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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 866-7:2000 The Euro
2、pean Standard EN 866-7:1999 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 7: Particular requirements for self-contained biological indicator systems
3、 for use in moist heat sterilizers Licensed Copy: sheffieldun 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
4、Standards Committee and comes into effect on 15 June 2000 BSI 06-2000 ISBN 0 580 34603 X BS EN 866-7:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN 866-7:1999. The UK participation in its preparatio
5、n was entrusted by Technical Committee LBI/35, Sterilizers, 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 pr
6、oposals for change, and keep the UK interests informed; 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
7、international or European publications referred to in this 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 inc
8、lude all the necessary 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 front cover, an inside front cover, the
9、EN title page, pages 2 to 8, an inside back cover and a back cover. The BSI copyright 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 S
10、tandardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung 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 866-7:1999 E EUROPEAN STANDARDEN 866-
11、7 NORME EUROPE ENNE EUROPA ISCHE NORM December 1999 ICS 11.080 English version Biological systems for testing sterilizers and sterilization processes Part 7: Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers Syste mes biologiques pour lessai de
12、s ste rilisateurs et les proce de s de ste rilisation Part 7: Exigences particulie res pour les syste mes autonomes dindicateurs biologiques destine s a e tre utilise s dans des ste rilisateurs a la vapeur deau Biologische Systeme fu r die Pru fung von Sterilisatoren und Sterilisationsverfahren Teil
13、 7: Spezielle Anforderungen an Bio-Indikator-Einheiten fu r den Gebrauch in Dampf-Sterilisatoren This European Standard was approved by CEN on 19 June 1999. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the
14、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).
15、 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, Czech Republic, Denmark, Finlan
16、d, 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 2006, Uncontrolled Copy, (c) BSI Page 2 EN 866-7:1999 BSI 06-2000 Foreword This Eur
17、opean 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 systems for testing sterilizers and sterilization processes: Part 1: General requir
18、ements; 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 systems for use in low temperature steam and formaldehyde sterilizers; Part 6: Par
19、ticular 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 ethylene oxide sterilizers. In addition CEN/TC 102 Working Group 7 has prepared EN 867
20、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 for use in the Bowie and Dick Test; Part 4: Specification for indicators as an alt
21、ernative 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 sterilizers Type B and Type S (in preparation). This European Standard shall be given the st
22、atus 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 CEN/CENELEC Internal Regulations, the national standards organizations of the foll
23、owing 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, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Sc
24、ope3 2Normative references3 3Definitions3 4General requirements3 5Test organisms3 6Population of test organisms4 7Carriers4 8Materials of construction4 9Resistance5 10Packaging and labelling5 Annex A (normative) Determination of growth inhibition by component materials, dimensional stability and the
25、 suitability of growth medium6 Annex B (normative) Determination of resistance to steam sterilization7 Bibliography8 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:11:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 866-7:1999 BSI 06-2000 Introduction This European Standard specifi
26、es the performance requirements for self-contained biological indicator systems supplied ready for use. These systems are intended for use primarily as routine monitors. When it is intended to use self-contained biological indicators in routine monitoring, the chosen indicator system should be emplo
27、yed along with any other chosen indicator system during the process development and validation stages. EN 866-3 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 o
28、r 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 are described, inter alia, in EN 285. The biological indicators specified in this standard are not intended for use i
29、n any process other than moist 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 allow necessarily the same level of sensit
30、ivity 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 recommendatio
31、ns of the manufacturer for storage and use should be followed and biological indicators should be transferred to the specific 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
32、indicators should 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 unsatisfact
33、ory, (see also EN 554) irrespective of the results obtained from the biological indicator. 1 Scope This part of EN 866 specifies the requirements for self-contained biological indicator systems intended for use in monitoring the performance of moist heat sterilizers operating at temperatures in exce
34、ss of 100 8C. NOTE 1EN 285 specifies the performance and test requirements for large steam sterilizers for porous loads and wrapped goods. NOTE 2Hermetically sealed ampules containing micro-organisms suspended in a growth medium with colour change indicator are only suitable for use in sterilizers i
35、ntended to process aqueous liquids in sealed containers and are not included within this standard. 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
36、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 amendment or revision. For undated references the latest edition of the publication referred to applies.
37、 EN 285:1996, Sterilization Steam sterilizers Large sterilizers. EN 866-1:1997, Biological systems for testing sterilizers and sterilization processes Part 1: General requirements. 3 Definitions For the purposes of this European Standard, the definitions given in EN 866-1 apply, together with the fo
38、llowing. 3.1 self-contained biological indicator system an inoculated carrier presented in a primary pack which also contains the growth medium required for recovery 3.2 survival-kill window the extent of exposure to a sterilization process under defined conditions when there is a transition from al
39、l biological indicators showing growth (survival exposure) to no biological indicators showing growth (kill exposure) NOTE The survival-kill window is calculated by the following formula: survival exposure $ log10(nominal population) 2 2 3 D value; kill exposure $ log10(nominal population) + 4 3 D v
40、alue The units for both survival and kill exposures will be the same as the units used for the D value. 4 General requirements The requirements of EN 866-1:1997 shall apply except for 4.4, 6.3, clauses 8, 9 and 10. 5 Test organisms The test organisms shall be spores of Bacillus stearothermophilus or
41、 other strains or organisms demonstrated equivalent performance as required by this European Standard. NOTE Bacillus stearothermophilus NCTC 10003, ATCC 7953, DSM 494, DSM 2027, DSM 22, DSM 5934, NCTC 10007, ATCC 12980 and CIP 52.81 have been found to be suitable. Licensed Copy: sheffieldun sheffiel
42、dun, na, Tue Nov 07 03:11:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 866-7:1999 BSI 06-2000 6 Population of test organisms 6.1 Replicate determinations of the viable count on the same batch of suspension used to prepare the biological indicators shall be within35 % of the nominal popula
43、tion. 6.2 The number of recoverable test organisms in 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. 6.3 Retrospective determinatio
44、n 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 sha
45、ll 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 populations stated by the manufacturer. NOTE The method specified by the manufacturer for the removal of test organisms from the carri
46、er should be used. 6.4 The nominal number of spores shall be not less than 1 3 105per unit and shall be stated in increments not greater than 0,1 3 105. 7 Carriers 7.1 The suitability of the carrier for use in steam sterilization processes shall be demonstrated in accordance with the requirements in
47、 6.1, 6.2 and annex A in EN 866-1:1997. 7.2 The conditions to be used to establish compliance shall be: exposure to dry saturated steam at not less than the manufacturers stated maximum; exposure temperature +5 8C for not less than 30 min. If the manufacturer does not state a maximum exposure temper
48、ature, a temperature of 145 8C and an exposure time of 30 min shall be used. NOTE These conditions have been selected to represent a realistic, but severe, challenge to the carrier whilst remaining within the practical limits of a steam sterilization process. 8 Materials of construction 8.1 The mate
49、rials of which the self-contained biological indicator system is made shall withstand exposure to the sterilization process for which it is intended without distortion, melting, corrosion or other failure which would impair its utility. Compliance shall be tested by observation of the assembled materials before and after exposure to dry saturated steam at not less than the manufacturers stated maximum exposure temperature +5 8C for not less than 30 min and at least twice the exposure time stated
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