Robots and robotic devices - Safety requirements for industrial robots - Part 2: Robot systems and integration (ISO 10218-2:2011)

ISO 10218-2:2011 specifies safety requirements for the integration of industrial robots and industrial robot systems as defined in ISO 10218-1, and industrial robot cell(s). The integration includes the following:
       the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell;
       necessary information for the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell;
       component devices of the industrial robot system or cell.
ISO 10218-2:2011 describes the basic hazards and hazardous situations identified with these systems, and provides requirements to eliminate or adequately reduce the risks associated with these hazards. ISO 10218-2:2011 also specifies requirements for the industrial robot system as part of an integrated manufacturing system. ISO 10218-2:2011 does not deal specifically with hazards associated with processes (e.g. laser radiation, ejected chips, welding smoke). Other standards can be applicable to these process hazards.

Roboter und Robotikgeräte - Sicherheitsanforderungen - Teil 2: Industrierobotersystem und Integration (ISO 10218-2:2011)

Dieser Teil der ISO 10218 legt Sicherheitsanforderungen für die Integration von Industrierobotern und
Industrierobotersystemen, wie in ISO 10218-1 festgelegt, sowie von Industrieroboterzellen fest. Die
Integration beinhaltet:
a) die Konstruktion, Herstellung, Einbau, Betrieb, Instandhaltung und Außerbetriebnahme des
Industrierobotersystems oder der -zelle;
b) erforderliche Informationen in Bezug auf a) oben;
c) Einzelgeräte des Industrierobotersystems oder -zelle
Er beschreibt die grundlegenden Gefährdungen und Gefährdungssituationen, die bei diesen Systemen
ermittelt wurden und sieht Anforderungen vor, um die mit diesen Gefährdungen verbundenen Risiken zu
beseitigen oder hinreichend zu verringern. Dieser Teil der ISO 10218 legt auch Anforderungen für das
Industrierobotersystem als Teil eines integrierten Fertigungssystems fest. Dieser Teil der ISO 10218 geht
nicht gezielt auf Gefährdungen in Verbindung mit Verfahren ein (z. B. Laserstrahlung, herausgeschleuderte
Späne, Schweißrauch) Für diese verfahrensbezogene Gefährdungen können andere Normen angewendet
werden.

Robots et dispositifs robotiques - Exigences de sécurité pour les robots industriels - Partie 2: Systèmes robots et intégration (ISO 10218-2:2011)

L'ISO 10218-2:2011 spécifie les exigences de sécurité pour l'intégration des robots industriels et des systèmes robots industriels tels que définis dans l'ISO 10218-1, et de la (ou des) cellule(s) robotisées industrielles. L'intégration inclut
la conception, la fabrication, l'installation, le fonctionnement, la maintenance et le démantèlement du système robot industriel ou de la cellule robotisée industrielle,
l'information nécessaire pour la conception, la fabrication, l'installation, le fonctionnement, la maintenance et le démantèlement du système robot industriel ou de la cellule robotisée industrielle, et
les composants du système robot industriel ou de la cellule robotisée industrielle.
L'ISO 10218-2:2011 décrit les phénomènes dangereux de base et les situations dangereuses identifiés avec ces systèmes, et fournit des exigences pour éliminer ou réduire de façon correcte les risques liés à ces phénomènes dangereux. L'ISO 10218-2:2011 spécifie également des exigences pour le système robot industriel en tant qu'élément d'un système de fabrication intégré. L'ISO 10218-2:2011 ne traite pas spécifiquement des phénomènes dangereux liés aux processus (par exemple rayonnement laser, éjection de copeaux, fumée de soudage). D'autres normes peuvent être appliquées pour le traitement de ces phénomènes dangereux.

