1、 DEUTSCHE NORMMay 2006DIN EN ISO 21469 ICS 67.250; 75.100 Supersedes DIN V 10517:2001-04 Safety of machinery Lubricants with incidental product contact Hygiene requirements (ISO 21469:2006) English version of DIN EN ISO 21469:2006-05 Sicherheit von Maschinen Schmierstoffe mit nicht vorhersehbarem Pr
2、oduktkontakt Hygieneanforderungen (ISO 21469:2006) Englische Fassung DIN EN ISO 21469:2006-05 Document comprises 13 pages No part of this standard may be reproduced without prior permission of DIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany, has the exclusiv
3、e right of sale for German Standards (DIN-Normen). English price group 10 www.din.de www.beuth.de !,ny“12.06 9759286DIN EN ISO 21469:2006-05 2 Start of validity This standard is valid from 1 May 2006. National foreword This standard has been published in accordance with a decision taken by CEN/TC 11
4、4 to adopt, without alteration, International Standard ISO 21469 as a European Standard. The responsible German body involved in its preparation was the Normenausschuss Lebensmittel und land-wirtschaftliche Produkte (Foodstuffs and Agricultural Products Standards Committee), Technical Committee Lebe
5、nsmittelhygiene, in cooperation with the Normenausschuss Maschinenbau (Mechanical Engineering Standards Committee), the Normenausschuss Materialprfung (Materials Testing Standards Committee), the Fachausschuss Minerall- und Brennstoffnormung (Mineral Oil and Fuels Technical Committee), and the Norme
6、nausschuss Sicherheitstechnische Grundstze (Safety Design Principles Standards Committee). This document has been drawn up on the basis of a proposal by the German lubricant industry and contains, unchanged, the International Standard ISO 21469:2006 which had been prepared by ISO/TC 199 Safety of ma
7、chinery (Secretariat: Germany). At first, a national standard had been prepared in the form of the German prestandard DIN V 10517:2001. While working on this project on an international level, CEN/TC 114 Safety of machinery (Secretariat: Germany) decided to begin work on the European level within th
8、e framework of the Vienna Agreement. At first, the experts working on this standard used the well-known term foodgrade lubricants (in German lebensmitteltechnische Schmierstoffe). In the draft international standard, this term was changed to lubricants with incidental product contact (in German Schm
9、ierstoffe mit nicht vorhersehbarem Produkt-kontakt), the reason being that the scope of the standard encompasses not only lubricants which can come in contact with foodstuffs, but also those in contact with cosmetics, pharmaceuticals, tobacco products and animal foodstuffs, including their packaging
10、. In addition, it is also possible that a user might assume that a foodgrade lubricant is suitable as or intended to be a food additive. Other technical rules continue to use the term foodgrade lubricants. Products designated as such are to be considered equivalent to lubricants with incidental prod
11、uct contact as defined in the present standard. The DIN Standards corresponding to the International Standards referred to in clause 2 and in the bibliography of the EN are as follows: ISO 6743-4 DIN EN ISO 6743-4 ISO 6743-12 DIN ISO 6743-12 ISO 12100-1 DIN EN ISO 12100-1 ISO 14159 DIN EN ISO 14159
12、ISO/IEC Guide 65 DIN EN 45011 Amendments This standard differs from DIN V 10517, April 2001 edition, as follows: a) The term foodgrade lubricant (in German lebensmitteltechnische Schmierstoffe) is no longer used. It has been replaced by the term lubricants with incidental product contact (in German
13、Schmierstoffe mit nicht vorhersehbarem Produktkontakt). DIN EN ISO 21469:2006-05 3 b) The scope now includes registration criteria for assessing conformance with this standard. c) A list of significant hazards has been included. d) The elements of risk assessment have been included in the clause on
14、hygiene requirements. e) The criteria to be used for certification (called registration criteria) are now given in an informative, not a normative, annex. f) The document has been drawn up according to the rules for the structure and drafting of International Standards. Previous editions DIN V 10517
15、: 2001-04 National Annex NA (informative) Bibliography DIN EN 45011, General criteria for certification bodies operating product certification DIN EN ISO 6743-4, Lubricants, industrial oils and related products (class L) Classification Part 4: Fam-ily H (Hydraulic systems) DIN EN ISO 12100-1, Safety
16、 of machinery Basic concepts, general principles for design Part 1: Basic terminology, methodology DIN EN ISO 14159, Safety of machinery Hygiene requirements for the design of machinery DIN ISO 6743-12, Lubricants, industrial oils and related products (class L) Classification Part 12: Fam-ily Q (hea
17、t transfer fluids) EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21469 February 2006 ICS 67.020; 13.110 English Version Safety of machinery - Lubricants with incidental product contact -Hygiene requirements (ISO 21469:2006) Scurit des machines - Lubrifiants en contact occasionnel avec des
18、 produits - Exigences relatives lhygine (ISO 21469:2006) Sicherheit von Maschinen - Schmierstoffe mit nicht vorhersehbarem 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/CENELEC Intern
19、al 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 Central Secretariat or to any CEN member.
