ISO 10218

ISO 10218 is an international safety standard for industrial robots. The third edition was published in 2025. It consists of two parts:

• Part 1: Industrial robots

• Part 2: Industrial robot applications and robot cells

The standard provides guidance to systematically analyze and reduce the risks of industrial robots. Industrial robots are used in industrial applications, where only professional workers are in contact with them.

The standard begins with a risk analysis of the robot and requires that the following risk classes be considered (chapter 4) according to ISO 12100 and Annex A of Part 1:

• Mechanical

• Electrical

• Thermal

• Noise

• Material/Substance

• Ergonomic

• Combination of hazards

The risks are reduced through design measures, risk‑reduction strategies (chapter 5), and verification measures to ensure the robot is correctly built and installed.

Safety functions and a user guide play a crucial role in the required robot safety. Robots are assessed for risk according to their mass, power, and maximum speed. For these systems, a so‑called “Performance Level (PL)” is used to define the required rigor for implementing safety functions according to the applied safety standards.

Annex G contains a comprehensive checklist (approximately 19 pages) with recommended methods for verification and validation of risk‑reduction measures. For example, to reduce the risk of singularities (5.3), the table recommends practical tests or a review of schematics and design materials.

The standard does not deal with software but refers to other functional safety standards such as ISO 13849‑1:2023 or IEC 62061:2021. A tool for a robot is typically an end‑effector mounted on the robot arm in order to handle the pieces that the robot is planned to work with.

Part 2 is about robot applications and covers a wide range of application areas and more specific risks, such as vibration, radiation, ergonomic hazards, or risks arising from the robot’s environment. The risks of the application can be determined by severity and exposure using concrete formulas. Part 2 also contains a chapter about collaborative robots (cobots), i.e., robots that cooperate with humans. Many chapters of Part 1 and Part 2 have a similar structure but different contents. The verification and validation method recommendations in Annex H are 34 pages long since they cover more and different risks.

Robot developers and application engineers should comply with ISO 10218, as they are responsible for ensuring safety functions and risk assessments meet the required Performance Levels (PL).

Validas can assist organizations in complying with ISO 10218 (both parts) by taking over the documentation tasks and providing a success guarantee as we do for tool & library qualification. The guarantee ensures the completeness of the documentation, including a detailed safety plan. Validas also guides robot developers and application engineers using a systematic process and tailored checklists that are used to examine and clearly document the safety aspects.

• ISO 10218-1:2025 Robotics — Safety requirements — Part 1: Industrial robots. https://www.iso.org/standard/73933.html

• ISO 10218-2:2025 Robotics — Safety requirements — Part 2: Industrial robot applications and robot cells. https://www.iso.org/standard/73934.html

• IEC 62061:2021 Safety of machinery — Functional safety of safety-related control systems. https://webstore.iec.ch/publication/59927