oSIST prEN ISO 25119-4:2022
(Main)Tractors and machinery for agriculture and forestry - Safety-related parts of control systems - Part 4: Production, operation, modification and supporting processes (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 (ISO 25119-4:2018)
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 limiting current flow in electric hybrids to prevent insulation failure/shock hazards;
— electromagnetic interference with the SRP/CS;
— SRP/CS 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.
Traktoren und Maschinen für die Land- und Forstwirtschaft - Sicherheitsbezogene Teile von Steuerungen - Teil 4: Fertigung, Betrieb, Modifikation und unterstützende Prozesse (ISO 25119-4:2018)
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. Es 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. Es 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 4: Procédés de production, de fonctionnement, de modification et d'entretien (ISO 25119-4:2018)
Traktorji ter kmetijski in gozdarski stroji - Varnostni deli krmilnih sistemov - 4. del: Proizvodni, obratovalni, spreminjevalni in podporni procesi (ISO 25119-4:2018)
General Information
RELATIONS
Standards Content (sample)
SLOVENSKI STANDARD
oSIST prEN ISO 25119-4:2022
01-januar-2022
Traktorji ter kmetijski in gozdarski stroji - Varnostni deli krmilnih sistemov - 4. del:
Proizvodni, obratovalni, spreminjevalni in podporni procesi (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 (ISO
25119-4:2018)Traktoren und Maschinen für die Land- und Forstwirtschaft - Sicherheitsbezogene Teile
von Steuerungen - Teil 4: Fertigung, Betrieb, Modifikation und unterstützende Prozesse
(ISO 25119-4:2018)Tracteurs et matériels agricoles et forestiers - Parties des systèmes de commande
relatives à la sécurité - Partie 4: Procédés de production, de fonctionnement, de
modification et d'entretien (ISO 25119-4:2018)Ta slovenski standard je istoveten z: prEN ISO 25119-4
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 25119-4:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 25119-4:2022
DRAFT
EUROPEAN STANDARD
prEN ISO 25119-4
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 4:
Production, operation, modification and supporting
processes (ISO 25119-4:2018)
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 4: Procédés de production, de fonctionnement, Steuerungen - Teil 4: Fertigung, Betrieb, Modifikation
de modification et d'entretien (ISO 25119-4:2018) und unterstützende Prozesse (ISO 25119-4:2018)
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 25119-4:2021 E
worldwide for CEN national Members.---------------------- Page: 3 ----------------------
oSIST prEN ISO 25119-4:2022
prEN ISO 25119-4:2021 (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
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prEN ISO 25119-4:2021 (E)
European foreword
The text of ISO 25119-4:2018 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 25119-4:2021 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 25119-4:2018 has been approved by CEN as prEN ISO 25119-4:2021 without any
modification.---------------------- Page: 5 ----------------------
oSIST prEN ISO 25119-4:2022
prEN ISO 25119-4:2021 (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/ECThe 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, 8, 9, 10, 11, 12
1.1.2 (c) 5, 6, 7, 8, 9, 10, 11, 12
1.2.1. Safety and reliability of 6, 7, 8, 9, 10, 11, 12
control systems
1.2.3. Starting 6, 7, 8, 9, 10, 11, 12
1.2.4.1. Normal stop 6, 7, 8, 9, 10, 11, 12
1.2.4.2. Operational stop 6, 7, 8, 9, 10, 11, 12
1.2.4.3. Emergency stop 6, 7, 8, 9, 10, 11, 12
1.2.5. Selection of control or 6, 7, 8, 9, 10, 11, 12
operating modes
1.2.6. Failure of the power supply 6, 7, 8, 9, 10, 11, 12
1.6.3. Isolation of energy sources 6, 7, 8, 9, 10, 11, 12
3.3.5. Control Circuit Failure 6, 7, 8, 9, 10, 11, 12
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.---------------------- Page: 6 ----------------------
oSIST prEN ISO 25119-4:2022
INTERNATIONAL ISO
STANDARD 25119-4
Second edition
2018-10
Tractors and machinery for
agriculture and forestry — Safety-
related parts of control systems —
Part 4:
Production, operation, modification
and supporting processes
Tracteurs et matériels agricoles et forestiers — Parties des systèmes
de commande relatives à la sécurité —
Partie 4: Procédés de production, de fonctionnement, de modification
et d'entretien
Reference number
ISO 25119-4:2018(E)
ISO 2018
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oSIST prEN ISO 25119-4:2022
ISO 25119-4:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© 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.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 2018 – All rights reserved
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oSIST prEN ISO 25119-4:2022
ISO 25119-4:2018(E)
Contents Page
Foreword ..........................................................................................................................................................................................................................................v
Introduction ................................................................................................................................................................................................................................vi
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 2
3 Terms and definitions ..................................................................................................................................................................................... 2
4 Abbreviated terms .............................................................................................................................................................................................. 2
5 Quality management system .................................................................................................................................................................... 3
6 Safety validation and verification ....................................................................................................................................................... 3
6.1 Objectives..................................................................................................................................................................................................... 3
6.2 General ........................................................................................................................................................................................................... 3
6.3 Prerequisites ............................................................................................................................................................................................. 3
6.4 Requirements ........................................................................................................................................................................................... 4
6.4.1 SRP/CS design validation and verification ................................................................................................ 4
6.4.2 Scope of safety validation and verification................................................................................................ 4
6.4.3 Activities.................................................................................................................................................................................. 4
6.4.4 Validation and verification plan .......................................................................................................................... 4
6.4.5 Validation and verification test specification .......................................................................................... 5
6.5 Work products ......................................................................................................................................................................................... 5
7 Configuration management ...................................................................................................................................................................... 5
7.1 Objectives..................................................................................................................................................................................................... 5
7.2 Prerequisites ............................................................................................................................................................................................. 5
7.3 Requirements ........................................................................................................................................................................................... 5
7.4 Work products ......................................................................................................................................................................................... 6
8 Product release ...................................................................................................................................................................................................... 6
8.1 Objectives..................................................................................................................................................................................................... 6
8.2 General ........................................................................................................................................................................................................... 6
8.3 Prerequisites ............................................................................................................................................................................................. 7
8.4 Requirements ........................................................................................................................................................................................... 7
8.4.1 Conditions for product release ............................................................................................................................ 7
8.4.2 Documentation of product release ................................................................................................................... 7
8.5 Work products ......................................................................................................................................................................................... 7
9 Production planning, production and production testing ........................................................................................ 7
9.1 Objectives..................................................................................................................................................................................................... 7
9.2 General ........................................................................................................................................................................................................... 7
