SIST EN 13951:2012

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Flüssigkeitspumpen - Sicherheitsanforderungen - Nahrungsmittelausrüstungen; Konstruktionsgegeln zur Sicherstellung der Hygiene bei der VerwendungPompes pour liquides - Prescriptions de sécurité - Matériel agro-alimentaire; Règles de construction pour assurer l'hygiène à l'utilisationLiquid pumps - Safety requirements - Agrifoodstuffs equipment; Design rules to ensure hygiene in use67.260Tovarne in oprema za živilsko industrijoPlants and equipment for the food industry23.080ýUSDONHPumpsICS:Ta slovenski standard je istoveten z:EN 13951:2012SIST EN 13951:2012en,fr01-julij-2012SIST EN 13951:2012SLOVENSKI
STANDARDSIST EN 13951:2004+A1:20081DGRPHãþD



SIST EN 13951:2012



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13951
April 2012 ICS 23.080; 67.260 Supersedes EN 13951:2003+A1:2008English Version
Liquid pumps - Safety requirements - Agrifoodstuffs equipment; Design rules to ensure hygiene in use
Pompes pour liquides - Prescriptions de sécurité - Matériel agro-alimentaire; Règles de conception pour assurer l'hygiène à l'utilisation
Flüssigkeitspumpen - Sicherheitsanforderungen - Nahrungsmittelausrüstungen; Konstruktionsregeln zur Sicherstellung der Hygiene bei der Verwendung This European Standard was approved by CEN on 22 January 2012.
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, 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 13951:2012: ESIST EN 13951:2012



EN 13951:2012 (E) 2 Contents Page Foreword .4Introduction .51 Scope .52 Normative references .63 Terms and definitions .64 List of hazards .95 Hygiene: safety requirements and/or measures . 125.1 General . 125.2 Materials . 125.2.1 Common requirements . 125.2.2 Food areas . 125.2.3 Non-food areas . 135.3 Design – Food areas . 145.3.1 General design criteria . 145.3.2 Avoidance of product retention . 145.3.3 Cleanability . 145.3.4 Sterilization . 155.3.5 Surface texture . 165.3.6 Permanent and dismantleable joints – General criteria. 165.3.7 Process flow obstructions and intrusions . 165.3.8 Product contact bearings . 165.3.9 Shaft seals . 165.3.10 Fasteners . 175.3.11 Access and drainage ports . 175.3.12 Sensors and sensor connections . 175.4 Design - Non-food areas . 175.4.1 General criteria . 175.4.2 Bearings . 185.4.3 Quick-release fasteners . 185.5 Auxiliary liquids, barriers and lubricants . 185.6 Guards and shrouds . 185.7 Legs . 186 Verification of hygiene measures . 186.1 General . 186.2 Inspection of documentation . 196.3 Inspection of the assembled pump or pump unit . 196.4 Materials . 196.5 Level of cleanability . 196.5.1 Cleanability levels 1 and 2 . 196.5.2 Cleanability level 3 . 196.5.3 Cleanability level 4 . 206.6 Surface roughness test . 207 Information for use . 207.1 General . 207.2 Instruction for use - Instruction handbook . 20Annex A (informative)
Materials in contact with foodstuffs (EU regulations). 21A.1 Metallic materials in contact with foodstuffs . 21SIST EN 13951:2012



EN 13951:2012 (E) 3 A.2 Elastomeric materials in contact with foodstuffs . 21A.3 Plastic materials in contact with foodstuffs . 21Annex B (informative)
Surface roughness . 22Annex C (informative)
Design practices . 23Annex D (informative)
Hygienic risk associated with types of pump inlet and outlet connections . 25D.1 General . 25D.2 Hazards sources . 25D.3 Criteria to be taken into account . 25Annex E (informative)
Hygienic risk linked to the choice of shaft sealing system and to the characteristics of the pumped product . 27Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC . 28Bibliography . 29 SIST EN 13951:2012



EN 13951:2012 (E) 4 Foreword This document (EN 13951:2012) has been prepared by Technical Committee CEN/TC 197 “Pumps”, 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 endorsement, at the latest by October 2012, and conflicting national standards shall be withdrawn at the latest by October 2012. 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 13951:2003+A1:2008. 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. The modifications brought to the previous version of EN 13951:2003 deal with normative reference updates, minor editorial changes, minor details add-on and the clause renumbering has been adapted accordingly. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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, Turkey and the United Kingdom.
SIST EN 13951:2012



