kSIST FprEN ISO 25119-3:2022
(Main)Tractors and machinery for agriculture and forestry - Safety-related parts of control systems - Part 3: Series development, hardware and software (ISO 25119-3:2018)
Tractors and machinery for agriculture and forestry - Safety-related parts of control systems - Part 3: Series development, hardware and software (ISO 25119-3:2018)
ISO 25119-3:2010 provides general principles for the series development, hardware and software of safety-related parts of control systems (SRP/CS) on tractors used in agriculture and forestry, and on self-propelled ride-on machines and mounted, semi-mounted and trailed machines used in agriculture. It can also be applied to municipal equipment (e.g. street‑sweeping machines). It specifies the characteristics and categories required of SRP/CS for carrying out their safety functions.
ISO 25119-3:2010 is applicable to the safety-related parts of electrical/electronic/programmable electronic systems (E/E/PES). As these relate to mechatronic systems, it does not specify which safety functions or categories are to be used in a particular case.
It is not applicable to non-E/E/PES systems (e.g. hydraulic, mechanic or pneumatic).
Traktoren und Maschinen für die Land- und Forstwirtschaft - Sicherheitsbezogene Teile von Steuerungen - Teil 3: Serienentwicklung, Hardware und Software (ISO 25119-3:2018)
Dieses Dokument stellt allgemeine Grundlagen und Leitsätze heraus für die Gestaltung und Entwicklung sicherheitsbezogener Teile von Steuerungen (SRP/CS) in land- und forstwirtschaftlichen Traktoren, selbstfahrenden Aufsitzmaschinen sowie Anbau-, Aufsattel- und Anhängemaschinen für landwirtschaftliche Geräte. Sie kann auch auf fahrbare kommunale Geräte (z. B. Straßenkehrmaschinen) angewendet werden.
Dieses Dokument gilt nicht für:
Flugzeuge und Luftkissenfahrzeuge für den landwirtschaftlichen Einsatz;
Rasen- und Gartengeräte.
Dieses Dokument legt die Merkmale und Kategorien von SRP/CS-Systemen fest, die zur Ausführung von Sicherheitsfunktionen erforderlich sind. Es enthält keine Performance Level für bestimmte Anwendungen.
ANMERKUNG 1 Maschinenspezifische Typ-C-Normen können Performance Level (AgPL) für Sicherheitsfunktionen von Maschinen in ihrem Anwendungsbereich festlegen. Andernfalls ist der Hersteller für die Festlegung des AgPl verantwortlich.
Dieses Dokument gilt für sicherheitsbezogene Teile elektrischer/elektronischer/programmierbarer elektronischer Systeme (E/E/PES) als Teil mechatronischer Systeme. Er behandelt die möglichen Gefahren durch Fehlfunktionen von sicherheitsbezogenen E/E/PES einschließlich der Wechselwirkungen dieser Systeme. Das Dokument behandelt nicht Gefahren in Verbindung mit Stromschlag, Feuer, Rauch, Hitze, Strahlung, Toxizität, Entflammbarkeit, Reaktivität, Korrosion, Freisetzung von Energie usw. soweit diese nicht direkt durch eine Fehlfunktion der sicherheitsbezogenen Systeme von E/E/PES verursacht werden. Darüber hinaus behandelt das Dokument die Fehlfunktionen sicherheitsbezogener Systeme von E/E/PES, die an Schutzmaßnahmen, Schutzeinrichtungen oder Sicherheitsfunktionen als Reaktion auf nicht durch E/E/PES verursachte Gefahren beteiligt sind.
Im Anwendungsbereich dieses Dokuments enthaltene Beispiele sind:
sicherheitsbezogene Teile einer Steuerung (SRP/CS), die den Stromfluss in elektrischen Hybridsystemen begrenzen, um Isolierungsausfälle und Gefahren durch elektrischen Schlag zu verhindern;
elektromagnetische Störungen mit dem SRP/CS;
für Brandschutzzwecke gestaltetet SRP/CS.
Im Anwendungsbereich dieses Dokuments nicht enthaltene Beispiele sind:
Isolierungsausfälle durch Reibung, die zu der Gefahr eines elektrischen Schlags führen;
elektromagnetische Nennstrahlung, die nahegelegene Maschinensteuerungssysteme beeinflusst;
Korrosion, die zu einer Überhitzung von Stromkabeln führt.
