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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 866-1 : 1997 The Eu
2、ropean Standard EN 866-1 : 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 1. General requirements Licensed Copy: sheffieldun sheffieldun, na, Tue N
3、ov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 866-1 : 1997 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 effect on 15 November 1997 BSI 1997 Th
4、e following BSI references relate to the work on this standard: Committee reference LBI/35/3 Draft for comment 95/121171 DC ISBN 0 580 28377 1 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was e
5、ntrusted 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 Industries BLWA Ltd.
6、(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 Society of Great Britain Licens
7、ed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BSI 1997i BS EN 866-1 : 1997 National foreword This Part of BS EN 866 has been prepared by Subcommittee LBI/35/3 and is the English language version of EN 866-1 : 1997 Biological systems for testing
8、sterilizers and sterilization processes Part 1: General requirements, published by the European Committee for Standardization (CEN). Cross-references Publication referred toCorresponding British Standard EN 550 : 1994BS EN 550 : 1994 Sterilization of medical devices Validation and routine control of
9、 ethylene oxide sterilization EN 552 : 1994BS EN 552 : 1994 Sterilization of medical devices Validation and routine control of sterilization by irradiation EN 554 : 1994BS EN 554 : 1994 Sterilization of medical devices Validation and routine control of sterilization by moist heat EN 868-1 : 1997BS E
10、N 868 Packaging materials and systems for medical devices which are to be sterilized Part 1 : 1997 General requirements and test methods EN 1174-1 : 1996BS EN 1174 Sterilization of medical devices Estimation of the population of micro-organisms on product Part 1 : 1996 Requirements EN 28601 : 1992BS
11、 EN 28601 : 1992 Specification for representation of dates and times in information interchange 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 title pa
12、ge, pages 2 to 10, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iiblank Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committ
13、ee 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 866-1 : 1997 E EUROPEAN STANDARDEN 866-1 NORME EUROPE ENNE EUROPA ISCHE NORM February 1997 ICS 11.08
14、0 Descriptors: Medical equipment, sterilizers, bioassay, manufacturing, biological indicators, specifications, preparation, packing, labelling English version Biological systems for testing sterilizers and sterilization processes Part 1: General requirements Syste mes biologiques pour lessai des ste
15、 rilisateurs et les proce de s de ste rilisation Partie 1: Exigences ge ne rales Biologische Systeme fu r die Pru fung von Sterilisatoren und Sterilisationsverfahren Teil 1: Allgemeine Anforderungen This European Standard was approved by CEN on 1997-01-10. CEN members are bound to comply with the CE
16、N/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
17、 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
18、. 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. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00
19、 2006, Uncontrolled Copy, (c) BSI Page 2 EN 866-1 : 1997 BSI 1997 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. This Standard is one of a series of European Standards concerned with biol
20、ogical systems for testing sterilizers. These European Standards are: EN 866-1Biological systems for testing sterilizers and sterilization processes Part 1: General requirements EN 866-2Biological systems for testing sterilizers and sterilization processes Part 2: Particular systems for use in ethyl
21、ene oxide sterilizers EN 866-3Biological systems for testing sterilizers and sterilization processes Part 3: Particular systems for use in moist heat sterilizers prEN 866-4Biological systems for testing sterilizers and sterilization processes Part 4: Particular systems for irradiation sterilizers pr
22、EN 866-5Biological systems for testing sterilizers and sterilization processes Part 5: Particular systems for low- temperature steam formaldehyde sterilizers prEN 866-6Biological systems for testing sterilizers and sterilization processes Part 6: Particular systems for dry heat sterilizers prEN 866-
23、7Biological systems for testing sterilizers and sterilization processes Part 7: Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers prEN 866-8Biological systems for testing sterilizers and sterilization processes Part 8: Particular requirements f
24、or self-contained biological indicator systems for use in ethylene oxide sterilizers In 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
25、 sterilizers Part 1: General requirements EN 867-2Non-biological systems for use in sterilizers Part 2: 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 test This European Standard shall be g
26、iven 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 Europea
27、n 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, F
28、inland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4General requirements4 5Test organisms and their preparation for
