SIST EN ISO 11161:2007

Safety of machinery - Integrated manufacturing systems - Basic requirements (ISO 11161:2007)

This International Standard specifies the safety requirements for integrated manufacturing systems (IMS) that incorporate two or more interconnected machines for specific applications, such as component manufacturing or assembly. It gives requirements and recommendations for the safe design, safeguarding and information for the use of such IMSs.

Sicherheit von Maschinen - Integrierte Fertigungssysteme - Grundlegende Anforderungen (ISO 11161:2007)

Diese internationale Norm legt Sicherheitsanforderungen für integrierte Fertigungssysteme (IFS) fest, die zwei oder mehr miteinander verbundene Maschinen für die Herstellung von Einzelteilen oder Baugruppen enthalten. Diese Norm beschreibt Anforderungen und Empfehlungen für die sichere Konstruktion, den sicheren Einbau und Inbetriebnahme, technische Schutzmaßnahmen und Benutzerinformationen für diese Art von IFS (siehe Bild 1 zur grundsätzlichen Anordnung eines IFS).
ANMERKUNG 1   Im Sinne dieser internationalen Norm, bezieht sich der Begriff System auf ein integriertes Fertigungssystem.
ANMERKUNG 2   Im Sinne dieser internationalen Norm, bezieht sich der Begriff Maschine auf Einzelmaschinen und dazugehörige Einrichtungen als Bestandteile des integrierten Fertigungssystems.
Diese internationale Norm verfolgt nicht die Absicht, Sicherheitsaspekte einzelner Maschinen und Einrich-tungen zu behandeln, die in den für diese Maschinen und Einrichtungen relevanten Normen enthalten sein können. Werden Maschinen und Einrichtungen eines integrierten Fertigungssystems getrennt oder einzeln bedient, während die Schutzwirkung der technischen Schutzmaßnahmen, die für den Produktionsbetrieb vorgesehen wurden, umgangen oder außer Kraft gesetzt wurde, müssen die entsprechenden geltenden Sicherheitsnormen für diese Maschinen und Einrichtungen herangezogen werden.

Sécurité des machines - Systemes de fabrication intégrés - Prescriptions fondamentales (ISO 11161:2007)

L'ISO 11161:2007 fixe les prescriptions de sécurité relatives aux systèmes de fabrication intégrés (IMS) composés de deux machines ou plus, interconnectées pour des applications spécifiques telles que la fabrication ou l'assemblage de composants. Elle donne des prescriptions et des recommandations relatives à une conception intrinsèquement sûre de l'IMS, à la protection et aux informations pour l'utilisation de ces IMS.
L'ISO 11161:2007 ne vise pas à couvrir séparément les aspects de sécurité des machines constitutives et des équipements associés qui peuvent être couverts par des normes concernant spécifiquement ces machines et ces équipements. Pour cette raison, elle ne traite que des aspects de sécurité liés à l'interconnexion des machines et des équipements. Lorsque des machines et des équipements d'un système de fabrication intégré sont utilisés séparément ou individuellement et tant que les effets protecteurs des moyens de protection fournis pour le mode de production sont inhibés ou temporairement neutralisés, les normes de sécurité pertinentes concernant ces machines et ces équipements s'appliquent.

Varnost strojev - Integrirani proizvodni sistemi - Osnovne zahteve (ISO 11161:2007)

