DIN EN 16590-4-2014 Tractors and machinery for agriculture and forestry - Safety-related parts of control systems - Part 4 Production operation modification and supporting processe.pdf

1、November 2014 Translation by DIN-Sprachendienst.English price group 14No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I

2、CS 35.240.99; 65.060.01!%+“2270208www.din.deDDIN EN 16590-4Tractors and machinery for agriculture and forestry Safety-related parts of control systems Part 4: Production, operation, modification and supporting processes(ISO 25119-4:2010 modified);English version EN 16590-4:2014,English translation o

3、f DIN EN 16590-4:2014-11Traktoren und Maschinen fr die Land- und Forstwirtschaft Sicherheitsbezogene Teile von Steuerungen Teil 4: Fertigung, Betrieb, Modifikation und untersttzende Prozesse (ISO 25119-4:2010modifiziert);Englische Fassung EN 16590-4:2014,Englische bersetzung von DIN EN 16590-4:2014-

4、11Tracteurs et matriels agricoles et forestiers Parties des systmes de commande relatives la scurit Partie 4: Procds de production, de fonctionnement, de modification et dentretien(ISO 25119-4:2010 modifi);Version anglaise EN 16590-4:2014,Traduction anglaise de DIN EN 16590-4:2014-11www.beuth.deIn c

5、ase of doubt, the German-language original shall be considered authoritative.Document comprises 31 pages 10.14 DIN EN 16590-4:2014-11 2 A comma is used as the decimal marker. National foreword This standard includes safety requirements. This document (EN 16590-4:2014) has been prepared by Technical

6、Committee CEN/TC 144 “Tractors and machinery for agriculture and forestry” (Secretariat: AFNOR, France). The responsible German body involved in its preparation was the DIN-Normenausschuss Maschinenbau (DIN Standards Committee Mechanical Engineering), Working Committee NA 060-16-12 AA Elektronik of

7、Section Landtechnik. Representatives of manufacturers and users of agricultural machinery, and of the employers liability insurance associations contributed to this standard. This standard contains specifications meeting the essential requirements set out in Annex I of the “Machinery Directive”, Dir

8、ective 2006/42/EC, and which apply to machines that are either first placed on the market or commissioned within the EEA. This standard serves to facilitate proof of compliance with the essential requirements of that directive. Once this standard is cited in the Official Journal of the European Unio

9、n, it is deemed a “harmonized” standard and thus, a manufacturer applying this standard may assume compliance with the requirements of the Machinery Directive (“presumption of conformity”). The European Standards referred to in Clause 2 and in the Bibliography of this document have been published as

10、 the corresponding DIN EN or DIN EN ISO Standards with the same number. For the International Standards referred to in this standard there are no national standards available unless they have been published as DIN ISO standards with the same number. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM

11、EN 16590-4 April 2014 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 25119-4:2010 modified) Tracteurs et matriels agricoles et forestier

12、s - Parties des systmes de commande relatives la scurit - Partie 4: Procds de production, de fonctionnement, de modification et dentretien (ISO 25119-4:2010 modifi) - Sicherheitsbezogene Teile von Steuerungen - Teil 4: Fertigung, Betrieb, Modifikation und untersttzende Prozesse (ISO 25119-4:2010 mod

13、ifiziert) This European Standard was approved by CEN on 23 February 2014. 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 bibliogr

14、aphical 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 responsibi

15、lity 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, Former Yugoslav Republic

16、 of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISA

17、TION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16590-4:2014 ETraktoren und Maschinen fr die Land- und ForstwirtschaftEN 1659

18、0-4:2014 (E) 2 Contents Page Foreword 4 Introduction .5 1 Scope 7 2 Normative references 7 3 Terms and definitions .7 4 Abbreviated terms .7 5 Configuration management 8 5.1 Objectives .8 5.2 General 8 5.3 Prerequisites 8 5.4 Requirements .8 5.5 Work products 9 6 Verification and validation 9 6.1 Ob

19、jectives .9 6.2 General 9 6.3 Prerequisites 9 6.4 Requirements .9 6.4.1 SRP design validation/verification .9 6.4.2 Scope of safety validation/verification 9 6.4.3 Activities 10 6.4.4 Validation/verification plan 10 6.4.5 Validation/verification, test specification of hardware and software 10 6.4.6

20、Validation/verification test specification of the complete system . 10 6.4.7 Validation/verification test specification 10 6.5 Work products . 11 7 Product release . 11 7.1 Objectives 11 7.2 General . 11 7.3 Prerequisites . 12 7.4 Requirements 12 7.4.1 Conditions for product release . 12 7.4.2 Docum

21、entation of product release . 13 7.5 Work products . 13 8 Production, production testing . 13 8.1 Objectives 13 8.2 General . 13 8.3 Prerequisites . 13 8.4 Requirements 14 8.4.1 Production plan . 14 8.4.2 Production test plan . 14 8.4.3 Personnel . 14 8.4.4 Process capability 14 8.4.5 Documentation

