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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 866-2 : 1998 The Eu
2、ropean Standard EN 866-2 : 1997 has the status of a British Standard ICS 11.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biological systems for testing sterilizers and sterilization processes Part 2. Particular systems for use in ethylene oxide sterilizers Licensed Copy
3、: sheffieldun sheffieldun, na, Tue Nov 07 02:55:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 866-2 : 1998 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 ef
4、fect on 15 March 1998 BSI 1998 The following BSI references relate to the work on this standard: Committee reference LBI/35/3 Draft for comment 95/121172 DC ISBN 0 580 28378 X Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparati
5、on 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
6、 Healthcare Industries BLWA Ltd (the Association of the Laboratory Supply Industry) Department of Health (Medical Devices Agency) European Sterilization Packaging Association (UK) Medical Sterile Products Association Public Health Laboratory Service Royal College of Pathologists Royal Pharmaceutical
7、 Society of Great Britain Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BSI 1998i BS EN 866-2 : 1998 National foreword This Part of BS EN 866 has been prepared by Subcommittee LBI/35/3 and is the English language version of EN 866-2 : 1997
8、 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-reference Publication referred toCorresponding British Standard EN 866-1 : 1997BS EN 866 Biol
9、ogical systems for testing sterilizers and sterilization processes Part 1 : 1997 General requirements 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, pages i and ii, the EN ti
10、tle page, pages 2 to 6, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iiblank Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Co
11、mmittee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 Copyright reserved to CEN members. Ref. No. EN 866-2 : 1997 E EUROPEAN STANDARDEN 866-2 NORME EUROPE ENNE EUROPA ISCHE NORM February 1997 ICS
12、 11.080 Descriptors: Medical equipment, sterilizers, sterilization, ethylene oxide, bioassay, specifications, biological indicators English version Biological systems for testing sterilizers and sterilization processes Part2: Particular systems for use in ethylene oxide sterilizers Syste mes biologi
13、ques pour lessai des ste rilisateurs et les proce de s de ste rilisation Partie 2: Syste mes particuliers destine s a e tre utilise s dans des ste rilisateurs a loxyde de thyle ne Biologische Systeme fu r die Pru fung von Sterilisatoren und Sterilisationsverfahren Teil 2: Spezielle Systeme fu r den
14、Gebrauch in Ethylenoxid-Sterilisatoren This 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-
15、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 t
16、he 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
17、, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 866-2 : 1997 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 102, Sterilize
18、rs 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 testing sterilizers. These European Standards are: EN 866-1Biological systems for testing sterilizers and sterilization processes Part 1: Gen
19、eral requirements EN 866-2Biological systems for testing sterilizers and sterilization processes Part 2: Particular systems for use in ethylene oxide sterilizers EN 866-3Biological systems for testing sterilizers and sterilization processes Part 3: Particular systems for use in moist heat sterilizer
20、s prEN 866-4Biological systems for testing sterilizers and sterilization processes Part 4: Particular systems for use in irradiation sterilizers prEN 866-5Biological systems for testing sterilizers and sterilization processes Part 5: Particular systems for use in low temperature steam and formaldehy
21、de sterilizers prEN 866-6Biological systems for testing sterilizers and sterilization processes Part 6: Particular systems for use in dry heat sterilizers prEN 866-7Biological systems for testing sterilizers and sterilization processes Part 7: Particular requirements for self-contained biological in
22、dicator systems for use in moist heat sterilizers prEN 866-8Biological systems for testing sterilizers and sterilization processes Part 8: Particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizers In addition, CEN/TC 102 Working Group 7 has prepare
23、d 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 Part 1: General requirements EN 867-2Non-biological systems for use in sterilizers Part 2: Process indicators (Class A) EN
24、 867-3Non-biological systems for use in sterilizers 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
25、 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/CENE
26、LEC 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
27、 United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4General requirements3 5Test organisms3 6Population of test organisms3 7Carriers4 8Resistance4 Annexes A(normative) Method for the determination of resistance to ethylene oxide sterilization5 B(inform
