oSIST prEN ISO 10218-2:2021
(Main)Robotics - Safety requirements for robot systems in an industrial environment - Part 2: Robot systems, robot applications and robot cells integration (ISO/DIS 10218-2:2020)
Robotics - Safety requirements for robot systems in an industrial environment - Part 2: Robot systems, robot applications and robot cells integration (ISO/DIS 10218-2:2020)
2022-03-29: DOW= DAV + 24 months
Robotik - Sicherheitsanforderungen für Industrieroboter - Teil 2: Robotersysteme und Integration (ISO/DIS 10218-2:2020)
Dieses Dokument legt Anforderungen für die Integration von Industrierobotersystemen, Industrieroboteranwendungen und Industrieroboterzellen fest. Folgende Themen werden behandelt:
- die Gestaltung, die Integration, die Abnahme, der Betrieb, die Instandhaltung, das außer Betrieb nehmen und die Entsorgung des Industrierobotersystems, der anwendung oder der zelle;
- Integration von Maschinen und Komponenten in das Industrierobotersystem, die anwendung oder zelle;
- Benutzerinformationen für die Gestaltung, die Integration, die Abnahme, den Betrieb, die Instandhaltung, das außer Betrieb nehmen und die Entsorgung des Industrierobotersystems, der anwendung oder der zelle.
Dieses Dokument gilt nicht für die folgenden Verwendungen und Anwendungen:
- 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;
- Tele-betriebene 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 Hersteller vernünftigerweise vorhersehbaren Fehlanwendungen verwendet werden. Robotersysteme können für ein breites Anwendungsspektrum verwendet und in (eine) Roboterzelle(n) integriert werden. Daher ist es nicht möglich, eine vollständige Liste aller signifikanten Gefährdungen, Gefährdungssituationen oder ereignisse zur Verfügung zu stellen, in die ein Roboter und eine Roboteranwendung involviert sein können. Zudem können gleiche Anwendungsarten verschiedene Risikoniveaus aufweisen, die sich aus den verschiedenen Auslegungen im Hinblick auf die vorgesehene Anwendung ergeben (z. B. Spritzlackieren kleiner oder großer Teile, Handhabung kleiner, gefährlicher Nutzlasten wie eines heißen Metallbolzens oder einer großen, harmlosen Nutzlast wie einer Schachtel Papiertücher).
Dieses Dokument liefert auch grundlegende Anforderungen an Industrieroboter, die in Anwendungen wie den folgenden Verwendung finden, wobei jedoch nicht sämtliche Gefährdungen in Zusammenhang mit diesen abgedeckt werden:
- Untertagenutzung;
- Hygieneanforderungen;
- aufgrund der Verarbeitung jeglicher Materialien, z. B. Nahrungsmittel, Kosmetik, Arzneimittel, Metall;
- kerntechnische Umgebungen;
- explosionsgefährdete Umgebungen;
- Verwendung von Robotersystemen 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.
Lärm ist als signifikante Gefährdung an Industrierobotersystemen erkannt und ist im Anwendungsbereich dieses Dokuments enthalten.
Für zugehörige Maschinen und Ausrüstung in Roboteranwendungen und Roboterzellen können weitere Normen gelten.
(ISO/DIS 10218-2:2020)
Robotika - Varnostne zahteve za robotske sisteme v industrijskem okolju - 2. del: Robotski sistemi, robotske aplikacije in integracija robotskih celic (ISO/DIS 10218-2:2020)
General Information
Relations
Overview
The oSIST prEN ISO 10218-2:2021 standard, titled Manipulating Industrial Robots – Safety – Part 2: Rebuilding, Redeployment and Use, is a key international standard developed by CEN and ISO/TC 299. It provides comprehensive safety requirements specifically for robot systems, robot applications, and the integration of robot cells within industrial environments. This second part complements Part 1 by focusing on the safe rebuilding, redeployment, and practical use of industrial robotic systems.
Issued as a draft in 2020 and under review through early 2021, this standard is poised to harmonize safety protocols to enhance automation safety and reliability worldwide. It addresses industrial manipulator systems extensively, providing detailed guidelines that ensure safety for operators, maintenance personnel, and surrounding machinery.
Key Topics
oSIST prEN ISO 10218-2:2021 thoroughly covers critical safety aspects revolving around industrial robots and their applications, including:
- Risk Assessment: Evaluates hazards associated with robot systems, their characteristics, and collaborative applications to identify potential risks early in system design and deployment.
