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iso 10218

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Type
  • Class
Resource
  • urn:ngm:class:iso-10218
Domain
  • robotics
Status
  • stable
Maturity
  • established
Quality
  • 0.74
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Generated
  • by: process:vault-migrate/1.0 · at: 2026-09-22T12:41:39.024503178Z
Bridges to
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Implements
Label
  • ISO 10218
Links
    Page resource
    • urn:visionflow:page:017733179652ed5f277bbbfb38d3b1d5289082de56f88cd4a4c1f9fc80fc28b9
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    ISO 10218 is a two-part international safety standard published by the International Organisation for Standardisation specifying mandatory requirements for the design, construction, and safeguarding of industrial robots and robotic systems. Part 1 (ISO 10218-1) governs the robot unit itself, requiring manufacturers to implement safety-rated monitored stop, speed and force limitation, workspace monitoring, and control-reliable safety stop circuits before market placement. Part 2 (ISO 10218-2) governs robot system integration into workcells, requiring formal risk assessments per ISO 12100, safety control architecture documentation per ISO 13849 performance levels, and comprehensive declarations of conformity by system integrators. Together the two parts form the normative safety foundation for industrial robotics globally and are the prerequisite for CE marking of robot workcells in European markets under the EU Machinery Directive.

    Overview

    • ISO 10218 is the principal international safety standard governing industrial robot installations and is recognised across Europe, North America, and Asia-Pacific markets.
    • Its two-part structure separates responsibilities: robot manufacturers (Part 1) and system integrators (Part 2) each carry distinct obligations.
    • The standard is normatively harmonised with the EU Machinery Directive 2006/42/EC, making compliance a precondition for CE Marking of robot workcells sold in the European Economic Area.
    • In North America, the equivalent national standard ANSI RIA R15.06 adopts ISO 10218 by reference, meaning the technical requirements are aligned globally.
    • The standard is maintained by ISO Technical Committee TC 299 (Robotics), which also oversees ISO TS 15066 and the broader ISO 10218 revision programme.
    • ISO 10218 underwent a significant revision cycle leading to the 2011 editions of both parts; a further revision (aligned with the new ISO 10218:2025 drafts) has been in progress to incorporate collaborative robotics advances and newer Functional Safety architectures.
    • Compliance is demonstrated through documented Risk Assessment, validation testing, and a Declaration of Conformity prepared by the system integrator.

    Key Components

    ISO 10218-1 (Robot Manufacturer Requirements)

    • Applies to the Industrial Robot unit as a product placed on the market.
    • Requires the manufacturer to conduct a product-level Risk Assessment per ISO 12100.
    • Mandates safety-rated monitored stop (SRMS) functions accessible to the control system.
    • Requires speed and separation monitoring capability and configurable workspace limiting devices.
    • Specifies control-reliable safety stop circuits meeting categories defined in ISO 13849 (performance level PLd or PLe for critical functions).
    • Addresses mechanical hard stops, brake release procedures, and pendant design safety requirements.
    • Requires supply of a technical file and instructions for safe integration.

    ISO 10218-2 (System Integration Requirements)

    • Applies to the Robot Workcell as assembled and installed by a system integrator.
    • Requires a formal Risk Assessment covering the complete installation, including tooling, workpieces, and the human operator’s tasks.
    • Mandates selection of appropriate safeguarding devices: physical guards, Safety Light Curtain systems, Area Scanner devices, or presence-sensing mats.
    • Requires documentation of the Safety Control Architecture referencing ISO 13849 performance levels or IEC 62061 Safety Integrity Levels.
    • Covers collaborative operation modes when ISO TS 15066 is invoked: safety-rated monitored stop, hand guiding, speed and separation monitoring, and power and force limiting.
    • Requires validation testing, CE Marking documentation, and a Declaration of Conformity before handover to the end user.
    • Specifies requirements for interlocked perimeter guarding, emergency stop circuits, and enabling device (three-position switch) for teach-mode operation.