28、ative) Bibliography6 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 866-2 : 1997 BSI 1998 Introduction This standard specifies the performance requirements for biological indicators supplied ready for use, and for suspensions of t
29、est 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, ethylene oxide sterilization processes. The use of the indicators specified in this standard is described in EN 550. The biologica
30、l indicators specified in this standard are not intended for use in any process other than ethylene oxide 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 fo
31、r 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 t
32、echniques 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 indic
33、ators 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 out
34、side its specified limits, a sterilization cycle should always be regarded as unsatisfactory, irrespective of the results obtained from the biological indicators. (See also EN 550). 1 Scope This Part of EN 866 specifies requirements for inoculated carriers and biological indicators intended for use
35、in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilant. These are intended for use in sterilizers employing pure ethylene oxide gas or admixtures of the gas with diluent gases, over a sterilizing temperature range of 20 8C to 65 8C. NOTE
36、. prEN 1422 specifies the performance and test requirements for ethylene oxide sterilizers. EN 550 specifies the requirements for the validation and routine monitoring of ethylene oxide sterilization. 2 Normative references This European Standard incorporates by dated or undated references provision
37、s 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 incorporated in it by am
38、endment or revision. For undated references the latest edition of the publication referred to applies. EN 866-1 : 1997 Biological systems for testing sterilizers and sterilization processes Part 1: General requirements 3 Definitions For the purposes of this standard, the definitions given in EN 866-
39、1 apply. 4 General requirements The requirements of EN 866-1 shall apply. 5 Test organisms The test organism shall be spores of Bacillus subtilis var. niger or other strains or organisms of demonstrated equivalent performance as required by this standard. NOTE. Bacillus subtilis NCTC 10073, DSM 2277
40、, ATCC 9372 or CIP 7718 have been found to be suitable. 6 Population of test organisms 6.1 Replicate determinations of the viable count on the same batch of suspension shall be within35 % of the nominal population. 6.2 The number of recoverable test organisms on each biological indicator shall be co
41、ntrolled during manufacture to be either within50 % of the nominal population stated by the manufacturer, or within the minimum and maximum populations stated by the manufacturer. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 866
42、-2 : 1997 BSI 1998 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 ap
43、propriate 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 the mid-point between the minimum and maximum populations stated by the manufacturer. NOTE. Guidance on the selection and validatio
44、n of methods for the removal of micro-organisms from the carrier is given in EN 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 106per unit and shall be stated in increments not greater than
45、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 Carriers 7.1 The suitability of the carrier for use in ethylene oxide sterilization processes shall be demo
46、nstrated in accordance with the requirements of 6.1 and 6.2 of EN 866-1 : 1997 and annex A of this standard. 7.2 The exposure conditions to be used to establish compliance shall be: temperature: not less than 55 8C; relative humidity: not less than 70 %; gas concentration: not less than 800 mg/l; ex
47、posure time: not less than 6 h. NOTE. These conditions have been selected to represent a realistic challenge to the carrier whilst remaining within the practical limits of an ethylene oxide sterilization process. 8 Resistance 8.1 General The manufacturer shall state the D value of each batch of biol
48、ogical indicators or inoculated carriers to an accuracy of0,5 min. 8.2 Biological indicators and inoculated carriers intended for use in routine monitoring 8.2.1 The D values obtained for the spore population on the inoculated carriers shall be not less than 12,5 min when exposed to (60030) mg/l eth
49、ylene oxide at (301) 8C and (6010) % relative humidity, and/or not less than 2,5 min when exposed to (60030) mg/l ethylene oxide at (541) 8C and (6010) % relative humidity, determined in accordance with the method given in annex A. (See 10.2 of EN 866-1 : 1997). NOTE. A temperature coefficient of inactivation of the test organism of not less than 2 can be used to relate these D values to other temperatures when all other conditions remain constant. 8.2.2 The D value obtained by the two methods shall be suc