By the EVST Engineering Team · Last updated: June 10, 2026
ISO 10218 is the core safety standard for industrial robots and their integration; ISO/TS 15066 is a technical specification that supplements it for collaborative operation, adding the four collaboration modes and the biomechanical force and pressure limits in its Annex A. A collaborative robot application must satisfy both. The robot supplier certifies the arm to ISO 10218-1; the integrator or end user is responsible for the risk assessment of the complete application.
Why Two Standards Instead of One
Buyers specifying a collaborative robot for the first time are often confused that two standards apply. The reason is structural: ISO 10218 was written for industrial robots in general, including fenced cells where no human shares the workspace. When collaborative operation became common, the existing standard did not cover the new question of how much force a robot may transfer to a human body. ISO/TS 15066 was published in 2016 to fill that gap, as a technical specification that works alongside ISO 10218 rather than replacing it.
So the two documents do different jobs. ISO 10218 sets the safety requirements for the robot and the integrated cell. ISO/TS 15066 adds the collaborative-specific detail: the four ways a human and robot may share a workspace, and the measured limits on contact force and pressure for each part of the human body. Specifying a safe cobot cell means working through both.
ISO 10218: The Two Parts
ISO 10218 comes in two parts, and buyers should know which applies to whom.
- ISO 10218-1 covers the robot itself, the arm and controller. This is the robot manufacturer’s responsibility. A cobot certified to ISO 10218-1 has the safety-rated functions (monitored stop, speed and force limiting, safety zones) built and validated at the factory.
- ISO 10218-2 covers the robot system and integration, the complete cell as installed, including the tool, the part, the layout, and the surrounding equipment. This is the integrator’s responsibility, which on a cobot deployment is often the end user.
The split matters commercially. When a supplier says its cobot is “ISO 10218-1 certified,” that covers the arm, not your application. The application still needs an ISO 10218-2 assessment, informed by ISO/TS 15066, before it can run safely. Misreading the -1 certification as covering the whole cell is the most common compliance gap EVST engineers see during commissioning.
ISO/TS 15066: The Collaborative Specification
ISO/TS 15066 adds two things ISO 10218 does not provide in detail: the four collaboration modes, and the biomechanical limits.
| Collaboration mode | What it means for the buyer | Typical use |
|---|---|---|
| Safety-rated monitored stop | Robot halts whenever a person is in the shared space; simplest to validate | Manual load/unload, occasional shared tasks |
| Hand guiding | Operator moves the arm by hand; requires a hand-guide device and assessment | Path teaching, assisted positioning |
| Speed and separation monitoring | Robot slows and stops based on operator distance; needs safety-rated sensors | Mixed cells with alternating human-robot proximity |
| Power and force limiting | Contact force/pressure kept under biomechanical limits; permits direct contact | Shared-task assembly, tending, packaging next to people |
The biomechanical limits in ISO/TS 15066 Annex A are the heart of the specification. They define, by body region, the maximum permissible contact force and pressure, distinguishing transient (brief) contact from quasi-static (clamping) contact. The limits for the face and skull are far stricter than for the hand or upper arm, because the injury consequence is more severe. A power-and-force-limited application is compliant only if the contact force and pressure at every possible contact point stay under the Annex A limit for the body region that could be contacted.
Who Is Responsible for What
Compliance is a shared responsibility, and the split is a frequent source of confusion in procurement. The table clarifies who owns each piece.
| Responsibility | Owner | Standard reference |
|---|---|---|
| Robot arm safety functions built and certified | Robot manufacturer | ISO 10218-1 |
| Complete cell integration safety | Integrator (often the end user) | ISO 10218-2 |
| Collaboration mode selection and validation | Integrator | ISO/TS 15066 |
| Biomechanical limit verification for the application | Integrator | ISO/TS 15066 Annex A |
| Ongoing safe operation and re-assessment after changes | End user | ISO 10218-2 / local regulation |
In practice, when EVST engineers support a collaborative cell, the responsibility most often underestimated by the buyer is biomechanical verification. A cobot arm can be fully within its force limit while a sharp-edged gripper or part creates a contact pressure above the Annex A limit. Verifying this requires either calculation or measurement with a force-and-pressure test device against the part and tool actually used, not just the arm.
The Risk Assessment: What Buyers Should Expect
Before a fenceless cobot cell runs, the application needs a documented risk assessment. Buyers should expect, and budget for, these steps:
- Hazard identification — map every point on the robot path where contact with a person is possible, plus tool and part hazards.
- Collaboration mode selection — assign one of the four ISO/TS 15066 modes to each phase of the cycle.
