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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12462:1998 The Euro
2、pean Standard EN 12462:1998 has the status of a British Standard ICS 07.080; 23.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Performance criteria for pumps BS EN 12462:1998 This British Standard, having been prepared under the direction of the Sector Commi
3、ttee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 December 1998 BSI 1998 ISBN 0 580 30175 3 Amendments issued since publication Amd. No.DateText affected National foreword This British Standard is the English language version o
4、f EN 12462:1998. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and
5、keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European p
6、ublications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary prov
7、isions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 7
8、 and a back cover. CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Re
9、f. No. EN 12462:1998 E EUROPEAN STANDARDEN 12462 NORME EUROPE ENNE EUROPA ISCHE NORM July 1998 ICS 07.080; 23.080 Descriptors: biotechnology, work safety, accident prevention, environmental protection, hazards, contamination, micro-organisms, transgenic micro-organisms, laboratory equipment, pumps,
10、specifications, operating requirements, leaktightness, cleaning, sterilization, classifications English version Biotechnology Performance criteria for pumps Biotechnologie Crite res de performance pour les pompes Biotechnik Leistungskriterien fu r Pumpen This European Standard was approved by CEN on
11、 1 July 1998. 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
12、 obtained on application to the Central Secretariat 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 Central
13、 Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
14、Page 2 EN 12462:1998 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biotechnology, 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 endor
15、sement, at the latest by January 1999, and conflicting national standards shall be withdrawn at the latest by January 1999. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. According to the CEN/CENELEC Internal
16、Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and
17、the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Hazards4 5Performance classes4 6Types of pumps5 7Classification and verification of performance6 8Marking and packaging6 9Documentation6 Annex A (informative) Bibliography7 Page 3 EN 12462:1998 BS
18、I 1998 Introduction The mechanical safety of pumps, which are widely used in biotechnological processes, is covered by EN 292-1 and EN 292-2. However, it is important to consider the performance of pumps used in these processes with regard to the potential hazard posed by the micro-organism in use.
19、For some micro-organisms, additional technology is needed to prevent their release to the environment. Consideration should be given to workers, the environment and the public in general. Use of this standard can facilitate the specification with regard to biosafety performance of pumps by the manuf
20、acturer in a form which can be easily understood and readily utilized by the end user. 1 Scope This European Standard specifies performance criteria for pumps used in biotechnological processes, in which the release of micro-organisms should be limited or prevented for reasons of safety. This standa
21、rd applies if the intended use of the pump includes hazardous or potentially hazardous micro-organisms. This standard applies to pumps with no auxiliary equipment, bordered by the connections on the unit of equipment. It also applies to pump systems equipped with all auxiliary equipment necessary fo
22、r operation of pumps and to accomplish cleaning and sterilization. NOTEAdditional criteria for individual components of equipment such as pipes and couplings are given in Performance criteria for piping and instrumentation Part 1: General performance criteria (see annex A 9) and Performance criteria
23、 for piping and instrumentation Part 2: Couplings (see annex A 7). These two European Standards are being prepared. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate pl
24、aces in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication ref
25、erred to applies. EN 285, Sterilization Steam sterilizers Large sterilizers. EN 292-1, Safety of machinery Basic concepts, general principles for design Part 1: Basic terminology, methodology. EN 292-2, Technical principles and specifications. EN 1672-2, Food processing machinery Basic concepts Part
26、 2: Hygiene requirements. EN 12296, Biotechnology Equipment Guidance on testing procedures for cleanability. EN 12297, Biotechnology Equipment Guidance on testing procedures for sterilizability. EN 12298, Biotechnology Equipment Guidance on testing procedures for leaktightness. ISO 4287, Geometrical
27、 Product Specifications (GPS) Surface texture: Profile method Terms, definitions and surface texture parameters. EN ISO 4288, Geometrical Product Specifications (GPS) Surface texture: Profile method Rules and Procedures for the assessment of surface texture. 3 Definitions For the purposes of this st
28、andard, the following definitions apply. 3.1 arithmetical mean deviation of the profile (Ra) the arithmetical mean of the absolute values of the profile departures within the sampling length ISO 4287 3.2 clean condition of (a) product, surface, device, gases and/or liquids with residual soil below a
29、 defined threshold level 3.3 cleanability ability to be made clean 3.4 cleaning in place (CIP) cleaning without dismantling of components of equipment and/or unit of equipment 3.5 component of equipment technical entity which forms part of a unit of equipment NOTEExamples of components of equipment
30、are vessels, valves and sensors. 3.6 hazard intrinsic potential property or ability of something (e.g. any agent, equipment, material or process) to cause harm EN 1620 NOTEHarm is an injury or damage to health of people and/or the environment. 3.7 leakage egress from equipment Page 4 EN 12462:1998 B
