1、* * m STD.BS1 BS EN 12347-ENGL 1998 m Lb24bb9 0715517 40T m BRITISH STANDARD Biotechnology - Performance criteria for steam sterilizers and autoclaves The European 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
2、COPYRIGHT LAW BS EN 12347:1998 BS EN 12347:1998 diredion 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 hd. No. O BSI 1998 National foreword Date Text affected This British Standard is the English lang
3、uage version of EN 123471998. The UK participation in its preparation was entrusted to Technid Committee CIv58, Biotechnology, which has the responsibility to: - aid enquirers to understand the text; - present to the responsible European committee any enquiries on the - monitor related international
4、 and European developments and promulgate interpretation, or proposals for change, and keep the UK interests informed; them in the UK. A list of organizations represented on this committee can be obtained on request to its secrem. Cross-references The British Standards which implement international
5、or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “InMonal Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Elecmnic Catalogue. A British Standard does not purport to include all the nec-
6、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 hnt cover, an inside front cover, the EN title page, pages 2 to
7、 8, an inside back cover and a back cover. ISBN O 580 29944 9 I l STDmBSI BS EN 12347-ENGL 3998 D Lb2+bb9 O735523 Ob8 EUROPEAN E7rANDrn EN 12347 NORME EUROPENNI3 EXJROP 07.100.99 11.080 Descriptors: Biotechnology, autoclaves, microorganisms, noxious microorganisms, accident prevention, hazards, defi
8、nitions, characteristics, leaktightness, cleaning, sterilization, classifications, specifications, verification English veision Biotechnology - Performance criteria for steam sterilize- and autochves Biotechnologie - Criteres de performance pow les stkrilkateum la vapeur deau et les autoclaves Biote
9、chnik - Liikrikrien fur Dampf-Smren und Autoklaven This European Standard was approved by CEN on 15 February 1998. CEN members are bound to comply with the CENICENELEC Internal Regulations which stipuiate the conditions for giving this European Standard the status of a national standard without any
10、alteration. Upto-date lists and bibiiographical references concerning such national standards may be obtained on application to the Centsal Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other hguage made by tran
11、slation under the responsibility of a CEN member into its own language and notifed to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austri4 Belgium, Czech Republic, Denmark, Finland, France, Germanx Greece, Iceland, Ireland, It
12、aly, Luxembourg, Netheriands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. European Committee for Standardization Comit Europen de Nonnalisation Europisches Komitee fur Normung Central Secretariat: rue de Stassart 36, B-1060 Brussels O 1998 CEN - AU rights of exploitation in any
13、form and by any means reserved worldwide for CEN national members Ref. No. EN 123471998 E STD-BSI BS EN 32347-ENGL 3998 m Lb24669 0735522 TT4 Page 2 EN 12347:1998 Foreword This European Standard has been prepared by Technical Committee CENiC 233, Biotechnology, the secretariat of which is held by AF
14、NOR. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free We Association. This European Standard shaii be given the status of a nationai standard, either by publication of an identical text or by endorsement, at the latest by Septembe
15、r 1998, and conflicting national standards shail be withdrawn at the latest by September 1998. According to the CENKENELEC Internal Regulations, the nationai standards organktions of the following countries are bound to implement this European Standad Austria, Beigium, Czech Republic, Denmark, FCnla
16、nd, France, Germany, Greece, Iceland, Ireland, I*, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Foreword Introduction 1 Scope 2 Normative references 3 Definitions 4Hazasds 5 Performance classification 6 7 Verifidon of performance 8 Markingand
17、packaging 9 Documents Annex A (informative) Bibliography Classification of steam sterilizers and autoclaves page 2 3 3 3 4 4 5 O BSI 1998 STD-BSI BS EN 12347-ENGL 1998 1624669 0735523 930 Introduction Steam sterilizers and autoclaves are used to destroy microorganisms by subjecting them to steam (st
18、eam 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 orand factories; - eliminating the risk associated with material which requires inactivation andor ste
19、rilization 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 in use. For some microorganisms addi
20、tional measures are needed to prevent their release from the autoclave before or after sterilization and to treat exhaust gases andor 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 fo
21、r 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 in biotechnological processes. This European Standard applie
22、s 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 safe. Additional criteria for individual compone
23、nts of a steam sterilizer or autoclave, such as fiiters, 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. Page 3 EN 123471998 2 Normative reference
24、s 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 herear. For dated references, subsequent amendments to or revisions of any of these pu
25、blications apply to this European Standard ony when incorporated in it by amendment or revision. For undated references, the latest edition of the publication referred to applies. EN 285, Sterilization - Steam stermizers - Large sterilizers EN 554, Sterilization of medical devices - Validation and m
26、utine control of sterilization by mist heat EN 861, 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 pr
27、EN 866-7, Biological systems for testing sterilizers and sterilization processes - Pa,rt 7: Particular requirements for self-contained biological indimtor systems for use in moist heat sWizers EN 867-1, Non-biological systemsfor use in sterilizers - Part 1: General requirements EN 867-2, Non-biologi
28、cal systems for use in sterizers - Part 2: Process indicators (Class A) EN 1619, Biotechnology - Ldrge-scale process and production. - Generul requirements for management and organizu,tion for strain consma,tion procedures EN 1620, Biotechnology - Large-scale process ar - release of microorganisms b
