【BS英国标准】BS EN 86631997 Biological systems for testing sterilizers and sterilization process.doc

BRITISH STANDARDBiological systems for testing sterilizers and sterilization processesPart 3. Particular systems for use in moist heat sterilizersThe European Standard EN 866-3 : 1997 has the status of aBritish StandardICS 11.080| BS EN866-3 : 1997|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 866-3 : 1997Committees 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 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 Products 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 into effect on15 November 1997BSI 1997The following BSI references relate to the work on this standard:Committee reference LBI/35/3Draft for comment 95/121173 DCISBN 0 580 28379 8Amd. No.DateText affectedAmendments issued since publicationBS EN 866-3 : 1997National forewordThis Part of BS EN 866 has been prepared by Subcommittee LBI/35/3 and is the English language version of EN 866-3 : 1997 Biological systems for testing sterilizers and sterilization processes Ð Part 3: Particular systems for use in moist heat sterilizers, published by the European Committee for Standardization (CEN).Cross-referencesPublication referred to Corresponding British StandardEN 285 : 1996BS EN 285 : 1997 Sterilization Ð Steam sterilizers Ð Large sterilizersEN 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 pagesThis document comprises a front cover, an inside front cover, pages i and ii, the ENtitle page, pages 2 to 6, an inside back cover and a back cover.BSI 1997iiiblankEUROPEAN STANDARDEN 866-3NORME EUROPE ENNEEUROPAÈ ISCHE NORMFebruary 1997ICS 11.080Descriptors: Medical equipment, sterilizers, sterilization, water vapour, bioassay, specifications, biological indicators, packing, labellingEnglish versionBiological systems for testing sterilizers and sterilization processes ÐPart 3: Particular systems for use in moist heat sterilizersSysteÁ mes biologiques pour l'essai des ste rilisateurs et les proce de s de ste rilisation ÐPartie 3: SysteÁ mes particuliers destine s aÁ eà tre utilise s dans des ste rilisateurs aÁ la chaleur humideBiologische Systeme fuÈ r die PruÈ fung von Sterilisatoren und Sterilisationsverfahren Ð Teil 3: Spezielle Systeme fuÈ r den Gebrauch in Sterilisatoren mit feuchter HitzeThis European Standard was approved 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 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 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, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.CENEuropean Committee for Standardization Comite Europe en de Normalisation EuropaÈ isches Komitee fuÈ r NormungCentral Secretariat: rue de Stassart 36, B-1050 Brussels1997 Copyright reserved to CEN members.Ref. No. EN 866-3 : 1997 EPage 5EN 866-3 : 1997BSI 1997ForewordThis European Standard has been prepared by 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 sterilizers and sterilization processes ÐPart 1: General requirementsEN 866-2Biological systems for testing sterilizers and sterilization processes ÐPart 2: Particular systems for use in ethylene oxide sterilizersEN 866-3Biological systems for testing sterilizers and sterilization processes ÐPart 3: Particular systems for use in moist heat sterilizersprEN 866-4Biological systems for testing sterilizers and sterilization processes ÐPart 4: Particular systems for use in irradiation sterilizersprEN 866-5Biological systems for testing sterilizers and sterilization processes ÐPart 5: Particular systems for use in low temperature steam and formaldehyde sterilizersprEN 866-6Biological systems for testing sterilizers and sterilization processes ÐPart 6: Particular systems for use in dry heat sterilizersprEN 866-7Biological systems for testing sterilizers and sterilization processes ÐPart 7: Particular requirements for self-contained biological indicator systems for use in moist heat sterilizersprEN 866-8Biological systems for testing sterilizers and sterilization processes ÐPart 8: Particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizersIn addition, CEN/TC 102 Working Group 7 has prepared a series of European Standards describing non-biological indicators for use in sterilizers. These European Standards are:EN 867-1Non-biological systems for use in sterilizers Ð Part 1: General requirementsEN 867-2Non-biological systems for use in sterilizers Ð Part 2: Process indicators (Class A)EN 867-3Non-biological systems for use in sterilizers Ð Part 3: Specification for Class B indicators for use in the Bowie and Dick test.