1、BRITISH STANDARDBS EN ISO 21469:2006Safety of machinery Lubricants with incidental product contact Hygiene requirementsThe European Standard EN ISO 21469:2006 has the status of a British StandardICS 67.020; 13.110g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g
2、44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 21469:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 16 March 2006 BSI 16 March 2006ISBN 0 580 47958 7National for
3、ewordThis British Standard is the official English language version ofEN ISO 21469:2006. It is identical with ISO 21469:2006.The UK participation in its preparation was entrusted to Technical Committee MCE/3, Safety of machinery, which has the responsibility to: aid enquirers to understand the text;
4、 present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK.A list of organizations represented on this committee can b
5、e obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogueunder the section entitled “International Standards Correspondence Index”, or by using the “Search” facili
6、ty of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations.S
7、ummary of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 7 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments i
8、ssued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21469February 2006ICS 67.020; 13.110English VersionSafety of machinery - Lubricants with incidental product contact -Hygiene requirements (ISO 21469:2006)Scurit des machines - Lubrifiants en contact oc
9、casionnelavec des produits - Exigences relatives lhygine (ISO21469:2006)Sicherheit von Maschinen - Schmierstoffe mit nichtvorhersehbarem Produktkontakt - Hygieneanforderungen(ISO 21469:2006)This European Standard was approved by CEN on 6 February 2006.CEN members are bound to comply with the CEN/CEN
10、ELEC Internal Regulations which stipulate the conditions for 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 Central Secretariat or to any CE
11、N member.This European Standard exists in three official versions (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 Central Secretariat has the same status as the officialversions.CEN membe
12、rs are the national standards bodies of Austria, Belgium, 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 a
13、nd United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21469
14、:2006: EForeword This document (EN ISO 21469:2006) 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 natio
15、nal standard, either by publication of an identical text or by endorsement, at the latest by August 2006, and conflicting national standards shall be withdrawn at the latest by August 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following count
16、ries are bound to implement this European Standard: Austria, Belgium, 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,
17、 Switzerland and United Kingdom. Endorsement notice The text of ISO 21469:2006 has been approved by CEN as EN ISO 21469:2006 without any modifications. EN ISO 21469:2006Reference numberISO 21469:2006(E)INTERNATIONAL STANDARDISO21469First edition2006-02-15Safety of machinery Lubricants with incidenta
18、l product contact Hygiene requirements Scurit des machines Lubrifiants en contact occasionnel avec des produits Exigences relatives lhygine EN ISO 21469:2006iiEN ISO 21469:2006iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
19、(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, g
20、overnmental 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. International Standards are drafted in accordance with the rules given in the ISO/I
21、EC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the mem
22、ber bodies casting a vote. 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. ISO 21469 was prepared by Technical Committee ISO/TC 199, Safety of machin
23、ery. EN ISO 21469:2006iv Introduction During the production of foodstuffs, cosmetics, pharmaceutical, tobacco and animal feeding products including packaging in direct contact with the product it is essential to avoid contamination with lubricants from machine elements such as gears, bearings, hydra
24、ulics, pneumatics, compressors, slideways and chains. In all cases where product and lubricant contact cannot be fully prevented, lubricants have to be used which are acceptable for use should cross-contamination occur. Up until 1998, the United States Department of Agriculture (USDA) issued the USD
25、A H1 authorization for lubricants, which met these requirements. Use of such lubricants gave users confidence that they were complying with best practice in relation to their duty of care to the consumer. Following the end of the USDA scheme, the need was recognized for an International Standard to
26、be developed in this area. The structure of safety standards in the field of machinery is as follows. a) Type-A standards (basis standards) give basic concepts, principle for design, and general aspects that can be applied to machinery. b) Type-B standards (generic safety standards) deal with one or
27、 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-hands controls, interlocking devices, pressure-
28、sensitive devices, guards). c) Type-C standards (machinery safety standards) deal with detailed safety requirements for a particular machine or group of machines. This International Standard is a type-B standard as stated in ISO 12100-1. When provisions of a type-C standard are different from those
29、which are stated in type-A or type-B standards, the provisions of the type-C standard take precedence over the provisions of the other standards for machines that have been designed and built according to the provisions of the type-C standard. 1Safety of machinery Lubricants with incidental product
30、contact Hygiene requirements 1 Scope This International Standard specifies hygiene requirements for the formulation, manufacture, use and handling of lubricants which, during manufacture and processing, can come into incidental contact (e.g. through heat transfer, load transmission, lubrication or t