31、SI 1998 3.8 leaktightness ability of component of equipment or unit of equipment to limit egress 3.9 micro-organism any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 1619 NOTEFor the purposes of this standard, the term micro-organism
32、covers the term of biological agent according to the Directive 90/679/EEC: micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites which may be able to provoke any infection, allergy or toxicity. 3.10 process micro-organism micro-organism used for
33、 production purposes in a biotechnological process or constituting (part of) the product itself 3.11 pump item of equipment used for moving liquids through pipes NOTEThe liquids may contain gases and/or solids. 3.12 residual soil soil left after cleaning 3.13 risk probability of occurrence of a haza
34、rd causing harm and the degree of severity of the harm 3.14 soil any unwanted matter (including product residues, micro-organisms, dust and debris) ISO/CD 14159 3.15 sterile state of being free from viable micro-organisms NOTE 1In practice no such absolute statement regarding the absence of viable m
35、icro-organisms can be proven. However, sterile conditions can be regarded as established by using an accepted or recognized method of sterilization. NOTE 2The process of inactivation of viable micro-organisms during a sterilization procedure is usually described by an empirical mathematical function
36、, commonly an exponential function. By their mathematical nature, such functions can be reduced to very low numbers, but not zero. However, these empirical functions can be applied to control or assess the process parameters of a sterilization procedure to realize a desired degree of inactivation of
37、 viable micro-organisms. 3.16 sterilizability ability of components of equipment, units of equipment or process plants to be made sterile 3.17 sterilization process used to reach a sterile state 3.18 target micro-organism process micro-organism and/or other micro-organisms relevant for a specific pr
38、ocess NOTEFor safety testing procedures, non-pathogenic micro-organisms should be used where possible. 3.19 unit of equipment assembly of components used to perform one or more unit operations 4 Hazards The following hazards shall be considered: release of micro-organisms by leakage from a pump duri
39、ng operation; release of micro-organisms after operation due to insufficient inactivation and/or removal of micro-organisms when the pump is opened or dismantled. 5 Performance classes 5.1 General With regard to the contained use of micro-organisms in pumps, the pump shall be classified for the foll
40、owing performance criteria: leaktightness; cleanability; sterilizability. The performance of the pump shall be determined separately for each of these criteria in accordance with Tables 1, 2 and 3. NOTEA pump can for example be in class SI-A for sterilizability, but in class LI-C for leaktightness.
41、Page 5 EN 12462:1998 BSI 1998 1) Use of BATNEEC does not mean that financial issues moderate the degree of safety. Where several methods are available, the user can choose the most convenient, provided that it gives results of the necessary quality. 5.2 Leaktightness The performance classes for leak
42、tightness of a pump are given in Table 1. Table 1 Leaktightness performance Performance class for leaktightness Leaktightness Index (LI) Description of performance class LI-ALeakage of target micro-organism not defined LI-BLeakage1)of target micro-organism detected and quantified under defined condi
43、tions LI-CLeakage1)of target micro-organism tested under defined conditions and leakage below prescribed threshold value2) 1) Based on leakage assessment by BATNEEC (Best Available Techniques Not Entailing Excessive Costs)1). 2) Prescribed threshold value should be based on the required safety level
44、 and can for example be the detection limit of an approved test method. 5.3 Cleanability The performance classes for cleanability of a pump are given in Table 2. Table 2 Cleanability performance Performance class for cleanability Cleanability Index (CI) Description of performance class CI-AVisible s
45、oil or cleanliness not defined CI-BCleanability tested1)and quantified under defined conditions or designed with regard to specified technical criteria CI-CCleanability tested1)and quantified under defined conditions and soil below detection limit or threshold value2) 1) Based on assessment by BATNE
46、EC (Best Available Techniques Not Entailing Excessive Costs)1). 2) Prescribed threshold value should be based on the required safety level and can for example be the detection limit of an approved test method. NOTECleanability applies as a performance criterion for the pump where: deposits of soil i
47、n the pump could jeopardize the sterilization procedure if the sterilization media do not reach all parts of the pump or if the required temperature is not reached; cleaning procedures are intended to remove and inactivate micro-organisms to make the pump safe for handling without using any other st
48、erilization or inactivation procedure. 5.4 Sterilizability The performance classes for sterilizability of a pump are given in Table 3. This criterion covers all methods of inactivation up to sterilization. The sterilizability performance therefore is usually combined with the cleanability criterion.
49、 Table 3 Sterilizability performance Performance class for sterilizability Sterilizability Index (SI) Description of performance class SI-APump not suited or tested for reduction of viable target micro-organisms SI-BPump can be treated for a specified reduction of viable target micro-organisms SI-CPump can be sterilized NOTEIn this table the result (performance) of an inactivation procedure is described and not the way or means of achieving the result. 6 Types of pumps 6.1 Type I pump To b
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