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
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
06-Jul-2007
Due Date
10-Sep-2007
Completion Date
23-Jul-2007

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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.

2

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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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©  ISO 2007
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
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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
...

SLOVENSKI oSIST prEN ISO 11161:2005

PREDSTANDARD
maj 2005
Varnost strojev – Integrirani proizvodni sistemi – Osnovne zahteve (ISO/DIS
11161:2005)
Safety of machinery - Integrated manufacturing systems - Basic requirements
(ISO/DIS 11161:2005)
ICS 13.110; 25.040.01 Referenčna številka
oSIST prEN ISO 11161:2005(en)
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

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EUROPEAN STANDARD
DRAFT
prEN ISO 11161
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2005
ICS
English version
Safety of machinery - Integrated manufacturing systems - Basic
requirements (ISO/DIS 11161:2005)
Sécurité des machines - Systèmes de fabrication intégrés -
Prescriptions fondamentales (ISO/DIS 11161:2005)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 114.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 11161:2005: E
worldwide for CEN national Members.

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prEN ISO 11161:2005 (E)




Foreword

This document (prEN ISO 11161:2005) 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 document is currently submitted to the parallel Enquiry.

This document has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements
of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of
this document.


Endorsement notice

The text of ISO 11161:2005 has been approved by CEN as prEN ISO 11161:2005 without
any modifications.

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prEN ISO 11161:2005 (E)



ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 98/37 EEC


This European Standard has been prepared under a mandate given to CEN by the European

Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive 98/37 EEC.

Once this standard is cited in the Official Journal of the European Communities under that
Directive and has been implemented as a national standard in at least one Member State,
compliance with the normative clauses of this standard confers, within the limits of the scope
of this standard, a presumption of conformity with the corresponding Essential Requirements
of that Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.






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DRAFT INTERNATIONAL STANDARD ISO/DIS 11161
ISO/TC 199 Secretariat: DIN
Voting begins on: Voting terminates on:
2005-03-17 2005-08-17
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Safety of machinery — Integrated manufacturing systems —
Basic requirements
Sécurité des machines — Systèmes de fabrication intégrés — Prescriptions fondamentales
[Revision of first edition (ISO 11161:1994)]
ICS 13.110; 25.040.01

ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2005

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ISO/DIS 11161
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©
ii ISO 2005 – All rights reserved

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ISO/DIS 11161
Contents Page
Foreword. v
Introduction . v
1 Scope . 1
2 Normative References. 1
3 Terms and definitions. 2
4 Safety strategy . 6
5 IMS specification. 12
5.1 General. 12
5.2 Use of the IMS . 13
5.2.1 General. 13
5.2.2 Functionality. 13
5.2.3 Work task(s) . 13
5.3 Space of the IMS . 14
5.3.1 General. 14
5.3.2 Layout . 14
5.3.3 Access to the IMS . 15
6 Risk assessment. 15
6.1 General. 15
6.2 Determination of limits. 15
6.3 Hazardous situations identification. 15
6.3.1 Hazards due to the machine and associated equipment. 16
6.3.2 Hazardous situation due to the localization of the equipment . 16
6.3.3 Hazardous situation due to the route . 17
6.4 Risk estimation . 17
6.5 Risk evaluation. 17
7 Risk reduction considerations and options. 17
7.1 General. 17
7.2 Task zone configuration. 18
7.3 Zone determination. 18
8 Safeguarding and span of control . 19
8.1 Safeguarding of zones . 19
8.2 Span of control. 19
8.3 Electrical equipment requirements. 20
8.4 Modes. 20
8.4.1 General. 20
8.4.2 Mode selection . 20
8.5 Safeguarding with protective devices suspended . 20
8.5.1 General. 20
8.5.2 Safeguarding during process observation . 21
8.5.3 Muting . 22
8.6 Control . 22
8.6.1 General. 22
8.6.2 IMS control system. 22
8.6.3 Local control . 22
8.7 Reset of perimeter safeguarding devices . 23
8.8 Start/restart. 23
8.9 Emergency stop. 23
8.10 Measures for the escape and rescue of trapped persons. 24
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ISO/DIS 11161
9 Information for use. 24
Annex A (informative) Examples of integrated manufacturing systems (IMS) . 25
Annex B (informative) Flow of information between the integrator, user and suppliers. 28
Annex C (informative) Span of control examples within an IMS . 29
Annex D (informative) Temporary observation of the automatic process. 33
Bibliography . 37
Figures
Figure 1 — Configuration of a typical manufacturing system (IMS) . vi
Figure 2 — Risk assessment and risk reduction for an IMS.8
Figure 3 — Step 1: Specification of the limits of the system.9
Figure 4 — Step 2a): Determination of tasks (requirements, location, access) .10
Figure 5 — Step 2b): Determination of hazards/hazard zones and associated hazardous situations .10
Figure 6 — Step 2c): Determination of the preliminary task zone(s).11
Figure 7 — Step 4b): Determination of the safeguarding .11
Figure 8 — Step 4b): Determination of the safeguarding including the span of control .12
Examples: machine tool, sorting machine.25
Example: a robot with ist control system.25
Figure A.1 — Examples of machines and parts of machines of IMSs.25
Figure A.2 — Legend .25
Figure A.3 — Presentation of example 1 .26
Figure A.4 — Presentation of example 2 .26
Figure A.5 — Presentation of example 3 .27
Figure C.1 — IMS composed of 5 machines and the machine handling system .29
Figure C.2 — IMS as in Figure C.1, but devided into two zones .30
Figure C.3 — IMS as in Figure C.2, but Zone A is equipped with a light curtain.31
Figure C.4 — IMS as in Figure C.2, but access 4 allows entry between Zones A and B.32
Figure D.1 — Safeguarding during process observation.34
Table B.1 .28
iv © ISO 2005 – All rights reserved