Dieses Dokument ist nicht anzuwenden auf nicht-E/E/PES-Systeme (z. B. hydraulische, mechanische und pneumatische).
ANMERKUNG 2 Siehe auch ISO 12100 zu Gestaltungsleitsätzen für die Sicherheit von Maschinen.
Dieses Dokument gilt nicht für sicherheitsbezogene Teile von Steuerungen, die vor dem Veröffentlichungsdatum dieses Dokuments hergestellt wurden.
Tracteurs et matériels agricoles et forestiers - Parties des systèmes de commande relatives à la sécurité - Partie 3: Développement en série, matériels et logiciels (ISO 25119-3:2018)
L'ISO 25119-3:2010 fournit des principes généraux pour le développement en série, les matériels et les logiciels des parties relatives à la sécurité des systèmes de commande (SRP/CS) utilisés sur les tracteurs et matériels agricoles et forestiers, sur les machines automotrices à conducteur porté et sur les machines portées, semi-portées et remorquées utilisées pour les équipements agricoles. Elle peut être également applicable aux équipements municipaux (par exemple machines de balayage des rues). Elle spécifie les caractéristiques et les catégories requises des SRP/CS pour réaliser leurs fonctions de sécurité.
L'ISO 25119-3:2010 est applicable aux parties relatives à la sécurité des systèmes électriques/électroniques/électroniques programmables (E/E/PES). Dans la mesure où celles-ci sont liées aux systèmes mécatroniques, elle ne spécifie ni les fonctions de sécurité ni les catégories censées être utilisées dans un cas particulier. Elle n'est pas applicable aux systèmes non-E/E/PES (par exemple hydraulique, mécanique et pneumatique).
Traktorji ter kmetijski in gozdarski stroji - Varnostni deli krmilnih sistemov - 3. del: Razvoj serije, strojna in programska oprema (ISO 25119-3:2018)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 25119-3:2022
01-januar-2022
Traktorji ter kmetijski in gozdarski stroji - Varnostni deli krmilnih sistemov - 3. del:
Razvoj serije, strojna in programska oprema (ISO 25119-3:2018)
Tractors and machinery for agriculture and forestry - Safety-related parts of control
systems - Part 3: Series development, hardware and software (ISO 25119-3:2018)
Traktoren und Maschinen für die Land- und Forstwirtschaft - Sicherheitsbezogene Teile
von Steuerungen - Teil 3: Serienentwicklung, Hardware und Software (ISO 25119-
3:2018)
Tracteurs et matériels agricoles et forestiers - Parties des systèmes de commande
relatives à la sécurité - Partie 3: Développement en série, matériels et logiciels (ISO
25119-3:2018)
Ta slovenski standard je istoveten z: prEN ISO 25119-3
ICS:
35.240.99 Uporabniške rešitve IT na IT applications in other fields
drugih področjih
65.060.01 Kmetijski stroji in oprema na Agricultural machines and
splošno equipment in general
oSIST prEN ISO 25119-3:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 25119-3:2022
oSIST prEN ISO 25119-3:2022
DRAFT
EUROPEAN STANDARD
prEN ISO 25119-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2021
ICS 35.240.99; 65.060.01
English Version
Tractors and machinery for agriculture and forestry -
Safety-related parts of control systems - Part 3: Series
development, hardware and software (ISO 25119-3:2018)
Tracteurs et matériels agricoles et forestiers - Parties Traktoren und Maschinen für die Land- und
des systèmes de commande relatives à la sécurité - Forstwirtschaft - Sicherheitsbezogene Teile von
Partie 3: Développement en série, matériels et logiciels Steuerungen - Teil 3: Serienentwicklung, Hardware
(ISO 25119-3:2018) und Software (ISO 25119-3:2018)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 144.
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 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
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
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 25119-3:2021 E
worldwide for CEN national Members.
oSIST prEN ISO 25119-3:2022
prEN ISO 25119-3:2021 (E)
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
oSIST prEN ISO 25119-3:2022
prEN ISO 25119-3:2021 (E)
European foreword
The text of ISO 25119-3:2018 has been prepared by Technical Committee ISO/TC 23 “Tractors and
machinery for agriculture and forestry” of the International Organization for Standardization (ISO) and
has been taken over as prEN ISO 25119-3:2021 by Technical Committee CEN/TC 144 “Tractors and
machinery for agriculture and forestry” the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN 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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this
document.
