Safety of machinery - Integration of machinery into a system - Basic requirements (ISO/DIS 11161:2023)

This document specifies the safety requirements for the integration of machinery into a system. It gives requirements and recommendations for inherently safe design, safeguarding and information for the use of an IMS. This document is not intended to cover safety aspects of individual machines and equipment that can be covered by standards specific to those machines and equipment. Therefore, it deals only with those safety aspects that are important for the safety-relevant interconnection of the machines and components. Where component machines of an integrated machinery system are operated separately or individually, the safety requirements of the relevant safety standards for these machines and equipment apply. This document is also applicable when a modification of an existing IMS results in a new configuration, function, capability or location.

Sicherheit von Maschinen - Integrierte Fertigungssysteme - Grundlegende Anforderungen (ISO/DIS 11161:2023)

Dieses Dokument legt die Sicherheitsanforderungen für die Integration von Maschinen in ein System fest. Es enthält Anforderungen und Empfehlungen für inhärent sichere Konstruktion, Schutzeinrichtungen und ergänzende Schutzmaßnahmen sowie Benutzerinformationen zu integrierten Fertigungssystemen (IMS).
ANMERKUNG   Im Kontext dieses Dokuments bezieht sich der Begriff System auf ein IMS, das auch mit anderen Domänen innerhalb der Lieferkette(n) eines Unternehmens (z. B. intelligente Fertigung) zusammenarbeiten kann. Siehe auch 5.2.2.
Dieses Dokument dient nicht dazu, Sicherheitsaspekte einzelner Maschinen und Ausrüstung abzudecken, die durch andere, für diese Maschinen und Ausrüstung spezifische Normen abgedeckt werden kann. Daher befasst es sich nur mit den Sicherheitsaspekten für die sicherheitsrelevanten Maschinen- und Komponentenverbindungen. Wo Komponentenmaschinen eines integrierten Fertigungssystems separat oder einzeln betrieben werden, gelten die Sicherheitsanforderungen der für diese Maschinen und Ausrüstung jeweils relevanten Sicherheitsnorm.
Dieses Dokument ist auch dann anwendbar, wenn sich aus der Modifikation eines bestehenden IMS eine neue Konfiguration, Funktion, Fähigkeit oder ein neuer Standort ergibt.
Dieses Dokument behandelt die signifikanten Gefährdungen, Gefährdungssituationen oder Gefährdungsereignisse von Maschinen, wenn sie bestimmungsgemäß und unter bestimmten Bedingungen von vernünftigerweise vorhersehbaren Fehlanwendungen verwendet werden. Dieses Dokument liefert auch Anforderungen an IMS, die in Anwendungen wie den folgenden Verwendung finden, wobei jedoch nicht die Gefährdungen in Zusammenhang mit diesen abgedeckt werden
—   Untertagenutzung,
—   kerntechnische Umgebungen,
—   explosionsgefährdete Umgebungen,
—   Gefahren beim Heben von Personen,
—   Verwendung von IMS in Umgebungen mit gefährlicher ionisierender und nichtionisierender Strahlungsbelastung,
—   bei öffentlichem Zugang.
Akustische Geräuschemissionen könnten als signifikante Gefährdung eingestuft werden, die Verringerung von Geräuschemissionen wird von diesem Dokument jedoch nicht abgedeckt.

Sécurité des machines - Systèmes de fabrication intégrés - Exigences fondamentales (ISO/DIS 11161:2023)

Varnost strojev - Integrirani proizvodni sistemi - Osnovne zahteve (ISO/DIS 11161:2023)

General Information

Status
Not Published
Public Enquiry End Date
29-Jun-2023
Technical Committee
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
19-Apr-2023
Due Date
06-Sep-2023
Completion Date
26-Jul-2023

