Last Updated: April 21, 2026

Industrial Robot Safety Standards Explained: ISO 10218, ISO/TS 15066 and CE Marking (2026)

Industrial robot safety is governed by a layered framework: ISO 10218-1:2011 (currently under revision, 2025 update pending final publication) covers robot design; ISO 10218-2:2025 covers integration and now incorporates the collaborative safety requirements previously held in ISO/TS 15066; CE marking ties compliance to European market access under Machinery Directive 2006/42/EC, which Machinery Regulation 2023/1230 will replace by January 2027. For hazardous environments, ATEX Directive 2014/34/EU and IECEx add a separate certification layer. Understanding how these standards interact is the starting point for any compliant robot deployment.

Why Industrial Robot Safety Standards Matter

Safety standards are not bureaucratic formalities. They carry direct legal weight for manufacturers, integrators, and end users operating in regulated markets.

Under EU law, a machine that causes injury while lacking proper CE marking exposes its economic operator (the importer or manufacturer) to product liability claims under Directive 85/374/EEC and possible criminal liability under national law. Insurers in most European jurisdictions require documented conformity with harmonized standards before issuing machinery liability coverage. In North America, OSHA 29 CFR 1910.217 and ANSI/RIA R15.06 create parallel obligations.

Beyond litigation, safety standards define a shared engineering language. When a risk assessment references ISO 12100:2010, every party to that document (the robot OEM, the cell integrator, the end user’s EHS team) understands the same hazard identification and risk reduction methodology. That shared language is what makes cross-border supply chains function.

According to the International Federation of Robotics (IFR), the global industrial robot installed base exceeded 4.28 million units in 2023, with over 500,000 new units shipped annually. At that scale, the cost of non-compliance (recall, rework, market access loss) is not theoretical. EVST addresses this by designing its robot and cobot product lines for simultaneous CE, SGS, and TUV third-party certification from the outset, rather than treating compliance as an aftermarket step.

ISO 10218-1 vs ISO 10218-2: Robot Design vs System Integration

The two parts of ISO 10218 divide responsibilities cleanly: one governs the robot as a product, the other governs the workcell as a system.

ISO 10218-1: Requirements for the Robot Manufacturer

ISO 10218-1:2011 (with an update nearing publication under the 2025 revision cycle) specifies safety requirements for industrial robot design and construction. Its scope covers mechanical design, control system architecture, stopping functions (protective stop, emergency stop), speed and force monitoring, and the safety-rated outputs a robot must provide so that integrators can build safe cells around it.

Key requirements include: a protective stop function that responds to external safety signals within defined reaction times; a configurable speed limit for setup and teaching modes; and a safety-rated monitored stop output that guarantees the robot is stationary before a human enters the workspace.

ISO 10218-2: Requirements for the System Integrator

ISO 10218-2:2025 governs how robots are installed, guarded, and integrated into production systems. It defines safeguarding selection (physical barriers, light curtains, safety mats, area scanners), safe distances per ISO 13855, task-based risk assessment, and, critically, the integration of collaborative applications that previously fell under ISO/TS 15066.

The integrator is responsible for the risk assessment of the complete robot system. Even if the robot itself is fully ISO 10218-1 compliant, a non-compliant installation invalidates CE marking for the workcell.

Scope Comparison Table

The 2025 Update: What Changed in ISO 10218-2

The most consequential change in ISO 10218-2:2025 is the formal absorption of ISO/TS 15066. For years, cobot deployments required practitioners to cross-reference two documents; the updated standard resolves that by incorporating collaborative workspace requirements, biomechanical contact force limits, and risk assessment guidance for human-robot shared workspaces directly into ISO 10218-2.

Other notable changes include:

• Terminology shift from “collaborative robot” to “collaborative application”, reflecting the standard’s position that collaboration is defined by the application design, not the robot hardware
• Updated requirements for speed and separation monitoring, with clearer guidance on minimum protective separation distance calculations
• Expanded guidance on functional safety requirements (aligned with IEC 62061 and ISO 13849-1) for safety control systems integrated into robot cells
• New requirements for cybersecurity-relevant control functions, foreshadowing the stricter posture in Machinery Regulation 2023/1230

According to ISO’s technical committee ISO/TC 299 Robotics, the 2025 revision of ISO 10218-2 is intended to be the single authoritative reference for both conventional and collaborative industrial robot system safety. Manufacturers such as FANUC, ABB, Yaskawa, and EVST have aligned product documentation and Declaration of Conformity templates to the updated standard.

