《BS-EN-866-6-2000.pdf》由会员分享，可在线阅读，更多相关《BS-EN-866-6-2000.pdf（8页珍藏版）》请在三一文库上搜索。
1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 866-6:2000 The Euro
2、pean Standard EN 866-6:1999 has the status of a British Standard ICS 11.080.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biological systems for testing sterilizers and sterilization processes Part 6: Particular systems for use in dry heat sterilizers Licensed Copy: sheff
3、ieldun sheffieldun, na, Tue Nov 07 03:11:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 June 20
4、00 BSI 06-2000 ISBN 0 580 34602 1 BS EN 866-6:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN 866-6:1999. The UK participation in its preparation was entrusted by Technical Committee LBI/35, Steriliz
5、ers, autoclaves and disinfectors, to Subcommittee LBI/35/3, Sterilization indicators, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
6、 monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in t
7、his 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 all the necessary provisions of a contract. Users
8、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 title page, pages 2 to 5 and a back cover. The BSI c
9、opyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:11:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r N
10、ormung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 866-6:1999 E EUROPEAN STANDARDEN 866-6 NORME EUROPE ENNE EUROPA ISCHE NORM December 1999 ICS 11.080 English versio
11、n Biological systems for testing sterilizers and sterilization processes Part6: Particular systems for use in dry heat sterilizers Syste mes biologiques pour lessai des ste rilisateurs et les proce de s de ste rilisation Partie 6: Syste mes particuliers destine s a e tre utilise s dans des ste rilis
12、ateurs a chaleur se che Biologische Systeme fu r die Pru fung von Sterilisatoren und Sterilisationsverfahren Teil 6: Spezielle Systeme fu r den Gebrauch in Heiluft-Sterilisatoren This European Standard was approved by CEN on 19 June 1999. CEN members are bound to comply with the CEN/CENELEC Internal
13、 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. T
14、his 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
15、the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:11:27 GMT+00:00 2
16、006, Uncontrolled Copy, (c) BSI Page 2 EN 866-6:1999 BSI 06-2000 Foreword This European Standard has been prepared by Technical Committee CEN/TC 102, Sterilizers for medical purposes, the Secretariat of which is held by DIN. EN 866 consists of the following parts under the general title Biological s
17、ystems for testing sterilizers and sterilization processes: Part 1: General requirements; Part 2: Particular systems for use in ethylene oxide sterilizers; Part 3: Particular systems for use in moist heat sterilizers; Part 4: Particular systems for use in irradiation sterilizers; Part 5: Particular
18、systems for use in low temperature steam and formaldehyde sterilizers; Part 6: Particular systems for use in dry heat sterilizers; Part 7: Particular requirements for self-contained systems for use in moist heat sterilizers; Part 8: Particular requirements for self-contained systems for use in ethyl
19、ene oxide sterilizers. In addition CEN/TC 102 Working Group 7 has prepared EN 867 consisting of the following parts under the general title Non-biological systems for use in sterilizers: Part 1: General requirements; Part 2: Process indicators (Class A); Part 3: Specification for Class B indicators
20、for use in the Bowie and Dick Test; Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration (in preparation); Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizer
21、s Type B and Type S (in preparation). 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 June 2000, and conflicting national standards shall be withdrawn at the latest by June 2000. According to the
22、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, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Swe
23、den, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4General requirements3 5Test organisms3 6Population of test organisms3 7Carriers4 8Resistance4 9Packaging and labelling4 Annex A (normative) Determination of resistance to dry
24、heat sterilization5 Bibliography5 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:11:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 866-6:1999 BSI 06-2000 Introduction This European Standard specifies the performance requirements for biological indicators supplied ready for use an
25、d for the suspensions of test organisms supplied either for the preparation of biological indicators or for the inoculation of products for use in validation studies and routine monitoring of dry heat sterilization processes. The biological indicators specified in this standard are not intended for
26、use in any process other than dry heat sterilization. The use of a 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 imply that the system will respond equa
27、lly 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 man
28、ufacturer 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 the expiry date stated by the manufacturer. Biological indicators s
29、hould always be used in combination with a physical and/or chemical monitoring in demonstrating the efficacy of a sterilizing process. When a physico-chemical variable of a sterilizing process is outside its specified limits, a sterilization cycle should always be regarded as unsatisfactory, irrespe
30、ctive of the results obtained from the biological indicators. 1 Scope This part of EN 866 specifies requirements for inoculated carriers and biological indicators intended for use in assessing the performance of dry heat sterilizers operating at temperatures in the range 140 8C to 250 8C. NOTEThe in
31、dicators specified in this standard are not suitable for assessing depyrogenation processes. 2 Normative references This 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 th
32、e 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 amendment or revision. For undated references the latest edition of the publication referred to applies. EN 86
33、6-1:1997, 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. 3 Definitions For the purposes of this Europea
34、n Standard, the definitions given in EN 866-1 and EN 866-3 apply. 4 General requirements The 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 organisms The test organism shall be spores of Bacillus subtilis or other strains or o
35、rganisms of demonstrated equivalent performance as required by this standard. NOTEBacillus subtilis CIP 77.18, NCIMB 8054, DSM 675 and ATCC 9372 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 wi
36、thin35 % of the nominal population. 6.2 The number of recoverable test organisms on each biological indicator shall be controlled 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.