20、 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 Central Secretariat has the same status as the official versions. CEN members ar
21、e 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 and
22、United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21
23、469:2006: EEN ISO 21469:2006 (E) 2 Foreword 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
24、 given the status of a national 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 organiza
25、tions of the following countries 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, Slovak
26、ia, Slovenia, Spain, Sweden, 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 21469:2006 (E) 3 Introduction During the production of foodstuffs, cosmetics, pharmaceutical, tobacco and animal
27、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, hydraulics, pneumatics, compressors, slideways and chains. In all cases where product and lubricant contact cannot be fully pr
28、evented, 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 USDA H1 authorization for lubricants, which met these requirements. Use of such lubricants gave users confidence that they w
29、ere 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 be developed in this area. The structure of safety standards in the field of machinery is as follows. a) Type-A standards
30、 (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 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
31、andards on particular safety aspects (e.g. safety distances, surface temperature, noise); type-B2 standards on safeguards (e.g. two-hands controls, interlocking devices, pressure-sensitive devices, guards). c) Type-C standards (machinery safety standards) deal with detailed safety requirements for a
32、 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 which are stated in type-A or type-B standards, the provisions of the type-C standard take precedence over the provisions
33、 of the other standards for machines that have been designed and built according to the provisions of the type-C standard. EN ISO 21469:2006 (E) 4 1 Scope This International Standard specifies hygiene requirements for the formulation, manufacture, use and handling of lubricants which, during manufac
34、ture and processing, can come into incidental contact (e.g. through heat transfer, load transmission, lubrication or the corrosion protection of machinery) with products and packaging used in the food, food-processing, cosmetics, pharmaceutical, tobacco or animal-feeding-stuffs industries. Included
35、in this document are registration criteria that can be used to assess conformance with this International standard for 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 confi
36、nes itself to hygiene without addressing occupational health and safety matters. Nevertheless, it is considered essential 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 take
37、n. 2 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 6743-99:2002, Lubri
38、cants, industrial oils and related products (class L) Classification Part 99: General ISO 6743 (all other parts), Lubricants, industrial oils and related products (class L) Classification ISO 12100-1:2003, Safety of machinery Basic concepts, general principles for design Part 1: Basic terminology, m
39、ethodology 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 lubricant substance capable of reducing friction, adhesion, heat and wear when introduced as a film between solid surfaces 3.2 product any substance intended to be applied or taken in
40、to humans or domestic animals, e.g. by ingestion, injection, topical application, insertion 3.3 manufacture obtainment, production, preparation and processing of lubricants and of products EN ISO 21469:2006 (E) 5 3.4 processing unit operations such as weighing, measuring, filling and refilling, stam
41、ping, printing, packing, container filling, container sealing/closure, cooling, storage and transportation of products 3.5 intended use use of a lubricant in accordance with the instructions of the lubricant and machinery manufacturers in consideration of the expected operating conditions including
42、service life, chemical, thermal and mechanical loads 3.6 incidental product contact contact with product that is not intended but which is not preventable 4 List of hazards The hygiene hazards that could possibly be associated with incidental product contact include the following: a) biological fact
43、ors, such as pathogens, spoilage micro-organisms or toxins; b) chemical factors, such as toxic, carcinogenic or mutagenic substances; 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 pr
44、oduct contact. 5 Hygiene requirements 5.1 Basic strategy for selection of hygiene measures by the manufacturer The basic strategy for 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, includi
45、ng a) identification of the product/process with which the lubricant is to be associated, b) the hazards associated with the product(s) 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 asso
46、ciated with those hazards (see 5.3), e) means of verification of the effectiveness of the risk reduction method (see Clause 6), and f) 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
47、is also given, schematically, in ISO 14159. EN ISO 21469:2006 (E) 6 5.2 Elements of manufacturers risk assessment The following are representative 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, u
48、se and replenishment: a) contamination of the lubricant by the packaging material; b) contamination of the lubricant with biological factors; 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 chan
49、ges caused by temperature exposure, mechanical activity, oxidation and degradation; g) reasonable foreseeable misuse. The outcome of the risk 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 incidental product contact are to be selected from ISO 6743-99:2002 ac