22、14 8.4.6 Non-compliance 14 8.4.7 Storage and transport conditions . 14 8.5 Work products . 14 DINEN 16590-4:2014-11EN 16590-4:2014 (E) 3 9 Operation planning and maintenance (instructions for operating, servicing, repair, and decommissioning) . 15 9.1 Objectives 15 9.2 General . 15 9.3 Prerequisites

23、 15 9.4 Requirements . 15 9.4.1 General . 15 9.4.2 Servicing schedule 15 9.4.3 Repair instructions 15 9.4.4 Service technician instructions . 16 9.4.5 User information 16 9.4.6 Field observation . 16 9.4.7 Storage and transport information 16 9.4.8 Decommissioning and disassembling 16 9.5 Work produ

24、cts . 16 10 Modifications (change management) 17 10.1 General . 17 10.2 Objectives 17 10.3 General . 17 10.4 Prerequisites 17 10.5 Requirements . 17 10.5.1 Product modification and improvement procedures . 17 10.5.2 Change request . 19 10.5.3 Assessing impact of modification . 20 10.5.4 Modification

25、 authorisation 20 10.6 Work products . 20 11 Procedure for suppliers of SRS, subsystems and components 21 11.1 Objectives 21 11.2 General . 21 11.3 Prerequisites 21 11.4 Requirements . 21 11.4.1 General . 21 11.4.2 Scope of requirements 21 11.4.3 Supplier selection 22 11.4.4 Project initiation 22 11

26、.4.5 Project planning 22 11.4.6 Project execution . 22 11.4.7 Confirmation measures for the development partners functional safety . 23 11.4.8 System validation 23 11.5 Work products . 23 12 Technical documentation . 23 12.1 Objectives 23 12.2 Requirements . 23 12.2.1 Document retention . 23 12.2.2

27、Document structure 23 Annex A (informative) Technical documentation checklist 25 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Machinery Directive 2006/42/EC . 28 Bibliography 29 DINEN 16590-4:2014-11EN 16590-4:2014 (E) 4 Foreword This docume

28、nt (EN 16590-4:2014) has been prepared by Technical Committee CEN/TC 144 “Tractors and machinery for agriculture and forestry”, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorse

29、ment, at the latest by October 2014, and conflicting national standards shall be withdrawn at the latest by October 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identif

30、ying 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 relationship with EU Directive(s), see informative Annex ZA, which is an in

31、tegral part of this document. EN 16590 Tractors and machinery for agriculture and forestry Safety-related parts of control systems consists of the following parts: Part 1: General principles for design and development Part 2: Concept phase Part 3: Series development, hardware and software Part 4: Pr

32、oduction, operation, modification and supporting processes The modifications to ISO 25119-4:2010 are indicated by a vertical line in the margin. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Sta

33、ndard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, S

34、pain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 16590-4:2014-11 EN 16590-4:2014 (E) 5 Introduction EN 16590 sets out an approach to the design and assessment, for all safety life cycle activities, of safety-relevant systems comprising electrical and/or electronic and/or programmable

35、 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 municipal equipment. It covers the possible hazards caused by the functional behaviour of E/

36、E/PES safety-related systems, as distinct from hazards arising from the E/E/PES equipment itself (electric shock, fire, nominal performance level of E/E/PES dedicated to active and passive safety, etc.). The control system parts of the machines concerned are frequently assigned to provide the critic

37、al functions of the 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 critical functions or form part of an operational function. In general, the designer (and to some ex

38、tent, 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 protective measures

39、(both SRP/CS and non-SRP/CS) with the end result of achieving a safe condition. EN 16590 allocates the ability of safety-related parts to perform a critical function under foreseeable conditions into five performance levels. The performance level of a controlled channel depends on several factors, i

40、ncluding 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 a

41、re considered: systematic, common-cause and random. In order to guide the designer during design, and to facilitate the assessment of the achieved performance level, EN 16590 defines an approach based on a classification of structures with different design features and specific behaviour in case of

42、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 to the control systems of protective equipment (e.g. interlocking devices, pressure se

43、nsitive devices). EN 16590 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 cycl

44、e 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

45、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 st

46、andards 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

47、particular machine or group of machines. DIN EN 16590-4:2014-11 EN 16590-4:2014 (E) 6 This part of EN 16590 is a type-B1 standard as stated in EN ISO 12100. For machines which are covered by the scope of a machine specific type-C standard and which have been designed and built according to the provi

48、sions of that standard, the provisions of that type-C standard take precedence over the provisions of this type-B standard. DIN EN 16590-4:2014-11 EN 16590-4:2014 (E) 7 1 Scope This part of EN 16590 provides general principles for the production, operation, modification and supporting processes 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 appl