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SLOVENSKI STANDARD
oSIST prEN ISO 11161:2023
01-junij-2023
Varnost strojev - Integrirani proizvodni sistemi - Osnovne zahteve (ISO/DIS
11161:2023)
Safety of machinery - Integration of machinery into a system - Basic requirements
(ISO/DIS 11161:2023)
Sicherheit von Maschinen - Integrierte Fertigungssysteme - Grundlegende
Anforderungen (ISO/DIS 11161:2023)
Sécurité des machines - Systèmes de fabrication intégrés - Exigences fondamentales
(ISO/DIS 11161:2023)
Ta slovenski standard je istoveten z: prEN ISO 11161
ICS:
13.110 Varnost strojev Safety of machinery
25.040.01 Sistemi za avtomatizacijo v Industrial automation
industriji na splošno systems in general
oSIST prEN ISO 11161:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11161:2023

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oSIST prEN ISO 11161:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11161
ISO/TC 199 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-04-11 2023-07-04
Safety of machinery — Integration of machinery into a
system — Basic requirements
Sécurité des machines — Systèmes de fabrication intégrés — Prescriptions fondamentales
ICS: 13.110; 25.040.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 11161:2023(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 2023

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oSIST prEN ISO 11161:2023
ISO/DIS 11161:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11161
ISO/TC 199 Secretariat: DIN
Voting begins on: Voting terminates on:

Safety of machinery — Integration of machinery into a
system — Basic requirements
Sécurité des machines — Systèmes de fabrication intégrés — Prescriptions fondamentales
ICS: 13.110; 25.040.01
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 11161:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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oSIST prEN ISO 11161:2023
ISO/DIS 11161:2023(E)
Contents Page
Foreword . vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 2
3.1 Terms and definitions . 2
3.2 Abbreviated terms . 5
4 Strategy for risk assessment and risk reduction . 5
4.1 General . 5
4.2 Risk assessment with layout analysis . 8
4.2.1 General . 8
4.2.2 Specification of the IMS . 8
4.2.3 Identification of tasks and associated access requirements . 8
4.2.4 Identification of hazards and hazardous situations . 8
4.2.5 Risk estimation and risk evaluation . 8
4.3 Risk reduction . 8
4.4 Validation of the IMS design . 8
5 Risk assessment process with layout analysis . 9
5.1 Information for risk assessment . 9
5.2 Specifications of the IMS . 9
5.2.1 Limits . 9
5.2.2 Functionality . . 9
5.2.3 Layout analysis . 10
5.3 Identification of tasks and associated access requirements . 11
5.3.1 General . 11
5.3.2 Determination of work task(s) .12
5.3.3 Task zone(s) . 13
5.3.4 Space requirements of the IMS . 14
5.3.5 Access to the IMS .15
5.4 Identification of hazards and hazardous situations . 15
5.4.1 General .15
5.4.2 Hazards and hazardous situations due to the component machine(s) and
associated equipment . 16
5.4.3 Hazardous situations due to the location of the equipment . 17
5.4.4 Hazardous situations due to the access path . 17
5.4.5 Hazardous situations due to influence of external sources . 17
5.5 Risk estimation . 17
5.6 Risk evaluation . 18
5.7 Risk reduction . 18
5.8 Documentation of risk assessment and risk reduction . 19
6 Design measures .20
6.1 General . 20
6.2 Space requirements.20
6.3 Task zone design .20
6.4 Mechanical design aspects . 21
6.4.1 General . 21
6.4.2 Materials . 21
6.4.3 Mechanical strength .22
6.4.4 Mechanical design .22
6.4.5 Stability . 22
6.4.6 Position holding . 23
6.4.7 Component malfunction . 23
iii
© ISO 2023 – All rights reserved

