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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12297:1998 The Euro
2、pean Standard EN 12297:1998 has the status of a British Standard ICS 07.080 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Equipment Guidance on testing procedures for sterilizability Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:44 GMT+
3、00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 September 1998 BSI 1998 ISBN 0 580 30068 4 BS EN 12297:1998 Ame
4、ndments issued since publication Amd. No.DateText affected National foreword This British Standard is the English language version of EN 12297:1998. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to u
5、nderstand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this commi
6、ttee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by usin
7、g the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary 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 fr
8、om legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 11 and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardizatio
9、n 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. Ref. No. EN 12297:1998 E EUROPEAN STANDARDEN 12297 NORME EUROP
10、E ENNE EUROPA ISCHE NORM March 1998 ICS Descriptors: Biotechnology, medical equipment, sterilization, disinfection, contamination, micro-organisms, noxious micro-organisms, tests, safety, hygiene conditions, inspection, accident prevention, environmental protection, work safety English version Biote
11、chnology Equipment Guidance on testing procedures for sterilizability Biotechnologie Equipement Guide des proce dures dessai pour le contro le de la capacite a la ste rilisation Biotechnik Gera te und Ausru stungen Leitfaden fu r Verfahren zur Pru fung der Sterilisierbarkeit This European Standard w
12、as approved by CEN on 2 March 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 nat
13、ional 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 n
14、otified 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, Switzerlan
15、d and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 12297:1998 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biotechnology, the Secretariat of which is held by AFNOR
16、. 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 September 1998, and conflicting national standards shall be withdrawn at the latest by September 1998. According to the CEN/CENELEC Internal Regul
17、ations, 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 the U
18、nited Kingdom. Contents Page Foreword2 1Scope3 2Definitions3 3Testing4 4Documentation5 Annex A (informative) Guidance on selection of sterilizability testing6 Annex B (informative) Information on test methods for sterilizability9 Annex C (informative) Bibliography11 Licensed Copy: sheffieldun sheffi
19、eldun, na, Sat Oct 28 05:24:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12297:1998 BSI 1998 1 Scope This European Standard gives guidance on general testing procedures to assess the sterilizability for micro-organisms of equipment (components and units of equipment) used in biotechnologi
20、cal processes. This European Standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process micro-organisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment. Thi
21、s European Standard is applicable to plants or components, such as valves and fittings, tanks, pumps, piping, separating and filling devices as well as instrumentation in contact with process fluids. This European Standard applies if the intended use of the equipment includes hazardous or potentiall
22、y hazardous micro-organisms. This European Standard is not applicable to testing for sterility of media and equipment prior to processing or operation, respectively. NOTE 1For disinfection of external surfaces such as walls, working benches and floors, attention is drawn to national and European Sta
23、ndards. NOTE 2For sterilization of equipment and media in autoclaves attention is drawn to national and European Standards such as EN 285 and EN 554 (see annex C 21, 22). 2 Definitions For the purposes of this standard, the following definitions apply. 2.1 component of equipment technical entity whi
24、ch forms part of a unit of equipment NOTEExamples of components of equipment are vessels, valves and sensors. 2.2 direct test method (in biotechnology) test method which employs micro-organisms for quantification 2.3 indirect test method (in biotechnology) test method which employs physical and/or c
25、hemical means for quantification 2.4 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 covers the term of biological agent according to the Directive 9
26、0/679/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. 2.5 process micro-organism micro-organism used for production purposes in a biotechnological process or constitutin
27、g (part of) the product itself 2.6 sterile state of being free from viable micro-organisms NOTE 1 In practice no such absolute statement regarding the absence of viable micro-organisms can be proven. However, sterile conditions can be regarded as established by using an accepted or recognized method
28、 of sterilization. NOTE 2 The process of inactivation of viable micro-organisms 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 z
29、ero. 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 micro-organisms. 2.7 sterilizability ability of components of equipment, units of equipment or plants to be made steri
30、le 2.8 sterilization process used to reach a sterile state 2.9 sterilizing in place (SIP) sterilization without opening or dismantling of components of equipment and/or unit of equipment 2.10 target micro-organism process micro-organism and/or other micro-organisms relevant for the specific process