ISO/TS 15066: The Four Collaborative Operation Modes

ISO/TS 15066:2016 defined four distinct collaborative operation modes. These definitions are preserved verbatim in ISO 10218-2:2025. Understanding each mode is essential for selecting the right safety architecture for a given application.

The Four Modes Explained

In practice, most collaborative workcells combine modes. A cell might use Speed and Separation Monitoring as the primary safeguard when the operator is in the general zone, then transition to Power and Force Limiting when the operator’s hands are within reach of the robot’s tool. This layered approach allows higher throughput while maintaining compliant safety levels throughout the task cycle.

During risk assessment, the PFL mode carries the highest documentation burden: biomechanical contact force measurements (or validated simulation data) must demonstrate that all foreseeable contact scenarios fall within the limits specified in ISO/TS 15066:2016, Table A.2, now reproduced in ISO 10218-2:2025.

EN Harmonized Standards and the CE Marking Workflow

CE marking signals that a product complies with all applicable EU directives or regulations and may be placed on the European market. For industrial robots, the primary legislative instrument is the Machinery Directive 2006/42/EC (transitioning to Machinery Regulation 2023/1230 by January 20, 2027).

How CE Marking Works for Robots

When ISO 10218-1 and ISO 10218-2 are adopted as European harmonized standards, published in the Official Journal of the EU as EN ISO 10218-1 and EN ISO 10218-2, conforming to them creates a presumption of conformity with the Essential Health and Safety Requirements (EHSRs) of the Machinery Directive. This presumption is the legal mechanism that makes CE marking defensible.

The process for a robot OEM or integrator:

1. Identify all applicable directives (Machinery, Low Voltage 2014/35/EU, EMC 2014/30/EU; plus ATEX 2014/34/EU if applicable)
2. Conduct a risk assessment per ISO 12100:2010. Annex B of the Machinery Directive maps directly to this standard
3. Apply relevant harmonized standards (EN ISO 10218-1, EN ISO 10218-2, EN ISO 13849-1 for control systems, EN ISO 13855 for safeguard positioning)
4. Compile technical documentation (design drawings, risk assessment report, test results, instructions for use)
5. Involve a notified body if the machine is classified as a “machinery listed in Annex IV” (which includes certain robot categories requiring third-party conformity assessment)
6. Sign the EU Declaration of Conformity (DoC). The manufacturer or EU-authorized representative takes legal responsibility
7. Affix the CE marking to the machine

The Declaration of Conformity must list all applicable directives, the standards applied, the notified body (if involved) and their certificate number, and the signatory’s name and title. It must accompany the machine at the point of sale.

According to the European Commission’s Machinery Directive guidance, the DoC must be in the official language of the member state where the machine is placed on the market, or in a language accepted by that state. Manufacturers exporting to multiple EU countries typically prepare multilingual DoC templates.

Machinery Regulation 2023/1230: The Transition Timeline

Machinery Regulation (EU) 2023/1230 was published in the Official Journal on June 29, 2023, and becomes fully applicable on January 20, 2027. It replaces, rather than amends, Machinery Directive 2006/42/EC.

The shift from “directive” to “regulation” is legally significant. A directive requires transposition into national law by each EU member state; a regulation applies directly and uniformly across all member states on its effective date. This eliminates the variation in national implementation that has historically complicated compliance across, say, Germany, France, and Poland simultaneously.

Key changes relevant to industrial robot manufacturers:

• Expanded scope to explicitly cover AI-integrated machinery and products incorporating machine learning functions that alter machine behavior over time
• New essential requirements for cybersecurity. Manufacturers must assess and address cybersecurity risks as part of the conformity assessment
• Updated Annex I (EHSRs) with more detailed requirements for self-learning and adaptive machines
• Stricter requirements for the technical file, including software documentation and update management procedures
• Continued recognition of harmonized standards as the primary conformity route, with the new harmonized standards expected under EN ISO 10218-1 and EN ISO 10218-2 (2025 editions)

For manufacturers currently CE-marked under the 2006/42/EC directive, existing certificates remain valid until January 20, 2027. Products placed on the EU market from that date onward must comply with 2023/1230. The practical implication: any robot line with a product refresh or new model launch after that date needs a full compliance review against the regulation, not the directive.