29、the manufacture of inoculated carriers5 6Carriers and their inoculation5 7Packaging and labelling of inoculated carriers for distribution6 8Preparation of biological indicators from inoculated carriers6 9Packaging and labelling of biological indicators6 10Determination of test organism resistance7 A
30、nnexes A(normative) Determination of growth inhibition by carriers exposed to the sterilization process8 B(normative) Determination of test organism resistance8 C(informative) Relationship between the components of biological test systems10 D(informative) Bibliography10 Licensed Copy: sheffieldun sh
31、effieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 866-1 : 1997 BSI 1997 Introduction European Standards for sterilizers (EN 285 and prEN 1422) and for the validation and process control of sterilization (EN 550 and EN 554) describe performance tests for steriliz
32、ers and methods of validation and routine control, respectively. This standard specifies the general requirements for biological indicators, and subsequent Parts specify the particular requirements for biological indicators for defined sterilization processes. The use of the indicators specified in
33、this standard is described in EN 550 and EN 554. 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 biological indicators specified in this stan
34、dard are not intended for use in any process other than that stated by the manufacturer. The use of a biological indicator in a process other than that stated by the manufacturer can give dangerously misleading results. The performance of a biological indicator can be affected by the conditions of s
35、torage 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 possib
36、le 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 appropriate physical and/or chemical monitoring in demonstrating the efficacy of a sterilization process. When
37、 a physico-chemical variable of a sterilization process is outside 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 and EN 554. 1 Scope This Part of EN 866 specifies general r
38、equirements for the manufacture of biological systems to be used in testing sterilizers and sterilization processes. The requirements of this Part of EN 866 apply to all biological systems specified in subsequent Parts of EN 866, unless the requirement is modified or added to by a subsequent Part, i
39、n which case the requirement of the particular Part will apply. 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 the publications are listed he
40、reafter. 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 550Sterilization of medical d
41、evices Validation and routine control of ethylene oxide sterilization EN 552Sterilization of medical devices Validation and routine control of sterilization by irradiation EN 554Sterilization of medical devices Validation and routine control of sterilization by moist heat EN 868-1Packaging materials
42、 and systems for medical devices which are to be sterilized Part 1: General requirements Requirements and test methods EN 1174-1Sterilization of medical devices Estimation of the population of micro-organisms on product Part 1: Requirements EN 28601 : 1992Data elements and interchange formats Inform
43、ation interchange Representation of dates and times (ISO 8601 : 1988 and technical corrigendum 1 : 1991) 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 biological indicator An inoculated carrier contained within its primary pack ready for use (see figure C.1 in
44、 annex C). 3.2 biological systems Those systems which depend for their function on the demonstration of viability of a test organism. NOTE. This demonstration of viability can be achieved by any method suitable for indicating, qualitatively or quantitatively, either the metabolic activity or the rep
45、lication of the organism. Tests based on physical or chemical detection of change in a particular chemical entity, whether or not this was originally derived or isolated from a biological system (e.g. an enzyme) are considered in the series EN 867 Non-biological systems for use in sterilizers. 3.3 c
46、arrier The supporting material on which the test organisms are deposited (see figure C.1 in annex C). 3.4 culture collection number The unique identification allocated by the recognized culture collection. 3.5 culture conditions The manufacturers stated combination of conditions, including the growt
47、h medium with the period and temperature of incubation, used to promote germination, outgrowth and/or multiplication of the test organism. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 866-1 : 1997 BSI 1997 3.6 D value (decimal r
48、eduction value) The time in minutes, or the absorbed irradiation dose in kilograys, required to secure inactivation of 90 % of the test organisms under stated exposure conditions. 3.7 inactivation The loss of the ability of the test organisms to germinate, outgrow and/or multiply under culture condi
49、tions. 3.8 inoculated carrier A carrier on which a defined number of test organisms has been deposited (see figure C.1 in annex C). 3.9 primary pack The packaging system which protects the inoculated carrier from damage and contamination without preventing penetration of the sterilizing agent(s) (see figure C.1 in annex C). 3.10 process challenge device An object which simulates the worst case of conditions as they are given for the sterilizing agent(s) in the items of the goods to be sterilized (see figure C.
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