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1 SVENSK STANDARD SS-EN ISO :2012 Fastställd/Approved: Publicerad/Published: Utgåva/Edition: 3 Språk/Language: engelska/english ICS: ; Maskinsäkerhet Styrsystem Säkerhetsrelaterade delar i styrsystem Del 2: Validering (ISO :2012) Safety of machinery Safety-related parts of control systems Part 2: Validation (ISO :2012) Denna standard är såld av SEK Svensk Elstandard som även lämnar allmänna upplysningar om svensk och utländsk standard. Postadress: SEK, Box 1284, Kista Telefon: E-post: Internet:
3 Europastandarden EN ISO :2012 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO :2012. Denna standard ersätter SS-EN ISO :2008, utgåva 2. The European Standard EN ISO :2012 has the status of a Swedish Standard. This document contains the official version of EN ISO :2012. This standard supersedes the Swedish Standard SS-EN ISO :2008, edition 2. Förhållandet till övriga delar under samma huvudtitel - Utdrag ur Förord i ISO :2012/ Relations to other parts under the same general title - Extract from the Foreword of ISO :2012 ISO consists of the following parts, under the general title Safety of machinery Safety-related parts of control systems: - Part 1: General principles for design - Part 2: Validation Copyright / Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen av denna produkt regleras av slutanvändarlicensen som återfinns i denna produkt, se standardens sista sidor. Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by the end-user licence for this product. You will find the licence in the end of this document. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), telephone Standards may be ordered from SIS Förlag AB, who can also provide general information about Swedish and foreign standards. Denna standard är framtagen av kommittén för Maskinsäkerhet, SIS / TK 282. Har du synpunkter på innehållet i den här standarden, vill du delta i ett kommande revideringsarbete eller vara med och ta fram andra standarder inom området? Gå in på - där hittar du mer information.
4 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO October 2012 ICS Supersedes EN ISO :2008 English Version Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO :2012) Sécurité des machines - Parties des systèmes de commande relatives à la sécurité - Partie 2: Validation (ISO :2012) Sicherheit von Maschinen - Sicherheitsbezogene Teile von Steuerungen - Teil 2: Validierung (ISO :2012) This European Standard was approved by CEN on 14 October 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, Former Yugoslav Republic 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 COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO :2012: E
5 SS-EN ISO :2012 (E) Contents Page Foreword...iv Introduction...v 1 Scope Normative references Terms and definitions Validation process Validation principles Validation plan Generic fault lists Specific fault lists Information for validation Validation record Validation by analysis General Analysis techniques Validation by testing General Measurement accuracy More stringent requirements Number of test samples Validation of safety requirements specification for safety functions Validation of safety functions Validation of performance levels and categories Analysis and testing Validation of category specifications Validation of MTTF d, DC avg and CCF Validation of measures against systematic failures related to performance level and category of SRP/CS Validation of safety-related software Validation and verification of performance level Validation of combination of safety-related parts Validation of environmental requirements Validation of maintenance requirements Validation of technical documentation and information for use...16 Annex A (informative) Validation tools for mechanical systems...17 Annex B (informative) Validation tools for pneumatic systems...21 Annex C (informative) Validation tools for hydraulic systems...31 Annex D (informative) Validation tools for electrical systems...40 Annex E (informative) Example of validation of fault behaviour and diagnostic means...53 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC...78 Bibliography...79 iii
6 SS-EN ISO :2012 (E) Foreword This document (EN ISO :2012) 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 April 2013, and conflicting national standards shall be withdrawn at the latest by April 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 identifying any or all such patent rights. This document supersedes EN ISO :2008. 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. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: 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, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO :2012 has been approved by CEN as a EN ISO :2012 without any modification. iv
7 SS-EN ISO :2012 (E) Introduction The structure of safety standards in the field of machinery is as follows: a) type-a standards (basic safety standards) giving basic concepts, principles for design and general aspects that can be applied to machinery; b) type-b standards (generic safety standards) dealing with one safety aspect or one type of safeguard that can be used across a wide range of machinery: type-b1 standards on particular safety aspects (for example safety distances, surface temperature, noise); type-b2 standards on safeguards (for example two-hand controls, interlocking devices, pressure-sensitive devices, guards); c) type-c standards (machine safety standards) dealing with detailed safety requirements for a particular machine or group of machines. This document is a type-b standard as stated in ISO 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. This part of ISO specifies the validation process for the safety functions, categories and performance levels for the safety-related parts of control systems. It recognizes that the validation of safety-related parts of control systems can be achieved by a combination of analysis (see Clause 5) and testing (see Clause 6), and specifies the particular circumstances in which testing ought to be carried out. Most of the procedures and conditions in this part of ISO are based on the assumption that the simplified procedure for estimating the performance level (PL) described in ISO :2006, 4.5.4, is used. This part of ISO does not provide guidance for situations when other procedures are used to estimate PL (e.g. Markov modelling), in which case some of its provisions will not apply and additional requirements can be necessary. Guidance on the general principles for the design (see ISO 12100) of safety-related parts of control systems, regardless of the type of technology used (electrical, hydraulic, pneumatic, mechanical, etc.), is provided in ISO This includes descriptions of some typical safety functions, determination of their required performance levels, and general requirements of categories and performance levels. Within this part of ISO 13849, some of the validation requirements are general, whereas others are specific to the type of technology used. v
8 SS-EN ISO :2012 (E) Safety of machinery Safety-related parts of control systems Part 2: Validation 1 Scope This part of ISO specifies the procedures and conditions to be followed for the validation by analysis and testing of the specified safety functions, the category achieved, and the performance level achieved by the safety-related parts of a control system (SRP/CS) designed in accordance with ISO NOTE Additional requirements for programmable electronic systems, including embedded software, are given in ISO :2006, 4.6, and IEC Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 12100:2010, Safety of machinery General principles for design Risk assessment and risk reduction ISO :2006, Safety of machinery Safety-related parts of control systems Part 1: General principles for design nt, the terms and definitions given in ISO and ISO apply. ISO 2012 All rights reserved 1