1、BS EN ISO14159:2008ICS 13.110NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSafety of machinery Hygiene requirementsfor the design ofmachinery (ISO14159:2002)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 3
2、0 June2009. BSI 2009ISBN 978 0 580 67931 5Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 14159:2008National forewordThis British Standard is the UK implementation of EN ISO 14159:2008.It is identical to ISO 14159:2002. It supersedes BS EN ISO 14159:2004which is withdrawn.The UK
3、 participation in its preparation was entrusted to TechnicalCommittee MCE/3, Safeguarding of machinery.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are re
4、sponsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 14159April 2008ICS 13.110 Supersedes EN ISO 14159:2004 English VersionSafety of machinery - Hygiene requirements for the design
5、ofmachinery (ISO 14159:2002)Scurit des machines - Prescriptions relatives lhyginelors de la conception des machines (ISO 14159:2002)This European Standard was approved by CEN on 21 March 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
6、 giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official v
7、ersions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium
8、, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STAND
9、ARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14159:2008: EBS EN ISO 14159:2008EN ISO 14159:2008
10、(E) 3 Foreword The text of ISO 14159:2002 has been prepared by Technical Committee ISO/TC 199 “Safety of machinery” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14159:2008 by Technical Committee CEN/TC 114 “Safety of machinery” the secretariat of whic
11、h 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 October 2008, and conflicting national standards shall be withdrawn at the latest by October 2008. Attention is drawn to the possi
12、bility 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 14159:2004. This document has been prepared under a mandate given to CEN by the Europ
13、ean Commission and the European Free Trade Association, and supports essential requirements of EC Directives. For relationship with EC Directives, see informative Annex ZA and ZB which are integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organ
14、izations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Ro
15、mania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14159:2002 has been approved by CEN as a EN ISO 14159:2008 without any modification. BS EN ISO 14159:2008EN ISO 14159:2008 (E) 4 Annex ZA (informative) Relationship between this European
16、Standard and the Essential Requirements of EU Directive 98/37/EC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive Machinery
17、 98/37/EC, amended by 98/79/EC. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers, withi
18、n 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 Directive 98/37/EC Clause(s)/sub-clause(s) of this EN Essential Requir
19、ements (ERs) of Directive 98/37/EC, amended by 98/79/EC Qualifying remarks/Notes All clauses Annex I, 2.1 Agri-foodstuffs machinery WARNING Other requirements and other EC Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 14159:2008EN ISO 14159:2008
20、(E) 5 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming
21、 to Essential Requirements of the New Approach Directive Machinery 2006/42/EC. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of t
22、his standard given in Table ZB.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 ZB.1 Correspondence between this European Standard and Directive 2006/42/EC Cl
23、ause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 2006/42/EC Qualifying remarks/Notes All clauses Annex I, 2.1 Foodstuffs machinery etc. WARNING Other requirements and other EC Directives may be applicable to the product(s) falling within the scope of this standard. BS EN IS
24、O 14159:2008ISO 14159:2002(E) ISO 2002 All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope 1 2 Normative references1 3 Terms and definitions .1 4 Hazards.4 5 Hygiene requirements and/or measures.4 5.1 Strategy for selecting hygiene measures .4 5.2 Hygienic design .7 6 Verificatio
25、n of hygiene measures and test methods .11 7 Instruction handbook, maintenance and cleaning.11 7.1 Instruction handbook11 7.2 Maintenance and cleaning11 8 Additional information (limitations of use) .12 Annex A (informative) Categorization of machinery and associated equipment for intended use13 Ann
26、ex B (informative) Examples of good and bad hygienic design features.14 Annex C (informative) Relationship between International Standards referenced in clause 2 and corresponding European Standards .29 Bibliography30 BS EN ISO 14159:2008ISO 14159:2002(E) iv ISO 2002 All rights reserved Foreword ISO
27、 (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 com
28、mittee 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 electrot
29、echnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the mem
30、ber bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsibl
31、e for identifying any or all such patent rights. ISO 14159 was prepared by Technical Committee ISO/TC 199, Safety of machinery. Annexes A to C are for information only. BS EN ISO 14159:2008ISO 14159:2002(E) ISO 2002 All rights reserved vIntroduction This International Standard is one of a series of
