【BS英国标准】BS EN 86621998 Biological systems for testing sterilizers and sterilization process.doc
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1、BRITISH STANDARDBiological systems for testing sterilizers and sterilization processesPart 2. Particular systems for use in ethylene oxide sterilizersThe European Standard EN 866-2 : 1997 has the status of aBritish StandardICS 11.080| BS EN866-2 : 1998|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PER
2、MITTED BY COPYRIGHT LAWBS EN 866-2 : 1998Committees responsible for thisBritish StandardThe preparation of this British Standard was entrusted by Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, to Subcommittee LBI/35/3, Sterilization indicators, upon which the following bodies
3、were represented:ABHI Special Interest Section (Sterilizers and Disinfectors) Association of British Healthcare IndustriesBLWA Ltd (the Association of the Laboratory Supply Industry) Department of Health (Medical Devices Agency)European Sterilization Packaging Association (UK) Medical Sterile Produc
4、ts AssociationPublic Health Laboratory ServiceRoyal College of PathologistsRoyal Pharmaceutical Society of Great BritainThis 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
5、into effect on 15 March 1998BSI 1998The following BSI references relate to the work on this standard:Committee reference LBI/35/3Draft for comment 95/121172 DCISBN 0 580 28378 XAmd. No.DateText affectedAmendments issued since publicationBS EN 866-2 : 1998National forewordThis Part of BS EN 866 has b
6、een prepared by Subcommittee LBI/35/3 and is the English language version of EN 866-2 : 1997 Biological systems for testing sterilizers and sterilization processes Part 2: Particular systems for use in ethylene oxide sterilizers, published by the European Committee for Standardization (CEN).Cross-re
7、ferencePublication referred to Corresponding British StandardEN 866-1 : 1997BS EN 866 Biological systems for testing sterilizers and sterilization processesPart 1 : 1997 General requirementsCompliance with a British Standard does not of itself confer immunity from legal obligations.Summary of pagesT
8、his document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 6, an inside back cover and a back cover.BSI 1998iiiblankEUROPEAN STANDARDEN 866-2NORME EUROPE ENNEEUROPA ISCHE NORMFebruary 1997ICS 11.080Descriptors: Medical equipment, sterilizers, steriliza
9、tion, ethylene oxide, bioassay, specifications, biological indicatorsEnglish versionBiological systems for testing sterilizers and sterilization processes Part 2: Particular systems for use in ethylene oxide sterilizersSyste mes biologiques pour lessai des ste rilisateurset les proce de s de ste ril
10、isation Partie 2: Syste mes particuliers destine s a e tre utilise s dans desste rilisateurs a loxyde de thyle neBiologische Systeme fu r die Pru fung von Sterilisatoren und Sterilisationsverfahren Teil 2: Spezielle Systeme fu r den Gebrauch in Ethylenoxid-SterilisatorenThis European Standard was ap
11、proved by CEN on 1997-01-10. 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 st
12、andards 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 notified t
13、o the Central Secretariat has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.CENEu
14、ropean Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r NormungCentral Secretariat: rue de Stassart 36, B-1050 Brussels1997 Copyright reserved to CEN members.Ref. No. EN 866-2 : 1997 EPage 5EN 866-2 : 1997BSI 1998ForewordThis European Standard has been prepa
15、red by Technical Committee CEN/TC 102, Sterilizers for medical purposes, the secretariat of which is held by DIN.This Standard is one of a series of European Standards concerned with biological systems for testingsterilizers. These European Standards are:EN 866-1Biological systems for testing steril
16、izers and sterilization processes Part 1: General requirementsEN 866-2Biological systems for testing sterilizers and sterilization processes Part 2: Particular systems for use in ethylene oxide sterilizersEN 866-3Biological systems for testing sterilizers and sterilization processes Part 3: Particul
17、ar systems for use in moist heat sterilizersprEN 866-4Biological systems for testing sterilizers and sterilization processes Part 4: Particular systems for use in irradiation sterilizersprEN 866-5Biological systems for testing sterilizers and sterilization processes Part 5: Particular systems for us
18、e in low temperature steam and formaldehyde sterilizersprEN 866-6Biological systems for testing sterilizers and sterilization processes Part 6: Particular systems for use in dry heat sterilizersprEN 866-7Biological systems for testing sterilizers and sterilization processes Part 7: Particular requir
19、ements for self-contained biological indicator systems for use in moist heat sterilizersprEN 866-8Biological systems for testing sterilizers and sterilization processes Part 8: Particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizersIn addition, C
20、EN/TC 102 Working Group 7 has prepared a series of European Standards describingnon-biological indicators for use in sterilizers. TheseEuropean Standards are:EN 867-1Non-biological systems for use in sterilizers Part 1: General requirementsEN 867-2Non-biological systems for use in sterilizers Part 2
21、: Process indicators (Class A)EN 867-3Non-biological systems for use in sterilizers Part 3: Specification for Class B indicators for use in the Bowie and Dick testThis European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at
22、 the latest by August 1997, and conflicting national standards shall be withdrawn at the latest by August 1997.This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive
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