Collaboration modes and safety features
The technical standards describe several collaborative operating modes that can be combined in a single application. Supervised safety stop halts the robot when a person enters the collaborative space and allows movement to resume when they leave. Manual guidance allows the operator to move the robot using a guidance device with limited speed and an emergency stop. Speed and separation monitoring maintains a safe distance between the robot and the person using sensors (laser scanners, curtains, vision) and reduces speed or stops movement when the distance decreases. Power and force limitation permits intended or incidental physical contact between the robot and the person, provided that the force, pressure, and energy transferred remain below the established biomechanical pain thresholds for each body region.
The safety functions that enable collaboration (speed, force, power, space, and tool limitations; safe stopping; and zone monitoring) must meet the performance or safety integrity level required by the risk analysis, in accordance with ISO 13849-1 and IEC 62061 standards, and may reside in the robot controller, external protective devices, or a combination of both. The contact thresholds for power and force limitations are validated by measurement with specific equipment in the actual application, with the tool and workpiece mounted and under the expected working conditions.
The risk assessment of the collaborative application considers, in addition to the hazards of the robot itself, those of the tool (edges, points, temperature, rotating elements), the workpiece, the environment (entrapment against fixed elements, falling objects), the operating, adjustment, and maintenance tasks, and foreseeable misuse. The manufacturer of the integrated application (which may be the user when integrating it themselves) is responsible for obtaining CE marking for the assembly in accordance with machinery legislation.
Applicable regulatory framework
- Machinery legislation. Directive 2006/42/EC, transposed by Royal Decree 1644/2008, until the application of Regulation (EU) 2023/1230 on 20 January 2027, which incorporates requirements on systems with autonomous behavior, cybersecurity and human-machine collaboration.
- Harmonized standards. ISO 10218-1:2025 (robots) and ISO 10218-2:2025 (robotic applications and cells), which integrate ISO/TS 15066; ISO 12100 (risk assessment), ISO 13849-1 and IEC 62061 (safety functions), ISO 13855 (positioning of guards).
- Work equipment. Royal Decree 1215/1997: adaptation, maintenance, information and training for the use of the application in the company.
- Prevention of occupational risks. Law 31/1995 and Royal Decree 39/1997: risk assessment, planning, information and training, consultation with representatives before the introduction of new technologies.
- Ergonomics. Royal Decree 487/1997 and ergonomic standards for shared tasks, postures, rhythms and mental workload.
- Psychosocial risks. Assessment of mental workload, imposed pace, autonomy and perception of safety in interaction with robots.
- Artificial intelligence. Regulation (EU) 2024/1689 when the application incorporates artificial intelligence systems considered to be high risk as safety components.
Risks and measures in implementation
- Contact and impact. Validation of force and pressure thresholds by body region, design of tools and parts without edges or points, and exclusion of contact with the head and neck.
- Entrapment. Analysis of the points of entrapment between the robot and fixed elements, with safety distances or stopping functions.
- Tools and processes. Risks inherent in welding, screwing, cutting, handling loads or chemicals, which collaboration does not eliminate.
- Operating modes. Secure management of changes between collaborative and non-collaborative modes, and of programming, adjustment, and maintenance tasks.
- Ergonomics. Design of the shared task to avoid forced postures, imposed rhythms and repetitive movements of the operator.
- Psychosocial factors. Training, information and participation to reduce uncertainty and the feeling of external control, and to avoid monotony.
- Cybersecurity. Protection of controllers and communications against unauthorized access that could disrupt safety functions.
- Training and procedures. Specific training for operators and maintenance personnel, work procedures, lockout/tagout procedures, and periodic verification of safety functions.
Organizational application: how to safely implement a collaborative application
- Define the task and the necessary mode of collaboration, and consult the project with the worker safety representatives as an introduction of new technology.
- Perform the risk assessment of the complete application (robot, tool, part, environment, operation and maintenance tasks, foreseeable misuses) in accordance with ISO 12100 and ISO 10218-2.
- Design and select safety features with the required performance level, configure speed, force, space and tool limits, and validate contact thresholds by measuring in the actual application.
- Ensure CE marking of the integrated assembly, with technical file, declaration of conformity and instructions, and compliance with Royal Decree 1215/1997.
- Design the shared task with ergonomic and psychosocial criteria, and train operators and maintenance personnel on the operation, limits, modes and energy-isolation procedures.
- Establish periodic verification of safety functions, maintenance, change management (tool, part, program, layout) and cybersecurity measures.
- Record incidents and near misses, review the assessment in case of any changes, and monitor ergonomic and safety perception indicators.
Preventive management software allows you to register robotic applications as work equipment with their risk assessment, safety validations, periodic verifications, change management, staff training and incidents, with traceability for audits and inspections.
Limits and common mistakes
- Assuming that a cobot is safe on its own and omitting the risk assessment of the complete application with the tool and the part.
- Relying on the force limitation without validating it through measurement under real working conditions.
- Ignoring pinch points against fixed elements and the risks of the tool and the process.
- Do not manage the CE marking of the integrated assembly when the user performs the integration.
- Neglecting ergonomics and psychosocial factors of shared tasks.
- Not periodically verifying safety features or reviewing the assessment after changes to the program, tool, or distribution.
Detailed technical requirements are set out in ISO standards 10218-1 and 10218-2 of 2025 and in machinery legislation; this sheet is for informational purposes only.
Practical example
Situation: A metal component manufacturing company wants to incorporate a collaborative robot for loading and unloading a machining machine, sharing space with the operator who performs quality control.
- Evaluation. The integrator and the prevention service evaluate the complete application: the gripper and the parts have sharp edges, there is a point of entrapment between the robot and the table, and the operator’s task includes awkward postures when inspecting the parts.
- Design. The gripper is redesigned with guards and the trajectory is reoriented to eliminate entrapment; speed and separation monitoring is configured with a laser scanner for the approach zone and power and force limitation for the delivery zone, with thresholds validated by measurement; the inspection table is raised to the appropriate ergonomic height.
- Compliance and training. The integrated unit receives the CE marking with its technical file, complies with Royal Decree 1215/1997, and operators and maintenance personnel are trained in the modes, limits, and energy-isolation procedures; the health and safety committee is consulted, and the staff is informed.
- Monitoring. Quarterly checks of safety functions, a change management procedure and incident log are established; after six months the assessment is reviewed following a part change and the absence of contacts outside the thresholds is confirmed.
Regulatory and reference framework
- Regulation (EU) 2023/1230 . Machinery Regulation; repeals Directive 2006/42/EC and applies from 20 January 2027.
- Royal Decree 1644/2008, of 10 October . Rules for the marketing and commissioning of machinery; transposition of Directive 2006/42/EC.
- Royal Decree 1215/1997, of July 18. Minimum health and safety requirements for the use of work equipment by workers.
- Law 31/1995, of November 8. Law on the Prevention of Occupational Risks; risk assessment, training and consultation regarding new technologies.
- ISO 10218-1:2025 . Robotics. Safety requirements. Part 1: Industrial robots.
- ISO 10218-2:2025 . Robotics. Safety requirements. Part 2: Applications of industrial robots and robotic cells.
- A3. Updated ISO 10218: Frequently Asked Questions . Summary of changes in the 2025 revision and integration of ISO/TS 15066.
The ISO 12100, ISO 13849-1, IEC 62061 and ISO 13855 standards complement the criteria for risk assessment, safety functions and positioning of guards, and Regulation (EU) 2024/1689 applies to high-risk artificial intelligence systems integrated as safety components.
