1、DEUTSCHE NORM June 1998 Biotechnology I Performance criteria for steam sterilizers and - EN 12347 aut oc I aves English version of DIN EN 12347 ICs 07.080; 07.1 00.99; 11 .O80 Descriptors: Biotechnology, steam sterilizers, autoclaves, performance criteria. Biotechnik - Leistungskriterien fr Dampf-St
2、erilisatoren und Autoklaven European Standard EN 12347 : 1998 has the status of a DIN Standard. A comma is used as the decimal marker. National foreword This standard has been prepared by CEN/TC 233. The responsible German body involved in its preparation was the Normenausschu Lebensmittel und landw
3、irtschaftliche Produkte (Foodstuffs and Agricultural Products Standards Committee), Technical Committee Biotechnik. The DIN Standards corresponding to the International Standards referred to in clause 2 of the EN are as follows: IEC 1 O1 0-1 IS0 4287-1 DIN 4762 DIN EN 61 O1 0-1 IS0 4288 DIN EN IS0 4
4、288 National Annex NA Standards referred to (and not included in Normative references) DIN 4762 DIN EN 61 O1 0-1 DIN EN IS0 4288 Surface roughness - Concepts, surface and its parameters (identical to Safety requirements for electrical equipment for measurement, control and laboratory use - General r
5、equirements (IEC 1 O1 0-1 : 1990 + Al : 1992, modified) Geometrical Product Specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture (IS0 4288 : 1985) IS0 4287-1 : 1984) EN comprises 11 pages. No pari of this standard may be reproduced witho
6、ut the prior permission of Ref. No. DIN EN 12347 : 1998-0 Y Deutsches Institut fr Normung e. V., Berlin. wth Verlag GmbH, D-10772 Berlin, has the exclusive right of sale for German Standards (DIN-Normen). English price group 08 Sales No . 1108 12.98 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM
7、EN 12347 March 1998 ICs 07.080; 07.1 00.99; 11 .O80 Descriptors: Biotechnology, steam sterilizers, autoclaves, performance criteria. English version Biotechnology Performance criteria for steam sterilizers and autoclaves Biotechnologie - Critres de perfor- mance pour les strilisateurs la vapeur deau
8、 et les autoclaves Biotechnik - Leistungskriterien fr Dampf-Sterilisatoren und Autoklaven This European Standard was approved by CEN on 1998-02-1 5. CEN members are bound to comply with the CENKENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of
9、 a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national stand- ards may be obtained on application to the Central Secretariat or to any CEN member. The European Standards exist in three official versions (English, French, German). A versi
10、on in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, the Czech Republic, Denmark, Finland, F
11、rance, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050
12、 Brussels O 1998. CEN - All rights of exploitation in any form and by any means reserved worldwide for CEN national members. Ref. No. EN 12347 : 1998 E Page 2 EN 12347: 1998 Contents Page Foreword ,.,. . . 2 Introduction . . 3 1 Scope . 3 2 Normative references . 3 3 Definitions .,. 4 4 Hazards 6 5
13、Performance classification 6 6 Classification of steam sterilizers and autoclaves ._. 8 7 Verification of performance ., 9 8 Marking and packaging IO 9 Documents 11 Annex A (informative) Bibliography . 11 Foreword This European Standard has been prepared by Technical Committee CENTC 233 “Biotechnolo
14、gy“, the secretariat of which is held by AFNOR. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. This European Standard shall be given the status of a national standard, either by publication of an identicai tex
15、t 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 CENICENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standar
16、d: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Page 3 EN 12347: 1998 Introduction Steam sterilizers and autoclaves are used to destroy microorganism
17、s by subjecting them to steam (steam sterilizers) or to steam at elevated temperatures and pressure (autoclaves). They are for example used for : - sterilizing materials and units of equipment before they are used in laboratories or/and factories ; - eliminating the risk associated with material whi
18、ch requires inactivation and/or sterilization prior to disposal in waste treatment operations ; - making equipment safe for (re)use. It is important to consider the performance of steam sterilizers and autoclaves used for these purposes with regard to the potential hazard posed by the microorganism
19、in use. For some microorganisms additional measures are needed to prevent their release from the autoclave before or after sterilization and to treat exhaust gases and/or condensates which can be released during or after the process. Consideration should be given to workers, the environment and the
20、public in general. See also EN 285 for general requirements for large steam sterilizers and autoclaves. I Scope This European Standard specifies performance criteria for the steam sterilizer and autoclave used for the destruction and prevention of release of microorganisms used in biotechnological p
21、rocesses. This European Standard applies if the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms used in biotechnological processes or if exposure of the worker or the environment to such microorganisms is restricted for reasons of safety. Ad
22、ditional criteria for individual components of a steam sterilizer or autoclave such as filters, couplings, pipes are given in European standards on biotechnology pertaining to performance criteria for filter elements, filtration equipment, tubes and pipes and couplings being prepared. 2 Normative re
23、ferences This European Standard incorporates by dated or undated references, provisions from other publications. 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 o
24、f 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 referred to applies. EN 285 Sterilization - Steam sterilizers - Large sterilizers EN 554 Sterilization of medical devices - Validat
25、ion and routine control of sterilization by moist heat EN 866-1 Biological systems for testing sterilizers and sterilization processes - Part 1 : General requirements Page 4 EN 12347: 1998 EN 866-3 prEN 866-7 EN 867-1 EN 867-2 EN 1619 EN 1620 EN 1672-2 prEN 12296 prEN I2297 prEN 12298 IS0 4287-1 IS0
26、 4288 Biological systems for testing sterilizers and sterilization processes - Part 3 : Particular systems for use in moist heat sterilizers Biological systems for testing sterilizers and sterilization processes - Part 7 : Particular requirements for self-contained biological indicator systems for u
