ISO 11161:1994

ISO
INTERNATIONAL
STANDARD 11161
First edition
1994-04-01
Industrial automation Systems - Safety
of integrated manufacturing Systems -
Basic requirements
Sys thmes d ‘automa tisa tion industrielle - Skcurit6 des sys temes de
fabrica tion in t&gr& - Prescrip tions fondamen tales
Reference number
ISO 11161 :1994(E)

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ISO 11161:1994(E)
Contents
Page
1
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
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3 Definitions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4 Safety strategy
3
4.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
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4.2 System specification
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.3 Application of a safety strategy
5
4.4 Hazard identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
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4.5 Risk assessment
. . . . . . . . . . . . . . . . . .*. 6
4.6 Ergonomie considerations
8
4.7 Marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8
..,.....,,,,.....,,..,..,...............,.
4.8 Requirements for documentation
8
5 Design requirements for safety functions of the control System
8
5.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8
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5.2 I nterferences
9
. . . . . . . . . . . . . . . . . . . . . . .
5.3 Limitation of fault effects for safety functions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.4 Safety measures
10
.*.
5.5 Manually-operated control devices
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.6 Status indicators
. . . . . . . . . . . . . . . . 11
5.7 Selection of the operating modes of the System
Control measures for the Suspension of safeguards . . . . . . . . . . . 11
5.8
11
5.9 Local Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
5.10 Starting . . .*.
12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.11 Stopping
13
5.12 Emergency movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0 ISO 1994
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronie or mechanical, including photocopying and
microfilm, without Permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-l 211 Geneve 20 l Switzerland
Printed in Switzerland

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0 ISO ISO 11161:1994(E)
5.13 Power interruption or fluctuation . 13
5.14 Power disconnection . 13
..................................................................... 13
5.15 Stored energy
13
5.16 Safety related Parameters .
13
6 Design and safeguarding of the System .
6.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6.2 Safeguarding requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
14
6.3 Guards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6.4 Interlocks and protective trip devices
17
6.5 Ena bling devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
................................................................... 17
6.6 Warning devices
17
6.7 Safety markings .
17
6.8 Safe working procedures .
18
6.9 Openings for loading and unloading of material .
....................................................... 18
6.10 Stopping timeldistance
. . 18
7 Training, installation, commissioning and functional testing
18
7.1 General .,.,,,.*.,.,.,.,.,.*.,.,.,.,.
18
7.2 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .” 18
7.3 Installation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7.4 Commissioning and functional testing
8 Use and care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~ 19
................................................................................. 19
8.1 General
................................................. 19
8.2 Requirements for personnel
19
8.3 Normal Operation .
20
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.4 Manual Operation
........................................................................ 20
8.5 Programming
.............................................................. 21
8.6 Program verification
8.7 Troubleshooting and Observation of production cycle . 21
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 21
8.8 Maintenance and repair
21
8.9 Fault elimination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
. 21
8.10 System restart procedures after maintenance and repair
. . .
Ill

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Q ISO
ISO 11161:1994(E)
A Examples of a typical integrated manufacturing System
23

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0 ISO
ISO 11161:1994(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. Esch 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.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard ISO 11161 was prepared by Technical Committee
ISO/TC 184, Industrial automation Systems and integration.
Annex A of this International Standard is for information only.

