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  • Machine safety
- June 26, 2026

Risk Assessment

A risk assessment forms the basis of machine safety. It is a systematic method for identifying hazards associated with a machine, assessing risks, and taking appropriate measures to reduce these risks to an acceptable level. A proper risk assessment is not only essential for safe machinery but is also a mandatory part of the CE marking process.

A risk assessment examines all phases of a machine’s life cycle: from transport, installation, and use to maintenance, malfunctions, cleaning, and decommissioning. This assessment considers not only the machine itself but also the interaction between people and machines.

Why is a risk assessment important?

A risk assessment identifies potential hazards at an early stage. Examples include:

  • moving parts;
  • crushing and shearing hazards;
  • electrical hazards;
  • hydraulic and pneumatic systems;
  • noise and vibrations;
  • ergonomic strain;
  • unexpected startup of machinery;
  • maintenance and breakdown situations.

By identifying these risks in advance, appropriate measures can be taken to prevent accidents and injuries.

Risk Assessment According to EN ISO 12100

The most important standard for risk assessment of machinery is NEN-EN-ISO 12100:2010 – Safety of machinery – General principles for design – Risk assessment and risk reduction. This standard describes the principles and methodology for identifying hazards, assessing risks, and selecting effective risk-reduction measures.

According to this standard, a risk assessment consists of four main steps:

Determining the machine’s limits

  • Intended Use
  • Reasonably foreseeable misuse
  • Users
  • Environmental Conditions

Identifying Hazards

  • What hazards could occur throughout the machine’s entire life cycle?

Assessing and Evaluating Risks

  • How serious could the injury be?
  • How often are people exposed to the hazard?
  • How likely is a hazardous situation?
  • Can the hazard be avoided?

Risk Reduction

  • Eliminating Hazards Through Design
  • Implementing Technical Protective Measures
  • Informing users about residual risks

The Three-Step Method for Risk Reduction

The EN ISO 12100 standard follows a set sequence for risk reduction:

Inherent Safety by Design

    The preference is always to eliminate hazards through safer design. For example, by shielding hazardous movements or limiting forces.

    Technical Protection Measures

      If risks cannot be completely eliminated, technical measures are implemented, such as:

      • protective barriers;
      • security doors;
      • light screens;
      • safety relay;
      • safety PLCs.

      Information for Users

        If any residual risks remain, they must be described in the user manual and, where necessary, indicated with warnings on the machine.

        Risk Assessment and CE Marking

        A risk assessment is a mandatory component of the technical file associated with CE marking. Manufacturers must be able to demonstrate that all relevant hazards have been assessed and that appropriate measures have been taken. This applies not only to new machines, but also to the assembly of machines, the import of machines from outside the EU, and major modifications to existing machines.

        An additional risk assessment may also be necessary for machinery that is already in use. Under the Working Conditions Decree, employers are required to ensure that work equipment is used safely and that risks are managed.

        Key Standards

        In addition to EN ISO 12100, the following standards are regularly applied in the field of machine safety:

        Standard Subject

        All of these standards are available from the NEN’s Normshop.

        Relevant sources:

        Standards: