1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12690:1999 The Euro
2、pean Standard EN 12690:1999 has the status of a British Standard ICS 07.080; 21.140 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Performance criteria for shaft sealsThis British Standard, having been prepared under the direction of the Sector Committee for Mat
3、erials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 June 1999 BSI 06-1999 ISBN 0 580 32270 X BS EN 12690:1999 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the English language version
4、of EN 12690:1999. 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
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
6、publications 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
7、 provisions 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
8、 to 7 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 national Members
9、. Ref. No. EN 12690:1999 E EUROPEAN STANDARD EN 12690 NORME EUROPE ENNE EUROPA ISCHE NORM February 1999 ICS 07.080; 07.100.01 Descriptors: biotechnology, environmental protection, accident prevention, work safety, hazards, contamination, microorganisms, noxious microorganisms, inspection, leaktightn
10、ess, laboratory equipment, sterilization, marking, technical notices. English version Biotechnology Performance criteria for shaft seals Biotechnologie Crite res de performance pour les dispositifs de tanche ite dynamique darbre Biotechnik Leistungskriterien fu r Wellendichtungen This European Stand
11、ard was approved 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
12、such national 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 langua
13、ge and notified 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, Sw
14、itzerland and United Kingdom.Page 2 EN 12690:1999 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
15、 of an identical 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. A
16、ccording 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, Port
17、ugal, Spain, 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 5 7 Marking and packaging 6 8 Documentation 6 Annex A (informative)
18、 Guidance on materials, design and manufacture 7 Annex B (informative) Guidance on seal classification and applications 7 Annex C (informative) Bibliography 7Page 3 EN 12690:1999 BSI 06-1999 Introduction The main function of a seal is to prevent either the escape of product or the ingress of contami
19、nating material depending on the particular application. Undemanding duties can be served by single seals but double seals with a barrier fluid between the primary and secondary seal can be necessary for more stringent applications such as pumps, agitators, centrifuges and homogenizers. Use of this
20、European Standard will aid the equipment manufacturer in the classification with regard to biosafety performance of shaft seals in biotechnological processes. The classification is easily understandable and readily utilizable for the user and the regulatory authorities. 1 Scope This European Standar
21、d specifies performance criteria for shaft seals in equipment 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 shaft seal includes hazardous or potentially h
22、azardous microorganisms used in biotechnological processes or where exposure of the worker and/or the environment to such microorganisms is restricted for reasons of safety. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications.
23、These normative references are cited 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 un
24、dated references the latest edition of the publication referred to applies. EN 285, Sterilization Steam sterilizers Large sterilizers. EN 1672-2, Food processing machinery Basic concepts Part 2: Hygiene requirements. EN 12296, Biotechnology Equipment Guidance on testing procedures for cleanability.
25、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 accordance with the
26、 biological risk. EN ISO 4287, Geometrical Product Specifications (GPS) Surface texture: Profile method Terms, definitions and surface texture parameters. (ISO 4287:1997) EN ISO 4288, Geometrical Product Specifications (GPS) Surface texture: Profile method Rules and Procedures for the assessment of
27、surface texture. (ISO 4288:1996) 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 arithmetical mean deviation of the profile (R a ) the arithmetical mean of the absolute values of the profile departures within the sampling length ISO 4287 3.2 barrier fluid fluid
28、between two seals 3.3 clean 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 clean 3.5 dynamic seal seal installed between a stationary and a moving element 3.6 hazard intrinsic property or ability
29、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 to the environment. 3.7 leakage egress from equipment 3.8 leaktightness ability of component of equipment or unit of equipment to limit egress 3.9 mechanica
30、l seal seal consisting of two plane faces arranged perpendicular to the axis of a moving shaftPage 4 EN 12690:1999 BSI 06-1999 3.10 microorganism any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 1619. NOTE For the purposes of this st
31、andard, the term microorganism covers the term of biological agent according to the 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. 3.11 primary seal sea
32、l between barrier fluid and the process 3.12 process microorganism microorganism used for production purposes in a biotechnological process or constituting (part of) the product itself 3.13 pump item of equipment for moving liquids through pipes NOTE The liquids may contain gases and/or solids. 3.14
33、 residual soil soil left after cleaning 3.15 risk combination of the probability and the degree of the possible injury or damage to health in a hazardous situation EN 1070 3.16 rotational shaft shaft that rotates around its axis 3.17 seal component installed between a moving and stationary element o
34、r between two stationary elements NOTE A seal can consist of one or more sealing elements between the stationary and moving elements and can contain pressurized, sterile fluid between these elements. 3.18 secondary seal seal between barrier fluid and a region not contaminated by the process 3.19 soi
35、l any unwanted matter (including product residues, microorganisms, dust and debris) ISO/CD 14159 3.20 sterile state of being free from viable microorganisms. NOTE 1 In practice no such absolute statement regarding the absence of viable microorganisms can be proven. However, sterile conditions can be
36、 regarded as established by using an accepted or recognized method of sterilization. NOTE 2 The process of inactivation of viable microorganisms during a sterilization procedure is usually described by an empirical mathematical function, commonly an exponential function. By their mathematical nature
37、, such functions can be reduced to very low numbers, but not to 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 viable microorganisms. 3.21 sterilizability ability of compo
38、nents of equipment, units of equipment or process plants to be made sterile 3.22 sterilization process used to reach a sterile state 3.23 target microorganism process microorganism and/or other microorganism relevant for a specific process NOTE For safety testing procedures, non-pathogenic microorga
39、nisms should 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 equipment is opened or dismant
40、led. NOTE Common causes of malfunctioning are age, loss of barrier fluid in double seals, rough shaft, incorrect fitting, incorrect specification, incorrect maintenance. 5 Performance classes 5.1 General The shaft seal shall be classified for the following performance criteria with regard to the con
41、tained use of microorganisms: leaktightness; cleanability; sterilizability. The performance of the shaft seal shall be determined separately for each of these criteria in accordance with Tables 1, 2 and 3. NOTE A shaft seal can for example be in class SI-A for sterilizability, but in class LI-C for
42、leaktightness.Page 5 EN 12690:1999 BSI 06-1999 * 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
43、classes for leaktightness of the shaft seal are given in Table 1. Table 1 Leaktightness performance Performance class for leaktightness Leaktightness Index (LI) Description of performance class LI-A leakage of target microorganism not defined LI-B leakage 1) of target microorganism detected and quan
44、tified 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 leakage assessment by BATNEEC (Best Available Techniques Not Entailing Excessive Costs) * 2) Prescribed threshold value should b
45、e 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 shaft seal are given in Table 2. Table 2 Cleanability performance Performance class for cleanability Cleanability Index (CI) Descri
46、ption 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 specified technical criteria CI-C cleanability 1) tested under defined conditions and soil below detection limit or threshold value 2
47、) 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 Cleanability applies as a performance criterion for the s
48、haft seal where: deposits of soil at or in the shaft seal could jeopardize the sterilization procedure if the sterilization media do not reach all parts of the shaft seal or if the required temperature is not reached; cleaning procedures are intended to remove and inactivate microorganisms to make t
49、he shaft seal safe for handling without using any other sterilization or inactivation procedure. 5.4 Sterilizability The performance classes for sterilizability of the shaft seal are given in Table 3. Table 3 Sterilizability performance Performance class for sterilizability Sterilizability Index (SI) Description of performance class SI-A shaft seal not suitable or not tested for reduction of viable target microorganisms SI-B shaft seal can be treated for a specified reduction of viable