Roboti in robotske naprave - Varnostne zahteve za industrijske robote - 2. del: Robotski sistem in integracija v proizvodno linijo (ISO 10218-2:2011)

Ta del ISO 10218 določa varnostne zahteve za integracijo industrijskih robotov in industrijskih robotskih sistemov, kot so opredeljeni v ISO 10218-1, ter industrijskih robotskih celic. Integracija vključuje: a) načrtovanje, izdelavo, vgradnjo, obratovanje, vzdrževanje in umik iz obratovanja industrijskega robotskega sistema ali celice; b) potrebne informacije za načrtovanje, izdelavo, vgradnjo, obratovanje, vzdrževanje in umik iz obratovanja industrijskega robotskega sistema ali celice; c) sestavne pripomočke industrijskega robotskega sistema ali celice. Ta del ISO 10218 opisuje osnovne nevarnosti in nevarne situacije, identificirane pri teh sistemih, in podaja zahteve za preprečevanje ali ustrezno zmanjševanje tveganj, povezanih s temi nevarnostmi. Čeprav je hrup identificiran kot pomembna nevarnost pri industrijskih robotskih sistemih, ga ta del ISO 10218 ne obravnava. Ta del ISO 10218 tudi določa zahteve za industrijski robotski sistem, ki je del integriranega proizvodnega sistema. Ta del ISO 10218 ne obravnava posebej nevarnosti, povezanih s procesi (npr. laserskega sevanja, izmetavanja sekancev, dima pri varjenju). Za take procesne nevarnosti se lahko uporabijo drugi standardi.

General Information

Status
Withdrawn
Public Enquiry End Date
30-Sep-2008
Publication Date
08-Aug-2011
Withdrawal Date
07-Apr-2025
Technical Committee
ITC - Information technology
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
28-Mar-2025
Due Date
20-Apr-2025
Completion Date
08-Apr-2025

Relations

Effective Date
01-Sep-2011
Effective Date
01-Sep-2011
Effective Date
01-May-2025
Effective Date
18-Jan-2023
Effective Date
14-Jun-2017
Standard

SIST EN ISO 10218-2:2011

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Frequently Asked Questions

SIST EN ISO 10218-2:2011 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Robots and robotic devices - Safety requirements for industrial robots - Part 2: Robot systems and integration (ISO 10218-2:2011)". This standard covers: ISO 10218-2:2011 specifies safety requirements for the integration of industrial robots and industrial robot systems as defined in ISO 10218-1, and industrial robot cell(s). The integration includes the following: the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell; necessary information for the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell; component devices of the industrial robot system or cell. ISO 10218-2:2011 describes the basic hazards and hazardous situations identified with these systems, and provides requirements to eliminate or adequately reduce the risks associated with these hazards. ISO 10218-2:2011 also specifies requirements for the industrial robot system as part of an integrated manufacturing system. ISO 10218-2:2011 does not deal specifically with hazards associated with processes (e.g. laser radiation, ejected chips, welding smoke). Other standards can be applicable to these process hazards.

ISO 10218-2:2011 specifies safety requirements for the integration of industrial robots and industrial robot systems as defined in ISO 10218-1, and industrial robot cell(s). The integration includes the following: the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell; necessary information for the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell; component devices of the industrial robot system or cell. ISO 10218-2:2011 describes the basic hazards and hazardous situations identified with these systems, and provides requirements to eliminate or adequately reduce the risks associated with these hazards. ISO 10218-2:2011 also specifies requirements for the industrial robot system as part of an integrated manufacturing system. ISO 10218-2:2011 does not deal specifically with hazards associated with processes (e.g. laser radiation, ejected chips, welding smoke). Other standards can be applicable to these process hazards.

SIST EN ISO 10218-2:2011 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 10218-2:2011 has the following relationships with other standards: It is inter standard links to SIST EN 775:1998/AC:1998, SIST EN 775:1998, SIST EN ISO 10218-2:2025, oSIST prEN ISO 10218-2:2021, oSIST prEN ISO 10218-2:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

SIST EN ISO 10218-2:2011 is associated with the following European legislation: EU Directives/Regulations: 2006/42/EC, 98/37/EC; Standardization Mandates: M/079, 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.

