ISO 10218-2:2025 — Safety Requirements for Industrial Robot Systems and Integration — Compliance Brief
Record covered: robotics-cert-011 Issuing body: ISO Technical Committee 299 (Robotics). Jurisdiction: International; harmonized in the EU as EN ISO 10218-2; US adoption as ANSI/A3 R15.06 Part 2. Status: ISO 10218-2:2025 published 2025 — first major revision since 2011; roughly three times the page count of the 2011 edition (terms and definitions grew from 2 to 15 pages; safety requirements from 28 to 50 pages — per IDEC's 2025 analysis; verified pattern).
1. What it is
Part 2 states the safety requirements for industrial robot applications and robot cells — the integrated system the end user actually operates. If Part 1 is the OEM's duty for the arm, Part 2 is the integrator's and employer's duty for everything around it: layout, safeguarding, the task program, workpieces, end-effectors, and the humans who interact with the cell. The 2025 revision is the most significant update to robot safety requirements in more than a decade, rewritten for collaborative applications, mobile automation, digital connectivity, and multi-robot cells that barely existed in 2011.
2. Scope — who and what it applies to
System integrators, facility engineers, and employers/end users who design, install, commission, operate, maintain, and decommission robot cells. The standard addresses the full lifecycle — design, integration, commissioning, operation, maintenance, decommissioning. A compliant Part 1 arm does not produce a compliant cell without Part 2 integration work; liability for the cell sits with the integrator/employer.
3. Key requirements and compliance obligations
- Risk assessment per ISO 12100 for the complete application, covering the robot system, workpieces, task program, and all task-related hazards. The integrator starts from the OEM's residual-risk information (Part 1) and owns the rest.
- Safeguarding design: spatial layout with defined operator access points; deterministic physical guarding and/or optoelectronic protective devices; interlocked guards; muting where material must flow.
- Collaborative applications — the headline change: the 2025 edition eliminated the term "collaborative robots" and folded in the former ISO/TS 15066. Only an application can be collaborative — defined as containing one or more collaborative tasks where robot and operator share the same safeguarded space. The four collaborative modes carry over with tightened requirements: safety-rated monitored stop, hand guiding, speed and separation monitoring, and power and force limiting (with biomechanical pressure/force thresholds from the former TS 15066 now in the main text).
- End-effectors and manual load/unload: safety requirements for EOAT and manual loading/unloading procedures folded in from ISO/TR 20218-1 and -2 — the tasks where hands are nearest the hazard.
- Lifecycle duties: commissioning validation that protective measures achieve the required Performance Level; documented maintenance and lockout/tagout integration; change management (any cell modification re-triggers the risk assessment).
- Functional safety made explicit: safety functions, their required performance levels, and validation requirements are stated directly, aligning cell design with ISO 13849/IEC 62061 practice.
4. Penalties / consequences of non-compliance
Same enforcement pathways as Part 1, but the exposure concentrates on the integrator/employer: EU market-surveillance action against the party that placed the cell (as machinery) on the market; US OSHA General Duty Clause citations after incidents, where the 2025 standard defines the recognized hazard and feasible abatement; and direct civil liability — the integrator is the deep pocket in cell-injury litigation. Insurance underwriters for automation projects increasingly ask for the cell risk assessment as a policy condition.
5. Version and edition status — live changes
- ISO 10218-2:2025 is current (2025; verified via A3/industry announcements).
- US adoption: ANSI/A3 R15.06-2025 Part 2 (Sept 2025); Canada CSA Z434 revision in progress.
- EU harmonization citation under the Machinery Regulation is the gating item for presumption of conformity — track the OJ list.
- The standard is expected to effectively shape new robot installations from January 2027 onward as national adoptions and EU citation complete (per industry commentary, Aug 2026) — aligning with the EU Machinery Regulation's application date.
- Flag: page-count and section-growth figures come from IDEC's published analysis; clause-level detail was not verified against the paywalled text.
6. Related certifications
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Robotics — A3 Certified Robot Integrator (robotics-cert-001): the credential that directly tests integrator competence in cell risk assessment and safeguarding — the core Part 2 duty.
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Robotics — TÜV Rheinland Functional Safety Engineer, Machinery track (robotics-cert-007): validates the safety-function design and Performance Level verification Part 2 demands.
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AMRs and mobile manipulators: the 2025 revision's expanded scope better covers cells that include autonomous mobile robots - treat the mobile base's navigation safety and the arm's manipulation safety as one application-level risk assessment, not two separate ones, since the hazards interact (e.g. arm motion during base transit).
7. Flags and honest caveats
- The "no more cobots, only collaborative applications" shift is real and deliberate — marketing a robot as "inherently safe" or "collaborative" without an application-level risk assessment is now flatly contrary to the standard's framing. Contracts and marketing copy should be updated.
- Retrofitting existing cells to the 2025 edition is a gap-analysis exercise, not an automatic legal duty in most jurisdictions — but any modification to a cell re-opens the assessment, and insurers/customers may demand current-edition conformance contractually.
Original ETS reference writing, verified against public sources on 2026-09-30. Thin sourcing is flagged inline. Not legal advice — confirm current editions with the issuing body.