Technical Compliance for CE Marking

Our team of expert engineers supports the manufacturer in the design, construction and verification of systems and machines for CE marking in accordance with the provisions of the Technical Standards and applicable European Directives.
 

Technical Compliance

Our technical compliance analysis services include:
 
  • Legal framework: analysis on applicable European Union Directive as 2006/42/EC Machinery Directive note.png , 2014/35/EU Low Voltage Directive, 2014/30/EU Electromagnetic Compatibility Directive.
  • Harmonized standards note.png : verification and application of safety regulation to design, built and sell a compliant machine. Some of these:
    • EN ISO  4413: “Hydraulic fluid power - General rules and safety requirements for systems and their components
    • EN ISO 4414: “Pneumatic fluid power - General rules and safety requirements for systems and their components
    • EN ISO 13850: “Safety of machinery - Emergency stop function - Principles for design
    • EN ISO 14119: “Safety of machinery - Interlocking devices associated with guards -- Principles for design and selection
    • EN ISO 13851: “Safety of machinery - Two-hand control devices - Functional aspects and design principles
    • EN ISO 13855: “Safety of machinery - Positioning of safeguards with respect to the approach speeds of parts of the human body
    • EN ISO 13857: “Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs
    • EN ISO 14120: “Safety of machinery - Guards - General requirements for the design and construction of fixed and movable guards
    • EN ISO 14122: “Safety of machinery - Permanent means of access to machinery
  • Product standard: analysis on applicable specific standard product (Type C). An example:
    • EN 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:
    • EN 60204-1: “Safety of machinery - Electrical equipment of machines - Part 1: General requirements
    • EN 61439: “Low-voltage switchgear and controlgear assemblies
    • EN 60529 “Degrees of protection provided by enclosures (IP Code)
  • Risk Analysis: review and assistance on risk analysis process as per:
    • EN 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”
  • 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 EN ISO 13849-1: “Safety of machinery -- Safety-related parts of control systems -- Part 1: General principles for design”.
  • Validation:  activities of Command and Control Systems related to Safety (SRP / Cs) validation by carrying out functional tests in fault conditions according to the provisions of EN ISO 13849-2 "Safety of machinery - Safety related parts of control systems - Part 2: Validation ”on the basis of the assigned Performance Level.
  • Lock-out / tag-out procedure: development of the LOTO procedure to safely isolate the power sources of a machine and allow control of dangerous energy.

These services are also applicable to sets of machines, to modifications of machines, to the insertion of machines and partly completed machinery into existing production lines.
 

Document Compliance

To support companies in the fulfillment of CE Marking and machine safety, we offer the following services:
 

  • Establishment of the Technical File in accordance with Annex VII of the Machinery Directive 2006/42/EC
  • Verification of the instruction manual of the machine and of the sets of machines
  • Preparation of the CE Declaration of Conformity and CE Marking for machines and sets of machines
  • Verification of instructions for the assembly of partly completed machinery
  • Preparation of the Declaration of Incorporation of the partly completed machinery
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