SIST EN ISO 10218-2:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Roboti in robotske naprave - Varnostne zahteve za industrijske robote - 2. del: Robotski sistem in integracija v proizvodno linijo (ISO 10218-2:2011)Roboter und Robotikgeräte - Sicherheitsanforderungen - Teil 2: Industrierobotersystem und Integration (ISO 10218-2:2011)Robots et dispositifs robotiques - Exigences de sécurité pour les robots industriels - Partie 2: Systèmes robots et intégration (ISO 10218-2:2011)Robots and robotic devices - Safety requirements for industrial robots - Part 2: Robot systems and integration (ISO 10218-2:2011)25.040.30Industrijski roboti. ManipulatorjiIndustrial robots. ManipulatorsICS:Ta slovenski standard je istoveten z:EN ISO 10218-2:2011SIST EN ISO 10218-2:2011en01-september-2011SIST EN ISO 10218-2:2011SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 10218-2
July 2011 ICS 25.040.30 English Version
Robots and robotic devices - Safety requirements for industrial robots - Part 2: Robot systems and integration (ISO 10218-2:2011)
Robots et dispositifs robotiques - Exigences de sécurité pour les robots industriels - Partie 2: Systèmes robots et intégration (ISO 10218-2:2011)
Roboter und Robotikgeräte - Sicherheitsanforderungen - Teil 2: Industrierobotersystem und Integration (ISO 10218-2:2011) This European Standard was approved by CEN on 21 April 2011.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10218-2:2011: ESIST EN ISO 10218-2:2011

Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC .4 SIST EN ISO 10218-2:2011

Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 2006/42/EC Machinery safety. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive and associated EFTA regulations. WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Reference numberISO 10218-2:2011(E)© ISO 2011
INTERNATIONAL STANDARD ISO10218-2First edition2011-07-01Robots and robotic devices — Safety requirements for industrial robots — Part 2: Robot systems and integration Robots et dispositifs robotiques — Exigences de sécurité pour les robots industriels — Partie 2: Systèmes robots et intégration
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ii © ISO 2011 – All rights reserved
ISO 10218-2:2011(E) © ISO 2011 – All rights reserved iii Contents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Hazard identification and risk assessment.4 4.1 General.4 4.2 Layout design.5 4.3 Risk assessment.6 4.4 Hazard identification.8 4.5 Hazard elimination and risk reduction.9 5 Safety requirements and protective measures.9 5.1 General.9 5.2 Safety-related control system performance (hardware/software).9 5.3 Design and installation.10 5.4 Limiting robot motion.14 5.5 Layout.16 5.6 Robot system operational mode application.17 5.7 Pendants.21 5.8 Maintenance and repair.22 5.9 Integrated manufacturing system (IMS) interface.23 5.10 Safeguarding.24 5.11 Collaborative robot operation.32 5.12 Commissioning of robot systems.35 6 Verification and validation of safety requirements and protective measures.36 6.1 General.36 6.2 Verification and validation methods.37 6.3 Required verification and validation.37 6.4 Verification and validation of protective equipment.37 7 Information for use.38 7.1 General.38 7.2 Instruction handbook.39 7.3 Marking.43 Annex A (informative)
List of significant hazards.44 Annex B (informative)
Relationship of standards related to protective devices.47 Annex C (informative)
Safeguarding material entry and exit points.49 Annex D (informative)
Operation of more than one enabling device.52 Annex E (informative)
Conceptual applications of collaborative robots.53 Annex F (informative)
Process observation.55 Annex G (normative)
Means of verification of the safety requirements and measures.58 Bibliography.71
ISO 10218-2:2011(E) iv © ISO 2011 – All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10218-2 was prepared by Technical Committee ISO/TC 184, Automation systems and integration, Subcommittee SC 2, Robots and robotic devices. ISO 10218 consists of the following parts, under the general title Robots and robotic devices — Safety requirements for industrial robots: ⎯ Part 1: Robots ⎯ Part 2: Robot systems and integration
ISO 10218-2:2011(E) © ISO 2011 – All rights reserved v Introduction This part of ISO 10218 has been created in recognition of the particular hazards that are presented by industrial robot systems when integrated and installed in industrial robot cells and lines. Hazards are frequently unique to a particular robot system. The number and types of hazards are directly related to the nature of the automation process and the complexity of the installation. The risks associated with these hazards vary with the type of robot used and its purpose and the way in which it is installed, programmed, operated, and maintained. For the purpose of understanding requirements in this part of ISO 10218, a word syntax is used to distinguish absolute requirements from recommended practices or suggested actions. The word “shall” is used to identify requirements necessary for compliance with this part of ISO 10218. Such requirements have to be accomplished unless an alternative instruction is provided or a suitable alternative is determined by a risk assessment. The word “should” is used to identify suggestions, recommended actions or possible solutions for requirements, but alternatives are possible and the suggested actions are not absolute. In recognition of the variable nature of hazards with the application of industrial robots, this part of ISO 10218 provides guidance for the assurance of safety in the integration and installation of robots. Since safety in the use of industrial robots is influenced by the design of the particular robot system, a supplementary, though equally important, purpose is to provide guidelines for the design, construction and information for use of robot systems and cells. Requirements for the robot portion of the system can be found in ISO 10218-1. Providing for a safe robot system or cell depends on the cooperation of a variety of “stakeholders” – those entities that share in a responsibility for the ultimate purpose of providing a safe working environment. Stakeholders may be identified as manufacturers, suppliers, integrators and users (the entity responsible for using robots), but all share the common goal of a safe (robot) machine. The requirements in this part of ISO 10218 may be assigned to one of the stakeholders, but overlapping responsibilities can involve multiple stakeholders in the same requirements. While using this part of ISO 10218, the reader is cautioned that all of the requirements identified may apply to them, even if not specifically addressed by “assigned” stakeholder tasks. This part of ISO 10218 is complementary and in addition to ISO 10218-1, which covers the robot only. This part of ISO 10218 adds additional information in line with ISO 12100 and ISO 11161, International Standards for requirements to identify and respond in a type-C standard to unique hazards presented by the integration, installation and requirements for use of industrial robots. New technical requirements include, but are not limited to, instructions for applying the new requirements in ISO 10218-1 for safety-related control system performance, robot stopping function, enabling device, programme verification, cableless pendant criteria, collaborating robot criteria and updated design for safety. This part of ISO 10218 and ISO 10218-1 form part of a series of standards dealing with robots and robotic devices. Other standards cover such topics as integrated robotic systems, coordinate systems and axis motions, general characteristics, performance criteria and related testing methods, terminology, and mechanical interfaces. It is noted that these standards are interrelated and also related to other International Standards. For ease of reading this part of ISO 10218, the words “robot” and “robot system” refer to “industrial robot” and “industrial robot system” as defined in ISO 10218-1. Figure 1 describes the relationship of the scope of machinery standards used in a robot system. The robot alone is covered by ISO 10218-1, the system and cell is covered by this part of ISO 10218. A robot cell may include other machines subject to their own C level standards, and the robot system can be part of an integrated manufacturing system covered by ISO 11161 which in turn can also make reference to other relevant B and C level standards. SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) vi © ISO 2011 – All rights reserved
Figure 1 — Graphical view of relationships between standards relating to robot system/cell
