Robot Safety Standards: ISO 10218 and ISO/TS 15066

Why robot safety standards exist

An industrial robot or cobot is a machine that can move a heavy load at high speed and with great force, and increasingly it works in the same space as people, without a safety cage. Standards are not a formality: they define a shared language for risk assessment, minimum design requirements and measurement methods, so that manufacturer, integrator and user talk about the same level of hazard in the same way. In the EU, meeting a harmonised standard gives a presumption of conformity with the essential requirements of the law. That helps, but it does not replace formal conformity assessment and CE marking.

For buyers in Poland — a factory rolling out cobots or an integrator building a robotic workstation — knowing these standards helps tell solid technical documentation from the marketing slogan "safe robot".

ISO 10218-1 and ISO 10218-2: the baseline standard for industrial robots

ISO 10218 is a two-part standard from ISO/TC 299 (part 1, part 2) and the worldwide reference point for industrial robot safety; in Europe it appears as EN ISO 10218-1/-2 and in Poland as PN-EN ISO 10218.

• ISO 10218-1 covers the robot itself: its design, its control system, its safety functions (safe stop, limits on speed and force) and the information the manufacturer must supply.
• ISO 10218-2 extends the requirements to integrating the robot into a specific workstation: guards, protective devices, collaborative zones, the choice of end-of-arm tooling and safe working procedures. Responsibility for this part rests mainly with the integrator, not the robot manufacturer.

The 2025 edition. Both parts were published in February 2025 — ISO 10218-1:2025 as the third edition and ISO 10218-2:2025 as the second — and replaced the 2011 editions. It is the first major revision in more than a decade. According to the ISO catalogue and industry analyses, requirements for functional safety and cybersecurity were expanded, new classifications of robots and applications were introduced, and the requirements for collaborative operation that used to sit in the separate specification ISO/TS 15066 were folded in. Older documents and quotes often still cite the 2011 edition; for a new project, ask the supplier explicitly against which edition the workstation is to be assessed.

ISO/TS 15066 and collaborative operation

ISO/TS 15066, published in February 2016 as a technical specification supplementing ISO 10218, was written with cobots in mind: situations where a person and a robot share a workspace without a physical barrier. It described four kinds of collaboration:

1. Safety-rated monitored stop: the robot stops completely when a person enters the collaborative zone and resumes only after they leave.
2. Hand guiding: the operator physically guides the arm, for example when programming by demonstration.
3. Speed and separation monitoring: the system monitors the person-robot distance and adjusts speed, down to a stop.
4. Power and force limiting: the design, drives and software limit force and pressure on contact with a person, which allows work without separation.

The fourth mode is the one most associated with the word cobot, and it comes with limit values for force and pressure on different parts of the body (hand, forearm, torso). We do not quote specific thresholds: they are in the full text of the standard, and manufacturers (for example Universal Robots, Techman, Doosan, Fanuc in its CRX line) publish results of their own measurements for their models. According to industry analyses, most TS 15066 requirements moved into ISO 10218-2:2025, so that is where to look for them in new projects.

Compliance is not a property of a robot in isolation from its use: permitted forces depend on the end tool, speed, payload mass and workstation geometry, so only a risk assessment of the specific application confirms it. We describe the design differences between a classic industrial robot and a cobot in “Cobot or Industrial Robot”.

What the Machinery Regulation (EU) 2023/1230 changes

The Machinery Directive 2006/42/EC is replaced by Regulation (EU) 2023/1230 of 14 June 2023, published in the Official Journal of the EU (L 165) on 29 June 2023. Unlike a directive, which has to be transposed into national law, a regulation applies directly in all member states in the same wording.

Date of application: 20 January 2027 (European Commission; dates as corrected in July 2023, OJ L 169). Earlier, from 20 January 2024, the provisions on notified bodies (Articles 26–42) started to apply. The directive 2006/42/EC remains in force up to and including 19 January 2027.

The main novelties compared with the directive:

• Machinery with AI-based safety functions. The regulation covers machinery with systems of fully or partially self-evolving behaviour, based on machine learning, that perform safety functions; third-party conformity assessment applies to such components (Annex I, Part A, Regulation 2023/1230) — a situation the 2006 directive did not foresee.
• Cybersecurity. The requirements protect software and control systems against unauthorised modification that could compromise the safety of the machine.
• Conformity assessment of higher-risk machinery. The regulation sets out when a notified body is needed.
• Digital instructions and declaration of conformity. The conditions under which they can be supplied electronically are clarified.

You will find the full list of high-risk machinery categories in Annex I in the text of the regulation on EUR-Lex; before concluding that a given category of robots (for example service humanoids) needs assessment by a notified body, check it there.

Robots with learning AI functions may in addition fall under the EU Artificial Intelligence Act (Regulation (EU) 2024/1689). That is a separate legal regime worth remembering for robots with autonomous navigation or person recognition; we do not make our own legal classification of products here.

What this means in practice in Poland

CE marking stays mandatory. Every industrial robot and cobot placed on the EU market needs the CE mark, an EU declaration of conformity and technical documentation, which the manufacturer keeps at the disposal of market surveillance authorities for at least 10 years after the machinery is placed on the market or put into service (Article 10 of Regulation 2023/1230). For most machinery internal production control applies; for higher risk a notified body is needed.

The slogan "compliant with ISO 10218" is not enough. Ask the supplier for the specific safety data sheet or declaration of conformity, and ask which edition of the standard is meant.

Authorities in Poland. The Office of Technical Inspection (UDT) supervises specific categories of equipment — among them pressure equipment, cranes and hoists. Industrial robots are not a separate category, but an obligation can arise indirectly, for instance when the arm is part of a hoisting installation. The National Labour Inspectorate (PIP) oversees occupational health and safety in general: an employer deploying robots or cobots includes automation risks (collision, trapping, software failure) in its occupational risk assessment. This is general information, not legal advice.

Checklist before buying (more in “How to Buy a Cobot Step by Step”): a current CE declaration of conformity, a safety data sheet with force measurements for the specific end tool, clarity on who — manufacturer or integrator — is responsible for compliance with ISO 10218-2 on the finished workstation, and a plan for the move to Regulation 2023/1230 from 20 January 2027 if the investment has a long horizon.

Disclaimer

This article is informational and is not legal advice. The legal situation keeps changing (the move from directive to regulation, the roll-out of the AI Act), so before a purchase or investment decision check the current editions of the standards in the ISO and PKN catalogues, the text of the regulation on EUR-Lex, and consult a law firm specialising in technical law. As of: 2 October 2026.