EN ISO 10218-2:2025
(Main)Robotics - Safety requirements - Part 2: Industrial robot applications and robot cells (ISO 10218-2:2025)
Robotics - Safety requirements - Part 2: Industrial robot applications and robot cells (ISO 10218-2:2025)
This document specifies requirements for the integration of industrial robot applications and industrial robot cells. The following are addressed:
— the design, integration, commissioning, operation, maintenance, decommissioning and disposal;
— integration of machines and components;
— information for use for the design, integration, commissioning, operation, maintenance, decommissioning and disposal.
This document is not applicable to the following uses and applications of industrial robots:
— underwater;
— law enforcement;
— military (defence);
— airborne and space, including outer space;
— medical;
— healthcare of a person;
— prosthetics and other aids for the physically impaired;
— service robots, which provide a service to a person and as such the public can have access;
— consumer products, as this is household use to which the public can have access;
— lifting or transporting people;
— multi-purpose lifting devices or machinery, e.g. cranes, forklift trucks.
NOTE Applications for the automation of laboratories are not considered as medical or healthcare of a person.
This document deals with the significant hazards, hazardous situations or hazardous events when used as intended and under specified conditions of misuse which are reasonably foreseeable by the integrator.
This document provides basic requirements for industrial robot applications, but does not cover the hazards related to the following:
— emission of airborne noise;
— severe conditions (e.g. extreme climates, freezer use, strong magnetic fields) outside of manufacturer’s specifications;
— underground use;
— use that has hygienic requirements;
— processing of any material (e.g. food, cosmetics, pharmaceutical, metal);
— use in nuclear environments;
— use in potentially explosive environments;
— mobility when robots or manipulators are integrated with driverless industrial trucks;
— mobility when robots or manipulators are integrated with mobile platforms;
— use in environments with hazardous ionizing and non-ionizing radiation levels;
— hazardous ionizing and non-ionizing radiation;
— handling loads the nature of which could lead to dangerous situations (e.g. molten metals, acids/bases, radiating materials);
— when the public or non-working adults have access.
Emission of acoustic noise could be identified to be a significant hazard, but emission of noise is not covered in this document.
Robotik - Sicherheitsanforderungen für Robotersysteme in industrieller Umgebung - Teil 2: Robotersysteme, Roboteranwendungen und Integration von Roboterzellen (ISO 10218-2:2025)
Dieses Dokument legt Anforderungen für die Integration von Industrieroboteranwendungen und Industrieroboterzellen fest. Folgende Themen werden behandelt:
- die Gestaltung, die Integration, die Abnahme, der Betrieb, die Instandhaltung, das Außerbetriebnehmen und die Entsorgung;
- Integration von Maschinen und Komponenten;
- Benutzerinformationen für die Gestaltung, die Integration, die Abnahme, den Betrieb, die Instandhaltung, das Außerbetriebnehmen und die Entsorgung.
Dieses Dokument gilt nicht für die folgenden Verwendungen und Anwendungen von Industrierobotern:
- Unterwasser;
- Strafverfolgung;
- Militär (Verteidigung);
- Luft- und Raumfahrt, einschließlich Weltraum;
- Medizin;
- persönliche Gesundheitsversorgung;
- Prothesen und sonstige Hilfsmittel für Körperbehinderte;
- Serviceroboter, deren Dienste von Personen beansprucht werden und daher öffentlich zugänglich sind;
- Konsumprodukte für die Verwendung im Haushalt, da diese öffentlich zugänglich sind;
- Anheben oder Transport von Personen;
- multifunktionale Hebeeinrichtungen oder maschinen, z. B. Krane, Gabelstapler;
- mobile Plattformen;
- fahrerlose Flurförderzeuge;
- telebetriebene Manipulatoren.
ANMERKUNG Anwendungen zur Automatisierung von Laboren gelten nicht als medizinisch oder persönliche Gesundheitsversorgung.
Dieses Dokument behandelt die signifikanten Gefährdungen, Gefährdungssituationen oder Gefährdungsereignisse von Maschinen, wenn sie bestimmungsgemäß und unter bestimmten Bedingungen von durch den Integrator vernünftigerweise vorhersehbaren Fehlanwendungen verwendet werden. Dieses Dokument liefert auch grundlegende Anforderungen an Industrieroboteranwendungen, wobei jedoch nicht die Gefährdungen in Zusammenhang mit Folgenden abgedeckt werden:
- Luftschallemission;
- Untertagenutzung;
- Hygieneanforderungen;
- Verarbeitung jeglicher Materialien (z. B. Nahrungsmittel, Kosmetik, Arzneimittel, Metall);
- kerntechnische Umgebungen;
- explosionsgefährdete Umgebungen;
- Verwendung von Roboteranwendungen in Umgebungen mit gefährlicher ionisierender und nichtionisierender Strahlungsbelastung;
- gefährliche ionisierende und nichtionisierende Strahlung;
- Handhabung von Lasten, deren Eigenschaften zu gefährlichen Situationen führen könnten (z. B. geschmolzene Metalle, Säuren/Basen, strahlende Materialien);
- wenn die Öffentlichkeit oder nicht arbeitende Erwachsene Zugang haben.
Geräuschemissionen könnten als eine signifikante Gefährdung angegeben werden, aber Geräuschemissionen werden in diesem Dokument nicht behandelt.