INTERNATIONAL STANDARD ISO 10218-2:2011(E) © ISO 2011 – All rights reserved 1 Robots and robotic devices — Safety requirements for industrial robots — Part 2: Robot systems and integration 1 Scope This part of ISO 10218 specifies safety requirements for the integration of industrial robots and industrial robot systems as defined in ISO 10218-1, and industrial robot cell(s). The integration includes the following: a) the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell; b) necessary information for the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell; c) component devices of the industrial robot system or cell. This part of ISO 10218 describes the basic hazards and hazardous situations identified with these systems, and provides requirements to eliminate or adequately reduce the risks associated with these hazards. Although noise has been identified to be a significant hazard with industrial robot systems, it is not considered in this part of ISO 10218. This part of ISO 10218 also specifies requirements for the industrial robot system as part of an integrated manufacturing system. This part of ISO 10218 does not deal specifically with hazards associated with processes (e.g. laser radiation, ejected chips, welding smoke). Other standards can be applicable to these process hazards. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 4413, Hydraulic fluid power — General rules and safety requirements for systems and their components ISO 4414, Pneumatic fluid power — General rules and safety requirements for systems and their components ISO 8995-1, Lighting of work places — Part 1: Indoor ISO 9946, Manipulating industrial robots — Presentation of characteristics ISO 10218-1, Robots and robotic devices — Safety requirements for industrial robots — Part 1: Industrial robots ISO 11161, Safety of machinery — Integrated manufacturing systems — Basic requirements ISO 12100, Safety of machinery — General principles for design — Risk assessment and risk reduction SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) 2 © ISO 2011 – All rights reserved ISO 13849-1:2006, Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design ISO 13850, Safety of machinery — Emergency stop — Principles for design ISO 13854, Safety of machinery — Minimum gaps to avoid crushing of parts of the human body ISO 13855, Safety of machinery — Positioning of safeguards with respect to the approach speeds of parts of the human body ISO 13856 (all parts), Safety of machinery — Pressure-sensitive protective devices ISO 13857, Safety of machinery — Safety distances to prevent hazard zones being reached by upper and lower limbs ISO 14118, Safety of machinery — Prevention of unexpected start-up ISO 14119, Safety of machinery — Interlocking devices associated with guards — Principles for design and selection ISO 14120, Safety of machinery — Guards — General requirements for the design and construction of fixed and movable guards ISO 14122 (all parts), Safety of machinery — Permanent means of access to machinery IEC 60204-1, Safety of machinery — Electrical equipment of machines — Part 1: General requirements IEC 61496-1, Safety of machinery — Electro-sensitive protective equipment — Part 1: General requirements and tests IEC 61800-5-2, Adjustable speed electrical power drive systems — Part 5-2: Safety requirements — Functional IEC/TS 62046, Safety of machinery — Application of protective equipment to detect the presence of persons IEC 62061:2005, Safety of machinery — Functional safety of safety-related electrical, electronic and programmable electronic control systems 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10218-1 and ISO 12100 and the following apply. 3.1 application intended use of the robot system, i.e. the process, the task and the intended purpose of the robot system EXAMPLE Spot welding, painting, assembly, palletizing. 3.2 collaborative robot robot designed for direct interaction with a human within a defined collaborative workspace (3.3) SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) © ISO 2011 – All rights reserved 3 3.3 collaborative workspace workspace within the safeguarded space where the robot and a human can perform tasks simultaneously during production operation 3.4 control station part of the robot system which contains one or more control devices intended to activate or deactivate functions of the system or parts of the system NOTE The control station can be fixed in place (e.g. control panel) or movable (e.g. control pendant). 3.5 distance guard guard that does not completely enclose a danger zone, but which prevents or reduces access by virtue of its dimensions and its distance from the danger zone EXAMPLE Perimeter fence or tunnel guard. 3.6 integration act of combining a robot with other equipment or another machine (including additional robots) to form a machine system capable of performing useful work such as production of parts NOTE This act of machine building can include the requirements for the installation of the system. 3.7 integrator entity that designs, provides, manufactures or assembles robot systems or integrated manufacturing systems and is in charge of the safety strategy, including the protective measures, control interfaces and interconnections of the control system NOTE The integrator can be a manufacturer, assembler, engineering company or the user. 3.8 integrated manufacturing system IMS group of machines working together in a coordinated manner, linked by a material-handling system, interconnected by controls (i.e. IMS controls), for the purpose of manufacturing, treatment, movement or packaging of discrete parts or assemblies [ISO 11161:2007, definition 3.1] 3.9 industrial robot cell one or more robot systems including associated machinery and equipment and the associated safeguarded space and protective measures 3.10 industrial robot line more than one robot cell performing the same or different functions and associated equipment in single or coupled safeguarded spaces 3.11 safe state condition of a machine or piece of equipment where it does not present an impending hazard SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) 4 © ISO 2011 – All rights reserved 3.12 simultaneous motion motion of two or more robots at the same time under the control of a single control station and which may be coordinated or synchronous using a common mathematical correlation 3.13 space three dimensional volume 3.13.1 operating space operational space portion of the restricted space (3.13.2) that is actually used while performing all motions commanded by the task programme NOTE Adapted from ISO 8373:1994, definition 4.8.3. 3.13.2 restricted space portion of the maximum space restricted by limiting devices that establish limits which will not be exceeded NOTE Adapted from ISO 8373:1994, definition 4.8.2. 3.13.3 safeguarded space space defined by the perimeter safeguarding 3.14 validation confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled 3.15 verification confirmation by examination and provision of objective evidence that the requirements have been fulfilled 4 Hazard identification and risk assessment 4.1 General 4.1.1 The operational characteristics of robots can be significantly different from those of other machines and equipment, as follows: a) robots are capable of high energy movements through a large operational space; b) the initiation of movement and the path of the robot arm are difficult to predict and can vary, for example due to changing operational requirements; c) the operating space of the robot can overlap a portion of other robots' operating space or the work zones of other machines and related equipment; d) operators can be required to work in close proximity to the robot system while power to the machine actuators is available. SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) © ISO 2011 – All rights reserved 5 4.1.2 It is necessary to identify the hazards and to assess the risks associated with the robot and its application before selecting and designing appropriate safeguarding measures to adequately reduce the risks. Technical measures for the reduction of risk are based upon the following fundamental principles: a) the elimination of hazards by design or their reduction by substitution; b) preventing operators coming into contact with hazards or controlling the hazards by achieving a safe state before the operator can come into contact with it; c) the reduction of risk during interventions (e.g. teaching). 