Endorsement notice
The text of ISO 25119-3:2018 has been approved by CEN as prEN ISO 25119-3:2021 without any
modification.
oSIST prEN ISO 25119-3:2022
prEN ISO 25119-3:2021 (E)
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
The relevant Essential Clause(s)/sub-clause(s) of Remarks/Notes
Requirements of Directive this EN
2006/42/EC
1.1.2. Principles of safety
integration
1.1.2 (a) 5, 6, 7, B5
1.1.2 (c) 5, 6, 7, B5
1.2.1. Safety and reliability of 5, 6, 7, B5
control systems
1.2.3. Starting 5, 6, 7, B5
1.2.4.1. Normal stop 5, 6, 7, B5
1.2.4.2. Operational stop 5, 6, 7, B5
1.2.4.3. Emergency stop 5, 6, 7, B5
1.2.5. Selection of control or 5, 6, 7, B5
operating modes
1.2.6. Failure of the power supply 5, 6, 7, B5
1.6.3. Isolation of energy sources 5, 6, 7, B5
3.3.5. Control Circuit Failure 5, 6, 7, B5
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.
oSIST prEN ISO 25119-3:2022
INTERNATIONAL ISO
STANDARD 25119-3
Second edition
2018-10
Tractors and machinery for
agriculture and forestry — Safety-
related parts of control systems —
Part 3:
Series development, hardware and
software
Tracteurs et matériels agricoles et forestiers — Parties des systèmes
de commande relatives à la sécurité —
Partie 3: Développement en série, matériels et logiciels
Reference number
ISO 25119-3:2018(E)
©
ISO 2018
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
© ISO 2018
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.
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Published in Switzerland
ii © ISO 2018 – All rights reserved
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Abbreviated terms . 2
5 System design . 3
5.1 Objectives. 3
5.2 General . 3
5.3 Prerequisites . 4
5.4 Requirements . 4
5.4.1 Structuring safety requirements . 4
5.4.2 Technical safety concept . 5
5.5 Work products . 7
6 Hardware . 7
6.1 Objectives. 7
6.2 General . 7
6.3 Prerequisites . 7
6.4 Requirements . 7
6.5 Hardware categories . 9
6.6 Work products . 9
7 Software .10
7.1 Software development planning .10
7.1.1 Objectives .10
7.1.2 General.10
7.1.3 Prerequisites .10
7.1.4 Requirements .10
7.1.5 Work products .13
7.2 Software safety requirements specification .13
7.2.1 Objectives .13
7.2.2 General.13
7.2.3 Prerequisites .13
7.2.4 Requirements .13
7.2.5 Work products .17
7.3 Software architecture design .17
7.3.1 Objectives .17
7.3.2 General.17
7.3.3 Prerequisites .17
7.3.4 Requirements .17
7.3.5 Work products .19
7.4 Software component design and implementation .19
7.4.1 Objectives .19
7.4.2 General.19
7.4.3 Prerequisites .19
7.4.4 Requirements .19
7.4.5 Work products .29
7.5 Software component testing .29
7.5.1 Objectives .29
7.5.2 General.29
7.5.3 Prerequisites .29
7.5.4 Requirements .29
7.5.5 Work products .37
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
7.6 Software integration and testing .37
7.6.1 Objectives .37
7.6.2 General.38
7.6.3 Prerequisites .38
7.6.4 Requirements .38
7.6.5 Work products .39
7.7 Software safety testing .40
7.7.1 Objectives .40
7.7.2 General.40
7.7.3 Prerequisites .40
7.7.4 Requirements .40
7.7.5 Work products .44
7.8 Software-based parameterisation .44
7.8.1 Objective . .44
7.8.2 General.44
7.8.3 Prerequisites .45
7.8.4 Requirements .45
7.8.5 Work products .46
Annex A (informative) Example of agenda for assessment of functional safety at AgPL = e .47
Annex B (normative) Independence by software partitioning .49
Bibliography .59
iv © ISO 2018 – All rights reserved
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(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 23, Tractors and machinery for agriculture
and forestry, Subcommittee SC 19, Agricultural electronics.
