SIST 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
- Status
- Published
- Public Enquiry End Date
- 29-May-2024
- Publication Date
- 08-Apr-2025
- Technical Committee
- ITC - Information technology
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 25-Mar-2025
- Due Date
- 30-May-2025
- Completion Date
- 09-Apr-2025
Relations
- Effective Date
- 01-May-2025
Overview
SIST 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.
Frequently Asked Questions
SIST EN ISO 10218-2:2025 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST 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.
SIST EN ISO 10218-2:2025 has the following relationships with other standards: It is inter standard links to SIST EN ISO 10218-2:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST 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 SIST 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 SIST standards.
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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
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Email: copyright@iso.org
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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
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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 .
...
SIST EN ISO 10218-2:2025 표준 문서는 산업 로봇 애플리케이션과 로봇 셀의 통합을 위한 요구사항을 명확하게 규정하고 있습니다. 이 표준은 로봇 시스템의 설계, 통합, 커미셔닝, 운영, 유지보수, 그리고 폐기 등에 대한 포괄적인 지침을 제공하며, 이는 산업 환경에서 로봇 기술의 안전한 적용을 보장하는 데 필수적인 요소입니다. 표준의 강점은 다양한 분야에서의 실제 적용 가능성을 보장하는 데 있습니다. 예를 들어, 로봇 시스템이 통합되는 기계 및 구성 요소와의 연계를 포함하여, 로봇이 의도된 대로 사용될 때 발생할 수 있는 주요 위험 요소를 처리하게 됩니다. 또한, 비의도적인 사용으로 인한 특정 위험을 합리적으로 예측하여 관리할 수 있는 기준을 제시합니다. 이는 로봇 통합업체가 안전한 작업 환경을 구축하고 위험 요소를 최소화하는 데 크게 기여합니다. 그러나, 이 문서는 특정 용도와 응용 분야에는 적용되지 않는다는 점을 명확히 하여, 예를 들어 수중, 군사, 의료, 서비스 로봇 및 소비자 제품과 같은 영역은 포함되지 않습니다. 이는 로봇 기술의 안전성을 높이기 위해 특정 분야의 필요성과 요구 사항을 반영하고 있다는 점에서 특히 중요합니다. 결론적으로 SIST EN ISO 10218-2:2025 표준은 산업 로봇 애플리케이션과 로봇 셀의 안전한 통합을 위한 강력한 틀을 제공하며, 로봇 기술의 발전과 함께 지속적인 안전성을 확보하는 데 필수적입니다. 이 표준은 산업계에서 로봇의 안전한 사용이 점점 중요해짐에 따라 그 관련성과 중요성이 더욱 부각되고 있습니다.
Die Norm SIST EN ISO 10218-2:2025 bietet eine umfassende Grundlage für die Sicherheit von industriellen Robotikanwendungen und Robotzellen. Ihr Anwendungsbereich umfasst die wesentlichen Anforderungen für das Design, die Integration, die Inbetriebnahme, den Betrieb, die Wartung, die Stilllegung und die Entsorgung von Industrierobotern. Dies zeigt die Breite der Themen, die in der Norm behandelt werden, was sie zu einem entscheidenden Dokument für Ingenieure und Integratoren macht. Ein herausragendes Merkmal dieser Norm ist der Fokus auf die Integration von Maschinen und Komponenten, wodurch eine ganzheitliche Herangehensweise an die Sicherheitsanforderungen in der Robotik gewährleistet wird. Die Norm adressiert signifikante Gefahren und gefährliche Situationen, die beim Einsatz von Robotern unter den vorgesehenen Bedingungen auftreten könnten. Dies trägt dazu bei, ein hohes Sicherheitsniveau in industriellen Umgebungen zu fördern. Ein weiterer Stärke der Norm ist ihre Klarheit in Bezug auf die nicht abgedeckten Anwendungen von Industrierobotern – von Unterwasseranwendungen bis hin zu militärischen Einsätzen. Diese spezifische Ausschlussdefinition ermöglicht es den Anwendern, die Norm gezielt für relevante Anwendungen zu verwenden und Missverständnisse über deren Reichweite zu vermeiden. Die normativen Anforderungen an Informationen zur Nutzung sind ebenfalls essentiell, da sie sicherstellen, dass alle Beteiligten, von Designern bis zu Betreibern, über die notwendigen Informationen verfügen, um die Robotikanwendungen sicher zu implementieren und zu betreiben. Diese Unterstützung fördert nicht nur die Sicherheit, sondern auch die Effizienz in der Industrie. Die SIST EN ISO 10218-2:2025 nimmt die potenziellen Gefahren ernst, die durch den Einsatz industrieller Roboter entstehen könnten, und ist damit besonders relevant für Unternehmen, die Technologien in anspruchsvollen Umgebungen integrieren möchten. Die Tatsache, dass sie sich auf wesentlich vorhersehbare Fehlbedienungen konzentriert, zeigt ein realistisches Verständnis der praktischen Herausforderungen in der Industrie. Insgesamt unterstreicht diese Norm die Bedeutung von Sicherheitsstandards in der Robotik und bietet eine wertvolle Ressource für die Entwicklung sicherer industrieller Robotikanwendungen und Robotzellen. Ihr klar definierter Anwendungsbereich und die Berücksichtigung relevanter Sicherheitsaspekte machen sie zu einer wichtigen Leitlinie für Praktiker in diesem sich schnell entwickelnden Bereich.