WICHTIG — Die elektronische Datei dieses Dokuments ist in Farbe, was für das korrekte Verständnis dieses Dokuments als nützlich erachtet wird. Anwender sollten daher beim Druck dieses Dokuments einen Farbdrucker in Betracht ziehen.
Robotique - Exigences de sécurité - Partie 2: Applications robotisées industrielles et cellules robotisées (ISO 10218-2:2025)
Le présent document spécifie les exigences applicables à l'intégration des applications robotisées industrielles et des cellules robotisées industrielles. Il traite des aspects suivants:
— conception, intégration, mise en service, fonctionnement, maintenance, mise hors service et élimination;
— intégration de machines et de composants;
— informations pour l'utilisation relatives à la conception, à l'intégration, à la mise en service, au fonctionnement, à la maintenance, à la mise hors service et à l'élimination.
Le présent document ne s'applique pas aux utilisations et aux applications suivantes des robots industriels:
— sous-marines;
— maintien de l’ordre ;
— militaires (défense);
— aériennes et spatiales, y compris l'espace intersidéral;
— médicales;
— santé d'une personne;
— prothèses et autres aides pour personnes physiquement déficientes;
— robots de service, qui fournissent un service à une personne et auxquels, en tant que tels, le public peut avoir accès;
— produits de consommation, car il s'agit d'une utilisation domestique à laquelle le public peut avoir accès;
— levage ou transport de personnes;
— dispositifs ou machines de levage multi-applications, par exemple grues, chariots élévateurs.
NOTE Les applications pour l'automatisation de laboratoires ne sont pas considérées comme relevant du domaine médical ou de la santé d'une personne.
Le présent document traite des phénomènes dangereux, situations dangereuses et événements dangereux significatifs lorsqu'ils sont utilisés normalement et dans des conditions spécifiées de mauvais usage raisonnablement prévisibles par l'intégrateur.
Le présent document fournit des exigences de base pour les applications robotisées industrielles, mais ne couvre pas les phénomènes dangereux relatifs:
— à l'émission de bruit aérien;
— aux conditions difficiles (par exemple, conditions climatiques extrêmes, utilisation de congélateur, champs magnétiques importants) en dehors des spécifications du fabricant;
— à une utilisation souterraine;
— à l’utilisation avec des exigences hygiéniques;
— au traitement d'une matière (par exemple alimentaire, cosmétique, pharmaceutique, métallique);
— à l’utilisation dans des environnements nucléaires;
— à l’utilisation dans des environnements potentiellement explosifs;
— à la mobilité lorsque des robots ou manipulateurs sont intégrés à des chariots industriels sans conducteur ou en font partie;
— à la mobilité lorsque des robots ou manipulateurs sont intégrés à des plateformes mobiles;
— à l’utilisation dans des environnements comprenant des niveaux de rayonnements ionisants et non ionisants dangereux;
— à des rayonnements ionisants et non ionisants dangereux;
— à la manutention de charges dont la nature peut conduire à des situations dangereuses (par exemple métaux en fusion, acides/bases, matériaux rayonnants);
— lorsque le public ou des adultes ne faisant pas partie du personnel disposent d'un accès.
L'émission de bruit aérien peut être identifiée comme un phénomène dangereux significatif, mais l'émission de bruit n'est pas couverte dans le présent document.
Robotika - Varnostne zahteve - 2. del: Uporaba industrijskih robotov in robotskih celic (ISO 10218-2:2025)
Ta dokument določa zahteve za integracijo industrijskih robotov in industrijskih robotskih celic. Obravnavano je naslednje: – načrtovanje, integracija, začetek uporabe, delovanje, vzdrževanje, izločitev iz uporabe in odlaganje; – integracija strojev in njihovih komponent; – informacije za uporabo pri načrtovanju, integraciji, začetku uporabe, delovanju, vzdrževanju, izločitvi iz uporabe in odlaganju. Ta dokument se ne uporablja za naslednje vrste uporabe industrijskih robotov: – uporaba pod vodo; – organi pregona; – vojska (obramba); – letalska in vesoljska uporaba, vključno z uporabo v vesolju; – medicinska uporaba; – zdravstvena oskrba oseb; – proteze in drugi pripomočki za osebe s telesno okvaro; – storitveni roboti, ki zagotavljajo storitve osebam in do katerih ima dostop javnost; – potrošniški izdelki, saj gre za gospodinjsko uporabo, do katere ima dostop javnost; – dvigovanje ali prevoz ljudi; – večnamenske dvižne naprave ali stroji, npr. žerjavi, viličarji. OPOMBA: Uporaba za avtomatizacijo laboratorijev se ne šteje za medicinsko uporabo ali zdravstveno oskrbo osebe. Ta dokument obravnava večja tveganja, nevarne situacije ali nevarne dogodke v okoliščinah predvidene uporabe in pod pogoji nepravilne uporabe, ki jih lahko oseba, ki izvaja integracijo, upravičeno predvidi. Ta dokument določa osnovne zahteve za uporabo industrijskih robotov, vendar ne zajema tveganj v zvezi z naslednjim: – emisije hrupa, ki se prenašajo po zraku; – zahtevni pogoji (npr. skrajne podnebne razmere, zmrzal, močna magnetna polja), ki niso v skladu s specifikacijami proizvajalca; – uporaba pod zemljo; – uporaba, pri kateri veljajo higienske zahteve; – obdelava materialov (npr. živilska, kozmetična, farmacevtska, kovinska industrija); – uporaba v jedrskih okoljih; – uporaba v potencialno eksplozivnih okoljih; – mobilnost, kadar so roboti ali manipulatorji integrirani z vozili brez voznika ali njihovim delom; – mobilnost, kadar so roboti ali manipulatorji integrirani z mobilnimi platformami ali njihovim delom; – uporaba v okoljih z ionizirajočim in neionizirajočim sevanjem; – nevarno ionizirajoče in neionizirajoče sevanje; – ravnanje s tovorom, ki lahko povzroči nevarne razmere (npr. taljena kovina, kisline/baze, sevajoči materiali); – primeri, v katerih ima dostop javnost ali nezaposlene odrasle osebe. Emisije akustičnega hrupa bi lahko predstavljale večje tveganje, vendar niso zajete v tem dokumentu.
