prEN ISO 11161

SLOVENSKI STANDARD
01-september-2024
Varnost strojev - Integrirani proizvodni sistemi - Osnovne zahteve (ISO/DIS
11161:2024)
Safety of machinery - Integration of machinery into a system - Basic requirements
(ISO/DIS 11161:2024)
Sécurité des machines - Intégration de machines dans un système -Exigences
fondamentales (ISO/DIS 11161:2024)
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
Safety of machinery — Integration
Secretariat: DIN
of machinery into a system — Basic
Voting begins on:
requirements
2024-07-29
ICS: 13.110; 25.040.01
Voting terminates on:
2024-10-21
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Reference number
ISO/DIS 11161:2024(en)
DRAFT
ISO/DIS 11161:2024(en)
International
Standard
ISO/DIS 11161
ISO/TC 199
Safety of machinery — Integration
Secretariat: DIN
of machinery into a system — Basic
Voting begins on:
requirements
ICS: 13.110; 25.040.01
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
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STANDARDS MAY ON OCCASION HAVE TO
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Published in Switzerland Reference number
ISO/DIS 11161:2024(en)
ii
ISO/DIS 11161:2024(en)
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 Risk assessment process supported by layout analysis . 5
4.1 General .5
4.2 Information for risk assessment .8
4.3 Specifications of the IMS .9
4.3.1 Limits .9
4.3.2 Functionality . .9
4.4 Identification of tasks and associated access requirements .10
4.4.1 General .10
4.4.2 Identification of work task(s) .10
4.4.3 Task zone(s) .11
4.4.4 Space requirements of the IMS . 13
4.4.5 Access to the IMS . 13
4.5 Identification of hazards and hazardous situations .14
4.5.1 General .14
4.5.2 Hazards and hazardous situations due to the component machine(s) and
component equipment . 15
4.5.3 Hazardous situations due to the location of component machines and
component equipment . 15
4.5.4 Hazardous situations due to the access path . 15
4.5.5 Hazardous situations due to influence of external sources . 15
4.6 Risk estimation .16
4.7 Risk evaluation .16
4.8 Risk reduction .16
4.9 Validation of the IMS design .17
4.10 Documentation of risk assessment and risk reduction .17
5 Design measures .18
5.1 General .18
5.2 Space requirements.18
5.3 Task zone design .18
5.4 Mechanical design aspects .19
5.4.1 General .19
5.4.2 Materials .19
5.4.3 Mechanical strength .19
5.4.4 Mechanical design . 20
5.4.5 Stability . 20
5.4.6 Position holding . 20
5.4.7 Component malfunction .21
5.5 Electrical, pneumatic and hydraulic design aspects . .21
5.6 Provisions for lifting or moving .21
5.7 Hazardous substances . 22
5.8 Temperature risks . 22
5.9 Fire risks . 22
5.10 Special equipment. 22
5.11 Power loss or change . 22
5.12 Hazardous energy . 22
5.12.1 General . 22

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ISO/DIS 11161:2024(en)
5.12.2 Isolation of hazardous energy sources . 23
5.13 Radiation . 23
5.14 Laser radiation . 23
5.15 Slipping, tripping, falling hazards . 23
5.16 Lightning .24
6 Safeguarding and span-of-control .24
6.1 Safeguarding of task zones .24
6.1.1 General .24
6.1.2 Task zone interface .24
6.1.3 Access path interface .24
6.1.4 Interface between the flow of materials .24
6.2 Identification of control zones .24
6.3 Span-of-control . 25
6.3.1 General . 25
6.3.2 Devices having a span-of-control . 26
6.3.3 Identification of span(s)-of-control . 26
6.3.4 Functional safety performance . 26
6.4 Start/restart . 26
6.5 Stop control .27
6.5.1 General .27
6.5.2 Normal stop .27
6.5.3 Operational stop .27
6.5.4 Emergency stop .27
6.6 IMS modes of operation . 28
6.6.1 General . 28
6.6.2 Mode selection . 28
6.6.3 Automatic mode(s) . 29
6.6.4 Manual mode(s) . 30
6.7 Safeguards .31
6.7.1 Selection and implementation of safeguards .31
6.7.2 Requirements for guards .31
6.7.3 Requirements for protective devices .31
6.8 Risk reduction measures when safeguards are suspended .31
6.8.1 General .31
6.8.2 Other risk reduction measures .31
6.8.3 Status indication .32
6.9 Muting and blanking .32
6.10 Automatic selection of active detection zones .32
6.11 Control .32
6.11.1 General .32
6.11.2 IMS control system . 33
6.11.3 Cyber security . 33
6.11.4 Local control . 33
6.11.5 Measures for the escape and rescue of trapped persons . 33
7 Information for use .34
7.1 General . 34
7.2 Marking . 34
8 Validation of the design .35
8.1 Validation that the design meets the functional requirements . 35
8.2 Verification and validation of the risk reduction measures. 35
Annex A (informative) Examples of integration of machinery into a system (IMS) .36
Annex B (informative) Flow of information between the suppliers, integrator and user .39
Annex C (informative) Examples of zone determination and span-of-control .40
Annex D (normative) IMS mode(s) .56

