oSIST prEN ISO 10218-2:2021

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

• Status: Not Published
• Public Enquiry End Date: 21-Feb-2021
• ICS: 25.040.30 - Industrial robots. Manipulators
• Technical Committee: ITC - Information technology
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 15-Dec-2020
• Due Date: 04-May-2021
• Completion Date: 22-Feb-2021
• Directive: 2006/42/EC - 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)
• Mandate: M/396 - Mandate to CEN and Cenelec for standardisation in the field of machinery
• Ref Project: prEN ISO 10218-2 - Manipulating industrial robots -- Safety -- Part 2: Rebuilding, redeployment and use

Relations

• Revised: SIST EN ISO 10218-2:2011 - Robots and robotic devices - Safety requirements for industrial robots - Part 2: Robot systems and integration (ISO 10218-2:2011)
• Effective Date: 14-Jun-2017
• Revised: SIST EN ISO 10218-2:2011 - Robots and robotic devices - Safety requirements for industrial robots - Part 2: Robot systems and integration (ISO 10218-2:2011)
• Effective Date: 18-Jan-2023
• Revised: SIST EN ISO 10218-2:2011 - Robots and robotic devices - Safety requirements for industrial robots - Part 2: Robot systems and integration (ISO 10218-2:2011)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 10218-2:2021
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
oSIST prEN ISO 10218-2:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 10218-2:2021

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oSIST prEN ISO 10218-2:2021
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

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oSIST prEN ISO 10218-2:2021
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
COPYRIGHT PROTECTED DOCUMENT
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: [phone]
43 claim limit (SILcl) from risk estimation parameters of Annex C . 131
Fax: [phone]
Email: [e-mail]
44 Annex F (informative) Comparison of stop functions . 135
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
© ISO 2020 – All rights reserved iii

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oSIST prEN ISO 10218-2:2021
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 2020 – All rights reserved iii

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oSIST prEN ISO 10218-2:2021
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

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oSIST prEN ISO 10218-2:2021
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.
92
© ISO 2020 – All rights reserved v

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oSIST prEN ISO 10218-2:2021
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.
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oSIST prEN ISO 10218-2:2021
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 2020 – All rights reserved vii

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oSIST prEN ISO 10218-2:2021
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
1
B
2
3
4
180
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
...