9.3 Prerequisites ............................................................................................................................................................................................. 8
9.4 Requirements ........................................................................................................................................................................................... 8
9.4.1 Production plan ................................................................................................................................................................ 8
9.4.2 Production test plan ........................................................................................................................................... ........... 8
9.4.3 Personnel ................................................................................................................................................................................ 8
9.4.4 Process capability ........................................................................................................................................................... 8
9.4.5 Documentation .................................................................................................................................................................. 8
9.4.6 Non-compliance .................. .................................................... .......................................................................................... 8
9.4.7 Storage and transport conditions ...................................................................................................................... 9
9.5 Work products ......................................................................................................................................................................................... 9
10 Operation planning and maintenance (instructions for operating, servicing, repair
and decommissioning) ................................................................................................................................................................................... 9
10.1 Objectives..................................................................................................................................................................................................... 9
10.2 General ........................................................................................................................................................................................................... 9
10.3 Prerequisites ............................................................................................................................................................................................. 9
10.4 Requirements ........................................................................................................................................................................................... 9
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oSIST prEN ISO 25119-4:2022
ISO 25119-4:2018(E)
10.4.1 General...................................................................................................................................................................................... 9
10.4.2 Servicing schedule .......................................................................................................................................................... 9
10.4.3 Repair instructions .....................................................................................................................................................10
10.4.4 Service technician instructions ........................................................................................................................10
10.4.5 User information ...........................................................................................................................................................10
10.4.6 Field observation ..........................................................................................................................................................10
10.4.7 Storage and transport information ...............................................................................................................10
10.4.8 Decommissioning and disassembling ........................................................................................................10
10.5 Work products ......................................................................................................................................................................................11
11 Modifications (change management) ..........................................................................................................................................11
11.1 Objective ....................................................................................................................................................................................................11
11.2 General ........................................................................................................................................................................................................11
11.3 Prerequisites ..........................................................................................................................................................................................11
11.4 Requirements ........................................................................................................................................................................................11
11.4.1 Product modification and improvement procedures ....................................................................11
11.4.2 Modification request .................................................................................................................................................13
11.4.3 Assessing impact of modification ...................................................................................................................14
11.4.4 Modification authorization ..................................................................................................................................14
11.5 Work products ......................................................................................................................................................................................14
12 Procedure for suppliers of SRP/CS, subsystems and components ................................................................15
12.1 Objectives..................................................................................................................................................................................................15
12.2 General ........................................................................................................................................................................................................15
12.3 Prerequisites ..........................................................................................................................................................................................15
12.4 Requirements ........................................................................................................................................................................................15
12.4.1 General...................................................................................................................................................................................15
12.4.2 Scope of requirements .............................................................................................................................................15
12.4.3 Supplier selection ...................................................................... ...................................................................................16
12.4.4 Project initiation ...........................................................................................................................................................16
12.4.5 Project planning ............................................................................................................................................................16
12.4.6 Project execution ..........................................................................................................................................................16
12.4.7 Confirmation measures for the development partners' functional safety ..................17
12.4.8 System validation .........................................................................................................................................................17
12.5 Work products ......................................................................................................................................................................................17
13 Technical documentation .........................................................................................................................................................................17
13.1 Objectives..................................................................................................................................................................................................17
13.2 Requirements ........................................................................................................................................................................................17
13.2.1 Document retention ...................................................................................................................................................17
13.2.2 Document structure ...................................................................................................................................................17
Annex A (informative) Technical documentation checklist ......................................................................................................19
Bibliography .............................................................................................................................................................................................................................22
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oSIST prEN ISO 25119-4:2022
ISO 25119-4:2018(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 25119-4:2010), 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 scope has been slightly modified;— and a new Clause 5 (quality management system) has been added;
— the former Clause 5 (configuration management) has been moved after Clause 6;
— Clause 6 has been revised;
— the example of technical documentation checklist has been modified;
— 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.© ISO 2018 – All rights reserved v
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oSIST prEN ISO 25119-4:2022
ISO 25119-4:2018(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 a...
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