prEN ISO 11161

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.
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ISO/DIS 11161:2023(E)
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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.
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
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 11161:2023(E)
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ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 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/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/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/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/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 standards in the field of machinery is as follows.
a) Type-A standards (basic safety standards) give basic concepts, principles for design and general
aspects that can be applied to machinery;
b) Type-B standards (generic safety standards) dealing with one or more safety aspect(s), or one or
more type(s) of safeguards that can be used across a wide range of machinery:
— type-B1 standards on particular safety aspects (for example, safety distances, surface
temperature, noise);
— type-B2 standards on safeguards (for example, two-hands control devices, interlocking devices,
pressure-sensitive devices, guards);
c) Type-C standards (machine safety standards) dealing with detailed safety requirements for a
particular machine or group of machines.
This document is a type-B1 standard as stated in ISO 12100.
This document is of relevance, in particular, for the following stakeholder groups representing the
market players with regard to machinery safety:
— machine manufacturers (small, medium and large enterprises);
— health and safety bodies (regulators, accident prevention organisations, market surveillance etc.)
Others can be affected by the level of machinery safety achieved with the means of the document by the
above-mentioned stakeholder groups:
— machine users/employers (small, medium and large enterprises);
— machine users/employees (e.g., trade unions, organizations for people with special needs);
— service providers, e. g. for maintenance (small, medium and large enterprises);
— consumers (in case of machinery intended for use by consumers).
The above-mentioned stakeholder groups have been given the possibility to participate at the drafting
process of this document.
In addition, this document is intended for standardization bodies elaborating type-C standards.
The requirements of this document can be supplemented or modified by a type-C standard.
vii
ISO/DIS 11161:2023(E)
For machines which are covered by the scope of a type-C standard and which have been designed and
built according to the requirements of that standard, the requirements of that type-C standard take
precedence.
Figure 1 shows the relationship between the safety standards relating to machines and their integration
into a system.
* Use applicable type-B standard(s) if no type-C standard exists; see ISO/TR 22100-1:2021, Figure 4
Figure 1 — Relationship between the safety standards relating to machines and their
integration into a system
viii
DRAFT INTERNATIONAL STANDARD ISO/DIS 11161:2023(E)
Safety of machinery — Integration of machinery into a
system — Basic requirements
1 Scope
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 complementary
protective measures, and information for use of an integrated manufacturing system (IMS).
NOTE In the context of this document, the term system refers to an IMS which can also collaborate with
other domains within the supply chain(s) of an enterprise (e.g., smart manufacturing). See also 5.2.2.
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 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.
This document deals with the significant hazards, hazardous situations or hazardous events when used
as intended and under specified conditions of misuse which are reasonably foreseeable. This document
also provides requirements for IMS used in applications as following, but does not cover the hazards
related to
— underground use,
— nuclear environments,
— potentially explosive environments,
— hazards due to the lifting of persons,
— use of IMS in environments with hazardous ionizing and non-ionizing radiation levels,
— when the public have access.
Emission of acoustic noise could be identified to be a significant hazard but the reduction of noise
emissions is not covered in this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 4413:2010, Hydraulic fluid power — General rules and safety requirements for systems and their
components
ISO 4414:2010, Pneumatic fluid power — General rules and safety requirements for systems and their
components
ISO 11553 (all parts), Safety of machinery — Laser processing machines
ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction
ISO/DIS 11161:2023(E)
ISO 13732-1, Ergonomics of the thermal environment — Methods for the assessment of human responses to
contact with surfaces — Part 1: Hot surfaces
ISO 13732-3, Ergonomics of the thermal environment — Methods for the assessment of human responses to
contact with surfaces — Part 3: Cold surfaces
ISO 13849-1:2023, Safety of machinery — Safety-related parts of control systems — Part 1: General
principles for design
ISO 13850:2015, Safety of machinery — Emergency stop function — Principles for design
ISO 13851, Safety of machinery — Two-hand control devices — Principles for design and selection
ISO 13856 (all parts), Safety of machinery — Pressure-sensitive protective devices
ISO 14118, Safety of machinery — Prevention of unexpected start-up
ISO 14119:2023, 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
ISO 14159, Safety of machinery — Hygiene requirements for the design of machinery
ISO 19353, Safety of machinery — Fire prevention and fire protection
ISO 20607:2019, Safety of machinery — Instruction handbook — General drafting principles
IEC 60204-1:2016, Safety of machinery — Electrical equipment of machines — Part 1: General requirements
IEC 61496-1:2020, Safety of machinery — Electro-sensitive protective equipment — Part 1: General
requirements and tests
IEC 62046:2018, Safety of machinery — Application of protective equipment to detect the presence of
persons
IEC/TS 62998-1, Safety of machinery — Safety-related sensors used for the protection of persons
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 12100 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1.1
integrated machinery system
two or more machines, capable of operating independently of each other, which are interconnected by
controls and act together in a coordinated manner
Note 1 to entry: An integrated machinery system is typically used for the purpose of fabrication, production,
treatment, processing or packaging of discrete parts or assemblies as part of an enterprise's supply chain.
Note 2 to entry: An integrated machinery system can be linked by a material-handling system.
ISO/DIS 11161:2023(E)
3.1.2
component machine
individual machine which is part of an integrated machinery system
Note 1 to entry: A component machine can be stationary or mobile during intended use or operation.