General Information
Relations
Overview
EN ISO 10218-2:2025 - "Robotics - Safety requirements - Part 2: Industrial robot applications and robot cells (ISO 10218-2:2025)" specifies safety requirements for the integration of industrial robot applications and robot cells. It covers the lifecycle from design, integration and commissioning to operation, maintenance, decommissioning and disposal, and requires the provision of user information for these stages. The standard addresses significant hazards and foreseeable misuse relevant to integrators and system builders, while explicitly excluding certain applications and environments (e.g., underwater, medical, military, airborne/space, service/consumer robots, nuclear or explosive environments).
Key topics and technical requirements
- Risk assessment: Methods for identifying significant hazards, hazardous situations and hazardous events for intended use and reasonable misuse.
- Design and mechanical requirements: Materials, mechanical strength, stability, position holding and protective measures for moving parts.
- Control and safety systems: Requirements for control reliability, stopping functions (normal, operational, emergency), selection of operating modes and failure-management measures.
- Integration of machines and components: Safety considerations when combining robots with tools, end-effectors, conveyors or other machinery in robot cells.
- Information for use: Mandatory instructions, warnings, markings and documentation for integrators, operators and maintenance personnel.
- Commissioning, maintenance and decommissioning: Safe procedures, access, isolation of energy sources and operator interventions.
- Scope exclusions and limits: Lists environments, uses and hazard types not covered (e.g., emission of airborne noise, extreme climates, hazardous radiation, handling molten metals, public access scenarios).
Practical applications
This standard is intended to be applied when integrating or commissioning industrial robot systems and robot cells used in manufacturing and automation tasks such as material handling, machine tending, welding, painting and assembly - where hazards arise from robot movements, tooling and cell layout. It helps ensure safe cell design, selection of protective devices and compliant control strategies.
Who should use this standard
- System integrators and robot integrators - for safe cell design and commissioning
- Machine builders and OEMs - when combining robots with other machines or modules
- Safety engineers and risk assessors - to perform compliant risk assessments and select safeguards
- Maintenance and operations teams - to follow safe procedures and documentation requirements
- Compliance officers and notified bodies - for conformity assessment and alignment with EU Machinery Directive requirements (see Annex ZA)
Related standards
- ISO 10218-1 (robot safety requirements for robot manufacturers) - complements Part 2 by addressing manufacturer-level robot design.
- Relevant machinery and functional safety standards used in conjunction for full compliance.
Keywords: ISO 10218-2:2025, robotics safety, industrial robot applications, robot cells, robot cell integration, risk assessment, robot safety requirements.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2025
Nadomešča:
SIST EN ISO 10218-2:2011
Robotika - Varnostne zahteve - 2. del: Uporaba industrijskih robotov in robotskih
celic (ISO 10218-2:2025)
Robotics - Safety requirements - Part 2: Industrial robot applications and robot cells (ISO
10218-2:2025)
Robotik - Sicherheitsanforderungen für Robotersysteme in industrieller Umgebung - Teil
2: Robotersysteme, Roboteranwendungen und Integration von Roboterzellen (ISO
10218-2:2025)
Robotique - Exigences de sécurité - Partie 2: Applications robotisées industrielles et
cellules robotisées (ISO 10218-2:2025)
Ta slovenski standard je istoveten z: EN ISO 10218-2:2025
ICS:
25.040.30 Industrijski roboti. Industrial robots.
Manipulatorji Manipulators
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10218-2
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2025
EUROPÄISCHE NORM
ICS 25.040.30 Supersedes EN ISO 10218-2:2011
English Version
Robotics - Safety requirements - Part 2: Industrial robot
applications and robot cells (ISO 10218-2:2025)
Robotique - Exigences de sécurité - Partie 2: Robotik - Sicherheitsanforderungen für
Applications robotisées industrielles et cellules Robotersysteme in industrieller Umgebung - Teil 2:
robotisées (ISO 10218-2:2025) Robotersysteme, Roboteranwendungen und
Integration von Roboterzellen (ISO 10218-2:2025)
This European Standard was approved by CEN on 3 January 2025.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10218-2:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive2006/42/EC aimed to be covered . 4
European foreword
This document (EN ISO 10218-2:2025) has been prepared by Technical Committee ISO/TC 299
"Robotics" in collaboration with Technical Committee CEN/TC 310 “Advanced automation technologies
and their applications” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2025, and conflicting national standards
shall be withdrawn at the latest by March 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10218-2:2011.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10218-2:2025 has been approved by CEN as EN ISO 10218-2:2025 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive2006/42/EC aimed to be covered
This European Standard has been prepared under a Commission’s standardization request “M/396
Mandate to CEN and CENELEC for Standardisation in the field of machinery" to provide one voluntary
means of conforming to essential requirements of Directive 2006/42/EC of the European Parliament
and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast).