This second edition cancels and replaces the first edition (ISO 25119-3:2010), which has been technically
revised. The main changes compared to the previous edition are as follows:
— the introduction has been modified to add specific information on safety standards;
— the prerequisites of functional safety have been specified;
— Clause 5 has been revised to:
— specify the prerequisites of functional safety, and
— simplify the general requirements of technical safety concepts;
— additional instructions have been added throughout the document to verify consistency of test
specifications and reports;
— Annex B has been changed to a normative annex;
— the document has been editorially revised.
A list of all parts in the ISO 25119 series can be found on the ISO website.
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.
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
Introduction
ISO 25119 (all parts) sets out an approach to the assessment, design and verification, for all safety life
cycle activities, of safety-related parts comprising electrical and/or electronic and/or programmable
electronic systems (E/E/PES) on tractors used in agriculture and forestry, and on self-propelled ride-
on machines and mounted, semi-mounted and trailed machines used in agriculture. It is also applicable
to mobile municipal equipment.
A prerequisite to the application of ISO 25119 (all parts) is the completion of a suitable hazard
identification and risk analysis (e.g. ISO 12100) for the entire machine. As a result, an E/E/PES is
frequently assigned to provide safety-related functions that create safety-related parts of control
systems (SRP/CS). These can consist of hardware or software, can be separate or integrated parts of
a control system, and can either perform solely safety-related functions or form part of an operational
function.
In general, the designer (and to some extent, the user) will combine the design and validation of these
SRP/CS as part of the risk assessment. The objective is to reduce the risk associated with a given hazard
(or hazardous situation) under all conditions of use of the machine. This can be achieved by applying
various measures (both SRP/CS and non-SRP/CS) with the end result of achieving a safe condition.
ISO 25119 (all parts) allocates the ability of safety-related parts to perform a safety-related function
under foreseeable conditions into five performance levels. The performance level of a controlled
channel depends on several factors, including system structure (category), the extent of fault detection
mechanisms (diagnostic coverage), the reliability of components (mean time to dangerous failure,
common-cause failure), design processes, operating stress, environmental conditions and operation
procedures. Three types of failures that can cause E/E/PES malfunctions leading to potential hazardous
situations are considered: systematic, common-cause and random.
In order to guide the designer during design, verification, and to facilitate the assessment of the achieved
performance level, ISO 25119 (all parts) defines an approach based on a classification of architecture
with different design features and specific behaviour in case of a fault.
The performance levels and categories can be applied to the control systems of all kinds of mobile
machines: from simple systems (e.g. auxiliary valves) to complex systems (e.g. steer by wire), as well as
the control systems of protective equipment (e.g. interlocking devices, pressure sensitive devices).
ISO 25119 (all parts) adopts a risk-based approach for the determination of the risks, while providing a
means of specifying the required performance level for the safety-related functions to be implemented
by E/E/PES safety-related channels. It gives requirements for the whole safety life cycle of E/E/PES
(design, validation, production, operation, maintenance, decommissioning), necessary for achieving the
required functional safety for E/E/PES that are linked to the performance levels.
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) deal 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 (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 (machinery safety standards) deal with detailed safety requirements for a
particular machine or group of machines.
This document is a type-B1 standard as stated in ISO 12100.
vi © ISO 2018 – All rights reserved
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
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 organizations, 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.
oSIST prEN ISO 25119-3:2022
oSIST prEN ISO 25119-3:2022
INTERNATIONAL STANDARD ISO 25119-3:2018(E)
Tractors and machinery for agriculture and forestry —
Safety-related parts of control systems —
Part 3:
Series development, hardware and software
1 Scope
This document sets out general principles for the design and development of safety-related parts of
control systems (SRP/CS) on tractors used in agriculture and forestry and on self-propelled ride-on
machines and mounted, semi-mounted and trailed machines used in agriculture. It can also be applied
to mobile municipal equipment (e.g. street-sweeping machines).
This document is not applicable to:
— aircraft and air-cushion vehicles used in agriculture;
— lawn and garden equipment.
This document specifies the characteristics and categories required of SRP/CS for carrying out their
safety-related functions. It does not identify performance levels for specific applications.
NOTE 1 Machine specific type-C standards can specify performance levels (AgPL) for safety-related functions
in machines within their scope. Otherwise, the specification of AgPL is the responsibility of the manufacturer.
