SIST EN ISO 20607:2020
(Main)Safety of machinery - Instruction handbook - General drafting principles (ISO 20607:2019)
Safety of machinery - Instruction handbook - General drafting principles (ISO 20607:2019)
This document specifies requirements for the machine manufacturer for preparation of the safety-relevant parts of an instruction handbook for machinery.
This document:
— provides further specifications to the general requirements on information for use given in ISO 12100:2010, 6.4.5; and
— deals with the safety-related content, the corresponding structure and presentation of the instruction handbook, taking into account all phases of the life cycle of the machine.
NOTE 1 The strategy for risk reduction at the machine is given in ISO 12100:2010, Clause 6, and includes inherently safe design measures, safeguarding and complementary risk reduction measures as well as information for use.
NOTE 2 Annex A contains a correspondence table between ISO 12100:2010, 6.4, and this document.
NOTE 3 Information for conception and preparation of instructions in general is available in IEC/IEEE 82079-1.
This document establishes the principles which are indispensable to provide information on residual risks.
This document does not address requirements for declaration of noise and vibration emissions.
This document is not applicable to machinery manufactured before the date of its publication.
Sicherheit von Maschinen - Betriebsanleitung - Allgemeine Gestaltungsgrundsätze (ISO 20607:2019)
Dieses Dokument legt Anforderungen für Maschinenhersteller für die Vorbereitung der sicherheitsrele-vanten Teile einer Betriebsanleitung für Maschinen fest.
Dieses Dokument:
— bietet weitere Spezifikationen für allgemeine Anforderungen an die in ISO 12100:2010, 6.4.5, angege-benen Benutzerinformationen; und
— behandelt den sicherheitsbezogenen Inhalt, die dazugehörige Struktur und Darstellung in der Betriebs¬anleitung unter Berücksichtigung aller Lebensphasen einer Maschine.
ANMERKUNG 1 In ISO 12100:2010, Abschnitt 6, wird die Strategie zur Risikominderung an der Maschine angegeben, dazu gehören inhärente Maßnahmen zur sicherheitsbezogenen Konstruktion, Schutzeinrichtungen und zusätzliche Maßnahmen zur Risikominderung sowie Benutzerinformationen.
ANMERKUNG 2 Anhang A enthält eine Korrespondenztabelle zwischen ISO 12100:2010, 6.4, und diesem Dokument.
ANMERKUNG 3 Informationen zur Konzeption und Erstellung von Anleitungen im Allgemeinen werden in IEC/IEEE 82079 1 zur Verfügung gestellt.
Dieses Dokument erstellt die Grundsätze, die unverzichtbar sind, um Informationen zu Restrisiken anzu-geben.
Dieses Dokument behandelt keine Anforderungen zur Angabe von Lärm und Vibrationsemissionen.
Dieses Dokument gilt nicht für Maschinen, die vor dem Veröffentlichungsdatum dieses Dokuments herge-stellt wurden.
Sécurité des machines - Notice d'instructions - Principes rédactionnels généraux (ISO 20607:2019)
Le présent document spécifie des exigences, pour le fabricant de machine, pour la préparation des parties relatives à la sécurité de la notice d'instructions de cette machine.
Le présent document:
— fournit des spécifications complémentaires aux exigences générales relatives aux informations pour l'utilisation données dans l'ISO 12100:2010, 6.4.5, et
— traite avec les contenus relatifs à la sécurité, de la structure correspondante et de la présentation de la notice d'instructions en tenant compte de toutes les phases du cycle de vie de la machine.
NOTE 1 La stratégie pour la réduction des risques au niveau de la machine est donnée dans l'ISO 12100:2010, Article 6, et comprend les mesures de prévention intrinsèque, la protection et/ou les mesures de prévention complémentaires ainsi que les informations pour l'utilisation.
NOTE 2 L'Annexe A contient un tableau de correspondance entre l'ISO 12100:2010, 6.4, et le présent document.
NOTE 3 Des informations pour la conception et la préparation des instructions en général sont disponibles dans l'IEC/IEEE 82079‑1.
