BS EN 12347-1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves《生物技术 蒸汽灭菌器和高压釜性能规范》.pdf

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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 autoclavesThis British Standard, having been prepared under the direction of the Sec

3、tor 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 issued since publication Amd. No. Date Text affected National foreword This British Standard is the English

4、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 understand the text; present to the responsible European committee any enquiries on the interpretation, or proposal

5、s 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 be obtained on request to its secretary. Cross-references The British Standards which implement internati

6、onal 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 “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include

7、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 obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN ti

8、tle page, pages 2 to 8, an 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 1998 CEN All rights of exploitation in any form and by any means rese

9、rved worldwide for CEN national members Ref. No. EN 12347:1998 E EUROPEAN STANDARD EN 12347 NORME EUROPE ENNE EUROPA ISCHE NORM March 1998 ICS 07.080; 07.100.99; 11.080 Descriptors: Biotechnology, autoclaves, microorganisms, noxious microorganisms, accident prevention, hazards, definitions, characte

10、ristics, leaktightness, cleaning, sterilization, classifications, specifications, verification English 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 Leistu

11、ngskriterien fu r Dampf-Sterilisatoren und Autoklaven This European Standard was approved by CEN on 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 a

12、ny alteration. Up-to-date lists and bibliographical references concerning 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 b

13、y 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ir

14、eland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.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 Standard h

15、as 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 conflicting na

16、tional 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, Germany,

17、Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 4 4 Hazards 4 5 Performance classification 5 6 Classification of steam sterilizers a

18、nd autoclaves 6 7 Verification of performance 7 8 Marking and packaging 7 9 Documents 7 Annex A (informative) Bibliography 8Page 3 EN 12347:1998 BSI 1998 Introduction Steam sterilizers and autoclaves are used to destroy microorganisms by subjecting them to steam (steam sterilizers) or to steam at el

19、evated 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 which requires inactivation and/or sterilization prior to disposal in wast

20、e 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 in use. For some microorganisms additional measures are needed to prevent

21、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 public in general. See also EN 285 for general requirements for large stea

22、m 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 in biotechnological processes. This European Standard applies if the intended use of steam steril

23、izers 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. Additional criteria for individual components of a steam sterilizer or autocl

24、ave, 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 are being prepared. 2 Normative references This European Standard incorporates by dated or undat

25、ed 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 of these publications apply to this European Standard only when

26、 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 Validation and routine control of sterilization by moist heat EN 866-1,

27、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 systems for use in moist heat sterilizers prEN 866-7, Biological systems for testing sterilizers and

28、 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: General requirements EN 867-2, Non-biological systems for use in sterilizers Part 2: Process indi

29、cators (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 process and production Plant building according to the degree of hazard EN 1672-2, Food processing mac

30、hinery Safety and hygiene requirements Basic concepts Part 2: Hygiene requirements prEN 12296, Biotechnology Equipment Guidance for testing procedures for cleanability prEN 12297, Biotechnology Equipment Guidance for testing procedures for sterilizability prEN 12298, Biotechnology Equipment Guidance

31、 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 Rules and procedures for the assessment of surface texturePage 4 EN 12347:1998 BSI 1998 3 Definiti

32、ons 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 atmospheric pressure 3.2 cleanability ability to be made clean 3.3 hazard intrinsic property or ability of som

33、ething (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. 3.4 leakage egress from equipment 3.5 leaktightness ability of component of equipment or unit of equipment to limit egress 3.6 microorganism any

34、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 Directive 90/679/EEC: microorganisms, including those which have b

35、een genetically modified, cell cultures and human endoparasites which can provoke any infection, allergy 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

36、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 microorganisms can be proven. However, sterile conditions can be regarded as established by using an accepted or recognized method of sterilizati

37、on. 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, such functions can be reduced to very low numbers, but not to zero. However, th

38、ese 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. 3.10 sterilizability ability of components of equipment, units of equipment or plants to be sterilized 3.11 sterilizat

39、ion process used to reach a sterile state 3.12 target microorganism process microorganism and/or other microorganisms relevant for the specific process NOTE For safety testing procedures, non-pathogenic microorganisms should be used where possible. 4 Hazards The following hazards shall be considered

40、: release of microorganisms after operation due to insufficient inactivation and/or removal of microorganisms when the equipment is opened or dismantled; release of microorganisms by leakage during or after operation; release of microorganisms by exhaust gases or condensate.Page 5 EN 12347:1998 BSI

41、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 contained use of

42、 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 criteria. The e

43、quipment shall be classified in accordance with Tables 1, 2 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 o

44、f 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-A Leakage not defined LI-B Leakage detected and quantified under defined conditions 1

45、) LI-C Leakage tested under defined conditions and leakage below prescribed threshold value 2) 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. NOTE Leakti

46、ght 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 In

47、dex (CI) CI-A Visible soil or cleanliness not defined CI-B Cleanability tested and quantified under defined conditions or designed with regard to specified technical criteria CI-C Cleanability tested and quantified under defined conditions and soil below detection limit or threshold value 1) 1) Base

48、d on assessment by BATNEEC (best available techniques not entailing excessive costs)* NOTE Cleanability applies as a performance criterion for the equipment where: deposits of soil in the equipment could jeopardize the sterilization procedure if the sterilization media do not reach all parts of the

49、equipment or 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.Page 6 EN 12347:1998 BSI 1998 Table 4 Minimum performance classification for type I and type II steam sterilizers and autoclaves Performance criterion Type I steam sterilizers and autoclaves Type II steam sterilizers and autoclaves Ho