- Safety Requirements and Risk Reduction Measures: Guidelines on design, integration, layout, safety functions, and safeguards to mitigate risk during the system lifecycle.
- Robot Cell Integration: Safety considerations when integrating robotic cells with external machinery and sub-assemblies, focusing on layout optimization and coordination.
- Stopping and Control Systems: Requirements for emergency stop functions, control devices, and interlocks to ensure safe halting of robotic operations.
- End-effectors and Special Components: Safety protocols related to end-effectors, vertical transfer components, lasers, and material handling stations.
- Collaborative Robotics: Specific guidelines for collaborative robot applications where humans and robots work in close proximity.
- Assembly, Installation, Commissioning, and Maintenance: Processes and safety measures for installation phases to ensure compliance and operational safety.
- Verification and Validation: Methods for confirming safety functions and protective measures comply with required performance levels and biomechanical thresholds.
- Information for Use: Proper marking, signaling, warning devices, signs, and comprehensive instruction manuals to support safe operation.
The standard also includes numerous annexes covering significant hazards, safety function performance requirements, verification techniques, safeguarding details, speed and separation monitoring, and legal compliance with directives such as 2006/42/EC.
Applications
This standard is essential for manufacturers, system integrators, safety engineers, and operators involved with industrial robotics, especially where robots are rebuilt, redeployed, or integrated into new production cells. Practical applications include:
- Designing and implementing safe robot systems compliant with international norms.
- Safeguarding human-robot collaborative workspaces in factories.
- Ensuring safe integration of robots with other automated equipment and material handling systems.
- Establishing maintenance and commissioning protocols to minimize risk.
- Facilitating verification and validation processes critical for certifiable safe robot use.
- Supporting occupational health and safety compliance in industries utilizing industrial robots.
Adhering to oSIST prEN ISO 10218-2:2021 enhances productivity while ensuring the safety and wellbeing of personnel working with advanced robotic systems.
Related Standards
oSIST prEN ISO 10218-2:2021 should be considered alongside complementary standards such as:
- ISO 10218-1: Safety requirements specific to the design and construction of industrial robots.
- ISO/TS 15066: Safety requirements for collaborative robots (cobots).
- IEC 61508 / ISO 13849: International standards on functional safety and safety-related control systems.
- Directive 2006/42/EC: The European Machinery Directive governing safety of machinery, referenced within the standard for regulatory compliance.
Integrating these standards provides a robust framework for safe industrial robot deployment, continuous risk management, and harmonized international safety practices.
Keywords: industrial robot safety, robot system integration, robotic cell safety, risk assessment robotics, collaborative robots, robot safeguards, ISO 10218-2, industrial automation safety, robot rebuilding standards, robotic applications safety.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2021
Robotika - Varnostne zahteve za robotske sisteme v industrijskem okolju - 2. del:
Robotski sistemi, robotske aplikacije in integracija robotskih celic (ISO/DIS 10218-
2:2020)
Robotics - Safety requirements for robot systems in an industrial environment - Part 2:
Robot systems, robot applications and robot cells integration (ISO/DIS 10218-2:2020)
Robotik - Sicherheitsanforderungen für Industrieroboter - Teil 2: Robotersysteme und
Integration (ISO/DIS 10218-2:2020)
(ISO/DIS 10218-2:2020)
Ta slovenski standard je istoveten z: prEN ISO 10218-2
ICS:
25.040.30 Industrijski roboti. Industrial robots.
Manipulatorji Manipulators
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10218-2
ISO/TC 299 Secretariat: SIS
Voting begins on: Voting terminates on:
2020-12-11 2021-03-05
Robotics — Safety requirements for robot systems in an
industrial environment —
Part 2:
Robot systems, robot applications and robot cells
integration
ICS: 25.040.30
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10218-2:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
ISO/DIS 10218‐2:2020(E)
ISO/DIS 10218-2:2020(E)
Contents
1 Foreword . v
2 Introduction . vi
3 1 Scope . 1
4 2 Normative references . 2
5 3 Terms, definitions and abbreviations . 5
6 4 Risk assessment . 24
7 4.1 General . 24
8 4.2 Characteristics of robot systems, robot applications and robot cells . 25
9 4.3 Characteristics of collaborative applications . 26
10 5 Safety requirements and/or protective/risk reduction measures . 29
11 5.1 General . 29
12 5.2 Design . 29
13 5.3 Robot cell integration with other machines and sub‐assemblies . 36
14 5.4 Layout . 38
15 5.5 Safety functions . 43
16 5.6 Stopping, robot system and application . 48
17 5.7 Controls . 50
18 5.8 Safeguards and their use. 58
19 5.9 End‐effectors . 64
20 5.10 Vertical transfer components . 68
21 5.11 Lasers and laser equipment . 69
22 5.12 Material handling, manual load/unload stations and material flow . 69
23 5.13 Collaborative applications . 72
24 5.14 Assembly, installation and commissioning . 80
25 5.15 Maintenance . 82
26 6 Verification and validation of safety requirements and protective measures . 83
27 6.1 General . 83
28 6.2 Verification and validation methods . 83
29 6.3 Required verification and validation . 84
30 6.4 Verification and validation of guards, protective devices, safety function parameter
31 settings and biomechanical threshold limits . 84
32 7 Information for use . 85
33 7.1 General . 85
34 7.2 Signals and warning devices . 86
35 7.3 Marking . 86
36 7.4 Signs (pictograms) and written warnings . 87
37 7.5 Instruction handbook . 87
© ISO 2020 38 Annex A (informative) List of significant hazards . 97
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
39 Annex B (informative) Illustrations of spaces . 103
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
40 Annex C (normative) Safety function performance requirements . 109
below or ISO’s member body in the country of the requester.
ISO copyright office
41 Annex D (normative) Required safety function information . 129
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
42 Annex E (informative) Example of determination of required performance level (PLr) or SIL
Phone: +41 22 749 01 11
43 claim limit (SILcl) from risk estimation parameters of Annex C . 131
Fax: +41 22 749 09 47
Email: copyright@iso.org
44 Annex F (informative) Comparison of stop functions . 135
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO/DIS 10218‐2:2020(E)
Contents
1 Foreword . v
2 Introduction . vi
3 1 Scope . 1
4 2 Normative references . 2
5 3 Terms, definitions and abbreviations . 5
6 4 Risk assessment . 24
7 4.1 General . 24
8 4.2 Characteristics of robot systems, robot applications and robot cells . 25
9 4.3 Characteristics of collaborative applications . 26
10 5 Safety requirements and/or protective/risk reduction measures . 29
11 5.1 General . 29
12 5.2 Design . 29
13 5.3 Robot cell integration with other machines and sub‐assemblies . 36
14 5.4 Layout . 38
15 5.5 Safety functions . 43
16 5.6 Stopping, robot system and application . 48
17 5.7 Controls . 50
18 5.8 Safeguards and their use. 58
19 5.9 End‐effectors . 64
20 5.10 Vertical transfer components . 68
21 5.11 Lasers and laser equipment . 69
22 5.12 Material handling, manual load/unload stations and material flow . 69
23 5.13 Collaborative applications . 72
24 5.14 Assembly, installation and commissioning . 80
25 5.15 Maintenance . 82
26 6 Verification and validation of safety requirements and protective measures . 83
27 6.1 General . 83
28 6.2 Verification and validation methods . 83
29 6.3 Required verification and validation . 84
30 6.4 Verification and validation of guards, protective devices, safety function parameter
31 settings and biomechanical threshold limits . 84
32 7 Information for use . 85
33 7.1 General . 85
34 7.2 Signals and warning devices . 86
35 7.3 Marking . 86
36 7.4 Signs (pictograms) and written warnings . 87
37 7.5 Instruction handbook . 87
38 Annex A (informative) List of significant hazards . 97
39 Annex B (informative) Illustrations of spaces . 103
40 Annex C (normative) Safety function performance requirements . 109
41 Annex D (normative) Required safety function information . 129
42 Annex E (informative) Example of determination of required performance level (PLr) or SIL
43 claim limit (SILcl) from risk estimation parameters of Annex C . 131
44 Annex F (informative) Comparison of stop functions . 135
ISO/DIS 10218‐2:2020(E)
45 Annex G (informative) Symbols . 137
46 Annex H (normative) Means of verification and validation of the design and protective
47 measures . 139
48 Annex I (informative) End‐effectors . 167
49 Annex J (informative) Safeguarding manual load and unload stations . 173
50 Annex K (informative) Safeguarding material entry and exit point . 187
51 Annex L (normative) Speed and separation monitoring (SSM) – protective separation distance195
52 Annex M (informative) Limits for quasi‐static and transient contact . 199
53 Annex N (informative) Power and force limited robot applications – Pressure and force
54 measurements . 211
55 Annex O (informative) Optional features . 229
56 Annex P (informative) Relationship of standards related to safeguards . 231
57 Annex ZA (informative) Relationship between this European Standard and the essential
58 requirements of Directive2006/42/EC aimed to be covered . 233
59 Bibliography . 237
iv © ISO 2020 – All rights reserved
ISO/DIS 10218‐2:2020(E)
60 Foreword
61 ISO (the International Organization for Standardization) is a worldwide federation of national standards
62 bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
63 ISO technical committees. Each member body interested in a subject for which a technical committee has
64 been established has the right to be represented on that committee. International organizations,
