The safety of robotics continues to gain in importance due to increasing automation and human-robot collaboration (HRC). With the revised ISO 10218 standard, an international safety standard has now been fundamentally modernized. We spoke with our SICK colleague Markus Bechtel, Application Engineer Robotics and Safety Solutions, about the most important updates and amendments.
Markus Bechtel: ISO 10218 is the key international standard for the safety of industrial robots. It continues to comprise two parts: Part 1 is aimed at robot manufacturers and defines requirements on the design of industrial robots as partly completed machinery. Part 2 is aimed at system integrators and describes the safety requirements for integrating robots into machines and systems.
One new aspect, in particular, is the full incorporation of the previous ISO/TS 15066 to now regulate the requirements on collaborative applications, i.e. human-robot collaboration, which allows a direct interaction with moving robots. A key element is the biomechanical limits that define the permissible forces and pressure loads in the event of a human-robot collision. These values form the basis for the safe design of collaborative applications.
Bechtel: The previous standard dated back to 2011 and robotics has developed rapidly since then. New technologies and integrated safety functions, AI-assisted systems and networked production environments present new risks, but also create new opportunities.
The update was necessary to represent the state of the art, in particular in the area of human-robot collaboration. The growing significance of cybersecurity in industrial automation, in line with the EU Machinery Regulation that will apply from January 2027, has also been taken into account.
Bechtel: ISO 10218 can be applied across industries – it is not aimed at specific industry sectors but instead applies to all applications where industrial robots are used. This includes traditional manufacturing lines as well as flexible, collaborative workplaces or highly automated systems in a wide variety of industries, from the automotive industry to electronics manufacturing right through to medical technology. It doesn't matter here whether the application involves a single robot in a small workshop or a whole fleet of robots in a complex, networked industrial environment.
Bechtel: Firstly, ISO 10218-1:2025 distinguishes between two robot classes, thus taking into account the fact that large, heavy industrial robots differ significantly from smaller, weaker robots for collaborative applications. These differences relate not only to the risk but also the typical usage scenarios. The standard therefore introduces two risk classes, each with specific requirements on safety, control and integration. This classification creates more clarity for manufacturers and simplifies the risk-based design of protective measures.
The structure was also revised to improve the overall readability and ease of application.
An especially important aspect of the new safety requirements relates to functional safety. While the previous standard often had a blanket requirement for a performance level d (PLd) – regardless of robot type or application – the new ISO 10218-2:2015, however, allows the actual risks to be taken into consideration in a more differentiated manner.
This means: For every safety-related function – for example emergency stop, safe speed monitoring or safe position limitation – an application-specific PL value based on the risk evaluation is now defined.
To assist the user with assessing the risks, the standard offers a comprehensive set of tables with limit values that help with determining the individual risk parameters such as severity, exposition, probability of occurrence and avoidability. This enables safety strategies to be better implemented on the basis of the ALARP - as low as reasonably practicable - principle, which gives new possibilities for realizing applications.
Manual operation in setup mode (teach mode) is also specified in more detail. The standard now places clearer requirements on the reduced speed, the safe monitoring of movements, and the design of the user guidance in this mode – in particular for class II robots. The aim is to further minimize the risks during setup and programming.
Bechtel: In future, robot manufacturers need to focus even more on specific applications and risk profiles when designing their products and meet more stringent requirements on the documentation of the risk assessment, safety functions, performance level and cybersecurity. This increases the development cost, but creates more clarity with regard to later integration.
System integrators benefit from the clear structure, in particular through the integration of collaborative applications and the definition of standardized safety functions. At the same time, the requirements on the quality and clarity of the risk assessment as well as the documentation and validation have increased. The standard therefore recommends the integrator and user (operating entity) coordinate closely when selecting and designing the robot application, in particular that they incorporate a risk assessment early on. This requires a close collaboration between the persons responsible for design, control technology and functional safety – and consequently interdisciplinary knowledge and structured processes.
Even though the standard is directed only at robot manufacturers and system integrators, it also has the operation and thus the operating entity in mind. ISO 10218-2:2025 defines requirements on the information that the manufacturer must provide to ensure safe operation, for example the required checks and inspection cycles.
Bechtel: The biggest challenge lies in the retrofittability of existing systems – in particular given that the new machinery directive now also regulates the issue of significant change Europe-wide. What was previously interpreted in the “Blue Guide” on the machinery directive and by the BMAS in Germany is now clearly anchored in EU law, which creates more legal certainty for operating entities and integrators.
Many older robot systems were designed according to previous standards and only partially satisfy the new requirements, for example with regard to cybersecurity or functional safety. For operating entities and integrators, this means that they need to take into consideration the new ISO 10218-2:2025 as the state of the art when modifying or extending these systems and – in case of a significant change – need to perform a new CE conformity assessment based on the requirements of the MD and future machinery directive.
The technical documentation will also become more comprehensive: The new standard requires a more precise description of safety-relevant functions, there validation and – in case of deviations – a clear justification.
Last but not least, the implementation of the new requirements poses personnel and technical challenges for smaller companies. Partnerships with experienced experts and access to pre-certified components and solutions will become increasingly important here.
Bechtel: The new ISO 10218:2025 creates, for the first time, a complete normative foundation for human-robot collaboration. Besides biomechanical limit values, it also defines the measurement procedures for validating these values. This is supplemented by clear requirements on the risk assessment, protective measures and user guidance – for example for setup mode (teach mode).
Bechtel: When integrating industrial robot cells – in particular in non-collaborative applications – the traditional protection principles continue to be important. These include:
In collaborative applications too, safeguarding can make a significant contribution to efficiency and safe processing. Intelligent protective field monitoring, for example, makes it possible for a robot to only switch to reduced power mode in case of an actual approach, which avoids unnecessary reductions in output and increases the productivity.
Monitoring the access means helps avoid process interruptions and can have a positive impact on the risk assessment, for example if passers-by can be excluded.
Innovative electro-sensitive protective devices on the end effector to protect against the residual risks associated with the tool or workpiece, or 3D vision systems allow new approaches that enable traditional but especially also collaborative applications to be designed to be even more productive.
The new standard fosters a holistic safety approach that takes into consideration the technical, organizational and human factors in equal measure.
To select suitable protection concepts, it is recommended to closely examine the specific application and the productivity requirements. It is then possible to derive an appropriate protection concept that optimally combines safety and efficiency. The prospect of being able to do away with additional safety devices is not expedient in most cases.
Investments in intelligent protection concepts usually pay off quickly – through higher system availability, fewer downtimes, and the avoidance of incentives for manipulation.
Bechtel: Manufacturers should take early and systematic steps towards meeting the requirements of the new ISO10218-2:2025. A possible plan of action might look as follows:
Bechtel: SICK supports companies in implementing the new ISO 10218-2:2025 with a practical guide based on long-standing experience,. In the guide, our safety experts describe in detail what is involved in designing robot applications in a standards-compliant manner. In addition, we offer targeted customer trainings that companies can use to continuously expand their knowledge and stay up-to-date.