Ta mednarodni standard določa varnostne zahteve za integrirane proizvodne sisteme (IMS), ki vsebujejo dva ali več med seboj povezanih strojev za določene uporabe, kot je na primer izdelava sestavnih delov ali montaža.  Podaja zahteve in priporočila za varno načrtovanje, varovanje in informacije za uporabo le teh IMS (glej Sliko 1 za osnovno konfiguracijo IMS). OPOMBA 1: V okviru besedila tega mednarodnega standarda se izraz sistem nanaša na integrirani proizvodni sistem. OPOMBA 2: V okviru besedila tega mednarodnega standarda se izraz stroj nanaša na sestavne stroje in pripadajočo opremo integriranega proizvodnega sistema. Ta mednarodni standard ni namenjen temu, da zajame varnostne vidike posameznih strojev in opreme, ki so lahko zajeti v standardih, določenih za te stroje in opremo. Zato obravnava samo varnostne vidike, ki so pomembni za ustrezno varnostno povezljivost strojev in komponent. Kjer se stroji in oprema integriranega proizvodnega sistema upravljajo ločeno ali posamezno in kadar so varovalni učinki zaščit, ki se zagotavljajo za proizvodni način, zadušeni ali začasno ustavljeni, veljajo ustrezni varnostni standardi za te stroje in opremo.

General Information

• Status: Published
• Publication Date: 22-Jul-2007
• Withdrawal Date: 16-May-2010
• ICS: 13.110 - Safety of machinery
• ICS: 25.040.01 - Industrial automation systems in general
• Technical Committee: VSN - Safety of machinery
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Jul-2007
• Due Date: 10-Sep-2007
• Completion Date: 23-Jul-2007
• Directive: 2006/42/EC - Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)
• Directive: 98/37/EC - Machinery
• Mandate: M/079 - Mandate to CEN and CENELEC for standardization in the field of machines
• Ref Project: EN ISO 11161:2007 - Safety of machinery - Integrated manufacturing systems - Basic requirements (ISO 11161:2007)

Relations

• Amended By: SIST EN ISO 11161:2007/A1:2010 - Safety of machinery - Integrated manufacturing systems - Basic requirements - Amendment A1 (ISO 11161:2007/Amd 1:2010)
• Effective Date: 01-Jun-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11161:2007
01-september-2007
Varnost strojev - Integrirani proizvodni sistemi - Osnovne zahteve (ISO
11161:2007)
Safety of machinery - Integrated manufacturing systems - Basic requirements (ISO
11161:2007)
Sicherheit von Maschinen - Integrierte Fertigungssysteme - Grundlegende
Anforderungen (ISO 11161:2007)

Sécurité des machines - Systemes de fabrication intégrés - Prescriptions fondamentales

(ISO 11161:2007)
Ta slovenski standard je istoveten z: EN ISO 11161:2007
ICS:
13.110 Varnost strojev Safety of machinery
25.040.01 Sistemi za avtomatizacijo v Industrial automation
industriji na splošno systems in general
SIST EN ISO 11161:2007 en,fr,de

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

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EUROPEAN STANDARD
EN ISO 11161
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2007
ICS 13.110; 25.040.01
English Version
Safety of machinery - Integrated manufacturing systems - Basic
requirements (ISO 11161:2007)

Sécurité des machines - Systèmes de fabrication intégrés - Sicherheit von Maschinen - Integrierte Fertigungssysteme -

Prescriptions fondamentales (ISO 11161:2007) Grundlegende Anforderungen (ISO 11161:2007)

This European Standard was approved by CEN on 13 April 2007.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European

Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the

official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11161:2007: E

worldwide for CEN national Members.
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EN ISO 11161:2007 (E)
Foreword

This document (EN ISO 11161:2007) has been prepared by Technical Committee ISO/TC 199

"Safety of machinery" in collaboration with Technical Committee CEN/TC 114 "Safety of

machinery", the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of

an identical text or by endorsement, at the latest by November 2007, and conflicting national

standards shall be withdrawn at the latest by November 2007.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of

the following countries are bound to implement this European Standard: Austria, Belgium,

Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United

Kingdom.
Endorsement notice

The text of ISO 11161:2007 has been approved by CEN as EN ISO 11161:2007 without any

modifications.
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INTERNATIONAL ISO
STANDARD 11161
Second edition
2007-05-15
Safety of machinery — Integrated
manufacturing systems — Basic
requirements
Sécurité des machines — Systèmes de fabrication intégrés —
Prescriptions fondamentales
Reference number
ISO 11161:2007(E)
ISO 2007
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ISO 11161:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 11161:2007(E)
Contents Page