65 governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
66 with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
67 The procedures used to develop this document and those intended for its further maintenance are described
68 in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
69 of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
70 ISO/IEC Directives, Part 2 (see www.iso.org/directives).
71 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
72 rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
73 rights identified during the development of the document will be in the Introduction and/or on the ISO list
74 of patent declarations received (see www.iso.org/patents).
75 Any trade name used in this document is information given for the convenience of users and does not
76 constitute an endorsement.
77 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
78 related to conformity assessment, as well as information about ISO's adherence to the World Trade
79 Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
80 www.iso.org/iso/foreword.html.
81 This document was prepared by Technical Committee ISO/TC 299, Robotics.
82 This second edition cancels and replaces the first edition (ISO 10218-2:2011), which has been technically
83 revised.
84 The main changes compared to the previous edition are as follows:
85 incorporating safety requirements for collaborative applications (formerly, the content of
86 ISO/TS 15066:2016);
87 clarifying requirements for functional safety;
88 adding requirements for cybersecurity to the extent that it applies.
89 A list of all parts in the ISO 10218 series can be found on the ISO website.
90 Any feedback or questions on this document should be directed to the user’s national standards body. A
91 complete listing of these bodies can be found at www.iso.org/members.html.
ISO/DIS 10218‐2:2020(E)
93 Introduction
94 This document has been created in recognition of the hazards that are presented by robots when they are
95 integrated and installed into robot systems, robot applications and robot cells. Part 1 of ISO 10218 addresses
96 robots as partly completed machines, while this document addresses robots integrated into complete
97 machines (systems) for specific applications.
98 This document is a type-C standard according to ISO 12100.
99 This document is of relevance for the following stakeholder groups representing the market players
100 regarding robot safety:
101 robot manufacturers (small, medium and large enterprises);
102 robot system/ application integrators (small, medium and large enterprises);
103 health and safety bodies (regulators, accident prevention organisations, market surveillance, etc).
104 Others can be affected by the level of safety achieved with the means of the document by the above-
105 mentioned stakeholder groups:
106 robot system users/employers (small, medium and large enterprises);
107 robot system users/employees (e.g. trade unions);
108 service providers, e. g. for maintenance (small, medium and large enterprises);
109 The above-mentioned stakeholder groups have been given the possibility to participate at the drafting
110 process of this document.
111 Robot systems and robot applications, and the extent to which hazards, hazardous situations and events, are
112 covered are indicated in the Scope of this document.
113 When provisions of a type-C standard are different from those which are stated in type-A or type-B
114 standards, the provisions of the type-C standard take precedence over the provisions of the other standards
115 for machines that have been designed and built in accordance with the provisions of the type-C standard.
116 Hazards associated with robot systems and robot applications are well recognized, but the sources of the
117 hazards are frequently unique to a robot application. The number and type(s) of hazard(s) are directly
118 related to the nature of the automation process and the complexity of the application. The risks associated
119 with these hazards vary with the robot used, its safety functions, and the way in which it is integrated,
120 installed, programmed, used, and maintained. This document provides requirements for safety in the
121 integration and installation of robots into robot systems and robot applications. The requirements include
122 safeguarding of operators during integration, commissioning, functional testing, programming, operation,
123 maintenance and repair. Requirements for the robot can be found in ISO 10218-1.
124 Both parts of ISO 10218 deal with robotics in an industrial environment, which is comprised of workplaces
125 where the public is excluded or restricted from access because the people (operators) are working adults.