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ISO/DIS 11161:2024(en)
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2006/42/EC aimed to be covered .60
Bibliography .64

v
ISO/DIS 11161:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 114, Safety of machinery,
in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 11161:2007), which has been technically
revised. It also incorporates the Amendment ISO 11161:2007/Amd1:2010.
The changes 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 11161:2024(en)
Introduction
Integrated machinery systems (see 3.1.1) can be different in terms of size and complexity, and can
incorporate different technologies that require diverse expertise and knowledge.
An integrated machinery system (IMS) 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, cleaning, set-up, observation), minimal downtime and prompt restart
are essential to lessen the motivation to defeat 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 (e.g. small, medium and large enterprises);
— health and safety bodies (e.g. regulators, accident prevention organisations, market surveillance).
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 (e.g. 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.
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.

vii
ISO/DIS 11161:2024(en)
Figure 1 shows the relationship between the safety standards relating to machines and their integration
into a system.
a
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 11161:2024(en)
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 machinery 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 4.3.2.
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 IMS 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 such as the following, but does not cover the hazards
related to them:
— 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 can be identified as a significant hazard. The reduction of acoustic 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 4871, Acoustics — Declaration and verification of noise emission values of machinery and equipment
ISO 11553 (all parts), Safety of machinery — Laser processing machines

ISO/DIS 11161:2024(en)
ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction
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 14119:2024, 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
1)
IEC 60204-1:2021 , 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 terminology 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/
1) i.e. Edition 6.1 which combines IEC 60204-1:2016 and Amendment 1, AMD 1:2021.

ISO/DIS 11161:2024(en)
3.1.1
integrated machinery system
IMS
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.
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.
Note 2 to entry: A component machine can also be machinery which cannot perform a specific task before being
integrated into an IMS.
3.1.3
integrator
entity who designs, provides, manufactures or assembles an integrated machinery system and the safety
strategy, including the 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 portion of the system in which operation is affected from a control unit which is within
visual line-of-sight of the span-of-control
3.1.5
blanking
function that permits an object of a size greater than the detection capability of the electro-sensitive
protective equipment 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 – Delete “optional” from the beginning of the definition.]
3.1.6
muting
temporary automatic suspension of a safety function(s) by the SRP/CS
[SOURCE: ISO 13849-1:2023, 3.1.15, modified – Acronym SRP/CS spelled out as safety-related part of a
control system.]
3.1.7
safeguarded space
area or volume where guards and/or protective devices are intended to protect persons from a hazard(s)
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 can initiate a stop of a machine or a portion of a machine. For example, an
emergency stop pushbutton can cause a local stop or global stop (see ISO 13850).

ISO/DIS 11161:2024(en)
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.
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.
[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 integrated machinery system mode (3.1.15).
3.1.15
integrated machinery system mode
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 3691-4:2023, 3.45]
3.1.17
operational stop
stop function of machinery for functional purposes only
3.1.18
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.

ISO/DIS 11161:2024(en)
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]
3.1.19
component equipment
any part of an integrated machinery system which is not a component machine
Note 1 to entry: Equipment itself is not a component machine (e.g. a welding current transformer, weld gun).
EXAMPLE Piping components, fixtures for workpieces, luminaires, cable trays.
3.1.20
visual line-of-sight
situation where a person has direct visibility of the span-of-control
Note 1 to entry: Direct visibility does not depend on additional means (e.g. mirrors, CCTV etc.). See also ISO 12100:2010,
6.2.2.1 a).
3.1.21
layout analysis
methodology to support hazard identification and task zone identification as well as determination of
control zones and span(s)-of-control, based on the arrangement of the component machines and component
equipment of the integrated machinery system
Note 1 to entry: Layout analysis can also be used to optimize the design of an integrated machinery system (e.g.
functional performance) to reduce or eliminate the incentive to defeat or circumvent risk reduction measures.
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
4 Risk assessment process supported by layout analysis
4.1 General
Component machines shall be in accordance with the requirements of ISO 12100 and applicable type-B and
type-C standards.
ISO/DIS 11161:2024(en)
Risk assessment and risk reduction when integrating the component machines and component equipment
into the IMS shall be done in accordance with ISO 12100 and can be supported by the layout analysis process
as shown in Figure 2.
ISO/DIS 11161:2024(en)
NOTE Figure 2 is based upon the schematic representation of the process of risk assessment and risk reduction
from ISO 12100:2010, Figure 1, supplemented with additional
...