SIST EN ISO 11161:2007

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 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
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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


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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.
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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.
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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
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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
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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]
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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]
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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]
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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
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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.

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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)
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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
...