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
2006/42/EC
The relevant Essential Requirements of Directive
Clause(s)/sub-clause(s) of this EN
2006/42/EC
1.1.2 (a) 5, 6, 7
1.1.2 (c) 5, 6, 7
1.1.2 (d) 5.2.2
1.1.2 (e) 5.2.7
1.1.3. Materials and products 5.2.2.2
1.1.4. Lighting 5.15.2, 5.15.4
1.1.5. Design of machinery to facilitate its handling 5.2.2, 5.2.3
5.4.1, 5.4.3, 5.4.4, 5.8.6.1, 5.12.2.1,
1.1.6. Ergonomics
5.14.4.2
1.2.1. Safety and reliability of control systems 5.2.8, 5.3, 5.4.7, 5.5, 5.6.1, 5.7, 5.9
1.2.2. Control devices 5.2.13, 5.7, 5.12.2.3, 5.14.4.1
1.2.3. Starting 5.5.7, 5.7.5
1.2.4.1. Normal stop 5.6.1, 5.6.4
1.2.4.2. Operational stop 5.5.8, 5.6.3
1.2.4.3. Emergency stop 5.6.2
1.2.4.4. Assembly of machinery 5.3
1.2.5. Selection of control or operating modes 5.7.2, 5.7.6.2
1.2.6. Failure of the power supply 5.2.10, 5.5.2, 5.6.1, 5.5.7.1, 5.9.1
1.3.1. Risk of loss of stability 5.2.5, 7.5.5
The relevant Essential Requirements of Directive
Clause(s)/sub-clause(s) of this EN
2006/42/EC
1.3.2. Risk of break-up during operation 5.2.2, 5.2.11, 5.2.13, 5.3.6, 7.5.9
1.3.3. Risks due to falling or ejected objects 5.9.1
1.3.4. Risks due to surfaces, edges or angles 5.2.2.4, 5.4.4, 5.9, 5.14.1
1.3.6. Risks related to variations in operating conditions 5.7.2
1.3.7. Risks related to moving parts 5.2.7, 5.8, 5.9, 5.10, 5.12, 5.14, 7.5.7
1.3.8. Choice of protection against risks arising from
5.2.2.4, 5.8, 5.9, 5.10.3, 5.12, 5.14
moving parts
1.3.8.1. Moving transmission parts 5.2.2.4
1.3.8.2. Moving parts involved in the process 5.2.2.4, 5.8, 5.9, 5.10, 5.12, 5.14
1.3.9. Risks of uncontrolled movements 5.2.8, 5.2.12.1
1.4.1. General requirements 5.2.2, 5.8.5, 5.8.6, 5.8.9
1.4.2.1. Fixed guards 5.8.5.1
1.4.2.2. Interlocking movable guards 5.8.5
1.4.2.3. Adjustable guards restricting access 5.8.5.1
1.4.3. Special requirements for protective devices 5.8.6, 5.8.9
1.5.1. Electricity supply 5.2.13
1.5.2 Static electricity 5.2.13
1.5.3. Energy supply other than electricity 5.2.13
1.5.4. Errors of fitting 5.2.2.4, 5.2.13, 7.5.9
1.5.5. Extreme temperature 5.2.6
1.5.6. Fire 5.2.6
1.5.8 Noise Not covered
1.5.9 Vibrations 5.14.4.1 7.5.19
1.5.12. Laser radiation 5.11
1.5.13. Emissions of hazardous materials and substances 5.2.4
1.5.14. Risk of being trapped in a machine 5.4.5, 5.8, 5.12.2.2, 5.14.1
1.5.15. Risk of slipping, tripping or falling 5.4.1, 5.7.8.3, 5.10.1,
1.6.1. Machinery maintenance 5.4.1, 5.7.8.1, 5.8.9.1, 5.16, 7.5.9
1.6.2. Access to operating positions and servicing points 5.4.1
1.6.3. Isolation of energy sources 5.2.13, 5.2.12
1.6.4. Operator intervention 5.4.1, 5.4.3
1.7.1. Information and warnings on the machinery 7.1, 7.2, 7.3, 7.4
1.7.1.1. Information and information devices 7.1, 7.2, 7.3, 7.4
1.7.1.2. Warning devices 5.7.2.5, 5.7.4, 7.2
The relevant Essential Requirements of Directive
Clause(s)/sub-clause(s) of this EN
2006/42/EC
1.7.2. Warning of residual risks 7.5.3, 7.5.17, 7.5.21
1.7.3. Marking of machinery 7.3
1.7.4. Instructions 7
1.7.4.1. General principles for the drafting of instructions 7.1, 7.5.3
1.7.4.2. Contents of the instructions 7.5
2.2.1. General 5.14.4
2.2.1.1. Instructions 7.5.19
2.3. Machinery for working wood and material with similar
5.8.1, 5.9.1, 5.9.4, 5.12.2.1
physical characteristics
4.1.2.2. Machinery running on guide rails and rail tracks 5.2.5
4.1.2.3. Mechanical strength 5.2.2
4.1.2.4. Pulleys, drums, wheels, ropes and chains 5.2.2.3
4.1.2.6. Control of movements 5.2.8, 5.4.7, 5.9.1
4.1.2.7. Movements of loads during handling 5.2.8, 5.7.8.2, 5.8, 5.14.4.2
4.1.2.8.1. Movements of the carrier 5.8, 5.10
4.1.3. Fitness for purpose 5.2.2.3
4.2.1 Control of movements 5.10.4
4.2.3 Installations guided by ropes 5.10.1
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
International
Standard
ISO 10218-2
Second edition
Robotics — Safety requirements —
2025-02
Part 2:
Industrial robot applications and
robot cells
Robotique — Exigences de sécurité —
Partie 2: Applications robotisées industrielles et cellules
robotisées
Reference number
ISO 10218-2:2025(en) © ISO 2025
ISO 10218-2:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 10218-2:2025(en)
Contents Page
Foreword .vii
Introduction .viii
1 Scope . 1
2 Normative references . 2
3 Terms, definitions, symbols and abbreviated terms . 4
3.1 Terms and definitions .4
3.1.1 Robot, robot system, robot application, robot cell - related .4
3.1.2 Sub-assemblies and components .5
3.1.3 Controls-related .6
3.1.4 Program-related .8
3.1.5 Power-, energy-related . .8
3.1.6 Hazard-related .8
3.1.7 Role-related .9
3.1.8 Functional safety-related .9
3.1.9 Spaces, zones and distances .10
3.1.10 Risk reduction measures . 12
3.1.11 Verification and validation . 13
3.1.12 Contact-related.14
3.2 Abbreviated terms and symbols.14
4 Risk assessment . 19
4.1 General .19
4.2 Characteristics of robot applications and robot cells .19
4.3 Characteristics of collaborative applications . 20
4.3.1 General . 20
4.3.2 Risk assessment for contacts between moving parts of the robot application