126 Other standards cover such topics as coordinate systems and axis motions, general characteristics,
127 performance criteria and related testing methods, terminology, and mechanical interfaces. It is noted that
128 these standards are interrelated and related to other International Standards.
vi © ISO 2020 – All rights reserved
ISO/DIS 10218‐2:2020(E)
129 For ease of reading this part of ISO 10218, the words “robot system” and “robot application” refer to
130 “industrial robot system” and “industrial robot application” as defined in ISO 10218-1 and ISO 10218-2.
131 “Robot” refers to “industrial robot”.
132 For understanding requirements in this document, a word syntax is used to distinguish requirements from
133 guidance or recommendations. The word “shall” is used for mandatory requirements to comply with this
134 document. The word “should” is used to identify guidance, suggestions, recommended actions or possible
135 solutions for requirements, but alternatives are possible.
136 This document has been updated based on experience gained since the release of ISO 10218-1 and
137 ISO 10218-2 in 2011. This document remains aligned with minimum requirements of a harmonized type-C
138 standard for robot systems and robot applications in an industrial environment. Providing for a safe robot
139 system or application depends on the cooperation of a variety of “stakeholders” – those entities that share
140 in a responsibility for the ultimate purpose of providing a safe working environment. Stakeholders may be
141 identified as manufacturers, suppliers, integrators, and users (the entity responsible for using robots), but
142 all share the common goal of a safe (robot) machine. The requirements in this document can be assigned to
143 one of the stakeholders but overlapping responsibilities can involve multiple stakeholders in the same
144 requirements. While using this document, the reader is cautioned that all the requirements identified could
145 apply to them, even if not specifically addressed by “assigned” stakeholder tasks.
146 It is important to emphasize that the term “collaborative robot” is not used in ISO 10218 as only the
147 application can be developed, verified, and validated as a collaborative application. In addition, the term
148 “collaborative operation” is not used in this edition.
149 Revisions include:
150 category 2 stopping functions;
151 cybersecurity;
152 definitions and abbreviations;
153 details within the information for use clause;
154 functional safety requirements;
155 risk estimation parameters and thresholds;
156 integrating the requirements of
157 ISO/TS 1506:2016 — Robots and robotic devices — Collaborative robots
158 hand-guided controls (HGC) requirements for collaborative applications;
159 power and force limiting (PFL) requirements for collaborative applications;
160 speed and separation monitoring (SSM) requirements for collaborative applications;
161 ISO/TR 20218-1:2018 — Robotics — Safety design for industrial robot systems — Part 1: End-
162 effectors
163 ISO/TR 20218-2:2017 — Robotics — Safety design for industrial robot systems — Part 2: Manual
164 load/ unload stations
165 RIA TR R15.806:2018 — A Guide to Testing Pressure and Force in Collaborative Robot Applications
166 marking;
167 mechanical strength and stability requirements;
168 mode selection;
169 power loss requirements;
ISO/DIS 10218‐2:2020(E)
170 risk estimation parameters.
171 ISO 10218 deals with safety of robotics in an industrial environment. Other standards cover such topics as
172 coordinate systems and axis motions, general characteristics, performance criteria and related testing
173 methods, terminology, and mechanical interfaces. It is noted that these standards are interrelated and
174 related to other International Standards.
175 Figure 1 is a figurative representation of the relationship of machinery safety standards that can be used to
176 support a robot application. The robot (1) is the scope of ISO 10218-1, while the robot system/ application/
177 cell (2) is covered by this document. A robot cell can include machines subject to their own type-C standards
178 (3). Machines can be integrated into an integrated manufacturing system addressed by ISO 11161 (4).
