1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12884:1999 The Euro
2、pean Standard EN 12884:1999 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Performance criteria for centrifugesThis British Standard, having been prepared under the direction of the Sector Committee for Materials a
3、nd Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 June 1999 BSI 06-1999 ISBN 0 580 32271 8 BS EN 12884:1999 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the English language version of EN 12
4、884:1999. 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 keep th
5、e 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 publicat
6、ions 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 provisi
7、ons 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 8, a
8、n inside back cover 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 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN na
9、tional Members. Ref. No. EN 12884:1999 E EUROPEAN STANDARD EN 12884 NORME EUROPE ENNE EUROPA ISCHE NORM February 1999 ICS 07.080, 07.100.01 Descriptors: biotechnology, materials, centrifuges, safety, hazards, environmental protection, accident prevention, contamination, microorganisms, definitions,
10、classifications, characteristics, leaktightness, cleaning, sterilization, verification, tests English version Biotechnology Performance criteria for centrifuges Biotechnologie Crite res de performance pour les centrifugeuses Biotechnik Leistungskriterien fu r Zentrifugen This European Standard was a
11、pproved by CEN on 28 January 1999. 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 nati
12、onal standards may be 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 no
13、tified to the Central 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
14、 and United Kingdom.Page 2 EN 12884:1999 BSI 06-1999 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 id
15、entical text or by endorsement, at the latest by August 1999, and conflicting national standards shall be withdrawn at the latest by August 1999. This draft European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. According
16、to the CEN/CENELEC Internal 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, Spa
17、in, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Hazards 4 5 Performance classes 4 6 Classification and verification of performance 6 7 Marking and packaging 7 8 Documentation 7 Annex A (informative) Bibliogr
18、aphy 8Page 3 EN 12884:1999 BSI 06-1999 Introduction The general safety of centrifuges used in biotechnological processes is covered by EN 292-1, EN 292-2, EN 12547 and EN 61010-2-020 (see annex A 5). The requirements regarding biosafety for laboratory centrifuges given in EN 61010-2-020 are not in c
19、onflict with this European Standard and can be classified into the classes defined here. For safety reasons it is necessary to consider the performance with respect to leaktightness, cleanability and sterilizability of equipment to be used for biotechnology operations. The actual performance demands
20、 will be dependent on the potential hazards to the workers, the environment and the general public of the microorganisms in use. If the performance is known or expected to be insufficient, additional technology may be needed to reach the desired containment level. Use of this European Standard will
21、aid the equipment manufacturer in the classification with regard to biosafety performance of centrifuges in biotechnological processes. The classification is easily understandable and readily utilizable for the user and the regulatory authorities. 1 Scope This European Standard specifies performance
22、 criteria for centrifuges used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment. This European Standard applies where the intended use of the centrifuges includes hazardous or potentially hazardous microorganisms used in bio
23、technological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety. This European Standard applies to centrifuges with no auxiliary equipment. It also applies to centrifuge systems equipped with all necessary auxiliary equipment
24、for example valves, probes, filters and steam traps, necessary for operation of centrifuges and to accomplish cleaning and sterilization. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited
25、 at the appropriate places 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
26、of the publication referred to applies. EN 292-1, Safety of machinery Basic concepts, general principles for design Part 1: Basic terminology, methodology. EN 292-2, Safety of machinery Basic concepts, general principles for design Part 2: Technical principles and specifications. EN 626-1, Safety of
27、 machinery Reduction of risks to health from hazardous substances emitted by machinery Part 1: Principles and specifications for machinery manufacturers. EN 1672-2, Food processing machinery Basic concepts Part 2: Hygiene requirements. EN 12296, Biotechnology Equipment Guidance on testing procedures
28、 for cleanability. EN 12297, Biotechnology Equipment Guidance on testing procedures for sterilizability. EN 12298, Biotechnology Equipment Guidance on testing procedures for leaktightness. EN 12460, Biotechnology Large-scale process and production Guidance on equipment selection and installation in
29、accordance with the biological risk. EN 12547, Centrifuges Common safety requirements. EN 12690, Biotechnology Performance criteria for shaft seals. EN ISO 4287, Geometrical Product Specifications (GPS) Surface texture: Profile method Terms, definitions and surface texture parameters. (ISO 4287:1997
30、) EN ISO 4288, Geometrical Product Specifications (GPS) Surface texture: Profile method Rules and Procedures for the assessment of surface texture. (ISO 4288:1996) 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 casing enclosure in which at least the drum rotate