and operator(s) .21
5 Safety requirements and risk reduction measures .22
5.1 General . 22
5.2 Design . 22
5.2.1 General . 22
5.2.2 Materials, mechanical strength and mechanical design . 23
5.2.3 Provisions for lifting or moving .24
5.2.4 Hazardous substances . .24
5.2.5 Stability .24
5.2.6 Temperature and fire risks . 25
5.2.7 Special equipment . 25
5.2.8 Position holding . 25
5.2.9 Additional axis (axes) . 25
5.2.10 Power loss or change . 26
5.2.11 Component malfunction . 26
5.2.12 Hazardous energy . 26
5.2.13 Electrical, pneumatic and hydraulic parts .27
5.2.14 Tool centre point (TCP) setting . 28
5.2.15 Payload setting . . 28
5.2.16 Cybersecurity . 28
5.3 Robot cell integration . 28
5.3.1 General . 28
5.3.2 Span-of-control . 29
5.3.3 Span-of-control of emergency stop function . 29
5.3.4 Operational modes with multi-robot applications or robot cells . 29
5.3.5 Local control, remote control and single-point-of-control . 29
5.3.6 Automatic workpiece feeding . 30
5.4 Layout . 30
iii
ISO 10218-2:2025(en)
5.4.1 General . 30
5.4.2 Use and limits .31
5.4.3 Design .31
5.4.4 Design for collaborative applications .32
5.4.5 Prevention of trapping within the safeguarded space .32
5.4.6 Establishing restricted spaces . 33
5.4.7 Limiting motion . 33
5.5 Safety functions . 34
5.5.1 General . 34
5.5.2 Functional safety standards . 35
5.5.3 Performance . 35
5.5.4 Failure or fault detection . 36
5.5.5 Parameterization of safety functions . 36
5.5.6 Speed limit(s) monitoring. 36
5.5.7 Start / restart interlock and reset .37
5.5.8 Monitored-standstill . 38
5.5.9 Communications . 38
5.5.10 Electromagnetic requirements . 39
5.6 Stopping . 39
5.6.1 General . 39
5.6.2 Emergency stop . 39
5.6.3 Protective stop . 40
5.6.4 Normal stop . 40
5.6.5 Associated equipment stopping .41
5.7 Control functions .41
5.7.1 General .41
5.7.2 Modes.41
5.7.3 Protection from unexpected start-up . 44
5.7.4 Status indication and warning devices . 44
5.7.5 Single-point-of-control . 44
5.7.6 Local and remote control .45
5.7.7 Enabling devices . 46
5.7.8 Control stations .47
5.7.9 Simultaneous motion . . . 49
5.8 Safeguards and their use . 49
5.8.1 General . 49
5.8.2 Establishing a safeguarded space . 50
5.8.3 Perimeter safeguarding . 50
5.8.4 Overriding of protective devices . 50
5.8.5 Guards . 50
5.8.6 Sensitive protective equipment .51
5.8.7 Muting . 53
5.8.8 Overriding of SPE . 53
5.8.9 Minimum distances . 53
5.8.10 Safeguarding to protect from unexpected restart . 54
5.9 End-effectors . 54
5.9.1 General . 54
5.9.2 Risk reduction measures . 55
5.9.3 Shape and surfaces . 56
5.9.4 Protective devices and/or safety functions . 56
5.9.5 End-effectors and robot application design .57
5.9.6 End-effectors exchange systems .57
5.10 Vertical transfer components . 58
5.10.1 Mechanical design . 58
5.10.2 Prevention of falling hazards . 58
5.10.3 Prevention of crushing hazards . 58
5.10.4 Control of movements .59
5.11 Lasers and laser equipment .59
5.12 Material handling, manual load/unload stations and material flow .59
iv
ISO 10218-2:2025(en)
5.12.1 Material handling .59
5.12.2 Manual load/unload stations and other manual stations.59
5.12.3 Material flow . 60
5.13 Adjacent robot cells .61
5.14 Collaborative applications .61
5.14.1 General .61
5.14.2 Safeguarded spaces.62
5.14.3 Transitions . 63
5.14.4 Hand-guided control (HGC) . 63
5.14.5 Speed and separation monitoring (SSM) . 64
5.14.6 Power and force limiting (PFL). 66
5.15 Assembly, installation and commissioning . 69
5.15.1 Commissioning of robot applications . 69
5.15.2 Environmental conditions .70
5.15.3 Power .70
5.15.4 Lighting .70
5.15.5 Labelling .70
5.16 Maintenance .71
5.16.1 General .71
5.16.2 Movement without drive power .71
6 Verification and validation .71
6.1 General .71
6.2 Verification and validation methods .71
6.3 Verification and validation of guards, protective devices, safety function parameter
settings and biomechanical threshold limits . 72
6.3.1 Guards and protective devices . 72
6.3.2 Safety function parameter settings . 72
6.3.3 Biomechanical limits . 72
6.4 Complementary protective measures . 72
7 Information for use .73
7.1 General . 73
7.2 Signals and warning devices . 73
7.3 Marking . 73
7.4 Signs (pictograms) and written warnings .74
7.5 Instruction handbook.74
7.5.1 General .74
7.5.2 Identification .74
7.5.3 Intended use .74
7.5.4 Transport, handling and lifting . 75
7.5.5 Installation . 75
7.5.6 Commissioning and programming . . 75
7.5.7 Abnormal and emergency situations .76
7.5.8 Settings and operation . 77
7.5.9 Maintenance . 77
7.5.10 Decommissioning . 78
7.5.11 Remote interventions. 78
7.5.12 Hazardous energy . 78
7.5.13 Limiting devices and restricted space . 78
7.5.14 Movement without drive power . 79
7.5.15 Control station(s) . 79
7.5.16 Functional safety . . . 79
7.5.17 Operating modes . 80
7.5.18 Enabling devices . 80
7.5.19 Vibration . 81
7.5.20 End-effector(s) . . 81
7.5.21 Manual load/ unload stations . 81
7.5.22 Collaborative applications . 81
7.5.23 Cybersecurity .
...
Frequently Asked Questions