4.1.3 The realization of these principles can involve: a) designing the robot system to allow tasks to be performed from outside the safeguarded space; b) the creation of a safeguarded space and a restricted space; c) provision of other safeguards when interventions have to occur within the safeguarded space. 4.1.4 The type of robot, its application and its relationship to other machines and related equipment will influence the design and the selection of the protective measures. These shall be suitable for the work being done and permit, where necessary, teaching, setting, maintenance, programme verification and troubleshooting operations to be carried out safely. 4.2 Layout design The design of the robot system and cell layout is a key process in the elimination of hazards and reduction of risks. The following factors shall be taken into account during the layout design process. a) Establishing the physical limits (three dimensional) of the cell or line, including other parts of a larger cell or system (integrated manufacturing system): 1) scale and origin for modelling the layout in design drawings; 2) location and dimensions of the components within available facilities (scale). b) Workspaces, access and clearance: 1) identifying the maximum space of the robot system, establishing restricted and operating spaces, and identifying the need for clearances around obstacles such as building supports; 2) traffic routes (pedestrian aisles, visitor routes, material movement outside the perimeter safeguarding of the cell or line); 3) access and safe pathway to support services (electricity, gas, water, vacuum, hydraulic, ventilation) and control systems; 4) access and safe pathway for service, cleaning, troubleshooting and maintenance purposes; 5) cables/other hazards for slips, trips and falls; 6) cable trays. c) Manual intervention – the layout should be designed to allow tasks requiring manual intervention to be performed from outside the safeguarded space. Where this is not practicable and when the intervention requires powered movements of the machine(s), appropriate enabling devices shall be provided. The enabling devices may be designed to control: 1) the whole robot cell; SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) 6 © ISO 2011 – All rights reserved 2) a zone in the robot cell; 3) a selected machine or equipment within the cell. NOTE See ISO 12100 for more information. d) Ergonomics and human interface with equipment: 1) visibility of operations; 2) clarity of controls; 3) clear association of controls with robot; 4) regional control design traditions; 5) position of workpiece relative to the operator; 6) foreseeable misuse; 7) collaborative operation. e) Environmental conditions: 1) ventilation; 2) weld spark. f) Loading and unloading the workpieces/tool change. g) Consideration of perimeter safeguarding. h) Requirements for and location of emergency stop devices and possible zoning of the cell (e.g. local stops or full cell stop). i) Requirements for and location of enabling devices. j) Attention to the intended use of all components. The risk assessment shall determine the additional space required beyond the restricted space to define the safeguarded space. 4.3 Risk assessment 4.3.1 General Because a robot system is always integrated into a particular application, the integrator shall perform a risk assessment to determine the risk reduction measures required to adequately reduce the risks presented by the integrated application. Particular attention should be paid to instances where safeguards are removed from individual machines in order to achieve the integrated application. Risk assessment enables the systematic analysis and evaluation of the risks associated with the robot system over its whole lifecycle (i.e. commissioning, set-up, production, maintenance, repair, decommissioning). Risk assessment is followed, whenever necessary, by risk reduction. When this process is repeated, it gives the iterative process for eliminating hazards as far as practicable and for reducing risks by implementing protective measures. SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) © ISO 2011 – All rights reserved 7 Risk assessment includes: ⎯ determination of the limits of the robot system (see 4.3.2); ⎯ hazard identification (see 4.4); ⎯ risk estimation; ⎯ risk evaluation. 4.3.2 Limits of the robot system The integration of a robot system begins with the specification of its intended use and limits described in ISO 12100, ISO 11161 and other applicable C level standards. This specification should include, for example: a) use limits: 1) description of functions, intended use and reasonably foreseeable misuse; 2) description of the different user modes; 3) analysis of process sequences including manual intervention; 4) description of interfaces, tooling and equipment; NOTE 1 It is advisable that the relevant C level standards for these devices be taken into account. 5) utility connections; 6) information supplied by the manufacturer, which is derived from the use of ISO 10218-1, including applied measures for risk reduction; 7) required power supply and their appliances; 8) required or anticipated user skills (competency); b) space limits (see 5.5 describing layout): 1) required machine movement range; 2) required space for installation and maintenance; 3) required space for operator tasks and other human intervention; 4) reconfiguration capabilities (ISO 11161); 5) required access (see 5.5.2); 6) foundations; 7) required space for supply and disposal devices or equipment; c) time limits: 1) intended life limit of the machinery and its components (wear parts, tools, etc.); 2) process flow charts and timings; 3) recommended service intervals; SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) 8 © ISO 2011 – All rights reserved d) other limits: 1) environmental (temperature, use indoors or outdoors, tolerance to dust and moisture, etc.); 2) required cleanliness level for the intended use and environment; 3) properties of processed materials; 4) hazardous environments; 5) lessons learned, i.e. study and comparison, including available accident and incident reports, of similar operations and systems. NOTE 2 Other national standards and local codes can also provide important information on sources of power and requirements for safe handling and installation. 4.4 Hazard identification 4.4.1 General The list of significant hazards for robot and robot systems contained in Annex A is the result of hazard identification and risk assessment carried out as described in ISO 12100. Further hazards (e.g. fumes, gases, chemicals and hot materials) can be created by specific applications (e.g. welding, laser cutting, machining) and by the interaction of the robot system with other machines (e.g. crushing, shearing, impact). These hazards shall be addressed on an individual basis with a risk assessment for the specific application. 