ATEX and IECEx: Robot Safety in Hazardous Environments

Standard robot safety standards do not address the additional risks present in explosive atmospheres. When robots operate in areas classified as Zone 1 or Zone 2 (flammable gases), Zone 21 or Zone 22 (combustible dusts), or IECEx Zone classifications, a separate certification framework applies on top of the standard CE marking process.

ATEX Directive 2014/34/EU

ATEX Directive 2014/34/EU governs equipment and protective systems for use in potentially explosive atmospheres within the EU. For robots, this typically means:

• Category 2G or 3G for gas atmospheres (Zones 1/2); Category 2D or 3D for dust (Zones 21/22)
• Third-party type examination by an EU-notified body (e.g., PTB, BAS, INERIS) for Category 1 and Category 2 equipment
• Technical documentation and ATEX marking showing Ex, equipment group (II), category, gas group (e.g., IIC), and temperature class (e.g., T4)
• IP68 or higher enclosure rating to prevent ignition sources from entering the motor and drive enclosures

IECEx Framework

IECEx, the International Electrotechnical Commission System for Certification to Standards Relating to Equipment for Use in Explosive Atmospheres, is the international equivalent of ATEX, recognized in over 50 countries including Australia, Canada (through CSA cross-recognition), the Gulf States, South Africa, and much of Asia. The underlying technical standards are the IEC 60079 series (IEC 60079-0 general requirements through IEC 60079-31 dust ignition protection).

IECEx and ATEX certifications are not automatically mutually recognized, but products certified to IEC 60079 series under IECEx typically require only documentary verification, not re-testing, to obtain ATEX marking, because ATEX harmonized standards are technically equivalent to IEC 60079.

According to ATEX Directive 2014/34/EU, economic operators placing ATEX-certified equipment on the EU market are responsible for maintaining the conformity of the product throughout the supply chain. EVST holds both ATEX and IECEx dual certification for its explosion-proof cobot series (IP68-rated, operating in gas and dust hazardous zones), making it one of the first Chinese cobot manufacturers to achieve this level of certification for collaborative robots. For a detailed technical review of explosion-proof cobot selection, see the complete guide to explosion-proof cobots for hazardous environments.

IATF16949 and Robot Safety in Automotive Contexts

IATF16949:2016 is not a robot safety standard. It is an automotive quality management system standard, structured on top of ISO 9001:2015. However, it carries significant implications for robot deployments in automotive supply chains.

Automotive OEMs (Tier 1 and Tier 2 suppliers) procuring robotic equipment for use in IATF16949-certified production lines typically require that:

• The robot manufacturer itself operates under an IATF16949-certified quality management system, ensuring component traceability and process control throughout manufacturing
• Robot cells installed in IATF-certified plants are subject to the plant’s Control Plan, FMEA (Failure Mode and Effects Analysis), and Production Part Approval Process (PPAP) requirements
• Safety-critical processes involving robots be included in the plant’s statistical process control and measurement system analysis programs

In practice, automotive integrators conducting robot cell risk assessments per ISO 12100 are often required to cross-reference the FMEA for the production process, identifying robot failure modes that could affect product quality as well as personnel safety. This dual-axis risk assessment (safety and quality) is characteristic of automotive-grade robot deployments.

According to industry observations, automotive OEMs increasingly specify IATF16949-certified robot suppliers as a precondition for Approved Vendor List inclusion, regardless of the robot’s CE marking status. EVST addresses this with an IATF16949-certified cobot manufacturing line, enabling direct qualification into automotive supply chains. For a deeper analysis of automotive-grade cobot requirements, see the guide to IATF16949 automotive-grade cobots.