EN ISO 10218-2:2025 is a standard published by the European Committee for Standardization (CEN). Its full title is "Robotics - Safety requirements - Part 2: Industrial robot applications and robot cells (ISO 10218-2:2025)". This standard covers: This document specifies requirements for the integration of industrial robot applications and industrial robot cells. The following are addressed: — the design, integration, commissioning, operation, maintenance, decommissioning and disposal; — integration of machines and components; — information for use for the design, integration, commissioning, operation, maintenance, decommissioning and disposal. This document is not applicable to the following uses and applications of industrial robots: — underwater; — law enforcement; — military (defence); — airborne and space, including outer space; — medical; — healthcare of a person; — prosthetics and other aids for the physically impaired; — service robots, which provide a service to a person and as such the public can have access; — consumer products, as this is household use to which the public can have access; — lifting or transporting people; — multi-purpose lifting devices or machinery, e.g. cranes, forklift trucks. NOTE Applications for the automation of laboratories are not considered as medical or healthcare of a person. This document deals with the significant hazards, hazardous situations or hazardous events when used as intended and under specified conditions of misuse which are reasonably foreseeable by the integrator. This document provides basic requirements for industrial robot applications, but does not cover the hazards related to the following: — emission of airborne noise; — severe conditions (e.g. extreme climates, freezer use, strong magnetic fields) outside of manufacturer’s specifications; — underground use; — use that has hygienic requirements; — processing of any material (e.g. food, cosmetics, pharmaceutical, metal); — use in nuclear environments; — use in potentially explosive environments; — mobility when robots or manipulators are integrated with driverless industrial trucks; — mobility when robots or manipulators are integrated with mobile platforms; — use in environments with hazardous ionizing and non-ionizing radiation levels; — hazardous ionizing and non-ionizing radiation; — handling loads the nature of which could lead to dangerous situations (e.g. molten metals, acids/bases, radiating materials); — when the public or non-working adults have access. Emission of acoustic noise could be identified to be a significant hazard, but emission of noise is not covered in this document.
This document specifies requirements for the integration of industrial robot applications and industrial robot cells. The following are addressed: — the design, integration, commissioning, operation, maintenance, decommissioning and disposal; — integration of machines and components; — information for use for the design, integration, commissioning, operation, maintenance, decommissioning and disposal. This document is not applicable to the following uses and applications of industrial robots: — underwater; — law enforcement; — military (defence); — airborne and space, including outer space; — medical; — healthcare of a person; — prosthetics and other aids for the physically impaired; — service robots, which provide a service to a person and as such the public can have access; — consumer products, as this is household use to which the public can have access; — lifting or transporting people; — multi-purpose lifting devices or machinery, e.g. cranes, forklift trucks. NOTE Applications for the automation of laboratories are not considered as medical or healthcare of a person. This document deals with the significant hazards, hazardous situations or hazardous events when used as intended and under specified conditions of misuse which are reasonably foreseeable by the integrator. This document provides basic requirements for industrial robot applications, but does not cover the hazards related to the following: — emission of airborne noise; — severe conditions (e.g. extreme climates, freezer use, strong magnetic fields) outside of manufacturer’s specifications; — underground use; — use that has hygienic requirements; — processing of any material (e.g. food, cosmetics, pharmaceutical, metal); — use in nuclear environments; — use in potentially explosive environments; — mobility when robots or manipulators are integrated with driverless industrial trucks; — mobility when robots or manipulators are integrated with mobile platforms; — use in environments with hazardous ionizing and non-ionizing radiation levels; — hazardous ionizing and non-ionizing radiation; — handling loads the nature of which could lead to dangerous situations (e.g. molten metals, acids/bases, radiating materials); — when the public or non-working adults have access. Emission of acoustic noise could be identified to be a significant hazard, but emission of noise is not covered in this document.