37、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 the glass beads, or other appropriate validation
38、 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 midpoint between the minimum and maximum population stated by the manufacturer. NOTEThe method specified by the manufacturer for removal of organi
39、sms from the carrier should be used. 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 0,1 3 106. NOTEInoculated carriers and/or biological
40、 indicators supplied for other purposes, e.g. qualification, validation or other specific tests, can require other nominal populations. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:11:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 866-6:1999 BSI 06-2000 7 Carriers 7.1 The suita
41、bility of the carrier for use in dry heat sterilization processes shall be demonstrated in accordance with the requirements in 6.1, 6.2 and annex A of EN 866-1:1997. 7.2 The exposure conditions to be used to establish compliance shall be: Dry heat at not less than 260 8C for not less than 60 min. 8
42、Resistance 8.1 General The manufacturer shall state the D value of each batch of biological indicators or inoculated carriers in minutes to one decimal place. The manufacturer shall state the accuracy with which the D value was determined (e.g.0,1 min). This accuracy shall not exceed0,2 min. 8.2 Bio
43、logical indicators and inoculated carriers intended for use in routine monitoring 8.2.1 The D values obtained by both the survivor curve method and the MPN method (see NOTE 2 in clause 10 of EN 866-1:1997) for the spore population on the inoculated carriers shall be not less than 5,0 min when expose
44、d to dry heat at (1601) 8C when determined in accordance with the method given in annex A. 8.2.2 The D value of the spores on the inoculated carrier or biological indicator shall be determined at not less than two other temperatures in the range 150 8C to 200 8C by either of the two methods given. T
45、hese data shall be used to calculate the z value, which shall not be less than 20 8C. 8.2.3 When the manufacturer specifies that the inoculated carrier or biological indicator is for use at only one temperature, 8.2.2 shall not apply. 8.2.4 When both of the reference methods in annex A have been use
46、d, the D value obtained by the two methods shall be such that the higher value obtained does not exceed the lower value by more than 50 % of the lower value. 8.3 Biological indicators intended for use in qualification, validation and other specific tests NOTEBiological indicators and inoculated carr
47、iers intended for use in validation, qualification and other specific tests have no specific requirements for the population or resistance of test organisms to allow users flexibility in devising test programs. The D value and population are determined and stated see 6.3 and 6.4, 8.1, 8.3a) and 8.3b
48、). When the purchaser specifies requirements other than those in 8.2 for biological indicators and inoculated carrier intended for use in validation, qualification and other specific tests the following shall apply. a) The D values shall be determined by both the survivor curve method and the MPN me
49、thod by exposure to dry heat at (1601) 8C in accordance with the method given in annex A. b) The D value obtained by the two methods shall be such that the higher value obtained does not exceed the lower value by more than 50 % of the lower value. Both D values shall be stated. c) If specified by the purchaser the D value of the spores on the inoculated carrier shall be determined at not less than two other temperatures by either of the two methods given. These data shall be used to calculate the z va