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 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(s).According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.ContentsPageForeword 2Introduction 31 Scope 32 Normative references 33 Definitions 34 General requirements 35 Test organisms 36 Population of test organisms 37 Carriers 48 Resistance 49 Packaging and labelling 4Annex A (normative) Method for the determination of resistance to steamsterilization 5Annex B (informative) Bibliography 6IntroductionThis standard specifies the performance requirements for biological indicators supplied ready for use, and for suspensions of test organisms supplied either for the preparation of biological indicators or for the inoculation of product for use in validation studies on, and routine monitoring of, moist heat sterilization processes. The use of the indicators specified in this standard is described, inter alia, in EN 285.The biological indicators specified in this standard are not intended for use in any process other than moist heat sterilization. The use of an inappropriate biological indicator in a process other than that stated by the manufacturer can give dangerously misleading results.The use of a biological system for testing a sterilization process does not allow necessarily the same level of sensitivity in response to inadequate levels of all the critical variables of the process.The performance of a biological indicator can be affected by the conditions of storage prior to use, the methods of use, and the techniques employed after exposure to the process. For these reasons, the recommendations of the manufacturer for storage and use should be followed and biological indicators should be transferred to the specified recovery conditions as soon as possible after exposure to the process. Biological indicators should not be used beyond any expiry date stated by the manufacturer.Biological indicators should always be used in combination with physical and/or chemical monitoring in demonstrating the efficacy of a sterilization process. When a physico-chemical variable of a sterilization process is outside its specified limits, a sterilization cycle should always be regarded as unsatisfactory (see also EN 554), irrespective of the results obtained from the biological indicators.1 ScopeThis Part of EN 866 specifies requirements for inoculated carriers and biological indicators intended for use in assessing the performance of moist heat sterilizers and sterilization processes operating at temperatures in excess of 100 ÊC.NOTE. EN 285 specifies the performance and test requirements for large steam sterilizers for wrapped goods and porous loads.2 Normative referencesThis European Standard incorporates by dated or undated reference 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 onlywhen incorporated in it by amendment or revision. For undated references, the latest edition of the publication referred to applies.EN 285 : 1996Sterilization Ð Steam sterilizers Ð Large sterilizersEN 866-1 : 1997 Biological systems for testing sterilizers and sterilization processes Ð Part 1: General requirements3 DefinitionsFor the purposes of this standard, the definitions given in EN 866-1 apply, together with the following.3.1 z valueFor a thermal sterilization process, the change in exposure temperature which corresponds to a tenfold change in D value.4 General requirementsThe requirements of EN 866-1 : 1997 shall apply, except for 7.2 and 9.2, which are replaced by clause 9 of this standard.5 Test organismsThe test organism shall be spores of Bacillus stearothermophilus or other strains or organisms of demonstrated equivalent performance as required by this standard.NOTE. Bacillus stearothermophilus NCTC 10003 and ATCC 7953, DSM 22 and CIP 5281 have been found to be suitable.6 Population of test organisms6.1 Replicate determinations of the viable count on the same batch of suspension shall be within 35 % of the nominal population.6.2 The number of recoverable test organisms on each biological indicator shall be controlled during manufacture to be within 50 % of the nominal population stated by the manufacturer.6.3 Retrospective determination of the count shall be made by performing a viable count under the culture conditions on a suspension of test organisms obtained by physical removal of the test organisms from the carrier through ultrasonication, shaking with glass beads, or other appropriate validated methods. Counts obtained shall be regarded as acceptable if they are within 250 % and +300 % of the nominal population stated by the manufacturer or of the mid-point between the minimum and maximum populations stated by the manufacturer.NOTE. Guidance on the selection and validation of methods for the removal of micro-organisms from the carrier is given inEN 1174-2.6.4 For inoculated carriers or biological indicators intended for use in routine monitoring, the nominal number of spores shall be not less than 1 3 105 per unit and shall be stated in increments not greater than0,1 3 105. (See also 8.2.2).When the purchaser specifies a nominal number of spores of 1 3 106 or greater for use in routine monitoring, the population shall be stated in increments of not more than 0,1 3 106.NOTE. Inoculated carriers and/or biological indicators supplied for other purposes, e.g. qualification, validation and other specific tests, may require other nominal populations.7 Carriers7.1 The suitability of the carrier for use in moist heat sterilization processes shall be demonstrated in accordance with 6.1 and 6.2 of EN 866-1 : 1997 and annex A of this standard.7.2 The conditions to be used to establish compliance shall be:± exposure to dry saturated steam at not less than the manufacturer's stated maximum;± exposure temperature +5 ÊC for not less than 30 min.If the manufacturer does not state a maximumexposure temperature, a temperature of 145 ÊC shall be used.NOTE. These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limitations of a moist heat sterilization process.8 Resistance8.1 GeneralThe manufacturer shall state the D value of each ba