27、se in moist heat sterilizers Non-biological systems for use in sterilizers - Part 1 : General requirements Non-biological systems for use in sterilizers - Pari 2 : Process indicators (Class A) Biotechnology - Large-scale process and production - General requirements for management and organization f
28、or strain conservation procedures Biotechnology - Large-scale process and production - Plant builiding according to the degree of hazard Food processing machinery - Safety and hygiene requirements - Basic concepts - Part 2 : Hygiene requirements Biotechnology - Equipment - Guidance for testing proce
29、dures for cleanability Biotechnology - Equipment - Guidance for testing procedures for sterilizability Biotechnology - Equipment - Guidance for testing procedures for ieaktig htness Surface roughness - Terminology - Part 1 : Surface and its parameters Geometrical Product Specifications (GPS) - Surfa
30、ce texture : Profile method - Rules and procedures for the assessment of surface texture 3 Definitions For the purposes of this standard, the following definitions apply : 3.1 autoclave Apparatus designed to sterilize materials and/or equipment by exposure to steam at a pressure above the atmospheri
31、c pressure. 3.2 cleanability Ability to be made clean. Page 5 EN 12347: 1998 3.3 hazard Intrinsic property or ability of something (e.g. any agent, equipment, material or process) to cause harm EN 16201. NOTE : Harm is an injury or damage to health of people and/or the environment. 3.4 leakage Egres
32、s from equipment. 3.5 leaktightness Ability of component of equipment or unit of equipment to limit egress. 3.6 microorganism Any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 16191. NOTE : For the purposes of this standard, the term
33、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 can provoke any infection, allergy or toxicity. 3.7 risk Probability of occurrence of a hazard c
34、ausing harm and the degree of severity of the harm. 3.8 steam sterilizer Apparatus designed to sterilize materials and/or equipment by exposure to steam. 3.9 sterile State of being free from viable microorganisms. NOTE 1 : In practice no such absolute statement regarding the absence of viable microo
35、rganisms 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 microorganisms during a sterilization procedure is usually described by an empirical mathematical function, co
36、mmonly 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 the process parameters of a sterilization procedure to realize a desired degree of inactivation of
37、viable microorganisms. Page 6 EN 12347 : 1998 3.10 sterilizability Ability of components of equipment, units of equipment or plants to be sterilized. 3.1 1 sterilization Process used to reach a sterile state. 3.12 target microorganism Process microorganism andlor other microorganisms relevant for th
38、e specific process. NOTE : For safety testing procedures, non-pathogenic microorganisms should be used where possible. 4 Hazards The following hazards shall be considered : - release of microorganisms after operation due to insufficient inactivation and/or removal of microorganisms when the equipmen
39、t is opened or dismantled ; - release of microorganisms by leakage during or after operation ; - release of microorganisms by exhaust gases or condensate. 5 Performance classification 5.1 General With regard to the contained use of microorganisms in the steam sterilizer or autoclave, the steam steri
40、lizer or autoclave shall be classified for the following performance criteria : - leaktightness ; - cleanability ; - sterilizability. The performance of the steam sterilizer or autoclave shall be determined for each of these criteria. The equipment shall be classified in accordance with tables 1, 2
41、and 3. For each criterion the equipment shall be classified independently. NOTE : Equipment can for example be in class SI-A for sterilizability, but in class LI-C for leaktightness. 5.2 Leaktightness The performance class for leaktightness of the steam sterilizer or autoclave shall be determined in
42、 accordance with table I. Page 7 EN 12347: 1998 Performance class for leaktightness Leaktightness Index (LI) LI-A LI-B LI-c Table 1 : Leaktightness performance Description of performance class leakage not defined leakage detected and quantified under defined conditions leakage tested under defined c
43、onditions and leakage below prescribed threshold value 2) Performance class for cleanability Cleanability Index (CI) NOTE : Leaktight means tight for target microorganisms. Description of performance class 5.3 Cleanability CI-B CI-c The performance class for cleanability of the steam sterilizer or a
44、utoclave shall be determined in accordance with table 2. cleanability tested and quantified under defined conditions or designed with regard to specified technical criteria cleanability tested and quantified under defined conditions and soil below detection limit or threshold value Table 2 : Cleanab
45、ility performance I CI-A I visible soil or cleanliness not defined I NOTE : Cleanability applies as a performance criterion for the equipment where : - deposits of soil in the equipment could jeopardise the sterilization procedure if the sterilization media do not reach all parts of the equipment or
46、 if the required temperature is not reached ; - cleaning procedures are intended to remove and inactivate microorganisms to make the equipment safe for handling without using any other sterilization or inactivation procedure. * Use of BATNEEC does not mean that financial issues moderate the degree o
47、f safety. Where several methods are available, the user may choose the most convenient, provided that it gives results of the necessary quality. Page 8 EN 12347 : 1998 Performance class for sterilizability Sterilizability Index (SI) SI-A SI-B SI-c 5.4 Steri lizabi iity Description of performance cla
48、ss equipment not suited or tested for reduction of viable target microorganisms equipment can be treated for a specified reduction of viable target microorganisms equipment can be sterilized The performance class for sterilizability of the steam sterilizer or autoclave shall be determined in accorda
49、nce with table 3. This criterion covers all methods of inactivation up to sterilization. The sterilizability performance therefore is usually combined with the cleanability criterion. Table 3 : Sterilizability performance 6 Classification of steam sterilizers and autoclaves 6.1 Type I steam sterilizers and autoclaves A steam sterilizer or autoclave meeting the following requirements shall be classified as type I : - the steam sterilizer or autoclave is capable of bringing all parts of the holding chamber to conditions that will cause a specified reduction of the amoun
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