31、NOTE For safety testing procedures, non-pathogenic micro-organisms should be used where possible. 2.11 unit of equipment assembly of components used to perform one or more unit operations Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page
32、4 EN 12297:1998 BSI 1998 3 Testing 3.1 General Testing procedures for sterilizability are required to verify whether equipment can be sterilized, so that potential risks to occupational health and/or the environment are eliminated. In particular it should be established that, for example, for mainte
33、nance work the utilized micro-organisms are inactivated to such a degree that no harm results to maintenance staff or to the environment from residual process micro-organisms. Testing procedures should be designed to ensure that relevant information on sterilizability can be obtained. 3.2 Methodolog
34、y To determine the sterilizability of plant and equipment choose and specify an appropriate test method or combination of test of methods (see annexes A and B): a) specify an appropriate indicator related to the proposed use of the equipment; b) select the analytical procedure to be used to determin
35、e the quantity of this indicator which is present in the equipment or plant. The appropriate biological indicator is preferably not harmful for the worker and/or the environment; c) specify a sterilization protocol including, as a minimum, the specification of the sterilizing agent and the mode of a
36、pplication; NOTE 1 Potential hazard to the operator during sterilization should be assessed. NOTE 2 Factors such as duration, temperature and dose should be included into the protocol. 3.3 Testing procedure Carry out the testing procedures as follows: a) load the equipment or plant with the indicato
37、r under conditions representative of conditions during processing; b) using the analytical procedure defined in 3.2, determine the quantity of indicator substance present at the time at which sterilization procedures would be applied; c) apply the sterilization protocol specified in 3.2 to the plant
38、 or equipment being tested for sterilizability; d) using the analytical procedure selected in 3.2, determine the quantity of indicator present in the equipment or plant after application of the sterilization protocol; e) using the data obtained, express the sterilizability of the equipment or plant;
39、 f) determine the appropriate sterilizability class to the equipment under test as described in the equipment standards with respect to the chosen indicator and sterilization protocol. 3.4 Choice of test methods If the results of the test method should be quickly available and with a limited amount
40、of work involved in sterilizability demonstration runs, indirect test methods should be used. Indirect test methods may however only be applied if a validated correlation between the measured effect and the desired performance has been shown. When direct test methods are used, they should be carried
41、 out using appropriate controls in order to eliminate false positive results as a consequence of incorrect handling of the samples. This means that parallel to the test sample preparation another culture tube is handled in the same way as the original sample but without inoculation as well as the in
42、clusion of media samples which are sterilized by a validated sterilization. 3.5 Direct test methods The validation of a sterilization cycle can be done by analysis of an undiluted sample of the sterilized process medium and by performing microbiological challenge tests. Microbiological challenge tes
43、ts are usually carried out by filling the equipment or component to be investigated to a representative volume with a suitable medium and adding indicator micro-organisms. This type of testing procedure is required if the indicator or process micro-organism(s) which is to be detected is present arou
44、nd or even below the detection limit of the test method of choice. A reliable reduction rate of indicator micro-organism can be determined whenever the number of colony forming units which can be detected is high enough to allow the determination of statistically reliable inactivation kinetics, for
45、example depending on the evaluation method 100 to 1 000 colony forming units/ml are required. NOTEPreferably an immobilized indicator micro-organism should be used. The efficacy of a heat sterilization is proved by the absence of process or indicator micro-organisms. Examples of appropriate indicato
46、r micro-organisms are given in the references listed in annex C 1 to 4, 9 to 12, 14. The type of micro-organism to be selected as indicator micro-organism depends on the characteristics of the process micro-organism and should be representative for a worst case situation. Licensed Copy: sheffieldun
47、sheffieldun, na, Sat Oct 28 05:24:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 12297:1998 BSI 1998 The choice of a specific indicator micro-organism should ensure that the degree of sterilization is measurable within a certain period of time during the sterilization procedure. In order to
48、 comply with these boundary conditions for gas sterilization procedures, e.g. ethylene oxide or formaldehyde, representative indicator micro-organism(s) should be selected (see annex C 3, 4, 14). Test sets with immobilized indicator micro-organisms, which can be prepared in laboratories or purchased
49、, should be placed at relevant places inside the equipment. The appropriate places for indicator micro-organisms should be identified either by suitable test methods or by risk assessment, Hazard Analysis Critical Control Points (HACCP) or Hazard and Operability studies (HAZOP). An example of a microbial challenge test method is given in annex C 7. 3.6 Indirect test methods Indirect test methods can be applied when direct test methods are not available or inappropriate. They can be validated by a direct test method