29、y exhaust gases or condensate. O BSI 1998 STD-ES1 BS EN 32347-ENGL 1998 W lb24bb9 0735525 703 = I Page 6 EN 1234E1998 LI-B LI-C 5 Performance classification 5.3 Cleanability 6.1 General With regard to the contained use of microorganisms in the steam stenizer or autoclave, the steam sterilizer or The
30、 performance class for cleanability of the steam sterilizer or autoclave shaU be determined in accordance with Table 2. Leakage detected and quanwied under defined conditions1) Leakage tested under defined conditions and leakage below prescribed threshold valu - cleanabiliw, - sterilizabiliw. The pe
31、rformance of the steam sterilizer or autoclave shall be determined for each of these criterh The equipment shai 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 steriiizabiiity, b
32、ut in class LI-C for leaktightness. 6.2 Leaktightness The performance class for leaktightness of the steam sterilizer or autoclave shall be determined in accordance with Table 1. Table 1 - Leaktightness performance Performance class for leaktightness Leaktightness Index (LI) Description of performan
33、ce class LI-A I Leakage not defined Table 2 - Cleanability performance Performance class for cleanability Cleanability Index (CI) CI-A CI-B CI-c Description of performance class Visible soil or cleanliness not dened Cleanability tested and quantied under defined conditions or designed with regard to
34、 specified technical Criteria Ceanabity tested and quantied under defined conditions and soil below detection limit or threshold vahe) I Based on assessment by BATNEEC est available techniques not entailing excessive costs)* NOTE Cleanability applies as a performance criterion for the equipment wher
35、e: - deposits of soil in the equipment could jeopardize the stenhation procedure if the stedization media do not reach all parts of the equipment or if the required temperature is not reached - cleaning procedures are intended to remove and inactivate microorganisms to make the equipment safe for ha
36、ndling, without using any other sterilization or inactivation procedure. * 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. O BSI 1
37、998 STD-BSI BS EN L2347-ENGL 1998 H 1624669 07L552b b4T H Page 6 EN l234R1998 Performance class for sterilizabity Steriiizability Index (SI) SI-A SI-B SIC 6.4 Steriiizabiuty The performance class for stenlizability of the steam sterilizer or autoclave shall be determined in accordance with Table 3.
38、This criterion covers ail methods of Iliactivation up to sterihaion. The sterilizability performance is therefore usually combined with the cleanability criterion. Description of performance class Equipment not suited or tested for reduction of viable target microorganisms Equipment can be treated f
39、or a speciied reduction of viable target microorganisms Equipment can be sterilized Performance criterion SteIiliZability NOTE In this table, the result (performaace) of an inactivation procedure is described, and not the way or means of achieving the result. ISrpe I steam steriiizers and autoclaves
40、 NTE 1 Release of microorganisms can occur when air is removed from the autoclave chamber while operating temperature and pressure are being reached, or when condensate, e.g. from the holding chamber or from exhaust filters, is released during or after the operating cycle. NOTE 2 Appropriate measure
41、s to prevent loss of containment can include provision of filters able to sterilize exhaust air, and discharge of condensate to equipment such as vessels containing sterilizing iiquids. - the steam sterilizer or autoclave has a minimum performance class as given in Wle 4. Cleanability CI-B) CI-B) CI
42、-BI) CI-BI) Iakti NOTE Conditions that are known to reduce the number of viable microorganisms in a load are generally combinations of time, elevated temperature, elevated pressure andor addition of chemicals. - the steam sterilizer or autoclave has a minimum performance class as given in Table 4. T
43、able 4 - Minimum performance classification for type I and type JI steam sterilizers and autoclaves Residual soil should not negatively affect sterilizability In general, this wiil require CI-B for deanabfi, but CI-A is also acceptable if it is validated that the residual soil does not affect the st
44、erilization result O BSI 1998 STDmBSI BS EN 12347-ENGL 1998 = 1624669 0715527 58b * * # 7 Verification of performance 7.1 General Verification of the classification shall be done in accordance with bles 1,2 and 3. The performance of the equipment is classified and verified by the manufacturer or by
45、the user. If the equipment is manufactured in accordance with an already classified prototype, it is classified in the same class as the prototype, if: - there is no change in design or materiais used; or - there are only minor and not biosafetyrelevant changes. If there are only minor and not biosa
46、fety-relevant changes, the manufacturer shall document the changes and shall make evident to the user that no Page 7 EN 12347:1998 7.4 Sterilizability For type I and type II steam sterilizers or autoclaves, the holding chamber shail be classified SIC. The holding chamber shall be tested according to
47、 the guidance given in prEN 12297. The awaliary equipment of a type I steam sterilizer or autoclave shall be classified SI-A if no test methods are executed to determine the sterilizability To be classified SI-B or SI-C, the amdiary equipment of a type I stem sterilizer or autoclave shall be tested
48、according to the guidance given in prEN 12297 and in EN 285. The indicators used in these tests shall fullil the requirements given in EN 866-1, EN 866-3, prEN 867 or EN 867-1 and EN 867-2. Tests shaii be performed at representative process conditions. rechssification is expected following these cha
49、nges. NOTE Verification of classification can, for example, be done by operating an appropriate quality assurance system. 7.2 Leaktightness 8 mm and packaging Each steam sterilizer and autoclave shall be identified in such a way that its performance with regard to cleanabiliQ, sterilizability and leaktightness can be The steam sterilizer or autoclave shall be classified LI-A if no test methods are executed to determine the leaktightness. To be classified LI-B or LI-C, the steam sterilizer or autoclave shall be tested according to the guidance giv
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