EN 13951:2012 (E) 5 Introduction This document is a type C standard as stated in EN ISO 12100. The machinery concerned and the extent to which hazards, hazardous situations and events are covered are indicated in the scope of this document. When provisions of this type C standard are different from those which are stated in type A or B standards, the provisions of this 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 this type C standard. In drafting this European Standard, it was assumed that pumps within the scope of this European Standard are in accordance with all relevant requirements of EN 809. EN 13951 provides additional hygiene related requirements to prevent the pump causing contamination of the pumped product when used in accordance with the instruction handbook. It is the responsibility of the manufacturer to ensure that the pump is designed and manufactured such that it can be adequately cleaned. However, due to the influence of the product, the process and the cleaning regime adopted, it is only the end-user that can ultimately ensure hygienic conditions during operation. 1 Scope This European Standard deals with the special technical safety requirements for liquid pumps and pump units operating with agrifood-stuff. This European Standard is intended to be used with EN 809 to give the additional requirements for hazards arising from the pumping of substances intended for human and domestic animal consumption (see Clause 4). This European Standard also establishes requirements and/or measures for the reduction of risks during use, including misuse foreseeable by the manufacturer. This European Standard is not intended to be used for pumps and pump units at any stage in the public water supply, nor for pumps handling pharmaceutical products, nor for any other application for which more appropriate standards exist. The pumps and pump units covered by this European Standard are the following:  rotodynamic pumps;  rotary positive displacement pumps;  reciprocating positive displacement pumps. Pumps dealing with agrifood-stuff which are not indicated in this scope are potentially covered by
EN 1672-2:2005+A1:2009. This document is not applicable to liquid pumps for agrifoodstuff applications which are manufactured before the date of its publication as an EN. SIST EN 13951:2012



EN 13951:2012 (E) 6 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 809, Pumps and pump units for liquids — Common safety requirements EN ISO 4287, Geometrical product specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters (ISO 4287:1997) EN ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction (ISO 12100:2010) 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 12100:2010 and the following apply. 3.1 food/agrifood-stuff products product, ingredient or material intended to be orally consumed at any stage of its production process 3.2 food hygiene taking of all measures during the preparation and processing of food to ensure that it is fit for human or animal consumption [SOURCE: EN 1672-2:2005+A1:2009] 3.3 adverse influence reduction of the fitness for consumption of a food; a food can be adversely influenced in particular by microbial pathogens or other unwanted micro-organisms, toxins, vermin, domestic animals and other contaminants 3.4 areas of equipment
Note 1 to entry: These areas are not to be confused with any others amongst those defined in other standards (e.g. electro-technical standards). 3.4.1 food area set of machinery surfaces which are exposed to the food and from which the food or other materials can drain, drip, diffuse or be drawn into (self returned) the food or food container [SOURCE: EN 1672-2:2005+A1:2009] 3.4.2 non-food area area other than those specified above 3.5 product/pumped product products passing through the pumps as a result of process, testing, cleaning, rinsing, or disinfecting products SIST EN 13951:2012



EN 13951:2012 (E) 7 3.6 cleaning set of operations which reduce the potential for contamination to an acceptable level 3.6.1 cleanable design and construction which permits soils to be removed by appropriate cleaning methods 3.6.2 cleanability ability of the pump to be cleaned by a defined procedure to defined conditions of cleanliness 3.6.2.1 cleaned in place or mechanical cleaning (CIP, NEP) CIP or NEP means soil removal by impingement, circulation or flowing chemical detergent solutions and water rinses into and on to the surfaces to be cleaned without dismantling Note 1 to entry: The term CIP corresponds to the abbreviation of the English wording "Cleaned In Place". In French, the term NEP is the abbreviation of the wording "Nettoyage En Place". In German, the term CIP is used. 3.6.2.2 cleaned out of place or manual cleaning (COP, NHP) COP or NHP means soil removal when the equipment is partially or totally dismantled Note 1 to entry: The term COP corresponds to the abbreviation of the English wording "Cleaned Out of Place". In French,
the term NHP is the abbreviation of the wording "Nettoyage Hors Place". In German, it is the term COP which is used. 3.7 contamination presence of soils [SOURCE: EN 1672-2:2005+A1:2009] 3.8 corrosion resistant material material resistant to normally occurring action of chemical or electrochemical nature at all stages of food processing, cleaning and disinfection according to the instructions for use 3.9 crevice surface defect e.g. crack, fissure, which has an adverse influence on cleanability 3.10 dead space space wherein a pumped product, or soils may be retained or not completely removed during the cleaning operation 3.11 disinfection process applied to a cleaned surface which is capable of reducing the numbers of viable micro-organisms, but not necessarily their spores, to a level considered safe for product production 3.12 sterilization validated process used to reach a state free from viable micro-organisms including all relevant bacterial spores SIST EN 13951:2012



