A systematic framework for risk assessment and risk reduction in machine design.
Sep 17, 2025
When developing machines, it is not enough to focus solely on function and performance. The design must also meet safety principles according to international standards. The most central is ISO 12100:2010, which serves as a framework for risk analysis and risk assessment throughout the entire lifecycle of the machine.
In this article, we will go through the standard's methodology for risk reduction, how risks are classified, and the role of the designer in the work with machine safety and CE marking.
General principles according to ISO 12100
The standard emphasizes that the risk assessment must take into account:
The machine's intended use and reasonably foreseeable misuse.
All phases of the lifecycle: design, transport, installation, operation, maintenance, and decommissioning.
Human interaction at every step.
Ergonomics and user-friendliness, including control interfaces.
The process should be systematic, iterative, and well-defined.
Three-step strategy for risk reduction
ISO 12100 describes a hierarchy in three levels, which should always be followed in order:
Inherently safe design measures
Here, risks should be eliminated at the source through design, for example by:
Minimizing stored energy
Removing sharp edges
Limiting access to hazardous areas
Protective measures and complementary safety systems
When elimination in design is not possible, protection should be introduced, e.g.:
Fixed or movable guards
Emergency stops and safety switches
Light curtains and presence sensors
User information
For remaining risks, clear information is required, e.g.:
Manuals and instructions
Warning signs and labeling
Recommendations for personal protective equipment
Training requirements
Risk assessment strategy
To carry out the risk assessment, ISO 12100 specifies the following steps:
Define the machine's boundaries and use
Identify risk sources and hazardous situations
Estimate the level of risk (severity x probability)
Determine if risk reduction is necessary
Implement measures according to the three-step model
Reassess remaining or new risks
The process is repeated until the risks are at an acceptable level.
Designer responsibilities in risk reduction
The designer plays a central role in both implementing protective measures and communicating residual risks.
This includes, among other things:
Design modifications and safety solutions
Documentation of risk assessment and measures
Technical file and user manuals
Classification of risks
ISO 12100 contains a detailed list of hazards that may arise when using machines.
Some examples:
Mechanical: Crushing, entrapment, falling parts
Electrical: Electric shocks, short circuits
Thermal: Burns from hot surfaces
Noise and vibration: Hearing damage, vibration injuries
Radiation: Laser, UV or IR
Chemical substances: Toxic or corrosive substances
Ergonomics: Poor work postures, repetitive movements
Environmental factors: Dust, moisture, extreme temperatures
Combination risks: When multiple hazards interact
This classification can be seen as a checklist to help designers not miss significant risks during the development work.
Conclusion
ISO 12100:2010 offers a clear and reusable method to:
Identify and analyze risks in machines
Reduce risks gradually through design, protection, and information
Ensure that machines meet the requirements for CE marking.
By working according to the standard, companies can create machines that are not only efficient but also intrinsically safe and legally sustainable.
FAQ - frequently asked questions
Is risk assessment according to ISO 12100 mandatory?
No, one does not have to follow ISO 12100, but it is a fundamental A-standard that is crucial for meeting the safety requirements in the EU Machinery Directive. The standard describes principles and methods for how risks should be assessed and reduced during design.
This constitutes a central part of the safety work required to meet the legal requirements for machines, according to the Machinery Directive (2006/42/EC) and the upcoming Machinery Regulation (2023/1230).
What is meant by “inherently safe designs”?
That risks are eliminated already at the design stage, rather than just adding protection afterwards.
What types of risks does ISO 12100 cover?
Among others, mechanical, electrical, thermal, ergonomic, and environmental risks.
When does the Machinery Regulation come into effect?
The new Machinery Regulation (EU 2023/1230) will be fully applicable from January 20, 2027.
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