Collaborative Robots and Machine Safety – Why the Safety of the Entire System Matters?
- Barabás Barnabás
- Jul 17
- 5 min read
CE Compliance, Risk Assessment and the Role of ISO 10218:2025 in Safe Human–Robot Collaboration
Reading time: Approximately 7 minutes
More and more companies are choosing collaborative robots (cobots) for automation
tasks because they enable greater production flexibility and more efficient human–robot collaboration. However, safety does not depend on the type of robot itself, but on the proper design of the entire system. This systems-based approach is the foundation of modern machine safety.
This article explains the role of CE compliance, risk assessment, the ISO 10218:2025 series of standards, and European machine safety requirements in creating safe human–robot collaboration. It also explains why using a collaborative robot alone is not sufficient to consider a system safe.
The Most Common Misconception About Collaborative Robots
With the widespread adoption of collaborative robots, many companies have come to believe that these machines are inherently safe and therefore require little or no additional safety measures.
The reality is far more complex.
The safety of a robot is determined not by the robot itself, but by the entire application, including:
the end-of-arm tool
the gripper
the workpiece
the robot's movement
the operator's workflow
the surrounding environment
Even a robot with rounded edges can become hazardous if it manipulates sharp components, applies high forces, or moves in an unfavorable direction.
For this reason, machine safety must always be considered at the system level.
Robot-Service Experience: When a Cobot Alone Was Not Enough
During automation projects, we frequently encounter the assumption that using a collaborative robot automatically eliminates the need for conventional safety measures.
In one automation project, for example, a customer wanted to build an assembly station where an operator and a robot would work directly alongside each other.
However, the detailed risk assessment revealed that the workpiece handled by the robot could create pinch and impact hazards in several operating conditions. Although the robot itself fulfilled the requirements for collaborative operation, the overall application required additional protective measures.
The final system incorporated a safety laser scanner, speed monitoring and an optimized workstation layout.
This project clearly demonstrated that safety is achieved not by a single piece of equipment, but through the careful engineering of the entire system.
What Does CE Compliance Mean?
Many people assume that the CE marking is simply a product characteristic.
In reality, for an automated manufacturing system, CE compliance demonstrates that the complete machine or system satisfies the applicable European safety requirements.
This includes:
risk assessment
appropriate technical solutions
safety functions
technical documentation
conformity assessment
CE compliance is therefore not just a label attached to a machine—it is the result of a documented engineering process.
Within the European Union, machine safety requirements are governed by the Machinery Regulation (EU) 2023/1230, which replaces the former Machinery Directive 2006/42/EC. The regulatory framework continues to evolve, but its objective remains unchanged: ensuring that machines and automated systems can be operated safely throughout their entire lifecycle.
CE compliance is not a one-time task but an ongoing engineering process that begins at the earliest design stage.
Why Is Risk Assessment So Important?
The purpose of a risk assessment is to identify potential hazards during the design phase before they can lead to injury or damage during operation.
Its methodology is based on EN ISO 12100, which defines the general principles for hazard identification, risk estimation and risk reduction. This standard forms the basis for the specific safety requirements applicable to industrial robots.
A comprehensive risk assessment should examine, among other things:
human–robot interaction
robot movement and speed
tooling and workpieces
operator tasks
maintenance activities
abnormal operating conditions
mechanical and electrical hazards
unexpected restart scenarios
the adequacy of safety functions
the effects of control system and software failures
The new ISO 10218:2025 places greater emphasis on functional safety and control logic. Consequently, a properly executed risk assessment not only supports regulatory compliance but also significantly reduces the likelihood of costly modifications and unexpected production downtime.
What Does ISO 10218:2025 Require?
The ISO 10218:2025 series specifies the safety requirements for industrial robots and robot systems.
One of its most significant changes is that collaborative applications are now fully integrated into the standard. As a result, the focus has shifted away from the concept of a "collaborative robot" toward that of a "collaborative application."
This means that the complete system—including the robot, tooling, workpiece, control system and operator environment—must collectively satisfy the applicable safety requirements.
ISO 10218:2025 also places greater responsibility on the system integrator, recognizing that safe operation depends not only on the robot manufacturer but also on the engineers who design and integrate the complete application.
This approach ensures that safety is considered from the earliest stages of system design rather than being treated as an afterthought.
A New Perspective on Collaborative Applications
When designing collaborative applications, the standard defines several collaboration modes, including.
When designing safety-related control systems, engineers typically apply the requirements of EN ISO 13849-1 or IEC 62061 to determine the appropriate Performance Level (PL) or Safety Integrity Level (SIL).
Collaborative operating mode | Description |
Safety-Rated Monitored Stop (SRMS | The robot safely stops when a person enters the collaborative workspace. |
Hand Guiding | The operator manually guides the robot using dedicated enabling devices. |
Speed and Separation Monitoring | The robot adjusts its speed according to the operator's distance. |
Power and Force Limiting | The robot limits force and contact pressure to minimize injury risk during physical contact. |
Why We No Longer Talk About "Collaborative Robots"?
For many years, the term "collaborative robot" was widely used throughout the industry.
However, ISO 10218:2025 introduces an important shift in perspective: it is not the robot that is collaborative, but the application.
The same robot may safely operate in a shared workspace in one application, while in another application it may require physical guarding and complete separation from personnel.
Safety is therefore always determined by the specific task, the operating environment and the implemented protective measures.
This change clearly illustrates that machine safety has shifted its focus from the product itself to the complete application.
Humans and Robots – Safety Is a Shared Responsibility
Machine safety can be illustrated with a familiar example.
A car is not considered safe simply because it has airbags. Safety results from the combined operation of seat belts, anti-lock braking systems, electronic stability control, airbags and traffic regulations.
Together, these elements create a safe system.
The same principle applies to industrial automation.
A robot used in a collaborative application is only one element of the overall safety chain. Proper engineering, risk assessment, safety functions and operator training together create a safe working environment.
Machine Safety Requires a Systems Approach
Although humans and machines appear fundamentally different, their safety relies on surprisingly similar principles.
Safety is never the result of a single component. Instead, it is achieved through multiple layers of protection working together.
The same applies to people—we are protected by knowledge, procedures, experience, appropriate equipment and informed decision-making.
Industrial automation requires exactly the same systems-based philosophy.
Ultimately, safety is not a characteristic of an individual component but the result of a properly engineered system.
Three Key Takeaways
A collaborative robot does not replace risk assessment.
Every application must be evaluated individually.
CE compliance applies to the complete system.
It certifies the conformity of the entire machine, not a single component.
Safety does not reduce productivity.
A well-designed safety concept increases equipment availability and minimizes unexpected downtime over the long term.
How Robot-Service Kft. Can Help.?
Robot-Service Kft. not only designs and builds robotic cells and automated manufacturing systems but also supports customers in developing machine safety concepts, performing risk assessments and achieving CE compliance.
Our specialists assist customers from the earliest design stages to ensure that automated systems are not only efficient but also fully compliant with applicable standards and regulatory requirements.
Our Key Services:
Risk assessment and machine safety review
Safe design of robotic cells and custom automation equipment
CE compliance support and system integration
For more information, visit:
The future of automated manufacturing will not be safe simply because collaborative robots are used. It will be safe because the entire system is designed in accordance with machine safety principles. Comprehensive risk assessment, the application of modern safety standards and professional system integration together create the environment in which humans and robots can truly work together safely and efficiently.
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