Le présent document définit les principes indispensables pour la fourniture d'informations sur les risques résiduels.
Le présent document ne répond pas aux exigences de déclaration d'émission acoustique et vibratoire.
Le présent document ne s'applique pas aux machines fabriquées avant la date de sa publication.
Varnost strojev - Navodila za uporabo - Splošna načela za načrtovanje (ISO 20607:2019)
Ta evropski standard določa zahteve za proizvajalce strojev glede priprave navodil za uporabo. Ta mednarodni standard določa dodano vrednost k splošnim zahtevam glede navodil za uporabo, ki so podane v točki 6.4 standarda EN ISO 12100:2010, in obravnava z varnostjo povezano vsebino, ustrezno strukturo in prikaz navodil za uporabo ob upoštevanju celotnega življenjskega cikla stroja. Če so navodila za uporabo zahtevana, so v tem mednarodnem standardu vzpostavljena načela, ki so nepogrešljiva za preprečevanje pomanjkanja informacij, predvsem tistih glede možnih ostalih tveganj. Ta mednarodni standard se uporablja pri pripravi navodil za uporabo strojev.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2020
Varnost strojev - Navodila za uporabo - Splošna načela za načrtovanje (ISO
20607:2019)
Safety of machinery - Instruction handbook - General drafting principles (ISO
20607:2019)
Sicherheit von Maschinen - Betriebsanleitung - Allgemeine Gestaltungsgrundsätze (ISO
20607:2019)
Sécurité des machines - Notice d'instructions - Principes rédactionnels généraux (ISO
20607:2019)
Ta slovenski standard je istoveten z: EN ISO 20607:2019
ICS:
01.110 Tehnična dokumentacija za Technical product
izdelke documentation
13.110 Varnost strojev Safety of machinery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 20607
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 13.110
English Version
Safety of machinery - Instruction handbook - General
drafting principles (ISO 20607:2019)
Sécurité des machines - Notice d'instructions - Sicherheit von Maschinen - Betriebsanleitung -
Principes rédactionnels généraux (ISO 20607:2019) Allgemeine Gestaltungsgrundsätze (ISO 20607:2019)
This European Standard was approved by CEN on 17 June 2019.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20607:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2006/42/EC aimed to be covered . 4
European foreword
This document (EN ISO 20607:2019) 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 January 2020, and conflicting national standards shall
be withdrawn at the latest by January 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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 the relationship with EU Directive(s) see informative Annex ZA, which is an integral part of this
document.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20607:2019 has been approved by CEN as EN ISO 20607:2019 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 2006/42/EC aimed to be covered
This European Standard has been prepared under a Commission’s standardization request "M/396
Mandate to CEN and CENELEC for Standardisation in the field of machinery"to provide one voluntary
means of conforming to essential requirements of 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).
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 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.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
2006/42/EC
Essential Requirement of Clause(s)/sub-clause(s) Remarks/Notes
Directive of this EN
Within the limits of the scope Clause 4 (except 4.11) and
essential requirement 1.7.4.2, Clause 5
except indent u), is covered.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 20607
First edition
2019-06
Safety of machinery — Instruction
handbook — General drafting
principles
Sécurité des machines — Notice d'instructions — Principes
rédactionnels généraux
Reference number
ISO 20607:2019(E)
©
ISO 2019
ISO 20607:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 20607:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles and general information . 2
4.1 General . 2
4.2 Target group for the instruction handbook. 2
4.3 Information needs . 3
4.4 Comprehensible terminology and wording . 3
4.5 Presentation of the instruction handbook . 3
4.6 Information from component or subsystem suppliers . 4
4.7 Legibility . 4
4.8 Warnings, hazard and safety symbols used in the instruction handbook . 4
4.9 Structuring . 4
4.10 Residual risks . 4
4.10.1 General. 4
4.10.2 Signals and warning devices provided with the machine . 4
4.11 IT security vulnerabilities . 5
5 Content and structure of the instruction handbook . 5
5.1 General . 5
5.2 Instruction handbook content . 6
5.2.1 Basic parts of an introduction handbook . 6
5.2.2 Safety . 7