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63 ISO
ISO 11161:1994(E)
Introduction
0.1 This International Standard is part of a series of Standards dealing
with safety of industrial machines. lt has been harmonized with other rel-
evant International Standards dealing with safety issues of industrial
equipment.
The intent of this International Standard is to provide safety requirements
and guidelines for the design, construction, installation, programming,
Operation, use, and maintenance of integrated manufacturing Systems. lt
describes basic types of hazards associated with these Systems and Steps
to be taken to assess the risks associated with these hazards and to
eliminate or reduce the hazards to an acceptable Ievel.
Where specific Points in this International Standard are considered to be
in conflict with the requirements of other international Standards (now or
in the future), these requirements will be analysed to determine if they are
to be included or deleted as System safety requirements.
0.2 This International Standard has been created in recognition of the
particular hazards which exist in integrated manufacturing Systems incor-
porating industrial machines and associated equipment.
The risks associated with these hazards vary with the types of industrial
machines incorporated in integrated manufacturing System and the appli-
cation of such a System as to how it is installed, programmed, operated,
maintained and repaired.
The requirements of this International Standard are aimed at minimizing
the possibilities of injuries to Personne1 while working on or adjacent to
an integrated manufacturing System. This International Standard contains
definitions, measures or procedures, and devices which are not specific
to Systems but tan also apply to safety requirements for individual ma-
chines and equipment. They are included in this International Standard to
make it more understandable or because no relevant international stan-
dards exist.
Figure0.1 Shows a typical System with the assumption that all of the
hazards presented by the System are contained within the work Zone.
These hazards are suitably protected by safeguarding means determined
by the risk assessment (see clause 4) and described in clauses 5 to 8 of
this International Standard.
Where hazards are presented by equipment outside the work zone (e.g.
electrical shock), it is intended that these hazards be suitably protected
by means described in relevant International Standards (e.g. IEC 204-1)
vi

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0 ISO
ISO 11161:1994(E)
which tan be integrated by the procedures developed by the System
supplier or User.
Supervisory
control
A
Localarea network/
data link
Figure 0.1 - Basic integrated manufacturing System
vii

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INTERNATIONAL STANDARD 0 ISO
ISO 11161:1994(E)
Industrial automation Systems - Safety of integrated
manufacturing Systems - Basic requirements
lSO/TR 8373: 1988, Manipulating industrial robots -
1 Scope
Vocabulary.
This International Standard specifies the safety re-
ISO 10218:1992, Manipulating industrial robots -
quirements for integrated manufacturing Systems that
Safety.
incorporate two or more industrial machines inter-
connected with and operated by a controller(s) ca-
CEI 204-1: 1992, Electrical equipment of industrial
pable of being reprogrammed for the manufacturing
machines - Part 1: General requiremen ts.
of discrete Parts or assemblies. lt describes the re-
quirements and recommendations for the safe instal-
EN 418:1992, Safety of machinery - Emergency
lation, programming, Operation, maintenance, or repair
stop equipment, Functional aspects - Principles for
of such Systems (see figureO.l for the basic config-
design.
uration of an integrated manufacturing System).
This International Standard is not intended to cover
safety aspects of individual machines and equipment
3 Definitions
which may be covered by Standards specific to those
machines and equipment. Where machines and
For the purposes of this International Standard, the
equipment of an integrated manufacturing System are following definitions apply.
operated separately or individually and while the pro-
tective effects of the safeguards provided for auto-
3.1 awareness barrier: Attachment or obstacle that
matic mode are muted or suspended, the relevant
by physical contact warns of an approaching or pres-
safety Standards for these machines and equipment
ent hazard.
shall apply.
3.2 barrier: Physical boundary to a hazard.
2 Normative references
3.3 controlled stop: The stopping of machine mo-
tion by reducing the command Signal to 0 once the
The following Standards contain provisions which,
Signal has been recognized by the control but retain-
through reference in this text, constitute provisions
ing power to the machine actuators during the
of this International Standard. At the time of publi-
stopping process. [IEC 204-1: 1992, 3.121
cation, the editions indicated were valid. All Standards
are subject to revision, and Parties to agreements
3.4 enabling device:
Manually-operated device
based on this International Standard are encouraged
which, when continuously activated in one Position
to investigate the possibility of applying the most re-
only, allows hazardous functions but does not initiate
cent editions of the Standards indicated below.
them. In any other Position, hazardous functions are
Members of IEC and ISO maintain registers of cur-
stopped safely.
rently valid International Standards.
3.5 guard: Machine element specifically used to
ISO 3864: 1984, Safety colours and safety signs.
provide protection by means of a physical barrief.
ISO 6385: 1981, Ergonomie principles in the design of Depending on its construction, a guard may be called
work sys tems. casing, cover, Screen, door, enclosing guard, etc.