179 Relevant type-A and -B standards are depicted by A and B in Figure 1.
A
B
181 Key
182 1 robots (ISO 10218-1)
183 2 robot systems/ robot applications/ robot cells (ISO 10218-2)
184 3 machine type-C standards, as applicable
185 4 integrated manufacturing systems (ISO 11161)
186 A type-A standard, i.e. ISO 12100 Risk assessment and risk reduction
187 B type-B standards, e.g. safety aspects (type-B1) and safety device (type-B2)
188 Figure 1 — Graphical view of relationships between standards
189 relating to the robot system, robot application and robot cell
viii © ISO 2020 – All rights reserved
ISO/DIS 10218‐2:2020(E)
191 Robotics — Safety requirements for robot systems in an industrial
192 environment — Part 2: Robot systems, robot applications and robot
193 cells integration
194 1 Scope
195 This document specifies requirements for the integration of industrial robot systems, industrial robot
196 applications and industrial robot cells. The following is addressed:
197 the design, integration, commissioning, operation, maintenance, decommissioning and disposal of the
198 industrial robot system, application or cell;
199 integration of machines and components to the industrial robot system, application or cell;
200 information for use for the design, integration, commissioning, operation, maintenance, decommissioning
201 and disposal of the industrial robot system, application or cell;
202 This document is not applicable to the following uses and applications:
203 underwater;
204 law enforcement;
205 military (defence);
206 airborne and space, including outer space;
207 medical;
208 healthcare of a person;
209 prosthetics and other aids for the physically impaired;
210 service robots, which provide a service to a person and as such the public can have access;
211 consumer products, as this is household use to which the public can have access;
212 lifting or transporting people;
213 multi-purpose lifting devices or machinery, e.g. cranes, forklift trucks;
214 mobile platforms;
215 tele-operated manipulators.
216 NOTE: Applications for the automation of laboratories are not considered as medical or healthcare of a person.
217 This document deals with the significant hazards, hazardous situations or hazardous events when used as
218 intended and under specified conditions of misuse which are reasonably foreseeable by the manufacturer.
©
ISO 2020 All rights reserved. 1
ISO/DIS 10218‐2:2020(E)
219 Robot systems can be used for a broad range of applications and integrated into robot cell(s). Therefore, it is
220 not possible to provide a list of all significant hazards, hazardous situations or events into which a robot and
221 robot application can be integrated. Moreover, same kind of applications can have different levels of risk,
222 resulting from different designs which correspond to the intended application (e.g. paint spraying on large or
223 small parts, handling of a small harmful payload like a hot metal bolt or a large harmless payload like a box of
224 paper tissues).
225 This document also provides basic requirements for industrial robots used in applications as following, but does
226 not cover the entirely the hazards related to:
227 underground use;
228 hygienic requirements;
229 due to the processing of any material, e.g. food, cosmetics, pharmaceutical, metal;
230 nuclear environments;
231 potentially explosive environments;
232 use of robot systems in environments with hazardous ionizing and non-ionizing radiation levels;
233 hazardous ionizing and non-ionizing radiation;
234 handling loads the nature of which could lead to dangerous situations (e.g. molten metals, acids/bases,
235 radiating materials);
236 when the public or non-working adults have access.
237 Acoustic noise has been identified to be a significant hazard with industrial robot systems and is included in the
238 scope of this document.
239 Other standards can be applicable to associated machinery and equipment in robot applications and robot cells.
240 2 Normative references
241 The following documents are referred to in the text in such a way that some or all their content constitutes
242 requirements of this document. For dated references, only the edition cited applies.
243 ISO 3864-1:2011, Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs
244 and safety markings
245 ISO 3864-2:2016, Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product
246 safety labels
247 ISO 3864-3:2012, Graphical symbols — Safety colours and safety signs — Part 3: Design principles for graphical
248 symbols for use in safety signs
2 © ISO 2020 – All rights reserved
ISO/DIS 10218‐2:2020(E)
249 ISO 3864-4:2011, Graphical symbols — Safety colours and safety signs — Part 4: Colorimetric and photometric
250 properties of safety sign materials
251 ISO 4413:2010, Hydraulic fluid power — General rules and safety requirements for systems and their components
252 ISO 4414:2010, Pneumatic fluid power — General rules and safety requirements for systems and their components
253 ISO 7010:2019: Graphical symbols — Safety colours and safety signs — Registered safety signs
254 ISO 8995-1:2002, Lighting of work places — Part 1: Indoor
255 ISO/DIS 10218-1:2020, Robotics — Safety requirements for robotics in an industrial environment — Part 1:
256 robots
257 ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction
258 ISO 13732-1:2006, Ergonomics of the thermal environment — Methods for the assessment of human responses
259 to contact with surfaces — Part 1: Hot surfaces
260 ISO 13732-3:2005, Ergonomics of the thermal environment — Methods for the assessment of human responses
261 to contact with surfaces — Part 2: Cold surfaces
