CE Mark Consultancy offer a comprehensive CE Marking service for the New Machinery Directive which is tailored to individual company needs.
Their services include advice and assistance on compliance with the Machinery Directive using our proven methodology:
The process of CE Marking is quite straightforward and involves the simple protocol below.
•Establish the applicable Article 100A EU Directives
•Perform a statutory recorded risk and hazard assessment for each machine, product or process
•Research & Apply the appropriate harmonised standards
•Test and assess against the requirements of these standards
•Establish the quality control systems to manufacture the product, machines and processes
•Create the Technical File for the product
•Issue when appropriate the Declaration of Conformity/Incorporation and Apply the CE Mark
They undertake a comprehensive Risk and Hazard Analysis as required by EN 14121-1 and EN 954-1 / EN ISO 13849-1, demonstrate compliance to the Essential Health & Safety Requirements (EHSR) and applicable Euro Norm (EN) Standards List, where these are used in support of the EHSR’s.
Our experienced and pragmatic approach allows us to provide solutions to overcome any non-conformity and deliver a full one-stop service for many types of machinery, across the whole gambit of industries.
There are many aspects to risks in machinery and the most common are associated with electrical and mechanical systems and other energy sources, such as electromagnetic interference (radiated or conducted), hydraulic and pneumatic and radiation.
Delivering solutions for all the major directives, where these apply to your machine, such as
•Assessment for EMC Compliance.
•Assessment for Low Voltage compliance.
•Assessment for compliance with the Pressure Equipment Directive.
The scope of the New Machinery Safety Directive defines a machine as follows:
“An assembly of linked parts of components, at least one of which moves, with the appropriate actuators, control and power circuits, joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material. “
“An assembly of machines which, in order to archive the same end, are arranged and controlled so that they function as an integral whole; including - Interchangeable equipment, placed on the market for the purpose of being assembled with other machinery. “
Safety components for machinery, described as:
“Components which are supplied separately to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.”
The minimum criteria for compliance are set out in the directives known as The Essential Health and Safety Requirements (EHSR).
The New Machinery Directive - Will you still comply?
The New Machinery Directive came into force at the end of 2009. Unlike previous versions, there is no transitional period for compliance.
There are radical changes to some parts of the Directive and you may need to address additional requirements for the Declaration and essential health and safety requirements (EHSRs), including where they affect control systems, if they are to comply with the new regulations.
New Machinery Directive scope
The Scope includes terms such as safety components, lifting accessories, chains, ropes and webbing. Now including devices for construction site hoists, and for lifting people with reduced mobility.
Compliance needs rigorous attention to detail, and involves four key elements:
•Demonstrating compliance with the essential health and safety requirements;
•Applying out the appropriate conformity assessment procedure;
•Creation of the Declaration of Conformity or Incorporation; and
•Applying the CE Mark, where appropriate.
The Directive does not concentrate simply on one item at a time – processes and systems are also involved. If you are creating a complex assembly, such as a production line, by interlinking a series of existing machines, you are effectively creating something new – so the whole assembly must comply with the Directive.
Similarly, altering the function or performance of a machine or complex assembly is also essentially creating a new machine, which must comply.
Alterations to the EHSRs are too numerous to detail here, but they affect issues such as ergonomics, operating positions, seating, lighting, manual controls, starting machinery, stability of machinery, protection devices, machinery instructions, plus machinery for foodstuffs, cosmetic and pharmaceutical products.
New Conformity Requirements
There are key changes to the Declaration of Conformity. The person who is authorised to compile the Technical File must be established in the European Community.
Where appropriate, there must be a statement confirming Declaration of Conformity with other applicable directives. And there is no longer a separate declaration for safety components, and the declaration must be typewritten or handwritten in capital letters.
There are also significant additions and changes to the EHSRs that will affect machine design, including requirements for guarding and control systems.
Some of the safety devices that fall under the scope of the Directive include, as already mentioned, control devices for calling lifting appliances and anti-fall devices for hoists, plus monitoring devices for loading and movement control in lifting machinery – as well as solenoid valves controlling dangerous movements of machinery.
Control systems must be designed and constructed in such a way that they will prevent a hazardous situation arising.
Manual controls must be clearly visible and identifiable, and the use of pictograms is recommended. And an operator must, from each control position, be able to ensure that no one is in the danger zone – even if that means that the machinery can be controlled only from positions in one or more predetermined zones or locations.
Starting your machine is also covered. The Directive states that it must be possible to start machinery only by the voluntary action of a manual control provided for that purpose.
The restarting of a machine or a change in operating conditions may however be effected by the voluntary action of a device other than the manual control provided for that purpose, unless this would lead to a dangerous situation.
There are obviously many more issues contained within the new Machinery Directive, it is worth highlighting that for control integrity, other European Standards are also relevant.
EN 954-1 Safety of Machinery – Safety Related Parts of Control Systems, will be replaced by two standards that co-exist. The original standard will remain valid until November 2011 to provide a period of transition to the new version. Designers and installers of electronic safety systems can choose between the requirements of either EN ISO 13849-1 or EN/IEC 62061, and still fully comply with the European Machinery Directive.
EN ISO 13849-1 has a four-stage approach to the design of safety-related control systems:
•Perform a risk assessment (EN ISO 14121).
•For the identified risks, allocate the safety measure (Performance Level or PL).
•Devise a system architecture that is suitable for the PL.
•Validate the design to check that it meets the requirements of the initial risk assessment.
If you need further guidance then please contact us and we will be happy to assist you