5.2.3 Machine overview . 8
5.2.4 Transportation, handling and storage . 9
5.2.5 Assembly, installation and commissioning . 9
5.2.6 Original equipment manufacturer settings .10
5.2.7 Operation .10
5.2.8 Product or capacity changeover .11
5.2.9 Inspection, testing and maintenance .11
5.2.10 Cleaning and sanitizing .12
5.2.11 Fault finding/troubleshooting and repair . .13
5.2.12 Dismantling, disabling and scrapping .13
5.2.13 Documents and drawings .13
5.2.14 Index .14
5.2.15 Glossary .14
5.2.16 Annexes .14
6 Language and formulation/style guide .14
6.1 General .14
6.2 Language version(s) .14
6.3 Formulation guidance for instructions .14
6.4 Simple wording for instructions .15
6.5 Warnings .15
7 Forms of publication .16
Annex A (informative) Correspondence between ISO 12100:2010, 6.4, and this document .17
Annex B (informative) Presentation and formatting.18
Annex C (informative) Recommendations for writing instructions .21
Bibliography .24
ISO 20607:2019(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 199, Safety of machinery.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved
ISO 20607:2019(E)
Introduction
This document is a type-B standard as stated in ISO 12100.
This document is of relevance, in particular, for the following stakeholder groups representing the
market players with regard to machinery safety:
— machine manufacturers (small, medium and large enterprises);
— health and safety bodies (regulators, accident prevention organisations, market surveillance etc.).
Others can be affected by the level of machinery safety achieved with the means of the document by the
above-mentioned stakeholder groups:
— machine users/employers (small, medium and large enterprises);
— machine users/employees (e.g. trade unions, organizations for people with special needs);
— service providers, e. g. for maintenance (small, medium and large enterprises);
— consumers (in case of machinery intended for use by consumers).
The above-mentioned stakeholder groups have been given the possibility to participate at the drafting
process of this document.
In addition, this document is intended for standardization bodies elaborating type-C standards.
The requirements of this document can be supplemented or modified by a type-C standard.
For machines which are covered by the scope of a type-C standard and which have been designed and
built according to the requirements of that standard, the requirements of that type-C standard take
precedence.
The structure of safety standards in the field of machinery is as follows.
a) Type-A standards (basic safety standards) give basic concepts, principles for design and general
aspects that can be applied to machinery;
b) Type-B standards (generic safety standards) dealing with one or more safety aspect(s), or one or
more type(s) of safeguards that can be used across a wide range of machinery:
— type-B1 standards on particular safety aspects (for example, safety distances, surface
temperature, noise);
— type-B2 standards on safeguards (for example, two-hand control devices, interlocking devices,
pressure-sensitive devices, guards);
c) Type-C standards (machine safety standards) dealing with detailed safety requirements for a
particular machine or group of machines.
This type-B standard is written to provide guidance to machine manufacturers on how to provide an
instruction handbook. According to ISO 12100:2010, 6.4.1.1, drafting information for use is an integral
part of the design of a machine. Information for use consists of communication links, such as texts,
words, signs, signals, symbols or diagrams, used separately or in combination to convey information to
the user. Information for use is intended for professional and/or non-professional users. Instructions
are a key part of the information for use of a machine. This document provides safety specifications for
machinery that is more specific than IEC/IEEE 82079-1.
The instruction handbook drafted in accordance with this document is intended to inform the user in
such a manner that after reading it, he/she is aware of how the machine can be used safely according to
its intended use during its life cycle, considering also aspects of reasonably foreseeable misuse.
ISO 20607:2019(E)
The objective fulfilled by this document is to improve the safety specifications and readability/ease of
use of the instruction handbook of the machine.
vi © ISO 2019 – All rights reserved
INTERNATIONAL STANDARD ISO 20607:2019(E)
Safety of machinery — Instruction handbook — General
drafting principles
1 Scope
This document specifies requirements for the machine manufacturer for preparation of the safety-
relevant parts of an instruction handbook for machinery.