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0 ISO
ISO 11161:1994(E)
3.6 hazard: Source of possible injuty or darnage to 3.18 Pendant: Unit Iinked to the control System with
health. which the System or portions of the System tan be
programmed (or moved).
3.7 hazard zone [area] [space]: Any zone within
and/or around machinery in which a person is ex-
3.19 person: Any individual.
posed to risk of injury or darnage to health.
3.20 personnel: Persons specifically employed and
3.8 hazardous Situation [condition] [motion]:
trained in the use and care of a machine or manufac-
Any Situation in which a person is exposed to a hazard
turing System.
or hazards.
3.21 protective device: Device (other than a guard)
3.9 hold-to-run control device: Manually-actuated
which reduces risk, alone or associated with a guard.
Start and stop control device which initiates and
maintains Operation of machine elements only as long
3.22 risk: Combination of the probability of injury
as the control is actuated in a set Position. The control
occurring and the degree of the injury or darnage to
automatically returns to the stop Position when re-
health in a definite hazardous Situation.
leased.
3.23 safeguard: Guard or protective device used in
3.10 industrial machine; machine: Individual com-
a safety function to protect persons from a present
ponent machine and associated equipment of an in-
or impending hazard.
tegrated manufacturing System.
3.24 safeguarded space: Spate determined by the
3.11 integrated manufacturing System; System:
safeguards.
Group of two or more industrial machines working
together in a coordinated manner normally intercon-
3.25 safeguarding: Those safety measures consist-
nected with and operated by a supervisoty controller
ing of the use of safeguards to protect persons from
or controllers capable of being reprogrammed for the
the hazards which cannot reasonably be removed or
manufacturing of discrete Parts or assemblies.
sufficiently eliminated by design.
3.12 interlocking device (as used with a guard):
Mechanical, electrical, or other type of device, the
3.26 safe working procedure: Specified procedure
purpose of which is to prevent the Operation of sys-
intended to reduce the possibility of injury while per-
tem elements under specified conditions (generally
forming an assigned task.
as long as the guard is not closed).
3.27 supplier: Entity (e.g. designer, manufacturer,
3.13 limiting device: Device which prevents a sys-
contractor, installer, integrator) who provides equip-
tem or System elements from exceeding a design
ment or Services associated with the manufacturing
Ilmit.
System or Portion of the System.
3.14 local control: State of the System or portions NOTE 1 The user may also act in the capacity of a sup-
plier to himself.
of the System in which the System is operated from
the control Panel or Pendant of the individual ma-
chines only.
3.28 task program: Set of motion and auxiliary
functions instructions which define the specific in-
3.15 lackout: Placement of a leck on the energy tended task of the manufacturing System.
isolating device (e.g. disconnecting means) in the
NOTE 2 This type of program is normally generated by
“OFF” or “OPEN” Position indicating that the energy
the User.
isolating device or the equipment being controlled
shall not be operated until the fernoval of the leck.
3.29 trip device: Device which Causes a System or
System element to stop when a person or a part of
3.16 muting: Temporary automatic Suspension of
his or her body goes beyond a safe limit.
the protective function of a safeguarding device dur-
ing normal Operation.
3.30 troubleshooting; fault finding: Act of meth-
3.17 operational stop: Stop which Stops the pro- odically determining the reason that the System or
duction process at a natura1 Point in the working portions of the System has failed to perform the task
process as soon as possible after its activation. or function as intended.
2