3.1.3
integrator
entity who designs, provides, manufactures or assembles an integrated machinery system and the
safety strategy, including the protective/risk reduction measures, control interfaces, interconnections
of the control system and instruction for use
Note 1 to entry: The integrator can be a manufacturer, assembler, engineering company or the user.
3.1.4
local control
state of the system or portions of the system in which operation is affected from a specific control panel
or pendant
3.1.5
blanking
optional function that permits an object of a size greater than the detection capability of the ESPE to be
located within the detection zone without causing an OFF-state of the output signal switching device(s)
[SOURCE: IEC 62046:2018, 3.1.4, modified – Acronym OSSD has been replaced by output signal
switching device.]
3.1.6
muting
temporary automatic suspension of a safety function(s) by the SRP/CS
[SOURCE: ISO 13849-1:2023, 3.1.8]
3.1.7
safeguarded space
area or volume enclosing (a) hazard zone(s) where guards and/or protective devices are intended to
protect persons
3.1.8
span-of-control
predetermined portion of the machinery under control of a specific device or safety function
Note 1 to entry: A protective device could initiate a stop of a machine or a portion of a machine. For example, an
emergency stop pushbutton could cause a local stop or global stop (see ISO 13850).
3.1.9
zone
space within machinery or an integrated machinery system
Note 1 to entry: An integrated machinery system can be segmented for specific purposes into zones. See also
Annex C.
3.1.10
control zone
identified portion of machinery or an integrated machinery system coordinated by the control system
3.1.11
detection zone
zone within which a specified test piece will be detected by the sensitive protective equipment
Note 1 to entry: ISO 13856-1 uses the term “effective sensing area” when describing pressure-sensitive mats and
floors. In this document the terms “detection zone” and “effective sensing area” are used synonymously.
ISO/DIS 11161:2023(E)
[SOURCE: IEC 61496-1:2020, 3.4, modified – “electro-” has been removed before “sensitive protective
equipment” and Note 1 to entry has been added]
3.1.12
task zone
predetermined space within or around machinery or an integrated machinery system in which
personnel can perform a specified activity
3.1.13
user
entity who utilizes the machinery
3.1.14
manual mode
control state that requires an operator to initiate and/or maintain operation of the machine by use of
actuating control
Note 1 to entry: The operation can be of the IMS, portions of the IMS, component machines or portions of
machines.
Note 2 to entry: See also 3.1.15, IMS mode.
3.1.15
IMS mode
mode specific to the integration of machinery into a system
Note 1 to entry: See also 7.6 and Annex D.
3.1.16
protective stop
safety-related stop function initiated by a protective device
[SOURCE: ISO 3691-4:2020, 3.46]
3.1.17
operational stop
safety-related stop function that does not cut off the energy supplied to the actuators and monitors and
maintains the stop condition in order to perform specific operations
3.1.18
whole body access
situation where a person can be completely inside a safeguarded space
3.1.19
smart manufacturing
manufacturing that improves its performance aspects with integrated and intelligent use of processes
and resources in cyber, physical and human spheres to create and deliver products and services, which
also collaborates with other domains within enterprises’ value chains
Note 1 to entry: Performance aspects include agility, efficiency, safety, security, sustainability or any other
performance indicators identified by the enterprise.
Note 2 to entry: In addition to manufacturing, other enterprise domains can include engineering, logistics,
marketing, procurement, sales or any other domains identified by the enterprise.
[SOURCE: ISO/TR 22100-4:2019, 3.16]
ISO/DIS 11161:2023(E)
3.1.20
equipment
tools or objects required to accomplish a task related the machine and single items or assemblies for
the utilization of electricity, pneumatic or hydraulic power by machines or component machines.
Note 1 to entry: Equipment itself is not a component machine (e.g., a welding current transformer, weld gun).
Note 2 to entry: Examples of equipment are piping components, fixtures for workpieces, luminaires, cable trays.
3.1.21
visual line-of-sight
condition in which the operator maintains direct unaided visual contact with the span-of-control
3.2 Abbreviated terms
AGV automatic guided vehicle
AOPD active opto-electronic protective device
AOPDDR active opto-electronic protective device responsive to diffuse reflection
ESPE electro-sensitive protective equipment
HMI human machine interface
IMS integrated machinery system
OSSD output signal switching device
PL performance level
PL required performance level
r
SPE sensitive protective equipment
SRP/CS safety-related part of a control system
VLOS visual line-of-sight
4 Strategy for risk assessment and risk reduction
4.1 General
Component machines shall comply with the requirements of ISO 12100 and applicable type-B and
type-C standards.
Risk assessment and risk reduction of an IMS shall be in accordance with ISO 12100.
Risk assessment shall also identify tasks or hazards which can arise due to influences external to the
IMS (e.g., Smart Manufacturing, network connections, see 7.11.3).
Risk reduction shall be done when integrating the component machines into the IMS to achieve adequate
risk reduction. Information for use of the IMS shall be in accordance with Clause 8.
The IMS shall be designed to facilitate manual intervention(s), including maintenance. Where multiple
configurations and modifications are foreseeable, the IMS shall be designed for each intended
functionality. For some manual intervention(s) where it is impractical to stop the whole IMS, segregated
zone(s) with safety functions including span(s)-of-control shall be established where operators can
perform their tasks safely.
ISO/DIS 11161:2023(E)
Clause 5 applies to the risk
...