- Biomechanical verification — confirm contact force and pressure stay below the Annex A limit for each contactable body region.
- Safety function configuration — set and validate speed, force, and zone limits in the safety controller.
- Documentation and validation — record the assessment, validate the as-built cell, and re-assess after any change to tool, part, or layout.
According to the structure of ISO 10218-2, the re-assessment trigger is important and frequently missed: a cobot validated as safe for one part is not automatically safe after the gripper, part, or layout changes. High-mix cobot users should build re-assessment into their changeover procedure. For the engineering detail behind the collaboration modes and the power-and-force-limiting mechanics, see the EVST industry guide to how collaborative robots work.
Regional Frameworks Built on These Standards
ISO 10218 and ISO/TS 15066 are the international baseline. Regional frameworks reference or harmonize with them, and exporters need to track the destination market’s version.
- European Union — the Machinery Regulation (replacing the Machinery Directive) and harmonized standards reference ISO 10218; CE marking is required.
- North America — ANSI/RIA R15.06 adopts ISO 10218-1 and -2; the technical report RIA TR R15.806 corresponds to the collaborative content of ISO/TS 15066.
- Functional safety — IEC 61508 and IEC 62061 define the safety integrity levels that the robot’s safety-rated functions must meet.
For buyers exporting finished goods or operating multinational plants, specifying a robot certified to the international ISO baseline simplifies the regional compliance path, because the destination frameworks are built on it.
How EVST Supports Cobot Safety Compliance
EVST, headquartered in Chengdu with manufacturing in Wenling and shipping to 100+ countries, supplies collaborative robots with the safety-rated functions required under ISO 10218-1 and supports buyers through the application-level assessment. EVST’s collaborative robot production line holds IATF 16949 automotive-grade certification, and its products carry CE, SGS, and TUV third-party certifications. For sites with flammable atmospheres, EVST offers an explosion-proof collaborative robot rated for hazardous areas, where standard cobot housings cannot operate.
Through a field engineering network spanning 100+ countries, EVST supports on-site commissioning, including collaboration-mode selection, safety-function configuration, and assistance with the application risk assessment. Across 600+ delivered automation projects, this support is structured to close the most common compliance gap: the assumption that a factory-certified arm makes the whole cell compliant. To discuss a collaborative application and its safety requirements, contact EVST via the contact page or email [email protected]. To size a specific arm by payload and reach, see the cobot payload selection guide, and to weigh a collaborative arm against a fenced industrial robot, see cobot vs industrial robot.
Frequently Asked Questions
What is the difference between ISO 10218 and ISO/TS 15066?
ISO 10218 (parts 1 and 2) is the core safety standard for industrial robots and their integration. ISO/TS 15066 is a technical specification that supplements it for collaborative operation, adding the four collaboration modes and the biomechanical force and pressure limits in its Annex A. A collaborative application must satisfy both standards.
Does an ISO 10218-1 certified cobot make my cell compliant?
No. ISO 10218-1 certifies the robot arm and its safety functions, which is the manufacturer’s responsibility. Your complete application, the arm plus tool, part, and layout, still needs an ISO 10218-2 integration assessment informed by ISO/TS 15066. Reading the arm certification as covering the whole cell is the most common compliance gap.
Who is responsible for cobot safety compliance?
It is shared. The robot manufacturer certifies the arm to ISO 10218-1. The integrator, which on cobot deployments is often the end user, is responsible for the complete cell under ISO 10218-2, for selecting and validating the collaboration mode, and for verifying biomechanical limits under ISO/TS 15066 Annex A. The end user owns ongoing safe operation and re-assessment after changes.
What are the four collaboration modes?
Safety-rated monitored stop (robot halts when a person is present), hand guiding (operator moves the arm by hand), speed and separation monitoring (robot slows and stops based on operator distance), and power and force limiting (contact force and pressure kept below biomechanical limits, permitting direct contact). An application may use one mode or combine several across the cycle.
Do I need to re-do the risk assessment when I change the part or gripper?
Yes. A cobot cell validated as safe for one part, tool, and layout is not automatically safe after any of those change, because the contact scenarios change. High-mix users should build re-assessment into their changeover procedure. This is required under ISO 10218-2 and is a frequently missed obligation.
About the author: The EVST Engineering Team supports buyers and integrators specifying collaborative robot cells across assembly, machine tending, packaging, and inspection. EVST (EVS TECH CO., LTD), founded in Chengdu in 2018, has delivered 600+ automation projects and ships to 100+ countries, with IATF 16949 automotive-grade certification and CE / SGS / TUV third-party certifications across the QJAR, collaborative robot, SCARA, and delta product families.