31、he corrosion protection of machinery) with products and packaging used in the food, food-processing, cosmetics, pharmaceutical, tobacco or animal-feeding-stuffs industries. Included in this document are registration criteria that can be used to assess conformance with this International standard for
32、 lubricants with incidental product contact (see Annex B). It is not applicable to substances used as product additives or to those in direct product contact (see Annex A), but confines itself to hygiene without addressing occupational health and safety matters. Nevertheless, it is considered essent
33、ial that where occupational health and safety is associated with the processes concerned it be considered along with hygiene so that measures satisfying the needs of both can be taken. 2 Normative references The following referenced documents are indispensable for the application of this document. F
34、or dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 6743-99:2002, Lubricants, industrial oils and related products (class L) Classification Part 99: GeneralISO 6743 (all other parts), Lubri
35、cants, industrial oils and related products (class L) ClassificationISO 12100-1:2003, Safety of machinery Basic concepts, general principles for design Part 1: Basic terminology, methodology3 Terms and definitions For the purposes of this document, the following terms and definitions apply.3.1lubric
36、ant substance capable of reducing friction, adhesion, heat and wear when introduced as a film between solid surfaces 3.2product any substance intended to be applied or taken into humans or domestic animals, e.g. by ingestion, injection, topical application, insertion 3.3manufacture obtainment, produ
37、ction, preparation and processing of lubricants and of products EN ISO 21469:200623.4processing unit operations such as weighing, measuring, filling and refilling, stamping, printing, packing, container filling, container sealing/closure, cooling, storage and transportation of products 3.5intended u
38、se use of a lubricant in accordance with the instructions of the lubricant and machinery manufacturers in consideration of the expected operating conditions including service life, chemical, thermal and mechanical loads 3.6incidental product contact contact with product that is not intended but whic
39、h is not preventable 4 List of hazards The hygiene hazards that could possibly be associated with incidental product contact include the following: a) biological factors, such as pathogens, spoilage micro-organisms or toxins; b) chemical factors, such as toxic, carcinogenic or mutagenic substances;
40、c) physical factors, such as wear metals. NOTE It is recognized that in some countries there may be limits on the amount of lubricant that can come into incidental product contact. 5 Hygiene requirements 5.1 Basic strategy for selection of hygiene measures by the manufacturer The basic strategy for
41、the selection by a manufacturer of hygiene measures for the design of incidental product contact lubricants shall be in accordance with ISO 12100-1:2003, 5.1, includinga) identification of the product/process with which the lubricant is to be associated, b) the hazards associated with the product(s)
42、 produced (see Clause 4), c) the risk assessment associated with each hazard identified (see 5.2), d) design methods which can eliminate hazards or reduce risks associated with those hazards (see 5.3), e) means of verification of the effectiveness of the risk reduction method (see Clause 6), and f)
43、a description of residual risks and any additional precautions that are deemed necessary (see Clause 7). NOTE Guidance on the process for selecting hygiene measures is also given, schematically, in ISO 14159. EN ISO 21469:200635.2 Elements of manufacturers risk assessment The following are represent
44、ative of the range and types of factors that shall be considered as elements in the risk assessment of a lubricant during its manufacture, handling, storage, use and replenishment: a) contamination of the lubricant by the packaging material; b) contamination of the lubricant with biological factors;
45、 c) contamination of the lubricant by the product; d) contamination of the lubricant with water; e) the service age of the lubricant; f) chemical/physical changes caused by temperature exposure, mechanical activity, oxidation and degradation; g) reasonable foreseeable misuse. The outcome of the risk
46、 assessment should translate into corrective and preventative actions in accordance with defined lubricant quality and usage criteria. NOTE It is recognized that product contact can lead to changes in product aspect, taste, odour or texture. 5.3 Hygienic design 5.3.1 Classification Lubricants for in
47、cidental product contact are to be selected from ISO 6743-99:2002 according to the intended application. They shall conform with the description given in the relevant other part of ISO 6743 and comply with the related ISO specifications. 5.3.2 Cross-contamination Lubricants shall be composed in such
48、 a way that if cross-contamination with the product occurs, residues in the processed product are innocuous with respect to the health of the consumer, as well as taste and odour and such that they do not have any other adverse influence on the products intended use.5.3.3 Composition Lubricants shal
49、l meet the qualitative and compositional requirements if they consist only of substances regarded as being safe for product, or incidental product, contact by governments or other recognized international organizations. These substances should be included in listings published by government or recognized international organizations (see Annex A), or which are authorized by them, for use in lubricants with incidental product contact. 5.3.4 Good manufacturing practice Manufacturers should exercise care in the manufacturing and
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