4.4.2 Task identification In order to determine the potential occurrence of hazardous situations it is necessary to identify the tasks that are to be carried out by operators of the robot system and its associated equipment. The integrator shall identify and document these tasks. The user shall be consulted to ensure that all reasonably foreseeable hazardous situations (task and hazard combinations) associated with the robot cell are identified, including indirect interactions (e.g. persons having no tasks associated with the system but having exposure to hazards associated with the system). These tasks include, but are not limited to: a) process control and monitoring; b) workpiece loading; c) programming and verification; d) brief operator intervention not requiring disassembly; e) set-up (e.g. fixture changes, tool change); f) troubleshooting; g) correction of malfunction(s) (e.g. equipment jams, dropped parts, event recovery and abnormal conditions); h) control of hazardous energy (including fixtures, clamps, turntables and other equipment); i) maintenance and repair; j) equipment cleaning. SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) © ISO 2011 – All rights reserved 9 4.5 Hazard elimination and risk reduction Having identified the hazards, it is necessary to assess the risks associated with the robot system before applying appropriate measures to adequately reduce the risks. Measures for the reduction of risk are based upon these fundamental principles: a) the elimination of hazards by design or the reduction of their risk by substitution; b) safeguarding to prevent operators coming into contact with hazards or to ensure the hazards are brought to a safe state before the operator can come into contact with them; c) the provision of supplementary protective measures such as information for use, training, signs, personal protective equipment, etc. The requirements contained in Clause 5 have been derived from the iterative process of applying risk reduction measures, in accordance with ISO 12100, to the hazards identified in Annex A. The integrator shall ensure that the risks identified in the risk assessment are adequately reduced by applying the requirements of Clause 5. If risks are not adequately reduced, further risk reduction measures shall be applied until they are adequately reduced. 5 Safety requirements and protective measures 5.1 General The integration of robot systems and cells shall comply with the requirements of this part of ISO 10218. In addition, the robot cell or robot line shall be designed according to the principles of ISO 12100 for relevant hazards that are not specifically dealt with by this part of ISO 10218 (e.g. sharp edges). The design of the robot system should follow ergonomic principles to ensure that it is easy to operate and maintain. The robot system shall be designed to avoid exposing personnel to hazards. NOTE 1 Not all of the hazards identified by this part of ISO 10218 apply to every robot system, nor will the level of risk associated with a given hazardous situation be the same from robot system to robot system. NOTE 2 Recommended methods of verification of various requirements in this clause are found in Clause 6. 5.2 Safety-related control system performance (hardware/software) 5.2.1 General Safety-related control systems (electric, hydraulic, pneumatic and software) shall comply with 5.2.2, unless the results of the risk assessment determine that an alternative performance criterion as described in 5.2.3 is appropriate. The safety-related control system performance of the robot system and any furnished equipment shall be clearly stated in the information for use. NOTE 1 Safety-related control systems can also be called SRP/CS (safety-related parts of control systems). For the purposes of this part of ISO 10218, safety-related control system performance is stated as: ⎯ Performance Levels (PL) and categories as described in ISO 13849-1:2006, 4.5.1; ⎯ Safety Integrity Levels (SIL) and hardware fault tolerance requirements as described in IEC 62061:2005, 5.2.4. Those two standards address functional safety in similar but different methods. Requirements in those standards should be used for the respective safety-related control systems for which they are intended. The designer may choose to use either of the two standards. The data and criteria necessary to determine the safety-related control system performance shall be included in the information for use. SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) 10 © ISO 2011 – All rights reserved NOTE 2 The comparison with ISO 13849-1 and IEC 62061 is described in ISO/TR 23849. Other standards offering alternative performance requirements, such as the term “control reliability” used in North America, may also be used.
When using these alternative standards to design safety-related control systems, an equivalent level of risk reduction shall be achieved. Any failure of the safety-related control system shall result in a stop category 0 or 1 in accordance with IEC 60204-1. 5.2.2 Performance requirement Safety-related parts of control systems shall be designed so that they comply with PL=d with structure category 3 as described in ISO 13849-1:2006, or so that they comply with SIL 2 with hardware fault tolerance of 1 with a proof test interval of not less than 20 years as described in IEC 62061:2005. This means in particular: a) a single fault in any of these parts does not lead to the loss of the safety function, b) whenever reasonably practicable, the single fault shall be detected at or before the next demand upon the safety function, c) when the single fault occurs, the safety function is always performed and a safe state shall be maintained until the detected fault is corrected, d) all reasonably foreseeable faults shall be detected. The requirements a) to d) are considered to be equivalent to structure category 3 as described in ISO 13849-1:2006. NOTE The requirement of single-fault detection does not mean that all faults will be detected. Consequently, the accumulation of undetected faults can lead to an unintended output and a hazardous situation at the machine. 5.2.3 Other control system performance criteria The results of a comprehensive risk assessment performed on the robot system and its intended application may determine that a safety-related control system performance other than that stated in 5.2.2 is warranted for the application. Selection of one of these other safety-related performance criteria shall be specifically identified, and appropriate limitations and cautions shall be included in the information for use provided with the affected equipment. 5.3 Design and installation 5.3.1 Environmental conditions The robot system and protective measures of the robot cell shall be designed taking into account environmental conditions like surrounding temperature, humidity, electro-magnetic disturbances, lighting, etc. These can lead to some requirements for the surrounding environment due to technical restrictions. The robot and robot system and cell components shall be chosen to withstand the expected operational and environmental conditions. 5.3.2 Location of controls Operational controls and equipment (e.g. weld controller, pneumatic valves, etc.) requiring access during automatic operation shall be located outside the safeguarded space forcing a person using the control SIST EN ISO 10218-2:2011

