Evolution of Safety Requirements in Industrial Robotics: Comparative Analysis of ISO 10218-1/2 (2011 vs. 2025) and Integration of ISO/TS 15066

Industrial robotics has established itself as an integral component of large-scale manufacturing enterprises. Simultaneously, collaborative robotics is gaining prominence, introducing novel paradigms of human-machine interaction. These advancements have necessitated a comprehensive revision of safety standards, specifically incorporating requirements for cybersecurity and protection against unauthorized access in networked robotic systems. This article presents a comparative analysis of the ISO 10218:2011 and ISO 10218:2025 standards, examining the evolution of their structure, terminology, technical requirements, and annexes. The analysis reveals significant expansions in functional safety and cybersecurity, the introduction of new classifications for robots and collaborative applications, and the normative integration of the technical specification ISO/TS 15066. Consequently, the new edition synthesizes mechanical, functional, and digital safety requirements, establishing a comprehensive framework for the design and operation of modern robotic systems.

💡 Research Summary

The paper presents a systematic comparative analysis of the ISO 10218‑1 and ISO 10218‑2 standards as they evolved from the 2011 edition to the 2025 edition, and examines how the collaborative‑robot safety technical specification ISO/TS 15066 has been incorporated into the newer version. Using a content‑comparison methodology, the authors classified every identified difference into three categories—technical, structural/methodological, and terminological/semantic—and evaluated the impact of each change on manufacturers, system integrators, and research institutions.

Key findings include:

1. Scope Expansion and Clarification – While the 2011 edition focused on inherent safe design and protective measures for partly completed machinery, the 2025 edition broadens the scope with a detailed exclusion list (underwater, military, medical, service, consumer, and personnel‑lifting robots) and explicitly defines environments where the standard does not apply (nuclear, hygienic, explosive atmospheres, extreme climates, underground). The new wording also introduces the concept of “reasonably foreseeable misuse,” aligning risk assessment with ISO 12100.

2. Shift from Regional to Global Standard – The 2011 version was an EN ISO harmonised standard tied to European directives; the 2025 version is a pure ISO document, enhancing worldwide applicability and exportability.

3. Modernised Normative References – References have been updated to the latest editions of ISO 13849‑1 (2023), IEC 62061 (2021), ISO 20607 (2019), ISO 3864, ISO 7010, ISO 14118, and ISO 14119, while ISO 10218‑2 is removed from the reference list of Part 1, reflecting a more current technical framework.

4. Terminology Overhaul – The terminology section grew from 38 terms to 81 terms, organized into 14 thematic groups. New terms cover collaborative task types, cybersecurity risks, software lifecycle management, and functional‑safety concepts, providing tighter alignment with ISO 12100, ISO 13849‑1, and IEC 62061.

5. Technical Requirements Enhancement – Functional safety requirements are now explicitly linked to ISO 13849‑1:2023 and IEC 62061:2021, demanding detailed safety‑related control system design, validation, and maintenance. A dedicated cybersecurity clause introduces requirements for networked robots, including access control, data integrity, and incident response.

6. New Classification System – Robots are classified into classes A‑D and collaborative applications into types 1‑3, enabling more granular risk assessment and certification pathways.

7. Integration of ISO/TS 15066 – The collaborative‑robot safety limits on force, pressure, and speed defined in ISO/TS 15066:2016 are directly embedded in ISO 10218‑2:2025, eliminating the need for a separate annex and ensuring that collaborative safety is part of the core standard.

8. Verification & Validation Framework – Annex G introduces a tabular tool that systematically maps design and safety requirements to verification activities, supporting manufacturers in demonstrating compliance throughout the product lifecycle.

9. Expanded Information for Use – The “Information for Use” chapter now includes guidance on cybersecurity, software management, emergency procedures, and validation of safety‑function parameters, reflecting the digitalisation of modern robotic systems.

Overall, the 2025 revision synthesises mechanical, functional, and digital safety requirements into a unified framework. By modernising structure, terminology, and technical content, and by embedding collaborative‑robot safety and cybersecurity directly into the standard, ISO 10218‑1/2 2025 provides a comprehensive, internationally harmonised basis for the design, integration, and certification of contemporary industrial and collaborative robots. This evolution is expected to facilitate safer human‑robot interaction, streamline compliance processes, and support the continued growth of networked, collaborative automation in manufacturing.