This document:
— provides further specifications to the general requirements on information for use given in
ISO 12100:2010, 6.4.5; and
— deals with the safety-related content, the corresponding structure and presentation of the
instruction handbook, taking into account all phases of the life cycle of the machine.
NOTE 1 The strategy for risk reduction at the machine is given in ISO 12100:2010, Clause 6, and includes
inherently safe design measures, safeguarding and complementary risk reduction measures as well as
information for use.
NOTE 2 Annex A contains a correspondence table between ISO 12100:2010, 6.4, and this document.
NOTE 3 Information for conception and preparation of instructions in general is available in IEC/IEEE 82079-1.
This document establishes the principles which are indispensable to provide information on
residual risks.
This document does not address requirements for declaration of noise and vibration emissions.
This document is not applicable to machinery manufactured before the date of its publication.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 12100 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
instruction handbook
part of the information for use provided by a machine manufacturer to the machine user that contains
instructions and advice concerning the use of the machinery during all phases of its life cycle
Note 1 to entry: Instruction handbook is a subset of information for use. For more information, see
ISO 12100:2010, 6.4.
ISO 20607:2019(E)
3.2
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 1 to entry: The integrator may be a manufacturer, assembler, engineering company or the user.
[SOURCE: ISO 11161:2007, 3.10]
3.3
risk reduction measure
action or means to eliminate hazards or reduce risks
Note 1 to entry: The term "risk reduction measure"used in this document corresponds to the term "protective
measure" used in ISO 12100.
EXAMPLE Inherently safe design; protective devices; personal protective equipment; information for use
and installation; organization of work; training; application of equipment; supervision.
[SOURCE: ISO/IEC Guide 51:2014, 3.13, modified — The synonymous term has been deleted and Note 1
to entry has been added.]
3.4
vulnerable user
user at greater risk of harm from products or systems, due to age, level of literacy, physical or mental
condition or limitations, or inability to access product safety information
[SOURCE: ISO/IEC Guide 51:2014, 3.16, modified — The term "consumer" has been replaced by "user" in
the term and in the definition.]
4 Principles and general information
4.1 General
The purpose of the instruction handbook is to provide the user with such information that the machinery
concerned can be effectively and safely used during the life cycle of the machine, also considering
reasonably foreseeable misuse. When the instruction handbook is being prepared, the communication
process “read – think – use” should be followed in order to achieve the maximum effect for the reader.
NOTE For general principles of design of instruction handbooks see also IEC/IEEE 82079-1:2019, 6.3.
The instruction handbook shall follow sequential operations, as applicable.
The instruction handbook shall provide the target group(s) with information on:
— intended use;
— the machine itself and, as appropriate, its parts and components;
— relevant phases of the life cycle of the machine according to ISO 12100;
— hazards that have been identified and risk reduction measures that have been applied in conjunction
with activities the user is expected to perform (human machine interaction); and
— residual risks, as these can require risk reduction by the user of the machine.
4.2 Target group for the instruction handbook
Target groups consisting of persons who interact directly with the machine and the task(s) they
perform shall be identified.
2 © ISO 2019 – All rights reserved
ISO 20607:2019(E)
Target groups that can interact with the machine shall be described in the instruction handbook and
typically include, but are not limited to:
a) installers (for example, system integrators);
b) operators;
c) maintenance personnel or technicians;
d) cleaning personnel;
e) dismantling personnel.
4.3 Information needs
The instruction handbook shall take into account the specific needs, foreseeable knowledge and
technical vocabulary of the target group intended to use the machine.
4.4 Comprehensible terminology and wording
The instruction handbook shall be:
a) comprehensible by using preferably standardized terms, well recognized technical terms or
explaining special technical terms and expressions, if used;
b) as simple and as brief as possible by using, for example
— language-independent instructions to support the text (pictograms, pictures, drawings etc.);
— short and simple sentences;
— where synonyms are available, use only one term;
— tables and listings;
— chronological, logical and sequential writing;
— repetition, where necessary;
— diagrams, charts;
c) expressed in consistent terms and units (for example, SI quantities);
d) drafted using the active voice;
e) easily translatable.
NOTE For guidance and examples on formulation, see Annex C.
