Machinery

CE self-certification consultancy

ROSAS’ safety engineers help to assess the safety and compliance of machines and to achieve the CE mark in conformity with the Directive 2006/42/CE. Although there are several European Directives that apply to the safety of industrial machinery and equipment, the most relevant is the Machinery Directive (Directive 2006/42/). This directive has a dual objective: to allow the free movement of machinery within the internal market whilst ensuring a high level of protection of health and safety. 

It is the manufacturer's responsibilty or his authorized representative to ensure that the equipment supplied is in conformity with the Directives. This standard covers machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices and partly completed machinery, and requires the following actions:

• Fulfilling the applicable Essential Health and Safety Requirements (EHSRs)
• Preparing a technical file
• Carrying out appropriate conformity assessments
• Providing a “CE Declaration of Conformity”
• Assign CE Marking where applicable
• Providing instructions for safe use

Documentation for examination from a notified body

Usually, the machinery directive only requires self-certification. However, certain types of equipment are subject to special measures. Those equipments are listed in Annex IV of the Directive which includes hazardous machines such as woodworking machines, presses, injection moulding machines, underground equipment, vehicle servicing lifts, etc. Annex IV Machines require an examination from a notified body. ROSAS engineers prepare all the documentation required for the examination and can serve as intermediaries between the company and the best suited notified body.

Documentation on the declaration of incorporation

In addition to machines, partly completed machinery also require a safety analysis. When separate equipment are assembled to form a complete machine, a declaration of incorporation should be issued with it. In this case, a documented safety analysis is mandatory, although CE marking is not compulsory. The declaration should state that the equipment must not be put in service until the machine into which it has been incorporated has been declared in conformity. A Technical File must be prepared and the partly completed machinery must be supplied with information containing a description of the conditions which must be met with a view to correct incorporation in the final machinery, so as not to compromise safety. In summary:

• Complete Machine > Declaration of Conformity > CE mark should be applied
• Partly Completed Machine > Declaration of Incorporation > CE mark should not be applied

Selection and application of one or more standards according to different guidelines

The European Machinery Directive (2006/42/CE) is not the only applicable Directive. Others may be involved, such as Low-voltage Directive (2014/35/EU), EMC Directive (2014/30/EU), ATEX product Directive (2014/34/EU), Pressure Equipment Directive (2014/68/EU). In fact, there are hundreds of standards and directives, which are all constantly evolving. Without standards, the machine directives doesn't enable the designs to be safe enough. While directives address the question “what do you need to be safe? ”, standards answer the question “how to be safe?”. ROSAS engineers offer their expertise to apply the different Directives and Harmonized Standards correctly. ROSAS supports you in:

• Determining the directives to apply and guide you through its implementation.
• Selecting which standards to apply and provide support for the evidence preparation.
• Analyzing the risks of a given element and develop solutions if required
• Reviewing existing documents
• Gaps analysis between different standards and directives

Methods, processes and standards used at ROSAS

In addition to the optimization of your process, our team can support you in applying the methods below.

Methods and Processes :

• Risk Assessment
• HAZOP, RGA, LOPA, PHA
• SFF, FTA, FMECA,FMEA, FMEDA
• Model-Based Engineering

Fundamental machinery standards :

• ISO 12100: Safety of machinery — General principles for design — Risk assessment and risk reduction
• ISO 13849: Safety of machinery — Safety-related parts of control systems
• IEC 62061: Safety of machinery – Functional safety of safety-related electrical, electronic and programmable electronic control systems
• IEC 61508: Functional safety of electrical/electronic/programmable electronic safety-related systems
• IEC 60204: Safety of machinery – Electrical equipment of machines