    Collaborative Operation Modes (via ISO TS 15066)

    • ISO 10218-2 defines the framework for collaborative robot operations; ISO TS 15066 provides the detailed biomechanical force and pressure limits.
    • Safety-Rated Monitored Stop: robot halts whenever a person enters the collaborative workspace; resumes only after the person exits.
    • Hand Guiding: operator directly guides the robot by hand at low speed; requires a hand-guiding device with enabling function.
    • Speed and Separation Monitoring: robot speed is reduced proportionally as the operator approaches, maintaining a minimum protective separation distance.
    • Power and Force Limiting (PFL): robot limits contact forces and pressures to ISO TS 15066 biomechanical thresholds, enabling physical contact without injury.
    • PFL mode is the basis for most Collaborative Robot (cobot) designs from manufacturers including Universal Robots, FANUC CR series, KUKA LBR iiwa, and ABB YuMi.

    Applications

    • Automotive manufacturing: robot workcells for welding, painting, and assembly lines in passenger car plants; compliance with ISO 10218-2 required by OEM supplier quality standards.
    • Electronics assembly: high-density workcells with Collaborative Robot units performing pick-and-place alongside human operators in consumer electronics factories.
    • Food and beverage: hygienic robot installations with washdown requirements; ISO 10218 provides the safety architecture baseline irrespective of sector-specific hygiene standards.
    • Medical device manufacturing: robot-assisted production cells in regulated GMP environments, where the Risk Assessment framework integrates with FDA and MDR quality system requirements.
    • Logistics and warehousing: autonomous mobile robot (AMR) systems operating alongside humans, where ISO 10218 principles inform the broader ISO 3691-4 standard for industrial trucks.
    • Research and education: laboratory robot installations in universities and R&D centres must comply with ISO 10218 wherever the robot is defined as industrial-grade equipment.
    • Aerospace component manufacturing: large-format robot cells for aircraft structural assembly, often requiring performance level PLe circuits given severity of potential harm.

    Standards and Context

    • ISO TC 299: the ISO technical committee responsible for all robotics standards, including ISO 10218, ISO TS 15066, ISO 8373 (vocabulary), and ISO 9283 (performance criteria).
    • ISO 12100: the overarching machinery risk assessment standard upon which ISO 10218-2’s risk assessment methodology is explicitly based.
    • ISO 13849: the machinery safety-related control system standard providing the performance level (PL a–e) framework referenced extensively in ISO 10218 safety control architecture requirements.
    • IEC 62061: the alternative functional safety standard (Safety Integrity Level-based) that may be used in place of or alongside ISO 13849 for safety control system design.
    • EU Machinery Directive 2006/42/EC: ISO 10218-1 and 10218-2 are harmonised standards under this Directive, meaning presumption of conformity is granted when they are followed.
    • EU Machinery Regulation (EU) 2023/1230: the successor to the Machinery Directive; ISO 10218 is expected to remain a harmonised standard under the new regulation when it becomes applicable.
    • ANSI/RIA R15.06: the North American industrial robot safety standard, which adopts ISO 10218-1 and 10218-2 in full as its normative technical content.
    • CSA Z434: the Canadian robot safety standard, similarly harmonised with ISO 10218.
    • IEC/TR 63316: a newer technical report linking collaborative robot standards to AI Safety considerations, representing the bridge from ISO 10218 into Autonomous Systems safety frameworks.
    • ROS 2 and MoveIt Safety: open-source robot middleware increasingly implements hardware abstraction layer constraints and safety stop interfaces inspired by ISO 10218 safety function requirements.

    Key Concepts in Scope

    • Safety Function: any function of a machine whose failure results in an increased risk.
    • Performance Level (PL a–e): the discrete level used to specify the ability of safety-related parts of control systems to perform safety functions under foreseeable conditions.
    • Safety-Rated Monitored Stop: a stop initiated by the safety system that allows re-start only after the hazardous condition is cleared.
    • Enabling Device: a three-position switch used during teach mode that permits robot motion only while deliberately held in the middle position.
    • Collaborative Workspace: the shared workspace where a robot and human operator can work simultaneously under ISO 10218-2 collaborative operation provisions.
    • Separation Distance: the minimum distance maintained between the robot and a human under speed and separation monitoring mode, calculated per ISO TS 15066 formulas.
    • Declaration of Conformity: the legal document produced by the system integrator certifying that the robot workcell meets the essential health and safety requirements of the applicable directives.

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