4.5 Presentation of the instruction handbook
The instruction handbook may be presented as a single document or as a set of separate documents, for
example, for the following reasons:
— instructions intended for different target groups (see 4.2);
— a single document is too large or complex;
— document is addressing different life phases of the machine.
When providing information for different target groups in a single document the information shall be
clearly separated so that a user does not accidently refer to information which does not apply.
ISO 20607:2019(E)
4.6 Information from component or subsystem suppliers
Where information from component or subsystem suppliers is necessary for the instruction handbook,
it shall either:
— be incorporated directly in the instruction handbook; or
— provide the relevant parts of the original instruction handbook of components/subsystems from
suppliers and making appropriate references therein.
4.7 Legibility
Text and graphical symbols shall be legible for the target group(s).
NOTE For examples of recommended text font sizes and graphical symbol heights, see Annex B.
4.8 Warnings, hazard and safety symbols used in the instruction handbook
Warnings, hazard and safety symbols shall be distinguishable from other content of the instruction
handbook.
When signs (pictograms) and/or written warnings are used to indicate important messages their
meaning shall be clearly explained.
NOTE 1 Annex C provides guidance on wording.
NOTE 2 Terms often used in instruction handbooks are "DANGER", "WARNING", "CAUTION" without or in
combination with pictograms. For the definitions of these terms and more information about colours for coding,
see ISO 3864-2.
NOTE 3 For safety signs and symbols, see ISO 7000 and ISO 7010.
4.9 Structuring
The instruction handbook should be structured in a such a way that the information can be quickly
located, for example, by using sections, chapters, sub-clauses, headings, numbers, highlighting, colors.
NOTE See Clause 5 for a recommended structure.
Instruction handbooks shall be presented in a such a way that the reader can determine if they are
complete (for example, using a table of contents and the numbering of pages).
4.10 Residual risks
4.10.1 General
Based on the risk assessment and the risk reduction measures the manufacturer of the machine shall
inform and warn the target group, if relevant, for each residual risk. General statements about residual
risks shall be avoided.
NOTE The information on residual risks form the basis for further risk reduction measures to be introduced
by the user of the machine.
Explanations on the risks and appropriate warnings shall be given.
4.10.2 Signals and warning devices provided with the machine
The instruction handbook shall describe signals and warning devices provided with the machine and
explain their meaning.
4 © ISO 2019 – All rights reserved
ISO 20607:2019(E)
4.11 IT security vulnerabilities
Where applicable, the instruction handbook shall provide information concerning IT security
vulnerabilities. See ISO/TR 22100-4:2018, 10.4.
5 Content and structure of the instruction handbook
5.1 General
The essential information, relevant for the user, shall be structured in an instruction handbook (see
Table 1 for an example). Table 1 does not take into account all different target groups, but is a template
for information that can be placed in an instruction handbook for the machine concerned. From this,
a writer can create a specific instruction handbook for a particular target group. An instruction
handbook for a user/operator need not contain all the sections of Table 1.