31、s and which may constrain process materials leaving the drum to particular paths EN 12547 NOTE The casing may consist of several components. 3.2 centrifuge separation device which has a rotatable chamber in which a mixture of process materials can be subjected to (radial) acceleration force 3.3 clea
32、n condition of (a) product, surface, device, gases and/or liquids with residual soil below a defined threshold value 3.4 cleanability ability to be made cleanPage 4 EN 12884:1999 BSI 06-1999 3.5 cleaning removal of soil 3.6 cleaning in place (CIP) cleaning without dismantling of components of equipm
33、ent and/or unit of equipment 3.7 closed system system where a barrier separates microorganisms or organisms from the environment EN 1620 3.8 drum chamber which holds the process material, and is arranged to rotate about its symmetrical axis EN 12547 3.9 gauge pressure pressure difference from atmosp
34、heric pressure 3.10 hazard intrinsic property or ability of something (e.g. any agent, equipment, material or process) to cause harm EN 1620 NOTE Harm is an injury or damage to health of people and/or the environment. 3.11 leakage egress from equipment 3.12 leaktightness ability of component of equi
35、pment or unit of equipment to limit egress 3.13 microorganism any microbiological entity, cellular or non cellular, capable of replication or of transferring genetic material EN 1619 NOTE For the purposes of this standard, the term microorganism covers the term of biological agent, according to the
36、Directive 90/679/EEC: microorganisms, including those which have been genetically modified, cell cultures and human endoparasites which may be able to provoke any infection, allergy or toxicity. 3.14 risk combination of the probability and the degree of the possible injury or damage to health in a h
37、azardous situation EN 1070 3.15 rotor assembled part of a centrifuge which rotates, comprising drum and shaft together with their attachments EN 12547 3.16 soil any unwanted matter (including product residues, microorganisms, dust and debris) ISO/CD 14159 3.17 sterile state of being free from viable
38、 microorganisms NOTE 1 In practice no such absolute statement regarding the absence of viable microorganisms can be proven. However, sterile conditions can be regarded as established by using an accepted or recognized method of sterilization. NOTE 2 The process of inactivation of viable microorganis
39、ms during a sterilization procedure is usually described by an empirical mathematical function, commonly an exponential function. By their mathematical nature, such functions can be reduced to very low numbers, but not to zero. However, these empirical functions can be applied to control or assess t
40、he process parameters of a sterilization procedure to realize a desired degree of inactivation of viable microorganisms. 3.18 sterilizability ability of components of equipment, units of equipment or process plants to be made sterile 3.19 sterilization process used to reach a sterile state 3.20 ster
41、ilizing in place (SIP) sterilization without opening or dismantling of components of equipment and/or unit of equipment 3.21 target microorganism process microorganism and/or other microorganisms relevant for a specific process NOTE For safety testing procedures, non-pathogenic microorganisms should
42、 be used where possible. 4 Hazards The following hazards shall be taken into account: release of microorganisms by leakage during operation; release of microorganisms after operation due to insufficient inactivation and/or removal of microorganisms when the centrifuge is opened or dismantled. 5 Perf
43、ormance classes 5.1 General The centrifuge shall be classified for the following performance criteria with regard to the contained use of microorganisms: leaktightness; cleanability; sterilizability. The performance of the centrifuge shall be determined separately for each of these criteria in accor
44、dance with Tables 1, 2 and 3. NOTE A centrifuge can for example be in class SI-A for sterilizability, but in class LI-C for leaktightness.Page 5 EN 12884:1999 BSI 06-1999 * Use of BATNEEC doed not mean that financial issues moderate the degree of safety. Where several methods are available, the user
45、 can choose the most convenient, provided that it gives results of the necessary quality. 5.2 Leaktightness The performance classes for leaktightness of the centrifuge are given in Table 1. Table 1 Leaktightness performance Performance class for leaktightness Leaktightness Index (LI) Description of
46、performance class LI-A leakage of target microorganism not defined LI-B leakage 1) of target microorganism detected and quantified under defined conditions LI-C leakage 1) of target microorganism tested under defined conditions and leakage below detection limit or threshold value 2) 1) Based on leak
47、age assessment by BATNEEC (Best Available Techniques Not Entailing Excessive Costs) * . 2) Prescribed threshold value should be based on the required safety level and can for example be the detection limit of an approved BATNEEC. 5.3 Cleanability The performance classes for cleanability of the centr
48、ifuge are given in Table 2. Table 2 Cleanability performance Performance class for cleanability Cleanability Index (CI) Description of performance class CI-A visible soil or cleanliness not defined CI-B cleanability 1) tested and quantified under defined conditions or designed with regard to specifi
49、ed technical criteria CI-C cleanability 1) tested under defined conditions and soil below detection limit or threshold value 2) 1) Based on assessment by BATNEEC (Best Available Techniques Not Entailing Excessive Costs) * . 2) Prescribed threshold value should be based on the required safety level and can for example be the detection limit of an approved BATNEEC. NOTE 1 Cleanability applies as a performance criterion for the centrifuge where: deposits of soil in the centrifuge