EN 13951:2012 (E) 8 Note 1 to entry: In a sterilization process, the nature of microbial death or reduction is described by an exponential function. Therefore, the number of micro-organisms that survive a sterilization process can be expressed in terms of probability. While the probability can be reduced to a very low number, it can never be reduced to zero. 3.13 durable ability of a surface to withstand the intended conditions of use, for example: to resist damage caused by the action of the process, contact with the pumped product including thermal actions 3.14 joint junction of two or more pieces of material [SOURCE: EN 1672-2:2005+A1:2009] 3.15 non absorbent material material which, under intended conditions of use, does not retain substances with which it comes into contact so that it has no adverse influence on pumped products 3.16 non toxic material material which does not produce or release substances injurious to health under intended conditions of use [SOURCE: EN 1672-2:2005+A1:2009] 3.17 seal component to prevent the unwanted entry or passage of any matter 3.18 self draining design and construction of the shape and surface finish so as to ensure the evacuation by gravity of the pumped products 3.19 smooth condition of a surface (with reference to surface finish) which satisfies operational and hygienic requirements 3.20 soil any unwanted matter, including product residues, micro-organisms, residual detergent or disinfecting agents [SOURCE: EN 1672-2:2005+A1:2009] 3.21 vermin animals (including mammals, birds, reptiles and insects) which may adversely influence the pumped products 3.22 toxic/toxicity toxicity of a material is defined by EU or local regulations. Note 1 to entry: Toxicity depends on the quantity of material which can migrate either by wear or by diffusion in the pumped product under intended use. SIST EN 13951:2012



EN 13951:2012 (E) 9 3.23 compatibility (material) compatibility means that the material is non absorbent and insoluble, and that the material surfaces do not deteriorate due to chemical, microbiological, mechanical or thermal action, as a result of contact with the pumped product 3.24 compatible (liquid) compatible means that the liquid identified does not create toxic conditions or any other adverse influence when mixed with the pumped product 3.25 method of assembly steps to assemble components or parts when they are in a dismantled state 3.26 auxiliary liquid auxiliary liquid is a liquid provided for flush, pressure balance, or other similar purposes 3.27 barrier liquid barrier liquid is an appropriate (that is clean, compatible, etc.) liquid inserted between two seals or barriers 4 List of hazards The potential hazards which can be associated with pumps and pump units used for pumping agrifoodstuffs products can arise from:  micro-biological causes such as pathogens, spoilage, micro-organisms or toxins resulting from their ingress to or retention by the product;  chemical causes resulting from contamination such as lubricating, cleaning, or disinfection substances;  foreign materials entering the product such as unwanted allergies, pests, metals, wear debris, etc., resulting from raw materials or other materials used in the construction of the equipment, or entry through unprotected openings;  mechanical causes such as possible mis-assembly or mis-use resulting in opportunities for micro-biological, chemical or foreign material hazards;  any deterioration resulting from thermal, chemical, or vibration effects on the pump or plant. The micro-biological hazards which may arise in a pump or pump unit reflect the particular characteristics of the installation in which it is installed such as whether the pumped product can develop micro-organisms, or whether these are reduced to non-hazardous levels by subsequent stages of the process, or the operating pattern involving a change in the product being pumped. For these reasons it is only possible to fully assess the hazards only by considering the whole production line. It is the responsibility of the user to consider the hazards and to carry out any tests deemed to be necessary to demonstrate the reduction of risks. The manufacturer of the pump or pump unit assists in the reduction of risks by designing the pump or pump unit to avoid undesirable features known to create risks to hygiene, and to accommodate effective cleaning. The reduction of other non-biological hazards should also be considered during the design of the pump or pump unit. SIST EN 13951:2012



