Europe

CE Mark and Compliance of industrial machinery

Industrial equipments manufactured or imported in Europe must respect European product directives. The main Directive that governs the safety of industrial equipment is the Machinery Directive 2006/42/CE according to which the CE marking can be affixed.
  
The manufacturer must construct the machinery in compliance with the technical safety requirements of the applicable directives and provide appropriate documentation to demonstrate CE conformity; specifically, it must produce:
 
  • Technical file to demonstrate the conformity of the machinery with the essential safety requirements and conformity assessment procedures required by the applicable directive; the technical file must contain, for example, construction drawings, risk analysis, test reports, and other documents
  • CE Declaration of conformity
  • CE Mark
 
We assist manufacturers and importers in the entire conformity assessment of machinery, determining the applicable essential safety and health requirements and compiling and verifying the technical file.

We provide concrete and viable solutions regarding the most complex safety issues, the compliance of machinery and risk management.
With our multidisciplinary team of professionals, we assist companies to apply best manufacturing practice to improve and optimize the availability and productivity of their machinery worldwide. A correct organizational and procedural approach of EU and Extra UE legislative and technical regulatory requirements compliance allows the manufacturer to:
 
  • Identify any contractual, documental and procedural non-conformities with respect to specific national and international laws
  • Preventing conflicts related to the conformity and the safety aspects of industrial machinery and products that could be advanced by the final customer or by the competent Authority for market surveillance
  • Sell a machinery which is in compliance with the enforced law and technical standards 
 

CE Marking Machinery

We assist manufacturers in design, construction and inspection of machinery for CE compliance.

Our analysis includes:
 
  • Legal framework: analysis on applicable European Union Directive as 2006/42/EC Machinery Directive note.png , 2014/35/EU Low Voltage directive, 2014/30/UE Electromagnetic Compatibility directive.
  • Harmonized standards note.png : verification and application of safety regulation to design, built and sell a compliant machine. Some of these:
    • ISO  4413: “Hydraulic fluid power -- General rules and safety requirements for systems and their components
    • ISO 4414: “Pneumatic fluid power -- General rules and safety requirements for systems and their components
    • ISO 13850: “Safety of machinery -- Emergency stop function -- Principles for design
    • ISO 14119: “Safety of machinery -- Interlocking devices associated with guards -- Principles for design and selection
    • ISO 13851: “Safety of machinery -- Two-hand control devices -- Functional aspects and design principles
    • ISO 13855: “Safety of machinery -- Positioning of safeguards with respect to the approach speeds of parts of the human body
    • ISO 13857: “Safety of machinery -- Safety distances to prevent hazard zones being reached by upper and lower limbs
    • ISO 14120: “Safety of machinery -- Guards -- General requirements for the design and construction of fixed and movable guards
    • ISO 14122: “Safety of machinery -- Permanent means of access to machinery -- Part 1: Choice of fixed means and general requirements of access
  • Product standard: analysis on applicable specific standard product (type-C). An example:
    •  ISO 10218-1: “Robots and robotic devices -- Safety requirements for industrial robots -- Part 1: Robots
  • Electrical compliance: verification and analysis of electrical installations as per national and international standard. Some of these:
    • IEC 60204-1: “Safety of machinery - Electrical equipment of machines - Part 1: General requirements
    • IEC 61439-1: “Low-voltage switchgear and controlgear assemblies - Part 1: General rules
    • IEC 60529:2017 “Degrees of protection provided by enclosures (IP Code)
  • Performance Level (PL): calculation of the PL achieved by the Safety Related Part of Control System (SRPC). Verification of electrical architecture Category, evaluation of the Diagnostic Coverage (DC), analysis of the selected component Mean Time To Failure (MTTF) and electrical Common Clause Failure (CCF) of the machine as per ISO 13849-1: “Safety of machinery -- Safety-related parts of control systems -- Part 1: General principles for design”.
  • Risk Analysis: review and assistance on risk analysis process as per:
    • ISO 12100: “Safety of machinery -- General principles for design -- Risk assessment and risk reduction”
    • ISO/TR 14121-2: “Practical guidance on conducting risk assessment for machinery in accordance\ with ISO 12100”
 

Product libility

The Company has proven experience in machinery technical compliance to safety requirements and in drafting advice with reference to domestic and international contracts, distribution, manufacturing and fabrication agreements and contract negotiations with suppliers.

Our professionals mainly deal with:
 
  • Drafting and revision of supply and purchase contracts and of their technical attachments
  • Revision of the technical documentation with legal relevance, with particular regard to the revision of "instructions and warnings" manuals of the product.
  

Management analysis of product conformity  with specific reference to the safety of machines and plants

Products liability refers to the liability of any or all parties related the chain of manufacture of any product for damage caused by that product. There are three types of product defects that incur liability in manufacturers and suppliers:
 
  • Design defects
  • Manufacturing defect
  • Defects in marketing (e.g. improper instruction, ..)
 
For these reasons is essential to verify the correctness and effectiveness of the system adopted and implemented by the Company regarding the management of the conformity process of products manufactured and marketed in Europe and in other countries.
 
Our team is able to assist you with the following services:
 
  • Audit about technical compliance, related to the project and manufacture processes
  • Preparation and review of technical documents attesting the conformity of the product supplied or to be requested from suppliers and sub-suppliers
  • Correct identification of roles and responsibilities, stipulation of contracts for the purchase and sale of machinery
  • Audit about the organizational model adopted that shall be in accordance with the law, technical regulatory and standard enforced in the market in which the product is sold
 
 

Analysis of product liability insurance

Product liability insurance protects a company against claims or suits arising from the defective products note.png manufactured and sold. This form of insurance covers a manufacturer's or seller's liability for bodily injury or property damage sustained by a third party due to a product's defect or malfunction.
For this reason is essential for manufacturing companies:
 
  • Evaluate carefully the risks deriving from the design, production and sales phases in order to adopt a specific plan to prevent product defects
  • Adopt a suitable policy also for the civil liability deriving from a defective product
 
Many of these insurances could be inadequate because they are generic and not intercalated in the productive business reality that is typical of every business company.
 
For this reason we assist our clients in all these matter, including:
 
  • The review and the evaluate of your business insurance coverage
  • Suggestions about your liability insurance


 


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