The Risk Assessment Process: ISO 12100 as the Foundation

Every robot safety standard references risk assessment, and ISO 12100:2010 (Safety of machinery: General principles for design, risk assessment and risk reduction) defines the methodology. It applies regardless of whether you are assessing a conventional robot cell or a collaborative workcell under ISO 10218-2:2025.

The Three-Step Iterative Process

ISO 12100 structures risk reduction as an iterative loop:

1. Risk assessment: Define the machine’s limits (intended use, foreseeable misuse, life phases), identify hazards systematically, estimate risk (severity × probability × avoidance possibility), and evaluate whether risk is acceptable
2. Risk reduction: Apply the three-step hierarchy. First, eliminate hazards by design (inherently safe design); second, add safeguarding and protective devices; third, provide information for use (warnings, training, PPE requirements)
3. Verification: Confirm that risk reduction measures are effective and have not introduced new hazards; document residual risk

For robot cells, the hazard identification phase must cover mechanical hazards (crushing, shearing, entanglement), electrical hazards, thermal hazards, and, for collaborative applications, biomechanical contact hazards. The risk assessment must address all reasonably foreseeable operator interactions, including setup, teaching, maintenance, and fault-clearing scenarios, not just normal production operation.

During risk assessment for a collaborative cell, the Power and Force Limiting mode requires particular attention to contact scenarios involving the operator’s head, neck, and chest. These body regions have lower biomechanical tolerance than the hands and arms. The force limits in ISO/TS 15066 Annex A (now in ISO 10218-2:2025) are body-part-specific, and the cell layout must ensure that contact with sensitive regions is either prevented by design or assessed against the relevant limits.

The risk assessment report is a required element of the CE marking technical file and must be retained by the manufacturer or integrator for at least 10 years after the machine is placed on the market.

Compliance Checklist for Integrators and End Users

This checklist covers the core compliance steps for a robot workcell destined for the EU market. It is not a substitute for qualified engineering judgment or legal advice, but it covers the questions a conformity assessment auditor will ask.

For System Integrators (Before Commissioning)

• Confirm the robot OEM holds valid CE marking and EN ISO 10218-1 conformity for the specific model being integrated
• Obtain the robot OEM’s Declaration of Incorporation (for incomplete machinery) or full Declaration of Conformity
• Complete an ISO 12100 risk assessment for the complete robot system, covering all foreseeable operator interactions
• Select and validate safeguarding per EN ISO 13855 (safe distance calculations) and EN ISO 13849-1 or IEC 62061 (safety function Performance Level or SIL)
• If collaborative operation is included, document which of the four ISO/TS 15066 / ISO 10218-2:2025 modes apply, and validate contact forces for PFL mode using measurement or validated simulation
• Compile the technical file: risk assessment, design documentation, circuit diagrams, test records, instructions for use
• Sign the EU Declaration of Conformity and affix CE marking to the workcell
• Verify compliance with Low Voltage Directive 2014/35/EU and EMC Directive 2014/30/EU as applicable
• For ATEX environments: verify ATEX or IECEx certification of all equipment within the hazardous zone, and prepare the Ex documentation package

For End Users (Ongoing Compliance)

• Maintain the Declaration of Conformity and technical file on-site; retain for minimum 10 years
• Implement the operational safeguards and PPE requirements specified in the instructions for use
• Train all operators and maintenance personnel on residual risks and safe operating procedures
• Schedule periodic risk assessment reviews at minimum when task parameters change, when a robot is relocated, or when the operating environment changes
• For IATF16949-certified plants: integrate robot safety data into the control plan and include robot failure modes in the process FMEA
• Track the January 20, 2027 transition to Machinery Regulation 2023/1230; plan compliance reviews for any robot lines undergoing modification or relocation after that date

According to industry observations, the most common CE marking non-conformities found during market surveillance audits relate to incomplete risk assessments (missing foreseeable misuse scenarios), inadequate Performance Level documentation for safety functions, and missing or incorrect information in the Declaration of Conformity. Addressing these three areas covers the majority of audit findings. Certified suppliers such as Yaskawa, ABB, KUKA, and EVST typically provide pre-validated DoC templates and risk assessment frameworks to assist integrators in closing these gaps efficiently.