Table 1 — Instruction handbook content example
Section Content
Basic parts of an instruction Title page
handbook
Table of contents
(see 5.2.1)
Introduction to/purpose of this instruction handbook
Safety (see 5.2.2) General safety information and general safety instructions
Machine overview Machine description
(see 5.2.3) Intended use
Key machine specifications
Controls and displays descriptions
Floor plan/layout
Transportation, handling Transporting, handling and storing the machine and/or the components
and storage (see 5.2.4)
Assembly, installation and Assembly/integration of the machine
commissioning
Positioning of the machine
(see 5.2.5)
Mechanical, pneumatic, hydraulic and electrical installation
Check and test of safety systems
Installation check
Commissioning
Original equipment manu- Mechanical settings and synchronization
facturer settings
Safety-related (setting) parameters
(see 5.2.6)
Pneumatic, hydraulic, electrical and vacuum settings
Other settings
Operation Operating modes
(see 5.2.7) Machine start-up and shut-down
Sequence or chronology of operations
Other operating instructions, if applicable
Product or capacity changeo- General product or capacity changeover information
ver (see 5.2.8)
Product-specific set-up information
Inspection, testing and Maintenance instructions
maintenance
(see 5.2.9)
ISO 20607:2019(E)
Table 1 (continued)
Section Content
Cleaning and sanitizing (see Cleaning and/or sanitizing of the machine
5.2.10)
Fault finding/ General fault finding/troubleshooting and repair information
troubleshooting and repair
Troubleshooting chart (electrical engineering)
(see 5.2.11)
Troubleshooting of electrical sensors, vacuum systems, pneumatic systems and
hydraulic systems
Dismantling, disabling and Dismantling, disabling and scrapping instructions
scrapping (see 5.2.12)
Documents and drawings Documents, drawings and parts list
(see 5.2.13)
Index, glossary, annexes See 5.2.14 to 5.2.16
5.2 Instruction handbook content
5.2.1 Basic parts of an introduction handbook
5.2.1.1 General
The following information shall be included in the instruction handbook, as applicable:
a) title page;
— date of issue, version of publication of the instruction handbook;
— machine designation (model and/or type);
— sufficient information to identify the machine(s) to which the handbook applies (e.g. identification
number, serial number(s), period of application);
b) table of contents;
c) introduction to/purpose of this instruction handbook;
d) how to read and apply the instruction handbook;
e) name of the manufacturer and contact details (postal address, phone numbers, email address,
website);
f) type of instruction handbook (for example, operation, maintenance, control software, user guide);
g) date of manufacture;
h) markings in order to indicate compliance with mandatory/legal requirements;
i) list of used abbreviations;
j) symbols and signs for text markings.
If an instruction handbook consists of more than one part, each part is given its own title page as
defined above. Identification of this information shall be in a prominent place.
If an instruction handbook consists of more than one part, each part shall be identified in relation to
the other parts (for example, part 2 of 5 parts). The following subjects shall be included, as applicable:
— addressed target groups;
— abilities/skills required by the target group(s);
6 © ISO 2019 – All rights reserved
ISO 20607:2019(E)
— reader's guide/marking conventions/structure of the instruction handbook.
5.2.1.2 Table of contents
The table of contents shall show the structure of the instruction handbook and serves as a navigation
aid within the document.
The instruction handbook shall have a table of contents, if it exceeds 12 pages unless the size or form
(for example, instruction card) makes this unnecessary.
Instruction handbooks shall have numbered pages or electronic equivalent (e.g. links).
The table of contents shall also indicate unnumbered text elements such as preface, abbreviated
instructions, reader instructions, register/index and appendices, as applicable.
The table of contents can be created in various ways, for example:
a) a full table of contents of the instruction handbook with:
1) the chapters and sections of the first three levels of the subdivision; and
2) the page number or electronic equivalent where each chapter and section begins;
b) a simplified table of contents with a full table of contents for each part;
c) the table of contents should reflect each target group and lifecycle phase.
In a simplified table of contents, there should at least the first level of subdivision with the corresponding
page numbers/electronic equivalents.
5.2.2 Safety
5.2.2.1 General
General safety requirements, not restricted to specific tasks, shall be provided together in a specific
part of the instruction handbook, preferably in the “Safety” clause. For specific tasks described in the
instruction handbook, safety information shall be included where the task is described.
5.2.2.2 General rules for preparation of the “Safety” clause
a) warnings about potentially hazardous situations that can occur during intended use of the machine;
b) warnings regarding potentially hazardous situations arising from reasonably foreseeable misuse;
c) residual risks to be described;
d) general warnings and precautions to be included.
The following topics shall be added, if relevant:
— substances and emissions that can create risk for the persons that can be involved in the machine
operations;
— warnings, where the use of the machine can negatively influence electrically controlled medical
devices, such as pacemakers;
— content related to the safety of the user groups. Attention should be given to protect vulnerable user
groups (e.g. children, elderly people);
— personal protective equipment to be used for specific tasks;
ISO 20607:2019(E)
— safety symbols, safety signs and/or pictograms used in and on the machine, including an image
of them;
— location of safety symbols, safety signs and/or pictograms on the machine;
— instructions for renewing of safety symbols, safety signs and/or pictograms on the machine, if
necessary.