Foreword............................................................................................................................................................. v

Introduction ....................................................................................................................................................... vi

1 Scope ......................................................................................................................................................1

2 Normative references ............................................................................................................................1

3 Terms and definitions ...........................................................................................................................2

4 Strategy for risk assessment and risk reduction ...............................................................................6

4.1 General....................................................................................................................................................6

4.2 Specification of the limits of the IMS...................................................................................................6

4.3 Determination of the task......................................................................................................................6

4.4 Identifying hazardous situations..........................................................................................................8

4.5 Risk estimation and risk evaluation.....................................................................................................8

4.6 Risk reduction........................................................................................................................................8

5 Risk assessment..................................................................................................................................10

5.1 Specifications of the IMS ....................................................................................................................10

5.2 Identification of hazards and hazardous situations.........................................................................12

5.3 Risk estimation ....................................................................................................................................13

5.4 Risk evaluation.....................................................................................................................................14

6 Risk reduction......................................................................................................................................14

6.1 Protective measures............................................................................................................................14

6.2 Validation of the protective measures...............................................................................................14

7 Task zone(s) .........................................................................................................................................14

7.1 General..................................................................................................................................................14

7.2 Determination.......................................................................................................................................15

7.3 Design ...................................................................................................................................................15

7.4 Functional analysis..............................................................................................................................16

8 Safeguarding and span of control .....................................................................................................16

8.1 Safeguarding of task zones ................................................................................................................16

8.2 Span of control.....................................................................................................................................17

8.3 Electrical equipment requirements....................................................................................................17

8.4 Modes....................................................................................................................................................17

8.5 Safeguards ...........................................................................................................................................18

8.6 Protective measures when safeguards are suspended...................................................................18

8.7 Muting and blanking............................................................................................................................20

8.8 Control ..................................................................................................................................................20

8.9 Reset of perimeter safeguarding devices .........................................................................................21

8.10 Start/restart...........................................................................................................................................21

8.11 Emergency stop...................................................................................................................................22

8.12 Measures for the escape and rescue of trapped persons...............................................................22

9 Information for use ..............................................................................................................................22

9.1 General..................................................................................................................................................22

9.2 Marking .................................................................................................................................................23

10 Validation of the design ......................................................................................................................23

10.1 Validation that the design meets the requirements .........................................................................23

10.2 Validation of the protective measures...............................................................................................23

Annex A (informative) Examples of integrated manufacturing systems (IMSs).........................................24

Annex B (informative) Flow of information between the integrator, user and suppliers...........................27

© ISO 2007 – All rights reserved iii
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ISO 11161:2007(E)

Annex C (informative) Span of control examples within an IMS ................................................................. 28

Annex D (informative) Temporary observation of the automatic process ................................................. 32

Bibliography ..................................................................................................................................................... 36

iv © ISO 2007 – All rights reserved
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ISO 11161:2007(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. 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.

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.

ISO 11161 was prepared by Technical Committee ISO/TC 199, Safety of machinery, in accordance with the

Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 11161:1994), which has been technically

revised.
© ISO 2007 – All rights reserved v
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ISO 11161:2007(E)
Introduction
The structure of safety standards in the field of machinery is as follows:

a) Type-A standards (basic safety standards) giving basic concepts, principles for design, and general

aspects that can be applied to all machinery.

b) Type-B standards (generic safety standards) dealing with one safety aspect or one type of safeguard that

can be used across a wide range of machinery:

⎯ type-B1 standards on particular safety aspects (e.g. safety distances, surface temperature, noise);

⎯ type-B2 standards on safeguards (e.g. two-hand controls, 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 International Standard is a type-B1 standard as stated in ISO 12100-1.

An integrated manufacturing system (IMS, see 3.1) can be very different in terms of size and complexity, and

can incorporate different technologies that require diverse expertise and knowledge.