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oSIST prEN ISO 11161:2023
ISO/DIS 11161:2023(E)
6.5 Electrical, pneumatic and hydraulic design aspects . . 23
6.6 Provisions for lifting or moving . 23
6.7 Hazardous substances . 24
6.8 Temperature risks . 24
6.9 Fire risks . 24
6.10 Special equipment. 24
6.11 Power loss or change . 24
6.12 Hazardous energy . 25
6.12.1 General . 25
6.12.2 Isolation of hazardous energy sources . 25
6.13 Radiation . 25
6.14 Laser radiation . 25
6.15 Slipping, tripping, falling hazards . 26
6.16 Lightning . 26
7 Safeguarding and span-of-control .26
7.1 Identification of control zones .26
7.2 Task zones . 27
7.2.1 General . 27
7.2.2 Task zone interface . 27
7.2.3 Access path interface . 27
7.2.4 Interface between the flow of materials . 27
7.3 Span-of-control . 27
7.3.1 General . 27
7.3.2 Devices having a span-of-control . 27
7.3.3 Identification of span(s)-of-control .28
7.3.4 Functional safety performance .28
7.4 Start/restart .28
7.5 Stop . 29
7.5.1 General .29
7.5.2 Normal stop .29
7.5.3 Operational stop .29
7.5.4 Emergency stop .29
7.6 IMS modes of operation . 30
7.6.1 General .30
7.6.2 Mode selection . 30
7.6.3 Automatic mode(s) . 32
7.6.4 Manual mode(s) . 32
7.7 Safeguards . 33
7.7.1 Selection and implementation of safeguards . 33
7.7.2 Requirements for guards . 33
7.7.3 Requirements for protective devices . 33
7.8 Protective/risk reduction measures when safeguards are suspended .33
7.8.1 General . 33
7.8.2 Other protective/risk reduction measures . 33
7.8.3 Determining other protective/risk reduction measures .34
7.8.4 Status indication .34
7.8.5 Suspension of safeguards of automatically operating equipment .34
7.9 Muting and blanking .34
7.10 Automatic selection of active detection zones .34
7.11 Control . 35
7.11.1 General . 35
7.11.2 IMS control system . 35
7.11.3 Cyber security . 35
7.11.4 Local control . 35
7.11.5 Measures for the escape and rescue of trapped persons .36
8 Information for use .36
8.1 General .36
iv
  © ISO 2023 – All rights reserved

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oSIST prEN ISO 11161:2023
ISO/DIS 11161:2023(E)
8.2 Marking . 37
9 Validation of the design .37
9.1 Validation that the design meets the functional requirements . 37
9.2 Verification and validation of the protective/risk reduction measures . 37
Annex A (informative) Examples of integration of machinery into a system (IMS) .38
Annex B (informative) Flow of information between the suppliers, integrator and user .41
Annex C (informative) Examples of zone determination and span-of-control .42
Annex D (normative) IMS mode(s) .58
Annex E (normative) Automatic selection of active detection fields .62
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2006/42/EC aimed to be covered .65
Bibliography .69
v
© ISO 2023 – All rights reserved

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oSIST prEN ISO 11161:2023
ISO/DIS 11161:2023(E)
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 199, Safety of machinery.
This third edition cancels and replaces the second edition (ISO 11161:2007 including AMD 1:2010),
which has been technically revised.
The main changes compared to the previous edition are as follows:
— The document title has been changed.
— The document has been completely revised and restructured.
— New Annexes have been added.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
vi
  © ISO 2023 – All rights reserved

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oSIST prEN ISO 11161:2023
ISO/DIS 11161:2023(E)
Introduction
An integrated machinery system (IMS, see 3.1.1) can be very different in terms of size and complexity,
and can incorporate different technologies that require diverse expertise and knowledge.
An integrated machinery system is considered to be a whole new and different machine. Ideally, the
entities which individually know only a part of the IMS will cooperate with the integrator. Manufacturing,
as a stand-alone application or connected with other domains in the context of Smart Manufacturing,
have tasks, which can be internal or external to the IMS. For frequent manual intervention(s) to parts
of the IMS (e.g., inspections, maintenance, set-up, observation), minimal downtime and prompt restart
are essential to lessen the motivation to defeat protective/risk reduction measures. This can be
accomplished by safeguarding for these intervention tasks and use of "task zones".
This document describes how to apply the requirements of ISO 12100 in the context of an IMS.
Some examples of integration of machinery into a system are included in Annex A.
The structure of safety standar
...

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