery, wherever it is supplied within the EEA and Switzerland.
By affixing the CE marking, manufacturers are declaring that their products meet all the relevant requirements to the directives for that product and this must be stated on the Declaration of Conformity.
Nick Doe is Electrical Controls Manager at Neilson Hydraulics & Engineering
The regulations on supplying new machinery include:
The Supply of Machinery (Safety) Regulations 2008 which implements the European Machinery Directive 2006/42/EC contains requirements for manufacturing safe new machinery.
These regulations apply to all new machinery placed on the UK market or put into service within the UK and Europe, and covers the general term Machinery as:
- Safety components (guards) independently placed on the market.
- A complex production line made up of individual machines and equipment.
- Lifting equipment and accessories.
To complement these regulations the manufacturer or its authorised representative must ensure that:
- Machinery meets all relevant essential health and safety requirements, listed in detail in the regulation.
- A Technical Construction File for the machinery has been drawn up and, in certain cases has been type examined by a nominated conformity assessment body.
- The machine will be issued with a Declaration of Conformity or in the case of part complete machinery, which will form part of a larger machine, a Declaration of Incorporation.
- There is a CE marking affixed to the machinery.
Health and Safety at Work Act 1974 which contains general requirements for the manufacture and supply of safe machinery, including second hand refurbished machinery.
The relevant requirements of the Health and Safety at Work Act 1974 are in Section 6, which places a duty on “any person who designs, manufactures, imports or supplies any article for use at work…to ensure, so far as is reasonably practicable, that the article is so designed and constructed that it will be safe and without risks to health…”
Completion of a Technical Construction File is not a requirement under the Health and Safety at Work Act 1974, but is a requirement under the Machinery Directive.
Other laws may also apply in addition to the Supply of Machinery Regulations 2008, such as:
- Electrical Equipment (Safety) Regulations 1994.
- Pressure Equipment Regulations 1999.
- Simple Pressure Vessels Regulations 1991.
- Equipment and Protective Systems intended for use in Explosive Atmospheres Regulations.
- Lifts Regulations 1997.
- Medical Devices Regulations 1994.
- Gas Appliances (Safety) Regulation 1995.
- Functional safety risk assessment / evaluation.
General principles of the Machinery Directive:
Determine the limits of the machinery, including the intended use and any reasonable foreseeable misuse thereof.
Identify the hazards that can be generated by the machinery and the associated hazardous situations.
Estimate the risks taking into account the severity of the possible injury or damage to health and the probability of its occurrence.
Evaluate the risks, with determining whether risk reduction is required, in accordance with the objective of this machine directive.
Eliminate the hazards or reduce the risks associated with these hazards by application of protective measures in the order of priority established in section 1.1.2(b) which is stated below:
a. Eliminate or reduce risks as far as possible (inherently safe machinery design and construction).
b. Take the necessary protective measures in relation to risks that cannot be eliminated.
c. Inform users of the residual risks.
All the above principles can be covered by using the process covered by EN ISO 12100:2010.