EN ISO 10218-2:2025 is classified under the following ICS (International Classification for Standards) categories: 25.040.30 - Industrial robots. Manipulators. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 10218-2:2025 has the following relationships with other standards: It is inter standard links to EN ISO 10218-2:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 10218-2:2025 is associated with the following European legislation: EU Directives/Regulations: 2006/42/EC; Standardization Mandates: M/396. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 10218-2:2025 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Der Standard EN ISO 10218-2:2025 legt umfassende Sicherheitsanforderungen für industrielle Roboteranwendungen und Roboterzellen fest. Sein Geltungsbereich erstreckt sich über die wesentlichen Aspekte der Integration, einschließlich Design, Inbetriebnahme, Betrieb, Wartung, Stilllegung und Entsorgung von industriellen Robotersystemen. Durch die klare Definition dieser zentralen Prozesse unterstützt der Standard Unternehmen dabei, sichere und effektive Roboteranwendungen zu gestalten. Ein wesentlicher Stärke des Dokuments ist die detaillierte Behandlung der Integration von Maschinen und Komponenten, was für die schlüsselfertige Bereitstellung von Automatisierungslösungen von entscheidender Bedeutung ist. Die Anforderungen für Informationen zur Nutzung in Bezug auf Design und Betrieb ermöglichen es den Integratoren, informierte Entscheidungen zu treffen und sicherzustellen, dass alle Sicherheitsaspekte berücksichtigt werden. Die präzisen Richtlinien helfen nicht nur bei der Minimierung von Risiken, sondern fördern auch die Einhaltung von Best Practices in der Robotik. Der Standard ist insbesondere relevant, da er sich auf signifikante Gefahren, gefährliche Situationen und Ereignisse konzentriert, die bei vorschriftsgemäßer Nutzung und vorhersehbaren Fehlanwendungen auftreten können. Dies liefert eine wertvolle Grundlage für die Risikobewertung und das Sicherheitsmanagement von Robotersystemen. Es ist wichtig zu beachten, dass der Standard nicht für alle Anwendungen von Industrierobotern anwendbar ist, beispielsweise nicht für den Einsatz im medizinischen Bereich, im Militär oder in gefährdeten Umgebungen. Dieser Ausschluss sorgt dafür, dass sich der Fokus klar auf industrielle Anwendungen konzentriert, wo die Risiken besser kontrolliert und gemanagt werden können. Zusammenfassend bietet die EN ISO 10218-2:2025 eine umfassende, praxisnahe Grundlage für die Gewährleistung der Sicherheit in industriellen Roboteranwendungen und stellt sicher, dass alle relevanten Aspekte der Integration und des Betriebs berücksichtigt werden.
Le document SIST EN ISO 10218-2:2025 définit des exigences essentielles pour l'intégration des applications de robots industriels et des cellules de robots industriels. Son champ d'application est à la fois vaste et ciblé, garantissant que les utilisateurs et les intégrateurs d'industries robotiques aient un cadre clair pour la conception, l'intégration, la mise en service, l'exploitation, la maintenance, le déclassement et l'élimination des systèmes robotiques. Parmi les points forts de cette norme, on note son approche exhaustive des dangers significatifs, des situations dangereuses et des événements dangereux qui peuvent survenir lors de l'utilisation prévue des robots industriels. Cette attention portée à la sécurité est cruciale, car elle permet de minimiser les risques potentiels lors de l'intégration de ces technologies avancées. De plus, le document met en avant l'importance de l'intégration efficace des machines et des composants, assurant ainsi une synergie optimale entre les différents éléments. La norme exclut également explicitement certaines applications, telles que l'utilisation sous-marine, les applications militaires, médicales et les robots de service, évitant ainsi toute ambiguïté concernant la portée de son application. Cela renforce sa pertinence pour les utilisateurs industriels, qui peuvent se concentrer sur les exigences spécifiques aux environnements de travail industriels. En matière de sécurité, le document aborde les situations de mauvaise utilisation qui pourraient être raisonnablement prévues par l'intégrateur, ce qui démontre son engagement en faveur de la sécurité des travailleurs. Toutefois, il est important de noter que la norme ne couvre pas certains risques comme l'émission de bruit aérien, les conditions extrêmes et certains environnement où des matériaux dangereux pourraient être manipulés, soulignant ainsi la nécessité pour les utilisateurs d'être conscients des limites de cette norme. En somme, le SIST EN ISO 10218-2:2025 se positionne comme un référentiel pertinent et essentiel pour les applications de robots industriels, offrant des lignes directrices claires et réfléchies qui favorisent non seulement la sécurité mais également l'efficacité opérationnelle dans les environnements de travail.
