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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 867-1 : 1997 The Eu
2、ropean Standard EN 867-1 : 1997 has the status of a British Standard ICS 11.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Non-biological systems for use in sterilizers Part 1. General requirements Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:29 GMT+00:00
3、2006, Uncontrolled Copy, (c) BSI BS EN 867-1 : 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 October 1997 BSI 1997 The following BSI references
4、 relate to the work on this standard: Committee reference LBI/35/3 Draft for comment 92/57874 DC ISBN 0 580 28130 2 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was entrusted by Technical Commi
5、ttee 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. (the Association of the Lab
6、oratory 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 Licensed Copy: sheffieldun sheffi
7、eldun, na, Tue Nov 07 02:55:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BSI 1997i BS EN 867-1 : 1997 National foreword This Part of BS EN 867 has been prepared by Subcommittee LBI/35/3, and is the English language version of EN 867-1 : 1997 Non-biological systems for use in sterilizers Part 1: Gen
8、eral requirements, published by the European Committee for Standardization (CEN). Cross-reference Publication referred toCorresponding British Standard EN 28601BS EN 28601 : 1992 Specification for representation of dates and times in information interchange Attention is also drawn to BS 7720 : 1995
9、Specification for non-biological sterilization indicators equivalent to the Bowie and Dick test. 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 p
10、age, pages 2 to 6, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iiblank Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committ
11、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 867-1 : 1997 E EUROPEAN STANDARDEN 867-1 NORME EUROPE ENNE EUROPA ISCHE NORM February 1997 ICS 11.08
12、0 Descriptors: Medical equipment, sterilizers, tests, sterilization, chemical indicators, classifications, specifications, labelling English version Non-biological systems for use in sterilizers Part1: General requirements Syste mes non-biologiques destine s a e tre utilise s dans des ste rilisateur
13、s Partie 1: Exigences ge ne rales Nichtbiologische Systeme fu r en Gebrauch in Sterilisatoren Teil 1: Allgemeine Anforderungen 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
14、 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. The European Standards exist in three official versions
15、 (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, Denm
16、ark, 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 02:55:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 867-1 : 1997 BSI 1997 Forewor
17、d 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 non-biological systems for testing sterilizers. These standards are: EN 867-1
18、Non-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 867-3Non-biological systems for use in sterilizers Part 3: Specification for Class B indicators for use in the Bowie and Dick test
19、In addition, CEN/TC 102 Working Group 7 has prepared a series of European Standards describing biological indicators for use in sterilizers. These European Standards are: EN 866-1Biological systems for testing sterilizers and sterilization processes Part 1: General requirements EN 866-2Biological sy
20、stems 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 sterilizers prEN 866-4Biological systems for test
21、ing 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 formaldehyde sterilizers prEN 866-6Biological sys
22、tems 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 indicator systems for use in moist heat s
23、terilizers prEN 866-8Biological systems for testing sterilizers and sterilization processes Part 8: Particular requirements for self-contained biological systems for use in ethylene oxide sterilizers This European Standard shall be given the status of a national standard, either by publication of an
24、 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
25、essential reuirements 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
26、, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Classification4 5General requirements4 6Labelling and instructions for use5 Annex A (informative) Bibliography6 Licensed Copy: sheff
27、ieldun sheffieldun, na, Tue Nov 07 02:55:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 867-1 : 1997 BSI 1997 Introduction European Standards for sterilizers (EN 285 and other standards in preparation by CEN/TC 102) and for the validation and process control of sterilization (EN 550, EN 552
28、 and EN 554) describe performance tests for sterilizers and methods of validation and routine control, respectively. This standard specifies the general requirements for non-biological indicators and subsequent parts specify the particular requirements for non-biological indicators for particular ap
29、plications and for defined tests of particular sterilization processes. The use of the indicators specified in this standard are described in EN 285, EN 550, EN 552 and EN 554. The non-biological indicators specified in this standard are not intended for use in any process other than that specified.