SIST EN ISO 10218-2:2025は、産業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件を詳細に規定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、廃棄に関連する包括的なガイドラインを提供しており、産業ロボットの安全な利用を促進します。特に、ロボットセルの統合において考慮すべき機械やコンポーネントの統合に関する要求が明確に記載されています。 この標準の強みは、産業ロボットアプリケーションにおける安全要求を網羅的に扱っている点にあります。特定の適用条件や設計基準に基づいて、統合時に予測可能な有害な状況やイベントについての詳細な情報を提供しており、リスク管理を支援します。また、医療や宇宙関連の用途、さらにはサービスロボットに関しては適用外となるため、より特化した分野における誤解を避ける助けにもなっています。 さらに、この文書は、産業ロボットのユーザーにとっての使いやすさに配慮した情報を提供し、運用における安全性を確保しています。ただし、空気中の騒音放出や過酷な環境条件に関するリスクは、文書の範囲外として明記されており、それによりユーザーは特定の条件下での利用に関する十分な注意を払う必要があります。 SIST EN ISO 10218-2:2025は、産業分野におけるロボットの安全性を確保するための不可欠なスタンダードであり、効果的な産業ロボットの導入と運用を支える基盤となるでしょう。そのため、エンジニアや設計者はこの文書を参照し、適切な安全基準に従ったロボットの利用を促進することが求められます。
La norme SIST EN ISO 10218-2:2025 présente une approche exhaustive des exigences de sécurité pour les applications robotiques industrielles et les cellules de robots. Son champ d'application est clairement défini, se concentrant sur l'intégration, la conception, la mise en service, l'exploitation, l'entretien, le déclassement et l'élimination des équipements robotiques industriels. Ce document est particulièrement pertinent dans le contexte actuel où l'automatisation joue un rôle croissant dans l'industrie. Une des forces majeures de cette norme réside dans sa capacité à traiter les exigences fondamentales tout en identifiant les situations dangereuses qui peuvent survenir dans des conditions d'utilisation normales et dans des cas de mauvaise utilisation raisonnablement prévisibles par l'intégrateur. En se concentrant sur les applications robotiques industrielles, elle offre des lignes directrices claires qui facilitent la conformité avec les normes de sécurité, minimisant ainsi les risques potentiels associés à l'utilisation de robots dans des environnements d'exploitation. Cependant, il est essentiel de noter que la norme ne s'applique pas à certaines utilisations spécifiques d'robots industriels tels que les applications sous-marines, militaires, médicales, et celles impliquant des robots de service. Cela permet de garantir que le document se concentre sur les scénarios où les exigences de sécurité peuvent être mises en œuvre de manière efficace. La clarté de ces exclusions renforce la pertinence de la norme pour l'industrie en limitant les ambiguïtés concernant son domaine d'application. En outre, cette norme aborde également des éléments comme l'intégration de machines et de composants, fournissant des informations précieuses pour assurer une conception et une intégration sûres. Bien que des aspects tels que l'émission de bruit aérien et l'utilisation dans des environnements extrêmes ne soient pas couverts, la norme reste un outil essentiel pour la maîtrise des dangers majeurs associés aux applications robotiques industrielles. Dans l'ensemble, la SIST EN ISO 10218-2:2025 se présente comme une norme robuste et pertinente qui répond aux besoins croissants de sécurité dans le secteur de la robotique industrielle, tout en offrant un cadre pratique et clair pour les intégrateurs et les opérateurs.
The SIST EN ISO 10218-2:2025 standard offers a comprehensive framework for ensuring safety in industrial robot applications and robot cells. Its scope meticulously outlines requirements spanning the entire lifecycle of industrial robots, including design, integration, commissioning, operation, maintenance, decommissioning, and disposal. This holistic approach is a critical strength, as it caters to the various phases of an industrial robot's life, ensuring that safety is considered at each stage. One of the notable strengths of this standard is its emphasis on the integration of machines and components, which is paramount for creating a safe working environment in manufacturing settings. By addressing the information needed for users during all stages of the robot's lifecycle, the standard promotes transparency and clarity regarding safety requirements, which is essential for effective management and operational excellence in industrial environments. Moreover, SIST EN ISO 10218-2:2025 is highly relevant as it tackles significant hazards, hazardous situations, and hazardous events that could arise when industrial robots are used as intended. It provides essential guidelines that help integrators foresee and mitigate potential risks associated with industrial robot applications. However, it does outline specific exclusions, not applicable to certain uses such as underwater operations, military applications, and healthcare, which helps narrow the focus on relevant industrial contexts while acknowledging that additional standards may be required for those excluded areas. The standard clearly specifies that it does not cover hazards related to extreme environmental conditions, emissions of airborne noise, or handling materials that might pose elevated risks. This clarity helps businesses prioritize their safety measures effectively while also guiding them around aspects of integration that fall outside the scope of this document. In summary, the SIST EN ISO 10218-2:2025 standard stands out for its thorough consideration of industrial robot safety requirements, its applicability to various operational contexts, and its proactive approach to hazard identification and risk management. This makes it an invaluable resource for industries utilizing robotic technology in their operations.










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