표준 문서 EN ISO 10218-2:2025는 산업 로봇 응용 프로그램과 로봇 셀의 통합에 대한 요구 사항을 규정하고 있습니다. 이 표준은 산업 로봇의 설계, 통합, 커미셔닝, 운영, 유지 관리, 폐기 및 처분에 관한 포괄적인 가이드라인을 제공합니다. 특히, 기계 및 구성 요소의 통합에 대한 요구 사항과 함께 사용을 위한 정보도 포함되어 있어, 로봇 시스템의 전체 라이프사이클에 걸친 안전을 강화합니다. 강점으로는, 이 표준이 산업 로봇 및 로봇 셀의 안전성을 위한 기초적인 요구 사항을 제공함과 동시에, 예측 가능한 오용 하의 위험 상황을 다룬다는 점입니다. 이를 통해 기업은 안전하고 효율적인 로봇 시스템을 구현할 수 있으며, 잠재적인 위험 요소를 사전에 인지하고 대처할 수 있는 기회를 가지게 됩니다. 그러나, EN ISO 10218-2:2025는 특정 산업 용도에 적용되지 않는 범위를 명확히 규정하고 있습니다. 예를 들어, 의료나 군사, 우주 및 항공 응용 프로그램과 같은 특수 환경에서의 로봇 사용에 대해서는 이 표준이 적용되지 않습니다. 이러한 제한은 표준이 일반 산업 환경 내에서의 안전성을 강화하는 데 집중했음을 시사합니다. 전반적으로 EN ISO 10218-2:2025는 산업 로봇 응용 프로그램의 안전 요건에 관한 중요한 가이드라인을 제시하며, 안전하고 효율적인 로봇 시스템의 구축에 필수적인 문서입니다. 이 표준의 적용을 통해 기업들은 로봇 통합 과정에서 발생할 수 있는 주요 위험 요소를 효과적으로 관리할 수 있습니다.
The EN ISO 10218-2:2025 standard provides a comprehensive framework for addressing safety requirements in industrial robot applications and robot cells. Its scope encompasses critical aspects such as the design, integration, commissioning, operation, maintenance, decommissioning, and disposal of these systems. This breadth ensures that stakeholders involved in these processes can rely on standardized guidelines that promote safety and efficiency. One of the primary strengths of this standard is its focus on the integration of machines and components, which is vital in ensuring that various robotic elements function cohesively within industrial environments. Additionally, the inclusion of detailed information regarding the use and maintenance of robots significantly aids users in understanding operational best practices, thus reducing risks associated with improper usage. Furthermore, the document effectively identifies areas where the standard may not apply, such as underwater operations, medical applications, or military uses. This delineation is crucial as it helps avoid misinterpretations that could lead to safety vulnerabilities in sectors that require specialized safety measures not encompassed by the standard. By clarifying that certain hazardous situations and environments fall outside its scope, it reinforces the importance of tailored safety protocols for those specific applications. The emphasis on addressing significant hazards, including scenarios of misuse that integrators may reasonably foresee, provides an added layer of safety assurance. By focusing on intended use and foreseeable misuse, the standard proactively manages risks associated with industrial robot applications. However, it is also important to note that the document does not encompass coverage for certain hazards like emission of airborne noise or severe environmental conditions outside the manufacturer's specifications. While acknowledging these exclusions, the standard still establishes fundamental requirements that contribute to the safe operation of industrial robot cells. Overall, the EN ISO 10218-2:2025 standard is highly relevant in today’s industrial landscape, where automation and robotics play an increasingly critical role. Its structured approach toward industrial robot applications not only enhances safety protocols but also fosters a culture of responsible integration and operation of robotic technologies.
EN ISO 10218-2:2025は、産業用ロボットアプリケーションおよびロボットセルの統合に関する要求事項を明確に定義した重要な標準です。この文書は、設計、統合、試運転、運用、保守、廃止、廃棄に関する詳細なガイドラインを提供し、機械やコンポーネントの統合に関する情報も含まれています。この標準の強みは、特定の条件下での使用や誤用時の危険を十分に考慮しており、統合者にとって予測可能なリスクを軽減するための基準を設けている点です。 特に、産業用ロボットの安全要件を扱っていることから、労働環境での安全性向上に寄与します。製造業において、ロボット技術の導入が進む中で、この文書は機械の設計から操作に至るまで、信頼性の高いプロセスを保証する役割を果たします。これにより、企業は産業用ロボットをより安全に活用でき、業務効率の向上が期待できます。 ただし、注意が必要なのは、この標準がカバーしない使用方法や適用範囲が明確に示されている点です。例えば、医療およびヘルスケア、軍事、航空宇宙用途などの特定のジャンルは、この文書の適用外となっています。これにより、特定の利用シーンにおける安全性への考慮がなされていることが強調されています。 さらに、産業用ロボットが直面する重大な危険や有害な状況についても対処しており、特に意図された使用方法を前提とした場合、会社や施設におけるリスク管理に役立つ情報が提供されています。これにより、企業は法令遵守を果たしつつ、効率よく技術を導入するための重要な基準として利用することができます。 総じて、EN ISO 10218-2:2025は、産業用ロボットアプリケーションとロボットセルに関連する安全基準を網羅し、産業界における健全な運用を支えるための不可欠な標準となっています。
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