This document is applicable to the safety-related parts of electrical/electronic/programmable
electronic systems (E/E/PES), as these relate to mechatronic systems. It covers the possible hazards
caused by malfunctioning behaviour of E/E/PES safety-related systems, including interaction of these
systems. It does not address hazards related to electric shock, fire, smoke, heat, radiation, toxicity,
flammability, reactivity, corrosion, release of energy, and similar hazards, unless directly caused by
malfunctioning behaviour of E/E/PES safety-related systems. It also covers malfunctioning behaviour
of E/E/PES safety-related systems involved in protective measures, safeguards, or safety-related
functions in response to non-E/E/PES hazards.
Examples included within the scope of this document:
— SRP/CS’s limiting current flow in electric hybrids to prevent insulation failure/shock hazards;
— electromagnetic interference with the SRP/CS;
— SRP/CS’s designed to prevent fire.
Examples not included in the scope of this document:
— insulation failure due to friction that leads to electric shock hazards;
— nominal electromagnetic radiation impacting nearby machine control systems;
— corrosion causing electric cables to overheat.
This document is not applicable to non-E/E/PES systems (e.g. hydraulic, mechanic or pneumatic).
NOTE 2 See also ISO 12100 for design principles related to the safety of machinery.
This document is not applicable to safety related parts of control systems manufactured before the
date of its publication.
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
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 25119-1, Tractors and machinery for agriculture and forestry — Safety-related parts of control
systems — Part 1: General principles for design and development
ISO 25119-2:2018, Tractors and machinery for agriculture and forestry — Safety-related parts of control
systems — Part 2: concept phase
ISO 25119-4:2018, Tractors and machinery for agriculture and forestry — Safety-related parts of control
systems — Part 4: Production, operation, modification and supporting processes
3 Terms and definitions
For the purposes of this document, the terms and definitions in ISO 25119-1 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/
4 Abbreviated terms
For the purposes of this document, the following abbreviated terms apply.
AgPL agricultural performance level
AgPL required agricultural performance level
r
CAD computer-aided design
Cat hardware category
CCF common-cause failure
DC diagnostic coverage
DC average diagnostic coverage
avg
ECU electronic control unit
ETA event tree analysis
E/E/PES electrical/electronic/programmable electronic systems
EMC electromagnetic compatibility
FMEA failure mode and effects analysis
FSM functional safety management
FTA fault tree analysis
HARA hazard analysis and risk assessment
HIL hardware in the loop
2 © ISO 2018 – All rights reserved
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
MTTF mean time to failure
MTTF mean time to dangerous failure
D
MTTF mean time to dangerous failure for each channel
DC
PES programmable electronic system
QM quality measures
RAM random-access memory
SOP start of production
SRL software requirement level
SRP safety-related parts
SRP/CS safety-related parts of control systems
UML unified modelling language
5 System design
5.1 Objectives
The objective is to define a system design for producing a detail design that fulfils the safety
requirements for the entire safety-related system.
5.2 General
Safety requirements constitute all requirements aimed at achieving and ensuring functional safety.
During the safety life cycle, safety requirements are detailed and specified in ever greater detail at
hierarchical levels. The different levels for safety requirements are illustrated in Figure 1. For the
overall representation of the procedure for developing safety requirements, see also 5.4. In order to
support management of safety requirements, the use of suitable tools for requirements management is
recommended.
Annex A provides guidance for an example agenda of the assessment of functional safety associated
with an AgPL = e.
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
Key
result
verification
validation
a
The first of two numbers separated by a slash refers to the respective part of ISO 25119, and the second
refers to the clause in that document: i.e. 2/6 is ISO 25119-2:2018/Clause 6, 3/5 is ISO 25119-3:2018/
Clause 5, and so on.
Figure 1 — Structuring of safety requirements
5.3 Prerequisites
The functional safety concept (ISO 25119-2:2018, Clause 7) is the prerequisite.
5.4 Requirements
5.4.1 Structuring safety requirements
During the functional safety concept phase, functional safety requirements are created to describe
the basic functioning of the safety-related system through which the safety goals are to be fulfilled.
The basic allocation of functional safety requirements to the system architecture is specified by
the technical safety concept specification in the form of technical safety requirements. This system
architecture comprises both hardware and software.
The hardware safety requirements refine and solidify the technical safety requirements. Clause 6
describes how to specify the hardware requirements in detail.