An integrated manufacturing system should be considered to be a whole new and different machine rather

than simply its parts combined. The integrator (see 3.10) needs the cooperation of entities who individually

know only a part of the whole. Where there are requirements for frequent manual interventions to parts of the

IMS, e.g. inspections, maintenance, set-up, it can be impractical or unnecessary to stop the whole IMS. This

International Standard gives requirements to provide for the safety of individuals who perform these tasks.

Safeguarding for these tasks relates to the concept and use of “task zones”.

The aim of this International Standard is to describe how to apply the requirements of ISO 12100-1:2003,

ISO 12100-2:2003 and ISO 14121 in this specific context.

A general configuration of an integrated manufacturing system is shown in Figure 1.

Some examples of integrated manufacturing systems are included in Annex A.
vi © ISO 2007 – All rights reserved
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ISO 11161:2007(E)
Key
1 control 6 hazard zone B
2 operator pendant 7 hazard zone C
3 safeguarded space 8 scrap and expendables flow
4 local controls 9 raw material flow
5 hazard zone A 10 finished goods
Figure 1 — Configuration of an IMS
© ISO 2007 – All rights reserved vii
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INTERNATIONAL STANDARD ISO 11161:2007(E)
Safety of machinery — Integrated manufacturing systems —
Basic requirements
1 Scope

This International Standard specifies the safety requirements for integrated manufacturing systems (IMS) that

incorporate two or more interconnected machines for specific applications, such as component manufacturing

or assembly. It gives requirements and recommendations for the safe design, safeguarding and information

for the use of such IMSs (see Figure 1 for the basic configuration of an IMS).

NOTE 1 In the context of this International Standard, the term system refers to an integrated manufacturing system.

NOTE 2 In the context of this International Standard, the term machine refers to the component machines and

associated equipment of the integrated manufacturing system.

This International Standard is not intended to cover safety aspects of individual machines and equipment that

may 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 machines and equipment of an integrated manufacturing system are operated separately or

individually, and while the protective effects of the safeguards provided for production mode are muted or

suspended, the relevant safety standards for these machines and equipment apply.
2 Normative references

The following referenced documents are indispensable for the application 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 12100-1:2003, Safety of machinery — Basic concepts, general principles for design — Part 1: Basic

terminology, methodology

ISO 12100-2:2003, Safety of machinery — Basic concepts, general principles for design — Part 2: Technical

principles

ISO 13849-1:2006, Safety of machinery — Safety-related parts of control systems — Part 1: General

principles for design

ISO 13849-2:2003, Safety of machinery — Safety-related parts of control systems — Part 2: Validation

ISO 13850:2006, Safety of machinery — Emergency stop — Principles for design

ISO 14120:2002, Safety of machinery — Guards — General requirements for the design and construction of

fixed and movable guards
ISO 14121:1999, Safety of machinery — Principles of risk assessment

ISO 14122-1:2001, Safety of machinery — Permanent means of access to machinery — Part 1: Choice of a

fixed means of access between two levels
© ISO 2007 – All rights reserved 1
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ISO 11161:2007(E)

ISO 14122-2:2001, Safety of machinery — Permanent means of access to machinery — Part 2: Working

platforms and walkways

ISO 14122-3:2001, Safety of machinery — Permanent means of access to machinery — Part 3: Stairways,

stepladders and guard-rails

ISO 14122-4:2004, Safety of machinery — Permanent means of access to machinery — Part 4: Fixed ladders

IEC 60204-1:2005, Safety of machinery — Electrical equipment of machines — Part 1: General requirements

IEC 62061:2005, Safety of machinery — Functional safety of safety-related electrical, electronic and

programmable electronic control systems
3 Terms and definitions
For the purposes of this document, the following definitions apply:
3.1
integrated manufacturing system
IMS

group of machines working together in a coordinated manner, linked by a material-handling system,

interconnected by controls (i.e. IMS controls), for the purpose of manufacturing, treatment, movement or

packaging of discrete parts or assemblies
NOTE See also Annex A.
3.2
detection zone

zone within which a specified test piece will be detected by the electro-sensitive protective equipment (ESPE)