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ISO/DIS 11161
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 11161:1992), which has been technically
revised.
Annexes A to D are informative.
Introduction
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 3.15) needs the cooperation of entities who individually
may know only a part of the whole. A portion of the complexity is that it is generally impractical to stop the
whole integrated manufacturing system, yet there will be requirements for manual intervention e.g. inspection,
maintenance, and setup, on an on-going basis. Requirements of this standard provide for the safety of the
individuals who perform these tasks. Safeguarding for these tasks relates to the concept and use of “zones”.
The aim of this 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. This standard is a type-B standard.
A general configuration of an integrated manufacturing system is shown in Figure 1.
Some examples of integrated manufacturing systems are included in Annex A.
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ISO/DIS 11161
Figure 1 — Configuration of a typical manufacturing system (IMS)
Legend
1 Supervisory control 7 Hazard zone 3
2 Operator pendant 8 Scrap and expendables
3 Physical environment 9 Raw material
4 Local control 10 Finished good
5 Hazard zone 2 11 Warning devices
6 Hazard zone 1 12 Control devices
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DRAFT INTERNATIONAL STANDARD ISO/DIS 11161
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 the manufacturing of discrete parts or assemblies. It
describes the requirements and recommendations for the safe design, installation and commissioning,
safeguarding, and information for 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 individual 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. 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 shall 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 and specifications
ISO 13849-1:1999, 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/IEC 13850:1996, Safety of machinery – Emergency stop equipment
ISO 14121:1999, Safety of machinery – Principles of risk assessment
EN 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
EN ISO 14122-2:2001, Safety of machinery – Permanent means of access to machinery – Part 2: Working
platforms and walkways
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ISO/DIS 11161
EN ISO 14122-3:2001, Safety of machinery – Permanent means of access to machinery – Part 3: Stairways,
stepladders and guard-rails
EN ISO 14122-4:2004, Safety of machinery – Permanent means of access to machinery – Part 4: Fixed
ladders
IEC 60204-1:2000, 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 purpose of this International Standard, 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 a variety of discrete parts or assemblies
(See also Annex E)
3.2
awareness barrier
attachment or obstacle that by physical contact warns of an approaching or present hazard
3.3
barrier
physical boundary to a hazard
3.4
bypassing
suspension of a safeguarding device
3.5
detection zone
zone within which a specified test piece will be detected by the electro-sensitive protective equipment (ESPE)
3.6
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/IEC 13850:1996 gives detailed provisions.
[ISO 12100-1:2003, 3.37]
3.7
enabling device
additional manually operated device used in conjunction with a start control and which, when continuously
actuated, allows a machine to function
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ISO/DIS 11161
NOTE IEC 60204–1:2003, 9.2.5.8 gives provisions on enabling devices.
[ISO 12100-1:2003, 3.26.2]
3.8
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]
3.9
harm
physical injury or damage to health
[ISO 12100-1: 2003, 3.5]
3.10
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]
3.11
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]
3.12
hazardous situation
circumstance in which a person is exposed to at least one hazard. The exposure can immediately or over a
period of time result in harm
[ISO 12100-1:2003, 3.9]
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ISO/DIS 11161
3.13
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 himself.
3.14
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]
3.15
local control
state of the IMS or portions of the IMS in which the IMS is operated from the control panel or pendant of the
individual
...

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