4 © ISO 2018 – All rights reserved
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
The software safety requirements are derived from the requirements of the technical safety concept
and the underlying hardware. The requirements for the software defined in Clause 7 shall be taken into
account.
This clause specifies the approach to be used in the specification of the technical safety concept
requirements during system design, thereby providing a basis for error-free system design.
5.4.2 Technical safety concept
5.4.2.1 General requirements of technical safety concept
The technical safety concept document includes the technical safety requirements for the system.
Each technical safety requirement shall be associated (e.g. by cross-reference) with higher-level safety
requirements, which may be:
— other technical safety requirements;
— functional safety requirements.
NOTE Traceability can be greatly facilitated by the use of suitable requirement management tools.
The implementation of each technical safety concept requirement shall take account of feasibility,
unambiguousness, consistency and completeness.
The technical safety concept shall take the following into account:
a) all safety goals and functional safety requirements;
b) all relevant norms, standards and statutory regulations;
c) the relevant results from safety analysis tools (FMEA, FTA, etc.); the safety analysis provides
iterative support for the technical safety concept during system development.
The completeness of the technical safety concept increases iteratively during system design. To ensure
completeness:
1) the version of the technical safety concept and the version of the relevant underlying sources shall
be specified;
2) the requirements from change management (see ISO 25119-4:2018, Clause 11) shall be met and,
for this reason, the technical safety requirements shall be structured and formulated to provide
support for a modification process;
3) the technical safety requirements shall be reviewed (see ISO 25119-4:2018, Clause 6).
The technical safety concept shall consider all phases of the life cycle (including production, customer
operation, servicing and decommissioning).
5.4.2.2 Specification of the technical safety concept
5.4.2.2.1 General
The technical safety concept shall include hardware and software safety requirements sufficient for
the design of the SRP/CS, and shall be determined in accordance with 5.4.2.1.
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
5.4.2.2.2 States and times
The behaviour of the SRP/CS, its components and their interfaces shall be specified for all relevant
operating states, including
— start-up,
— normal operation,
— shut-down,
— restart after reset, and
— reasonably foreseeable unusual operating states (e.g. degraded operating states).
In particular, failure behaviour and the required reaction shall be described exactly. Additional
emergency operation functions may be included.
The technical safety concept shall specify a safe state for each functional safety requirement, the
transition to the safe state, and the maintenance of the safe state. In particular, it shall be specified
whether shutting off the SRP/CS immediately represents a safe state, or if a safe state can only be
attained by a controlled shut down.
The technical safety concept shall specify for each functional safety requirement the maximum time
that may elapse between the occurrence of an error and the attainment of a safe state (response time).
All response times for subsystems and sub-functions shall be specified in the technical safety concept.
If no safe state can be achieved by a direct shut down, a time shall be defined during which a special
emergency operation function has to be sustained for all subsystems and sub-functions. This emergency
operation function shall be documented in the technical safety concept.
5.4.2.2.3 Safety architecture, interfaces and marginal conditions
The safety architecture and its sub-components shall be described. In particular, the technical measures
shall be specified. The technical safety concept shall separately describe the following components (as
applicable):
— sensor system, separate for each physical parameter recorded;
— miscellaneous digital and analogue input and output units;
— processing, separate for each arithmetic unit/discrete logical unit;
— actuator system, separate for each actuator;
— displays, separate for each indicator unit;
— miscellaneous electromechanical components;
— signal transmission between components;
— signal transmission from/to systems external to the SRP/CS;
— power supply.
The interfaces between the components of the SRP/CS, interfaces to other systems and functions in the
machine, as well as user interfaces, shall be specified.
Limitations and marginal conditions of the SRP/CS shall be specified. This applies in particular to
extreme values for all ambient conditions in all phases of the life cycle.
6 © ISO 2018 – All rights reserved
oSIST prEN ISO 25119-3:2022
ISO 25119-3:2018(E)
5.5 Work products
The following work product shall be applicable to system design:
a) technical safety concept specification.
6 Hardware
6.1 Objectives
The objective is to define acceptable hardware architectures for SRP/CS.
6.2 General
Improving the hardware structure of the SRP/CS can provide measures for avoiding, detecting or
tolerating faults. Practical measures can include redundancy, diversity and monitoring.
In general, the following fault criteria shall be taken into account.
— If, as a consequence of a fault, further components fail, the first fault and all following faults are
conside
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