Standardized symbols (see, for example, ISO 7010, IEC 61310) shall be used to indicate important
messages such as cautions, warnings and safety instructions.
5.2.2.3 Emergency situations
Where applicable, the instruction handbook shall include information to address specific emergency
situations, such as:
a) the operating method to be followed in the event of accident or breakdown;
b) the type of fire-fighting equipment to be used; and
c) a warning of possible emission or leakage of hazardous substance(s) and, if applicable, an indication
of means for fighting their effects.
5.2.3 Machine overview
The instruction handbook shall include a general description of the machine. The following information
shall be included, where applicable:
a) machine description;
b) graphical description (for example, floor plan, drawings, images);
c) intended use including the type of material/products that can be processed by the machine;
d) specific applications that are prohibited;
e) key machine specifications, such as:
— length, width and height;
— mass;
— operating speed;
— characteristics of the power supply;
— limits for intended operating conditions, such as temperature, relative humidity and air
pressure;
— intended life limit of the machine;
— lifetime (mission time) of components, where relevant for safety aspects;
f) control and display descriptions;
g) requirements regarding (work)place or environment in which the machine is foreseen to be used
(for example, indoors, outdoors, clean room, potentially explosive atmosphere).
8 © ISO 2019 – All rights reserved
ISO 20607:2019(E)
5.2.4 Transportation, handling and storage
The following information shall be included in the instruction handbook for transportation, handling
and storage of the machine and/or the components, if relevant:
— physical characteristics such as dimensions during transportation, mass and centre of gravity of
the machine, gripping/lifting points to be used;
— recommended transportation and handling method including required skills and equipment;
— environmental conditions for storage, such as limits for temperature, relative humidity and
avoidance of direct sunlight.
5.2.5 Assembly, installation and commissioning
5.2.5.1 Assembly of the machine
Machines that are not assembled or installed by the manufacturer or under the manufacturer’s
responsibility shall contain the following instructions, if relevant:
— requirements and procedures for assembly and mounting (for example, temporary support or
safeguarding, appropriate climatic conditions);
— requirements for testing, where necessary;
— use of special tools and equipment;
— information on safe disposal of packaging materials and preservation measures.
5.2.5.2 Positioning of the machine
Machines that are not positioned by the manufacturer or under the manufacturer’s responsibility shall
contain the following instructions, if relevant:
— minimum requirements for placing (for example, floor characteristics, point load, dynamic load,
levelling, alignment);
— minimum requirements for fixing and anchoring the machine;
— requirements for accessibility around the machine (for example, for maintenance, cleaning,
sanitizing, work spaces).
5.2.5.3 Installation
The instruction handbook shall include information for mechanical, pneumatic, hydraulic and electrical
installations, and in particular the required characteristics of the energy supply (for example,
mechanical, pneumatic, hydraulic, electrical).
Other information to include in the instruction handbook, if relevant, are:
— characteristics of necessary fluids including hazardous substances;
— necessity for an additional exhaust extraction system and its characteristics.
5.2.5.4 Checking and testing of safety systems
The instruction handbook shall include procedures for checking and testing safety systems.
Machines where the installation check is not performed by the manufacturer or under the
manufacturer’s responsibility shall include procedures for checking the correct installation, if relevant.
ISO 20607:2019(E)
Each safety relevant check shall be described with the following content:
— what to be checked;
— how to check;
— criteria for acceptance/non-acceptance;
— action required in case of non-acceptance.
5.2.5.5 Commissioning
If the machine is not commissioned by the manufacturer or under the manufacturer’s responsibility, the
instruction handbook shall include procedures for commissioning and first use of the machine, such as:
— specific risks and hazards, and precautions to be taken;
— information about special procedures for commissioning, if required;
— securing and packaging materials that shall be removed (also consider protective films, strips, etc.);
— necessary tools and equipment;
— procedures, such as adjustments, testing, measuring and reporting; and
— inspections.
5.2.6 Original equipment manufacturer settings
The instruction handbook shall include instructions
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