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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12347:1998 The Euro
2、pean Standard EN 12347:1998 has the status of a British Standard ICS 07.080; 11.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Performance criteria for steam sterilizers and autoclaves Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:42 GMT+00:00
3、 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 August 1998 BSI 1998 ISBN 0 580 29944 9 BS EN 12347:1998 Amendments
4、issued since publication Amd. No.DateText affected National foreword This British Standard is the English language version of EN 12347:1998. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understan
5、d 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 committee can
6、 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 using the Fi
7、nd 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 from legal
8、 obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 8, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for S
9、tandardization 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 12347:1998 E EUROPEAN STANDARDEN 12347
10、 NORME EUROPE ENNE EUROPA ISCHE NORM March 1998 ICS 07.080; 07.100.99; 11.080 Descriptors: Biotechnology,autoclaves,microorganisms,noxiousmicroorganisms,accidentprevention,hazards,definitions, characteristics, leaktightness, cleaning, sterilization, classifications, specifications, verification Engl
11、ish version Biotechnology Performance criteria for steam sterilizers and autoclaves Biotechnologie Crite res de performance pour les ste rilisateurs a la vapeur deau et les autoclaves Biotechnik Leistungskriterien fu r Dampf-Sterilisatoren und Autoklaven This European Standard was approved by CEN on
12、 15 February 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 m
13、ay 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 notified to the Ce
14、ntral 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 King
15、dom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 12347:1998 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 S
16、tandard 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 identical text or by endorsement, at the latest by September 1998, and confl
17、icting national standards shall be withdrawn at the latest by September 1998. According 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,
18、Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions4 4Hazards4 5Performance classification5 6Classification of steam sterilizers and a
19、utoclaves6 7Verification of performance7 8Marking and packaging7 9Documents7 Annex A (informative) Bibliography8 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12347:1998 BSI 1998 Introduction Steam sterilizers and autoclaves are
20、used to destroy microorganisms 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 ass
21、ociated with material which 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
22、 by the microorganism 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, th
23、e environment and the public in general. See also EN 285 for general requirements for large steam sterilizers and autoclaves. 1 Scope This European Standard specifies performance criteria for steam sterilizers and autoclaves used for the destruction and prevention of release of microorganisms used i
24、n biotechnological processes. 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
25、reasons of safety. Additional 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, which
26、are being prepared. 2 Normative references 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 a
27、mendments 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 referred to applies. EN 285, Sterilization Steam sterilizers Large sterilizers EN 554, Steriliza
28、tion of medical devices Validation and routine control of sterilization by moist heat EN 866-1, Biological systems for testing sterilizers and sterilization processes Part 1: General requirements EN 866-3, Biological systems for testing sterilizers and sterilization processes Part 3: Particular syst
29、ems for use in moist heat sterilizers prEN 866-7, Biological systems for testing sterilizers and sterilization processes Part 7: Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers EN 867-1, Non-biological systems for use in sterilizers Part 1: G
30、eneral requirements EN 867-2, Non-biological systems for use in sterilizers Part 2: Process indicators (Class A) EN 1619, Biotechnology Large-scale process and production General requirements for management and organization for strain conservation procedures EN 1620, Biotechnology Large-scale proces
31、s and production Plant building according to the degree of hazard EN 1672-2, Food processing machinery Safety and hygiene requirements Basic concepts Part 2: Hygiene requirements prEN 12296, Biotechnology Equipment Guidance for testing procedures for cleanability prEN 12297, Biotechnology Equipment
32、Guidance for testing procedures for sterilizability prEN 12298, Biotechnology Equipment Guidance for testing procedures for leaktightness ISO 4287-1, Surface roughness Terminology Part 1: Surface and its parameters ISO 4288, Geometrical Product Specifications (GPS) Surface texture: Profile method Ru
33、les and procedures for the assessment of surface texture Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 12347:1998 BSI 1998 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 autoclave apparatus
34、designed to sterilize materials and/or equipment by exposure to steam at a pressure above the atmospheric pressure 3.2 cleanability ability to be made clean 3.3 hazard intrinsic property or ability of something (e.g. any agent, equipment, material or process) to cause harm EN 1620 NOTEHarm is an inj
35、ury or damage to health of people and/or the environment. 3.4 leakage egress 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 genet
36、ic material EN 1619 NOTEFor the purposes of this standard, 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 can provoke any infection, a
37、llergy or toxicity. 3.7 risk probability of occurrence of a hazard causing 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
38、 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 microorganisms during a sterilization procedure i
39、s 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 the process parameters of a sterilizat
40、ion procedure to realize a desired degree of inactivation of viable microorganisms. 3.10 sterilizability ability of components of equipment, units of equipment or plants to be sterilized 3.11 sterilization process used to reach a sterile state 3.12 target microorganism process microorganism and/or o
41、ther microorganisms relevant for the specific process NOTEFor 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 micr
42、oorganisms when the equipment is opened or dismantled; release of microorganisms by leakage during or after operation; release of microorganisms by exhaust gases or condensate. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 12347:
43、1998 BSI 1998 * Use of BATNEEC does not mean that financial issues moderate the degree of safety. Where several methods are available, the user may choose the most convenient, provided that it gives results of the necessary quality. 5 Performance classification 5.1 General With regard to the contain
44、ed use of microorganisms in the steam sterilizer or autoclave, the steam sterilizer 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 criter
45、ia. The equipment shall be classified in accordance with Tables 1, 2 and 3. For each criterion the equipment shall be classified independently. NOTEEquipment can for example be in class SI-A for sterilizability, but in class LI-C for leaktightness. 5.2 Leaktightness The performance class for leaktig
46、htness of the steam sterilizer or autoclave shall be determined in accordance with Table 1. Table 1 Leaktightness performance Performance class for leaktightness Description of performance class Leaktightness Index (LI) LI-ALeakage not defined LI-BLeakage detected and quantified under defined condit
47、ions1) LI-CLeakage tested under defined conditions and leakage below prescribed threshold value2) 1) Based on leakage assessment by BATNEEC (best available techniques not entailing excessive costs)* 2)Prescribed threshold value can for example be the detection limit of an approved BATNEEC. NOTELeakt
48、ight means tight for target microorganisms. 5.3 Cleanability The performance class for cleanability of the steam sterilizer or autoclave shall be determined in accordance with Table 2. Table 2 Cleanability performance Performance class for cleanability Description of performance class Cleanability I
49、ndex (CI) CI-AVisible soil or cleanliness not defined CI-BCleanability tested and quantified under defined conditions or designed with regard to specified technical criteria CI-CCleanability tested and quantified under defined conditions and soil below detection limit or threshold value1) 1) Based on assessment by BATNEEC (best available techniques not entailing excessive costs)* NOTECleanability applies as a performance criterion for the equipment where: deposits of soil