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Q ISO
ISO 11161:1994(E)
3.31 uncontrolled stop: Stopping of machine mo-
layout and/or model;
tion by removing power to the machine actuators
Survey about the interaction of different working
which Cause hazardous conditions, all brakes or other
processes and manual activities;
mechanical stopping devices being activated (see IEC
204-1).
analysis of process sequences including manual
interaction;
3.32 User: Entity who utilizes and maintains the
man
ufacturing System.
description of the interfaces with conveyer or
transport lines;
process flow Charts;
foundation Plans;
Plans for supply and disposal devices;
4 Safety strategy
determination of the space required for supply and
4.1 General
disposal of material;
This clause deals with the Overall strategy of deter-
available accident records;
mining the safety requirements for a System. This
Overall strategy is a combination of the measures in-
study of similar System installations.
corporated at the design Stage and those measures
required to be implemented by the User.
~ne designer shall have a specific and documented
idea of the probable human activities on the site, and
The design of the System shall be the first consider-
in particular:
ation while still maintaining an acceptable level of
Performance. This Phase of the safety strategy
visits (presence of third Parties not directly con-
should:
cerned by the Operation);
specify the limits or Parameters of the System (see
process control and monitoring;
.
.
4 2) I
workpiece loading;
apply a safety strategy (4.3);
takeover of manual control by Operator;
identify the hazards (4.4);
brief interventions not requiring disassembly;
assess the associated risks (4.5);
setti ng ;
remove the hazards or limit the risks as much as
practicable.
troubleshooting;
Where it is not possible to reduce the risks to an ac-
maintenance.
ceptable level by the above measures, provisions for
safeguarding in the design Phase shall be considered
This information will enable the designer to work out
in such a manner that the flexibility of the System in
a coherent, purposeful Programme of action based on
its application is retained without impairing its safety.
the following elements:
In addition, information (e.g. written instructions,
- analysis of reference situations (Old or more recent
warning signs) concerning hazards which are difficult
on other sites);
to recognize shall be provided.
- allowance for effects of industrial variability
(equipment wear, dimensional variations of prod-
4.2 System specification
uct, etc.);
A System concept shall define the System specifi-
- participation of Personne1 having to work on the
cation. This includes or takes into account:
System in the future.
description of functions;

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63 ISO
ISO 11161:1994(E)
4.2.1 System design criteria
4.3 Application of a safety strategy
Besides the description of functions, all necessary
An integrated manufacturing System shall be de-
requirements to ensure safe Operation should be
signed and safeguarded to ensure orderly transport
considered in the design criteria list. This includes all
and installation as well as proper and safe use and
protective measures to effectively reduce the hazards
maintenance in accordance with the risk assessment
listed in 4.4 where they exist.
(see 4.5). To achieve these objectives the relationship
between human factors, the work being carried out,
Such a design implies a coherent procedure which
the hazards arising and the production process should
minimizes the effects of project fragmentation. This
be taken into account.
requires:
The factors of noise, hazardous materials, heat, low
integration of the man-machine interface;
temperature, radiation and similar influences of the
physical operating environment shall be considered
early definition of the Position of those working on
so as not to create health hazards.
the System (in time and space);
The supplier(s) of the System (or Parts of the System)
cutting down on
early consideration of ways of
shall state the expected conditions of the physical
isolated work;
environment and the requirements of the extemal
.
* I . ’ r c I powers sources and how they are to be connected to
consiaerarjon or envrronmenraj aspects (e.g. qual-
ensure proper Operation. The user shall ensure that
ity of air, lighting conditions, noise).
either these conditions are met or that alternative
means are provided and that the System operates
A System shall not be designed exclusively in terms
under these conditions according to the specification.
of its working functions; it shall also be considered
from the viewpoints of its use and Operation.
4.2.2 Project Organkation
4.3.1 Design and development
During planning, design and construction of a manu-
All available knowledge concerning safety should be
facturing System, safety measures especially those
considered during the development of Single units,
related to the interactions between individual ma-
sections of System and complete Systems so that,
chines shall be coordinated. This applies also where
through its application, accident and health hazards
a System consists of a combination of sections
shall be prevented or reduced to an acceptable level.
and/or Single units from different suppliers.
This includes the clarity of the complete System, the
sections of System and the Single units. Particularly,
The Coordination of activities include, for example:
the normal operating positions of personnel shall
grant sufficient Vision of the flow of production and
- planning;
the machining operations which may require addi-
tional measures (e.g. Video monitoring).
- procurement;
Normal positions for operating and maintenance per-
- delivery and assembly;
sonnel shall be easily accessible and located outside
hazardous areas. Elements requiring routine mainte-
- installation procedure and Stage of testing;
nance (e.g. Points of lubrication, setting mechanisms)
shall be arranged, where practicable, outside the haz-
- partial acceptance/acceptance;
ardous areas. lt is preferable to achieve the desired
levels of safety by the use of nonhazardous elements
- delivery of the System in final working Order;
to remove or reduce hazards. Secondly, alternative
process sequences or working processes giving a
- System verification (runoff) including correction of
lower level of risk may be used.
any fau ts or failures found;
Manually-operated Start and stop controls shall be lo-
- maintainability;
cated in such a way that the hazard zone which is
- ergonomic factors. associated with that control facility is clearly identified.