262 ISO 13849-1:2015, Safety of machinery — Safety‐related parts of control systems — Part 1: General principles for
263 design
264 ISO 13850:2015, Safety of machinery — Emergency stop — Principles for design
265 ISO 13854:2017, Safety of machinery — Minimum gaps to avoid crushing of parts of the human body
266 ISO 13855:2010, Safety of machinery — Positioning of safeguards with respect to the approach speeds of parts of
267 the human body
268 ISO 13856-1:2013, Safety of machinery — Pressure‐sensitive protective devices — Part 1: General principles for
269 design and testing of pressure‐sensitive mats and pressure‐sensitive floors
270 ISO 13856-2:2013, Safety of machinery — Pressure‐sensitive protective devices — Part 2: General principles for
271 design and testing of pressure‐sensitive edges and pressure‐sensitive bars
272 ISO 13856-3:2013, Safety of machinery — Pressure‐sensitive protective devices — ISO 13856-2:2013, Safety of
273 machinery — Pressure‐sensitive protective devices — Part 3: General principles for design and testing of pressure‐
274 sensitive bumpers, plates, wires and similar devices
275 ISO 13857:2019, Safety of machinery — Safety distances to prevent hazard zones being reached by upper and
276 lower limbs
277 ISO 14118:2017, Safety of machinery — Prevention of unexpected start‐up
278 ISO 14119:2013, Safety of machinery — Interlocking devices associated with guards — Principles for design and
279 selection
280 ISO 14120:2015, Safety of machinery — Guards — General requirements for the design and construction of fixed
281 and movable guards
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282 ISO 14122-1:2016, Safety of machinery — Permanent means of access to machinery — Part 1: Choice of fixed
283 means and general requirements of access
284 ISO 14122-2:2016, Safety of machinery — Permanent means of access to machinery — Part 2: Working platforms
285 and walkways
286 ISO 14122-3:2016, Safety of machinery — Permanent means of access to machinery — Part 3: Stairs, stepladders
287 and guard‐rails
288 ISO 14122-4:2016, Safety of machinery — Permanent means of access to machinery — Part 4: Fixed ladders
289 ISO 14738:2002, Safety of machinery — Anthropometric requirements for the design of workstations at machinery
290 ISO 15534-1:2000, Safety of machinery — Ergonomic design for the safety of machinery — Part 1: Principles for
291 determining the dimensions required for openings for whole‐body access into machinery
292 ISO 15534-2:2000, Safety of machinery — Ergonomic design for the safety of machinery — Part 2: Principles for
293 determining the dimensions required for access openings
294 ISO 19353:2005, Safety of machinery — Fire prevention and protection
295 ISO 20607:2019, Safety of machinery — Instruction handbook — General drafting principles
296 ISO 20643:2005, Mechanical vibration — Hand‐held and hand‐guided machinery — Principles for evaluation of
297 vibration emission
298 IEC 60073:2002, Basic and safety principles for man‐machine interface, marking and identification ‐ Coding
299 principles for indication devices and actuators
300 IEC 60204-1:2016, Safety of machinery — Electrical equipment of machines — Part 1: General requirements
301 IEC 60825-1:2014, Safety of laser products ‐ Part 1: Equipment classification and requirements
302 IEC 61310-1:2007, Safety of machinery — Indication, marking and actuation — Part 1: Requirements for visual,
303 acoustic and tactile signals
304 IEC 61310-2:2007, Safety of machinery — Indication, marking and actuation — Part 2: Requirements for marking
305 IEC 61310-3:2007, Safety of machinery — Indication, marking and actuation — Part 3: Requirements for location
306 and operation of actuators
307 IEC 61496-1:2012, Safety of machinery — Electro‐sensitive protective equipment — Part 1: General requirements
308 and tests
309 IEC 61496-2:2013, Safety of machinery — Electro‐sensitive protective equipment — Part 2: Particular
310 requirements for equipment using active opto‐electronic protective devices (AOPDs)
311 IEC 61496-3:2018, Safety of machinery — Electro‐sensitive protective equipment — Part 3: Particular
312 requirements for active opto‐electronic protective devices responsive to diffuse Reflection (AOPDDR)
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313 IEC/TS 61496-4-2:2014, Safety of machinery — Electro‐sensitive protective equipment — Part 4‐2: Particular
314 requirements for equipment using vision based protective devices (VBPD) — Additional requirements when using
315 reference pattern techniques (VBPDPP)
316 IEC/TS 61496-4-3:2015, Safety of machinery — Electro‐sensitive protective equipment — Part 4‐3: Particular
317 requirements for equipment using vision based protective devices (VBPD) — Additional requirements when using
318 stereo vision techniques (VBPDST)
319 IEC 61508-2:2010, Functional safety of electrical/electronic/programmable electronic safety‐related systems —
320 Part 2: Requirements for electrical/electronic/programmable electronic safety‐related systems
321 IEC 62046:2018, Safety of machinery — Application of protective equipment to detect the presence of persons
322 IEC 62061:2005 +A1:2012+A2:2015, Safety of machinery — Functional safety of safety‐related electrical,
323 electronic, and programmable electronic control systems
324 IEC 62745:2017, Safety of machinery — Requirements for cableless control systems of machinery
325 IEC/TS 62998-1:2019, Safety of machinery — Safety‐related sensors used for the protection of persons
326 3 Terms, definitions and abbreviations
327 For the purposes of this document, the terms, definitions and abbreviations given in ISO 12100, ISO 10218-1
328 and the following apply.