[IEC/TS 62046:2004, 3.1.3]
3.3
emergency stop
function which is intended:

⎯ to avert arising or to reduce existing hazards to persons, damage to machinery or to work in progress;

⎯ to be initiated by a single human action
NOTE ISO 13850 gives detailed provisions.
[ISO 12100-1:2003, 3.37]
3.4
enabling device

additional manually operated device used in conjunction with a start control and which, when continuously

actuated, allows a machine to function
NOTE IEC 60204-1:2005, 9.2.5.8 gives provisions on enabling devices.
[ISO 12100-1:2003, 3.26.2]
2 © ISO 2007 – All rights reserved
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ISO 11161:2007(E)
3.5
guard
physical barrier, designed as part of the machine, to provide protection
NOTE 1 A guard may act:

⎯ alone; it is then only effective when it is “closed” for a movable guard or “securely held in place” for a fixed guard;

⎯ in conjunction with an interlocking device with or without guard locking; in this case, protection is ensured whatever

the position of the guard.

NOTE 2 Depending on its construction, a guard may be called e.g. casing, shield, cover, screen, door, enclosing guard.

NOTE 3 See ISO 12100-2:2003, 5.3.2, and ISO 14120 for types of guards and their requirements.

[ISO 12100-1:2003, 3.25]
3.6
harm
physical injury or damage to health
[ISO 12100-1:2003, 3.5]
3.7
hazard
potential source of harm

NOTE 1 The term hazard can be qualified in order to define its origin (e.g. mechanical hazard, electrical hazard) or the

nature of the potential harm (e.g., electric shock hazard, cutting hazard, toxic hazard, fire hazard).

NOTE 2 The hazard envisaged in this definition:

⎯ either is permanently present during the intended use of the machine (e.g. motion of hazardous moving elements,

electric arc during a welding phase, bad posture; noise emissions; high temperature);

⎯ or may appear unexpectedly (e.g. explosion, crushing hazard as a consequence of an unintended/unexpected start-

up, ejection as a consequence of a breakage, fall as a consequence of acceleration/deceleration).

[ISO 12100-1: 2003, 3.6]
3.8
hazard zone
danger zone

any space within and/or around machinery in which a person can be exposed to a hazard

[ISO 12100-1:2003, 3.10]
3.9
hazardous situation
circumstance in which a person is exposed to at least one hazard
NOTE The exposure can immediately or over a period of time result in harm.
[ISO 12100-1:2003, 3.9]
© ISO 2007 – All rights reserved 3
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ISO 11161:2007(E)
3.10
integrator

entity who designs, provides, manufactures or assembles an integrated manufacturing system and is in

charge of the safety strategy, including the protective measures, control interfaces and interconnections of the

control system

NOTE The integrator may be a manufacturer, assembler, engineering company or the user.

3.11
interlocking device
interlock

mechanical, electrical or other type of device, the purpose of which is to prevent the operation of hazardous

machine functions under specified conditions (generally as long as a guard is not closed)

[ISO 12100-1: 2003, 3.26.1]
3.12
local control

state in which the control of a task zone can only be performed at that task zone

3.13
muting

temporary automatic suspension of a safety function(s) by safety-related parts of control systems

[ISO 13849-1:2006, 3.1.8]
3.14
operator

person or persons given the task of installing, using, adjusting, maintaining, cleaning, repairing or transporting

machinery
3.15
protective measure
measure intended to achieve risk reduction, implemented

⎯ by the designer (inherently safe design, safeguarding and complementary protective measures,

information for use) and

⎯ by the user (organization: safe working procedures, supervision, permit-to-work systems; provision and

use of additional safeguards; use of personal protective equipment; training)
[ISO 12100-1:2003, 3.18]
3.16
protective device
safeguard other than a guard
[ISO 12100-1:2003, 3.26]
3.17
risk

combination of the probability of occurrence of harm and the severity of that harm