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0 ISO
ISO 11161:1994(E)
4.3.2 Safeguarding a) moving mechanical components in
Where the measures in accordance with 4.3.1 are not
1) normal Operation either individually or in con-
or only partially applicable in reducing risks to an ac-
junction with other elements of the System
ceptable level, the safeguards given in clause 6 shall
or related equipment in the hazard Zone,
be provided. These safeguards shall not complicate
2) unexpected Operation (e.g. falling of mechan-
Operation and maintenance more than necessary. This
ical components, tipping of the machinery);
includes the clear arrangement in conjunction with the
complete System, the sections of System and the
b) power sources;
Single units.
Depending upon the design and application of the
c) stored energy;
System, the use of a Single safeguard or a combi-
d) interferences
nation of several different safeguards may be neces-
sary. The selection of the safeguards depends upon
1) electrical [e.g. electromagnetic interference
the identified hazards.
(EMI), electrostatic discharge (ESD), radio fre-
Safeguarding means shall remain effective for all op-
quency interference (RFI)],
erating modes (see IEC 204-1:1992, subclause 9.2.4
for Suspension of safeguards under special condi- 2) mechanical (e.g. Vibration, shock);
tions).
e) hazardous atmospheres or materials
4.3.3 Warning signs and personal protective
1) explosive or combustible,
equipment
2) corrosive,
Where the measures given in 4.3.2 and 4.3.2 are not
or only partially applicable, warning devices (see 6.6)
3) radiation (e.g. ionization, thermal);
and signs shall indicate the presence of the remaining
hazards which are difficult to recognize.
iilure or fault of
The following hazards tan be difficult to recognize:
) protective means including removal, disas-
- those due to unexpected movements; sembly, or defeating,
- those due to unexpected effects of energy (e.g.
) components, devices, or circuits,
by overpressure, tension, rotation, gravity, noise,
heat, low temperature, radiation); or 3) power sources or means of power distribution
including fluctuations or disturbances,
- those due to unexpected escape of hazardous
information transmission;
materials. 4)
Where necessary, the use of personal protective
g) human error
equipment shall be specified.
1) design, construction, or modification,
4.4 Hazard identification
2) operating Systems, application Software, and
programming,
Hazards tan arise from
3) application and implementation,
- the System itself;
4) setup including work handlinglholding and
- the interaction of the System with other machinery
tooling,
or equipment outside the System;
Operation or use,
- the physical environment in which the System is 5)
used; or
6) maintenance and repair,
- interactions between personnel and the System.
7) documentation and traininglinstruction;
Examples of sources of hazards are:

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0 ISO
ISO 11161:1994(E)
h) ergonomic conside,rations The hazardous situations which tan occur in each area
of the System to which persons tan have access,
1) lighting,
shall be identified.
2) Vibration,
4.6 Ergonomie considerations
3) noise,
4.6.1 Man-machine interface
climatic conditions,
4)
The following measures are designed to facilitate the
5) Operator control Station design/layout.
activities of automated System monitoring and data
processing.
4.5 Risk assessment
4.6.1.1 Direct view of operations
A risk assessment shall be performed which shall
serve as a basis for determining safety objectives and
The site shall be designed to facilitate the acquisition
me
...