329 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
330 — ISO Online browsing platform: available at https://www.iso.org/obp
331 — IEC Electropedia: available at http://www.electropedia.org/
332 3.1 Robot, robot system, robot application, application, collaborative, robot cell
333 3.1.1
334 industrial environment
335 workplace where the public is restricted from access or not reasonably expected to be present for the intended
336 tasks and robot applications (3.1.4)
337 NOTE 1 to entry: This includes manufacturing, laboratory automation/ production, pharmaceutical automation/
338 production, packing, packaging, palletizing, warehousing, logistics, loading/ unloading and more.
339 3.1.2
340 industrial robot
341 robot
342 automatically controlled, reprogrammable multipurpose manipulator(s) (3.2.5), programmable in three or
343 more axes (3.2.1), which can be either fixed in place or fixed to a mobile platform (3.2.8) for use in automation
344 applications in an industrial environment (3.1.1)
345 NOTE 1 to entry: The industrial robot includes:
346 the manipulator (3.2.5), including robot actuators (3.2.10) controlled by the robot controller;
347 the robot controller.
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348 NOTE 2 to entry: This includes any auxiliary axes that are integrated into the kinematic solution.
349 NOTE 3 to entry: The following are considered industrial robots:
350 the manipulating portion(s) of mobile robots, where a mobile robot consists of a mobile platform (3.2.8) with an
351 integrated manipulator (3.2.5) or robot;
352 robots with hand-guided controls (HGC);
353 robots with power and force limited (PFL) capabilities;
354 robots with built-in speed and separation monitoring (SSM) safety functions (3.10.3).
355 3.1.3
356 industrial robot system
357 robot system
358 machine comprising:
359 industrial robot (3.1.2);
360 end-effector(s) (3.2.2);
361 any end-effector sensors and equipment (e.g. vision systems, adhesive dispensing, weld controller) needed
362 to support the intended task;
363 task program (3.4.1.1)
364 3.1.4
365 robot application
366 industrial robot application
367 a machine comprising:
368 industrial robot system (3.1.3);
369 workpiece(s);
370 any obstacle or object that has influence on the risk assessment of the intended use
371 3.1.5
372 application
373 intended use and purpose of the robot (3.1.2) or robot system (3.1.3), i.e. the process, the task(s)
374 EXAMPLE: Manipulating. processing, machining, inspection, spot welding, painting, assembly, palletizing.
375 3.1.6 3.1.5
376 collaborative application
377 an application (3.1.5) that contains one or more collaborative task(s) (3.1.7)
378 NOTE 1 to entry: Collaborative applications (3.1.6) can include collaborative tasks (3.1.7) and non-collaborative tasks.
379 3.1.7
380 collaborative task
381 a portion of the robot sequence where both the robot application (3.1.4) and operator(s) (3.9.2) are within the
382 same safeguarded space (3.11.1.4)
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oSIST prEN ISO 10218-2:2
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Frequently Asked Questions
oSIST prEN ISO 10218-2:2021 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Robotics - Safety requirements for robot systems in an industrial environment - Part 2: Robot systems, robot applications and robot cells integration (ISO/DIS 10218-2:2020)". This standard covers: 2022-03-29: DOW= DAV + 24 months
2022-03-29: DOW= DAV + 24 months
oSIST prEN ISO 10218-2:2021 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.
oSIST prEN ISO 10218-2:2021 has the following relationships with other standards: It is inter standard links to SIST EN ISO 10218-2:2011, SIST EN ISO 10218-2:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
oSIST prEN ISO 10218-2:2021 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.
You can purchase oSIST prEN ISO 10218-2:2021 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.








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