ISO 10218-2:2011(E) © ISO 2011 – All rights reserved 11 actuators to be outside the safeguarded space. Controls and equipment should be placed and constructed so as to allow a clear view of the robot restricted space. 5.3.3 Actuating controls Actuating controls shall meet the requirements of IEC 60204-1. The controls shall be designed consistent with ISO 10218-1. The robot system shall not respond to any external remote commands or conditions that would cause hazardous situations. 5.3.4 Power requirements All sources of robot and other equipment power (e.g. pneumatic, hydraulic, mechanical, electrical) shall meet the requirements as specified by the machine and component manufacturers. Electrical installations shall meet the requirements of IEC 60204-1. Hydraulic power installations shall meet the requirements of ISO 4413 and pneumatic power installations shall meet those of ISO 4414. 5.3.5 Equipotential bonding/earthing requirements (grounding) Protective bonding and functional bonding shall meet the requirements of IEC 60204-1. 5.3.6 Isolating sources of energy Means shall be provided to isolate hazardous energy sources without exposing personnel to a hazard. These means shall be lockable and/or secured only in the de-energized position. The robot system should have a single supply disconnecting device for each type of energy source. For multiple robot or large installations, multiple disconnecting devices for each type of energy can be necessary. The span of control for each of these devices shall be clearly marked in the vicinity of the handle of the disconnecting device (e.g. text or symbol
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