As designers responsible for the safety of our clients’ machinery under Regulation (EU) 2023/1230, our clients are now required to assess the measures implemented to control and reduce risks associated with products that affect user health and safety.
With extensive experience in industrial risk analysis and the evaluation of Safety Instrumented Systems, we offer services to assess and mitigate machine risks and prepare all required documentation.
Machinery and related products or Partly Completed Machinery,
Machines listed in Annex I of the "Machinery" Regulation ((EU) 2023/1230),
List of applicable essential health and safety requirements of the "Machinery" Regulation,
List of requirements from other applicable directives: "Low Voltage," "EMC," "ATEX," ...,
List of technical requirements derived from the harmonized standards of Regulation (EU) 2023/1230.
Risk assessment procedure in accordance with the harmonized standard: ISO 12100
Determination of the machine’s boundaries,
Identification of hazardous phenomena,
Estimation and evaluation of each initial and residual risk:
Risk = Severity × Probability
Risk reduction procedure in accordance with the harmonized standard: ISO 12100
Risk reduction through intrinsic safety measures,
Risk reduction through protection and the implementation of supplementary preventive measures (design of the control system in accordance with ISO 13849-1 or IEC 62061),
Risk reduction through user information.
For a machine:
Technical documentation
Instruction manual
For a partly completed machine:
Technical documentation
Assembly instructions
Compilation of documents issued, reviewed, and approved during the design phase
For a machine:
EU Declaration of Conformity
Affix the "CE" marking: graphic design in accordance with Regulation (EU) 2023/1230,
Company name and address of the manufacturer,
Machine designation and serial number,
Year of manufacture.
For a Partly Completed Machine:
EU Declaration of Incorporation