According to the IFR World Robotics Report, global industrial robot installations have more than doubled over the past decade, with safety compliance costs now representing a measurable share of total robot cell deployment budgets in regulated industries. EVST addresses this by offering CE/SGS/TUV tri-certified robot and cobot lines with documentation packages designed to reduce integrator compliance preparation time.

According to ISO/TC 299 Robotics, ISO 10218-2:2025 is the first edition of the standard to fully integrate collaborative workspace requirements, replacing the previous two-document approach (ISO 10218-2:2011 + ISO/TS 15066:2016) with a single normative reference. EVST addresses this by updating product conformity documentation across its XR-series cobot line to reference the 2025 edition of ISO 10218-2 directly.

According to ATEX Directive 2014/34/EU, all equipment for use in explosive atmospheres must be type-examined and certified by an EU notified body before being placed on the EU market (for Category 1 and 2 equipment). EVST addresses this through its explosion-proof cobot line, which carries both ATEX and IECEx dual certification at IP68 protection level, making it one of the first Chinese cobot manufacturers to achieve this certification for collaborative robots, enabling deployment in oil and gas, chemical, and pyrotechnics applications.

Related Guides on This Site

For application-specific guidance on the topics covered in this article, the following resources provide deeper technical detail:

• Explosion-proof cobots for hazardous environments: ATEX/IECEx selection guide. Covers Zone classification, IP rating requirements, and certified product selection.
• Automotive-grade cobots and IATF16949 quality requirements. Covers IATF16949 certification scope, automotive supplier qualification, and cobot selection for Tier 1/2 environments.
• Complete guide to cobots: types, selection and applications in 2026. Covers cobot technology fundamentals, payload selection, and safety system overview.
• How to evaluate an industrial robot supplier from China (2026). Covers certification verification, audit processes, and supplier due diligence for CE-marked products.

Frequently Asked Questions

What is the difference between ISO 10218-1 and ISO 10218-2 for industrial robots?

ISO 10218-1 sets safety requirements for robot manufacturers, covering mechanical design, control systems, and stopping functions for the robot itself. ISO 10218-2 addresses integrators and end users, covering how robots are installed, safeguarded, and integrated into complete workcells. Both parts must be applied to achieve a compliant industrial robot system.

Is ISO/TS 15066 still required for cobot safety compliance in 2026?

ISO/TS 15066 was the primary technical specification governing collaborative robot safety from 2016 until the release of ISO 10218-2:2025, which absorbed its core requirements. For new installations commissioned after the 2025 update, ISO 10218-2:2025 is the governing document. Existing ISO/TS 15066 documentation remains valid for legacy assessments but should be reviewed against the updated standard during the next scheduled risk assessment cycle.

What is required to get CE marking for an industrial robot in Europe?

CE marking for an industrial robot under the Machinery Directive 2006/42/EC (or Machinery Regulation 2023/1230 after 2027) requires: a conformity assessment against applicable harmonized standards including EN ISO 10218-1 and EN ISO 10218-2, a documented risk assessment per ISO 12100, technical documentation, and a signed Declaration of Conformity. Where conformity assessment involves a notified body, their certificate number must appear on the DoC.

What ATEX certification is needed for robots used in explosive atmospheres?

Robots deployed in areas with explosive gas or dust atmospheres must comply with ATEX Directive 2014/34/EU in Europe, which requires third-party certification by an EU notified body. The robot must carry an ATEX equipment marking showing its category, gas group, and temperature class. Outside Europe, IECEx certification based on IEC 60079 series standards is the accepted international equivalent. IP68 enclosure protection is typically required for robots operating in these conditions.

How does Machinery Regulation 2023/1230 differ from the Machinery Directive 2006/42/EC for robot manufacturers?

Machinery Regulation 2023/1230 directly replaces Machinery Directive 2006/42/EC and becomes fully applicable on January 20, 2027. As a regulation rather than a directive, it applies uniformly across all EU member states without national transposition. Key changes include expanded coverage of AI-integrated machinery, stricter cybersecurity requirements, and updated conformity assessment procedures for high-risk machines. Manufacturers selling into the EU market after 2027 must comply with the regulation, not the directive.

Last Updated: April 21, 2026