30、 The use of an inappropriate indicator can give dangerously misleading results. The performance of a non-biological indicator can be affected by the conditions of storage prior to use, the methods of use, and the conditions of storage after exposure to the process. For these reasons, the recommendat
31、ions of the manufacturer for storage and use should be followed precisely. Non-biological indicators should not be used beyond any expiry date stated by the manufacturer. When a physical and/or chemical variable of a sterilizing process is outside its specified limits, a sterilization cycle should a
32、lways be regarded as unsatisfactory, irrespective of the results obtained from the non-biological indicators. 1 Scope This European Standard specifies general requirements for indicators which are not dependent for their action on the presence or absence of living organisms, and which are used to mo
33、nitor the presence or attainment of one or more of the variables required for a satisfactory sterilization process. This standard does not specify requirements for the use of biological systems. NOTE. Biological test systems are regarded as those tests which are dependent for their interpretation on
34、 the demonstration of viability of an organism. Test systems of this type are considered in EN 866 Biological systems for testing sterilizers and sterilization processes. The requirements of this part of EN 867 apply to all indicator systems specified in subsequent parts of EN 867, unless the requir
35、ement is modified or added to by a subsequent part, in 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 p
36、laces 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 amendment or revision. For undated references the latest edition of the publication re
37、ferred to applies. EN 28601Data elements and interchange formats Information interchange Representation of dates and times (ISO 8601 : 1988 and technical corrigendum 1 : 1991) 3 Definitions For the purposes of this European Standard the following definitions apply: 3.1 graduated response A progressi
38、ve visible change occurring on exposure to one or more process variables allowing assessment of the level achieved. 3.2 defined end-point The visible change occurring after exposure to the specified variable(s) at a level equal to or greater than that specified for the indicator. 3.3 indicator The i
39、ndicator system in the form in which it is intended to be used. 3.4 indicator reagent The active ingredient or combination of ingredients before conversion into the indicator. 3.5 indicator system The combination of the indicator reagent and its substrate. Licensed Copy: sheffieldun sheffieldun, na,
40、 Tue Nov 07 02:55:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 867-1 : 1997 BSI 1997 4 Classification NOTE. In the subsequent parts of this standard indicators are classified by their intended use and, within each of these classifications, by the process for which they are designed to be
41、used. 4.1 Process indicators Class A Process indicators are intended for use with individual packs of product intended to be sterilized to demonstrate that the pack has been exposed to the process. They may be designed to react to one or more of the critical process variables but may be designed to
42、achieve their end-point reaction after exposure to sub-optimal levels of the process variable. Process indicators have a defined end-point reaction. 4.2 Indicators for use in specific tests Class B These indicators are designed for use in a specific test procedure defined in the relevant sterilizer/
43、sterilization standard. These indicators may have a graduated response or a defined end-point reaction. 4.3 Single-variable indicators Class C Single-variable indicators are designed to monitor the attainment of the required value of one critical variable in the sterilization process. Single-variabl
44、e indicators may have a graduated response or a defined end-point reaction. 4.4 Multi-variable indicators Class D Multi-variable indicators are designed to monitor the attainment of the required value of two or more critical variables in the sterilization process. Multi-variable indicators may have
45、a graduated response or a defined end-point reaction. 5 General requirements 5.1 General 5.1.1 The requirements of this section shall apply to all indicators unless specifically excluded or amended in a subsequent part of this standard. 5.1.2 The manufacturer shall establish, document and maintain a
46、 formal quality system to cover all operations required by this standard. NOTE. EN ISO 9001 and EN ISO 9002 and of the EN 45000 series describe requirements for quality systems for manufacture and testing. 5.2 Labelling Where a date is required on labelling or information supplied with the product,
47、this shall be expressed in accordance with EN 28601. 5.3 Test methods The test methods specified in this standard are reference methods. When alternative methods are used routinely these shall be defined, validated and have known correlation with the reference method. 5.4 Marking 5.4.1 Each indicato
48、r shall be clearly marked with the type of process for which it is intended to be used and the class of indicator as defined in this standard (see 4.1 to 4.4 inclusive). If the use of the indicator is limited to specific sterilization cycles, this information shall also be stated or coded on the ind
49、icator, e.g. steam 15 min 121 C. Where the size or format of the indicator does not permit this information to be stated in a font of 6 characters per centimetre, or larger, the information shall be provided on the label and/or instructions for use. 5.4.2 Abbreviated descriptions of the process, if used, shall be in accordance with the following symbols: STEAM all steam sterilization processes DRY all dry heat sterilization processes EO all ethylene oxide sterilization processes IRRAD all ionizing radiat