EN 13951:2012 (E) 10 The hazards can be generated at any time during the stages of installation, commissioning, adjustment, operation, maintenance, or disposal, from the normal usage or from foreseeable misuse of the pump or pump unit. The risks of hazards shall be assessed using the procedure described in EN ISO 12100 (see Figure 1) and steps taken to reduce the risks to an acceptable level using the safety requirements or methods, and means of verification given in this European Standard and indicated also in Table 1. Figure 1 — The iterative process to achieve safety SIST EN 13951:2012



EN 13951:2012 (E) 11 Table 1 — List of hazards related to hygiene which are addressed in this European Standard
EN 13951
Reference to sub-clause Significant hazards to hygiene Measures to reduce the hazard Means of verification Hazards arising from the ingress of foreign matter
Clause Clause
- wear debris.……. 5.2.1, 5.2.2.1 6.4
- sealing of openings and joints.……. 5.3.6, 5.3.11, 5.3.12, 5.4.1 6.3
- sealing around shafts.……. 5.3.9 6.3
- spillage of product.……. 5.4.1 6.3
- vermin.…. 5.4.1, 5.7 6.3 Hazards arising from microbiological causes
- retention of product.
- general. 5.3.1, 5.3.2, 5.4.1 6.5
- cleaning.5.3.2, 5.3.3 6.5
- draining.…. 5.3.2, 5.3.3.1, 5.3.11 6.3
- surface finish/texture.….5.3.5 6.6
- obstructions/protrusions.….5.3.2, 5.3.7 6.3
- bearings.…….5.3.8, 5.4.2 6.2, 6.3
- shaft seals.…….5.3.9 6.3
- fasteners.………. 5.3.10, 5.4.3 6.3
- sensors.……. 5.3.12 6.2, 6.3
- lubricants.……. 5.5 6.2, 6.3 Hazards arising from chemical causes
- material compatibility 5.2 6.4
- general. 5.2.1, 5.2.2.1, 5.3.9 6.4
- metals. 5.2.2.2 6.2, 6.4
- non-metals. 5.2.2.3 6.2, 6.4
- non-food areas. 5.2.3 6.4
- soldering. 5.3.6 6.3
- cleaning fluids. 5.3.3.1 6.3, 6.5
- sensors. 5.3.12 6.3
- auxiliary liquids. 5.3.8, 5.5 6.2, 6.4
- barrier liquids. 5.5 6.2, 6.3 Hazards arising from mechanical causes
- material finishes. 5.2 6.3, 6.6
- joints.…. 5.3.6 6.2, 6.3
- fasteners.……. 5.3.10 6.2, 6.3
- mis-assembly. 5.4.3 6.2, 6.3
SIST EN 13951:2012



EN 13951:2012 (E) 12 5 Hygiene: safety requirements and/or measures 5.1 General The operating conditions and features required of every pump unit covered by this European Standard shall be either defined by the user in a specification or by the manufacturer's description which includes limits of operation. The manufacturer shall assess any foreseeable hazards to hygiene arising from operating conditions where specified of the pump or pump unit. The pump or pump unit shall be designed in such a way as to reduce hazards identified by this European Standard to an acceptable level. Specifications shall classify the pumps and units, including auxiliary equipment, according to the levels of cleanability required. It is the purchaser's responsibility to select the levels of cleanability appropriate to the application, taking into account the risks arising from the pumped product, the placement of the pump in the process and the cleaning regime anticipated. Where the means of reducing the risk is by a safe system of working the machinery, the manufacturer shall include in the information for use details of the systems of the element of training required by the operating personnel. 5.2 Materials 5.2.1 Common requirements Materials shall be suitable for intended use. Surfaces of materials and coatings shall be durable, cleanable, undamaged and without breaks, resistant to chipping, flaking, erosion, corrosion and abrasion, and prevent penetration of unwanted matter during intended use. The pump components intended to be dismantled for cleaning shall not be painted. 5.2.2 Food areas 5.2.2.1 Additional requirements In addition to the common requirements set out in 5.2.1, materials used in the food contact area shall be compatible with the pumped product under all foreseeable conditions of use. The compatibility shall not be compromised by the cleaning solutions nor by any disinfection and sterilization treatments specified by the customer. The materials shall be non-absorbant, except where this is technically or functionally unavoidable in which circumstance it shall not reduce the level of safety intended. Operation at intended pressures and product velocities shall not be detrimental
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