[ISO 12100-1:2003, 3.11]
4 © ISO 2007 – All rights reserved
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ISO 11161:2007(E)
3.18
safeguard
guard or protective device
[ISO 12100-1:2003, 3.24]
3.19
safeguarded space

space determined by the protective measures such that the hazard(s) covered by these measures cannot be

reached
3.20
safeguarding

protective measure using safeguards to protect persons from the hazards which cannot reasonably be

eliminated or risks which cannot be sufficiently limited by inherently safe design measures

NOTE ISO 12100-2:2003, Clause 5, deals with safeguarding.
[ISO 12100-1:2003, 3.20]
3.21
safety function

function of a machine whose failure can result in an immediate increase of the risk(s)

[ISO 12100-1:2003, 3.28]
3.22
safe working procedure

specified procedure intended to reduce the possibility of injury while performing an assigned task

3.23
span of control
predetermined portion of the IMS under control of a specific device
3.24
supplier

entity (e.g. designer, manufacturer, contractor, installer, integrator) who provides equipment or services

associated with the IMS or a portion of the IMS
NOTE The user may also act in the capacity of a supplier.
3.25
task zone

any predetermined space within and/or around the IMS in which an operator can perform work

NOTE See also hazard zone and safeguarded space.
3.26
trouble shooting
fault finding

act of methodically determining the reason that the IMS, or portions of the IMS, has failed to perform the task

or function as intended
3.27
user
entity who utilizes and maintains the IMS
© ISO 2007 – All rights reserved 5
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ISO 11161:2007(E)
4 Strategy for risk assessment and risk reduction
4.1 General

The strategy for risk assessment and risk reduction of an IMS shall be in accordance with ISO 12100-1,

ISO 12100-2 and ISO 14121.

The integrator shall consult with the user and the suppliers (see Annex B) of the component machines and

associated equipment to achieve adequate reduction of risk. The integrator shall review the technical aspects

and develop the information for use of the IMS in accordance with Clause 9.

The IMS shall be designed to facilitate safe manual interventions, including maintenance. For some manual

interventions, it can be impractical to stop the whole IMS, in which case the IMS shall be segregated into

zone(s) where operators can perform their tasks safely. Clause 5 applies to the risk assessment, including

⎯ specification of the IMS (5.1),
⎯ identification of hazards and hazardous situations (5.2),
⎯ risk estimation (5.3), and
⎯ risk evaluation (5.4).
Clause 6 applies to risk reduction including
⎯ protective measures (6.1), and
⎯ validation of protective measures (6.2).

IMS risk assessment and risk reduction is an iterative process described in the following steps (see Figure 2

of ISO 12100-1:2003).
4.2 Specification of the limits of the IMS

In order to perform an adequate risk assessment, the following basis IMS parameters shall be defined:

⎯ functionalities;
⎯ limits;
⎯ interfaces between the different parts of the IMS.
See Figure 2.
4.3 Determination of the task

The integrator shall determine the foreseeable tasks (for the IMS multiple configurations) and their associated

requirements of location and access. See Figure 3.
6 © ISO 2007 – All rights reserved
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ISO 11161:2007(E)
Key
1 machine A – robot 3 machine C – material handling system (conveyor)
2 machine B – machine tool 4 IMS
Figure 2 — Specification of the limits of the IMS
Key
1 task 1: tool changing
2 task 2: cleaning
3 access to task 1 and task 2
Figure 3 — Determination of tasks (requirements, location, access)
© ISO 2007 – All rights reserved 7
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ISO 11161:2007(E)
4.4 Identifying hazardous situations
The IMS risk assessment shall cover hazardous situations resulting from
⎯ integration of the component machines and associated equipment,
⎯ any alterations to the protective measures of the machine(s), or
⎯ change of use of the machine(s).
See Figure 4.
Key
1 IMS
2 hazard zones

Figure 4 — Identification of hazards/hazard zones and associated hazardous situations

4.5 Risk estimation and risk evaluation

The integrator shall estimate and evaluate risk for each identified hazard and hazardous situation within each

tas
...