32、standards relating to the safety of machinery (ISO 12100 series). It differs from other safety standards, however, in that it is concerned with the associated hygiene risks of the machinery to the consumer of the product being processed, not to the operator of the machine. Hygiene risks are very dif
33、ferent from other safety risks. They are more associated with the ability of machines to be freed from product debris and micro-organisms, and thus preventing product contamination, rather than from the dangers of moving parts or electrical hazards to the operator. For this reason, and whilst this I
34、nternational Standard considers machines and their associated equipment, it can be used to provide guidance to the manufacturers of all equipment types where hygiene risks to the consumer of products to be processed by such equipment could occur. This International Standard is a Type B standard (see
35、 ISO 12100) and as such is very general. It is applicable to all machines and associated equipment in applications where hygiene risks to the consumer of the product can occur (e.g., food, pharmaceuticals, biotechnology, cosmetics). Other standards, such as for example machinery specific Type C stan
36、dards (see Bibliography), may be required to provide guidance for specific types of equipment and/or for specific industry sectors. Historically, there have been cases where safety criteria have been addressed in machinery design without taking into account the implications linked to hygienic risks
37、(and vice versa). In almost all cases, at least one of the different methods of design, safeguarding or residual safeguards can be chosen which will meet both safety and hygiene essential requirements and adequately control both risks. The option chosen shall satisfy both hygiene and safety risks, e
38、ven if it may not be the most obvious option to have been adopted had the risk only been to safety or to hygiene. When no design or safeguarding options are within the state of the art to adequately control both hygiene and safety risks, then one of the risks, or both, would have to be dealt with by
39、 residual safeguards, including instructions to the user. The assessment of the respective safety and hygiene risks shall indicate their relative significance, and the highest level of protection (i.e. safeguarding) shall be implemented to deal with the severest risk, and residual safeguards shall b
40、e used for the lesser risk. The technical solutions given in this International Standard permit both objectives to be met for those significant and common risks identified as justifying common requirements specified in this International Standard. BS EN ISO 14159:2008BS EN ISO 14159:2008INTERNATIONA
41、L STANDARD ISO 14159:2002(E) ISO 2002 All rights reserved 1Safety of machinery Hygiene requirements for the design of machinery 1 Scope This International Standard specifies hygiene requirements of machines and provides information for the intended use to be provided by the manufacturer. It applies
42、to all types of machines and associated equipment used in applications where hygiene risks to the consumer of the product can occur. This International Standard does not cover requirements relative to the uncontrolled egress of microbiological agents from the machine. 2 Normative references The foll
43、owing normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Internationa
44、l Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid Internation
45、al Standards. ISO 4287:1997, Geometrical Product Specifications (GP ) Surface texture: Profile method Terms, definitions and surface texture parameters ISO 12100-1:1), Safety of machinery Basic concepts and general principles for design Part 1: Basic terminology and methodology ISO 12100-2:2), Safet
46、y of machinery Basic concepts and general principles for design Part 2: Technical principles 3 Terms and definitions For the purposes of this International Standard, the following terms and definitions apply. 3.1 associated equipment all equipment associated with a machine, not defined as machinery
47、(3.13), that is essential to the functioning of the machine for it to hygienically process a product (e.g. fittings, piping, tubing) 3.2 bond joining of materials with an adhesive 1) To be published. (Revision of ISO/TR 12100-1:1992) 2) To be published. (Revision of ISO/TR 12100-2:1992) BS EN ISO 14
48、159:2008ISO 14159:2002(E) 2 ISO 2002 All rights reserved 3.3 cleaning in place cleaning (3.4) of equipment by impingement or circulation of flowing chemical solutions, cleaning liquids and water rinses into, onto and over surfaces in equipment or systems without dismantling and designed for the purp
49、ose 3.4 cleaning removal of soil (see 3.31) 3.5 cleanable equipment designed to be freed from soil 3.6 consumer end user of the product (including domestic animals) 3.7 corrosion resistant material material having the property to maintain its original surface characteristics for its intended life time when exposed to the conditions encountered in the environment of intended use, including exposed contact with product, cleaning, disinfection, pasteurization or sterilization conditions 3.8 crevice sharp, cleft-like, irregular open
